<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02203305</url>
  </required_header>
  <id_info>
    <org_study_id>14-1544</org_study_id>
    <nct_id>NCT02203305</nct_id>
  </id_info>
  <brief_title>Cochlear Implantation in Cases of Single-Sided Deafness</brief_title>
  <acronym>CI in SSD</acronym>
  <official_title>Cochlear Implantation in Cases of Single-Sided Deafness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Med-El Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <brief_summary>
    <textblock>
      The primary goal of this project is to determine whether subjects with Single-Sided Deafness&#xD;
      (SSD) experience an improvement in speech perception, localization, and quality of life with&#xD;
      a cochlear implant as compared to an unaided listening condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single-sided deafness (SSD) can be defined as moderate-to-profound sensorineural hearing loss&#xD;
      with limited speech perception benefit in one ear and normal hearing in the contralateral&#xD;
      ear. Though one ear is within the normal hearing limits, SSD may result in reduced speech&#xD;
      perception in noise, variable abilities on localization tasks, increased subjective report of&#xD;
      hearing handicap, and reduced quality of life.&#xD;
&#xD;
      This patient population cannot utilize conventional amplification due to the severity of the&#xD;
      hearing loss and poor speech discrimination abilities in the affected ear. Current treatment&#xD;
      options include: contralateral routing of the signal (CROS) hearing aids, and bone-conduction&#xD;
      devices. A CROS hearing aid is a two-part system that includes a microphone/transmitter on&#xD;
      the affected ear and a receiver on the normal hearing ear. The microphone/transmitter sends&#xD;
      the acoustic signal from the affected ear to the receiver, which is presented to the normal&#xD;
      hearing ear. Bone-conduction devices utilize a percutaneous, implanted titanium abutment to&#xD;
      send the acoustic signal from the affected side to the normal hearing ear via vibrations. The&#xD;
      goal of both of these technologies is to send the signal from the affected side to the normal&#xD;
      hearing side, thereby leaving the patient in a unilateral listening condition.&#xD;
&#xD;
      Though CROS hearing aids and bone-conduction devices provide the patient with auditory&#xD;
      information from both sides to the better hearing ear, the ability to use binaural cues for&#xD;
      speech perception in noise is variable.&#xD;
&#xD;
      It is of interest whether cochlear implantation of the affected ear would benefit the SSD&#xD;
      population. A cochlear implant is a two-part system, including the internal electrode array&#xD;
      and external speech processor. The internal electrode array is surgically implanted into the&#xD;
      affected cochlea. The external speech processor receives sounds and transmits this signal to&#xD;
      the internal portion. The electrode array presents the acoustic signal via electrical pulses&#xD;
      within the cochlea, which is interpreted by the brain as sound.&#xD;
&#xD;
      Presumably, cochlear implantation may provide the SSD population improvements in speech&#xD;
      perception in the affected ear, which cannot benefit from appropriately fit hearing aids.&#xD;
      Cochlear implantation may provide a benefit over current treatment options in the SSD&#xD;
      population, as it stimulates the auditory pathway on the affected side, thus allowing for&#xD;
      ipsilateral representation of acoustic signals arriving to each ear independently.&#xD;
&#xD;
      The primary goal of this project is to determine whether subjects with SSD experience an&#xD;
      improvement in speech perception, localization, and quality of life with a cochlear implant&#xD;
      as compared to an unaided listening condition. Secondary aims include: 1) a comparison of&#xD;
      speech perception, localization, and quality of life outcomes in the study population to a&#xD;
      SSD control group with long-term listening experience with a current treatment option (i.e.&#xD;
      bone-conduction device), and 2) a within-subject comparison of speech perception and&#xD;
      localization abilities with cochlear implantation versus the bone-conduction test device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">September 16, 2021</completion_date>
  <primary_completion_date type="Actual">September 16, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Word Recognition in Quiet Over Time</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the normal/better hearing ear. Scored as the percent correctly repeated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Localization Results (Measured in Variable Error) Over Time</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in variable error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Localization Results (Measured in Constant Error) Over Time</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Localization Results (Measured in Adjusted Constant Error) Over Time</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in adjusted constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Subjects completed subjective questionnaires to order to evaluate the perceived benefits of cochlear implantation. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as the percent correctly repeated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 10-talker masker from the front speaker. Scored as the percent correctly repeated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 4-talker masker from the front speaker. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower numbers indicate better performance (range -7.5 to 23.5 dB SNR).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the normal/better hearing ear. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. A lower value indicates better performance (range -7.5 to 23.5 dB SNR).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower values indicate better performance (range -7.5 to 23.5 dB SNR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)</measure>
    <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
    <description>Results on recorded speech perception materials: aided word recognition. Recorded 50-word CNC words were evaluated preoperatively with a conventional hearing aid. Performance was compared to the CI alone at the 12 month interval. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores &lt;20%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus with a bone-conduction device. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)</measure>
    <time_frame>preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)</time_frame>
    <description>Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)</measure>
    <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
    <description>Subjects completed subjective questionnaires. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)</measure>
    <time_frame>preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)</time_frame>
    <description>Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)</measure>
    <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
    <description>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)</measure>
    <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
    <description>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)</measure>
    <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
    <description>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)</measure>
    <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
    <description>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)</measure>
    <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
    <description>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)</measure>
    <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
    <description>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)</measure>
    <time_frame>Assessment completed after 12 months of implantable bone-conduction listening experience</time_frame>
    <description>The speech perception (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 10-talker masker at 0 dB SNR with the target speech presented from the front and the masker (1) presented from the front (SoNo), (2) presented towards the implanted ear (SoNbc), and (3) presented towards the acoustic ear (SoNnh). Performance was scored as the percent of words correctly repeated, with higher values indicating better performance. The task was completed with the participants listening with their bone-conduction device on versus off.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech Recognition in Noise for a Control Group: BKB-SIN Test</measure>
    <time_frame>Assessment completed after 12 months of implantable bone-conduction listening experience</time_frame>
    <description>The speech perception outcomes in the study population (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 4-talker masker with the target speech presented from the front and the masker (1) presented from the front, (2) presented towards the implanted ear, and (3) presented towards the acoustic ear. Performance was scored as the dB SNR when the participant understood 50% correct, with lower values indicating better performance. Participants completed the task with the device on and off.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Localization for a Control Group</measure>
    <time_frame>Assessment completed after 12 months of implantable bone-conduction listening experience</time_frame>
    <description>Subjects were asked to identify the noise source from an 11-speaker array with the bone-conduction device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Subjects in the control group were implantable bone-conduction device recipients (alternative treatment option) with at least 12 months of listening experience with their implanted bone-conduction device. Participants completed the task with their device on and off.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)</measure>
    <time_frame>Assessment completed after 12 months of implantable bone-conduction listening experience</time_frame>
    <description>Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the average responses across questions for each subscale (Speech Hearing, Spatial Hearing, and Qualities of Hearing). Results are also reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.&#xD;
Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)</measure>
    <time_frame>Assessment completed after 12 months of implantable bone-conduction listening experience</time_frame>
    <description>Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Results are reported as the average responses for each of the four subscales: ease of communication, reverberation, effectiveness in background noise, and reverberation. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.&#xD;
Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Pitch Perception With the Cochlear Implant Over the Post-activation Period</measure>
    <time_frame>post-activation period (1, 3, 6, and 12 months post-activation)</time_frame>
    <description>Participants completed an adaptive pitch matching task that compared the pitch of acoustic stimulation presented to their normal hearing ear with the perception of stimulation from the cochlear implant. Two stimuli were used: clicks &amp; tones. Pitch perception was evaluated for the 5 most apical electrodes. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / frequency information presented by the electrode. Results are reported as the averaged normalized score for clicks &amp; tones for each electrode (electrodes 1-5) at each interval (1, 3, 6, and 12 months post-activation). A value of 1.0 indicates the participant perceived the same frequency as the center frequency presented by the electrode. A value &lt; 1.0 indicates a lower perceived pitch and a value &gt; 1.0 indicates a higher perceived pitch than the electric frequency information.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Unilateral Moderate to Profound Hearing Loss</condition>
  <condition>Asymmetric Hearing Loss</condition>
  <condition>Single-Sided Deafness (SSD)</condition>
  <arm_group>
    <arm_group_label>Cochlear Implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cochlear implantation of the affected ear</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A control group without the study intervention (cochlear implantation) will complete the test battery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cochlear Implant: Asymmetric hearing loss</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cochlear implantation of the poorer hearing ear</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cochlear Implant</intervention_name>
    <description>cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss</description>
    <arm_group_label>Cochlear Implant</arm_group_label>
    <arm_group_label>Cochlear Implant: Asymmetric hearing loss</arm_group_label>
    <other_name>MED-EL CONCERT cochlear implant system</other_name>
    <other_name>MED-EL SYNCHRONY cochlear implant system</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD.</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>bone-conduction device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (SSD):&#xD;
&#xD;
          -  Unilateral moderate-to-profound sensorineural hearing loss [Unaided residual hearing&#xD;
             thresholds measured from 250-8000 Hertz (Hz) (Pure Tone Average (PTA) ≥70 decibel (dB)&#xD;
             Hearing Level (HL) in the ear to be implanted]&#xD;
&#xD;
          -  Normal to mild residual hearing thresholds from 250-8000 Hz in the contralateral ear&#xD;
             (≤35 dB HL at each frequency, 250-8000 Hz)&#xD;
&#xD;
          -  Greater than or equal to 18 years of age at implantation&#xD;
&#xD;
          -  Duration of moderate-to-profound sensorineural hearing loss less than or equal to 5&#xD;
             years [Either reported by subject or documented in previous audiograms] [Can be less&#xD;
             than or equal to 10 years if the subject consistently utilized hearing technology&#xD;
             (such as a bone conduction device or conventional hearing aid) within the past 5&#xD;
             years]&#xD;
&#xD;
          -  Previous experience with a current treatment option for SSD, including a conventional&#xD;
             hearing aid, bone-conduction device, or CROS/BICROS (Bilateral Contralateral Routing&#xD;
             Of the Signal) technology. [At least one month of listening experience with device]&#xD;
             [Dissatisfaction with and/or discontinued use of current treatment option due to:&#xD;
             insufficient gain, poor sound quality, and/or lack of perceived benefit]&#xD;
&#xD;
          -  Aided word recognition in the ear to be implanted of 60% or less as measured with&#xD;
             Consonant-Nucleus-Consonant (CNC) words (50-word list) [When listening with an&#xD;
             appropriately fit hearing aid and masking applied to the contralateral ear] [Aided&#xD;
             testing will be conducted in a sound-proof booth with the subject seated 1 meter from&#xD;
             the sound source, facing 0° azimuth. Recorded materials will be presented at 60 dB&#xD;
             Sound Pressure Level (SPL).] [The hearing aid output will be measured using National&#xD;
             Acoustic Laboratory-NonLinear (NAL-NL1) targets.]&#xD;
&#xD;
          -  Realistic expectations&#xD;
&#xD;
          -  Willing to obtain recommended meningitis vaccinations per Center for Disease Control&#xD;
             (CDC) recommendations&#xD;
&#xD;
          -  No reported cognitive issues [Pass the Mini Mental State Examination (MMSE) screener]&#xD;
&#xD;
          -  Able and willing to comply with study requirements, including travel to&#xD;
             investigational site and study-related activities&#xD;
&#xD;
        Exclusion Criteria (SSD):&#xD;
&#xD;
          -  Non-native English speaker [Speech perception materials are presented in English]&#xD;
&#xD;
          -  Conductive hearing loss in either ear&#xD;
&#xD;
          -  Compromised auditory nerve, including those with a history of vestibular schwannoma&#xD;
&#xD;
          -  Ossification&#xD;
&#xD;
          -  Inability to participate in follow-up procedures (i.e., unwillingness, geographic&#xD;
             location)&#xD;
&#xD;
          -  History of meningitis, autoimmune disease, or any medical condition that&#xD;
             contraindicate middle or inner ear surgery or anesthesia&#xD;
&#xD;
          -  Meniere's disease with intractable vertigo&#xD;
&#xD;
          -  Trauma that precludes inner ear surgery&#xD;
&#xD;
          -  Case of sudden sensorineural hearing loss that has not been first evaluated by a&#xD;
             physician&#xD;
&#xD;
          -  Pregnancy [Subjects who are pregnant or become pregnant prior to surgery are excluded&#xD;
             due to the potential risk of anesthesia to an unborn child.] [Subjects who become&#xD;
             pregnant after surgery may continue to participate in study procedures]&#xD;
&#xD;
          -  Tinnitus as the primary purpose for seeking cochlear implantation&#xD;
&#xD;
          -  Subject obtains a severe or catastrophic score on the Tinnitus Handicap Inventory&#xD;
             (Newman, Jacobson &amp; Spitzer, 1996).&#xD;
&#xD;
        Inclusion Criteria (asymmetric hearing loss):&#xD;
&#xD;
        a. Ear to be implanted i. Moderate-to-profound sensorineural hearing loss ii. PTA ≥70 dB HL&#xD;
        iii. Aided word recognition of 60% or less as measured with CNC words (50-word list).&#xD;
&#xD;
        b. Contralateral ear i. PTA ≥35 and ≤55 dB HL ii. Aided word recognition of 80% or more as&#xD;
        measured with CNC words (50-word list).&#xD;
&#xD;
        iii. Use of conventional amplification c. Greater than or equal to 18 years of age at&#xD;
        implantation d. Duration of moderate-to-profound sensorineural hearing loss in the ear to&#xD;
        be implanted is less than or equal to 5 years [Either reported by subject or documented in&#xD;
        previous audiograms. Can be up to 10 years if the subject consistently utilized hearing&#xD;
        technology in the ear to be implanted (such as a bone conduction device or conventional&#xD;
        hearing aid) within the past 5 years] e. Previous experience with a current treatment&#xD;
        option for asymmetric hearing loss, including a conventional hearing aid, bone-conduction&#xD;
        device, or CROS/BiCROS technology. [At least one month of listening experience with device.&#xD;
        Dissatisfaction with and/or discontinued use of current treatment option due to:&#xD;
        insufficient gain, poor sound quality, and/or lack of perceived benefit.] f. Realistic&#xD;
        expectations g. Willing to obtain recommended meningitis vaccinations per CDC&#xD;
        recommendations h. No reported cognitive issues [Pass the Mini Mental State Examination&#xD;
        (MMSE) screener] i. Able and willing to comply with study requirements, including travel to&#xD;
        investigational site and study-related activities&#xD;
&#xD;
        Exclusion Criteria (Asymmetric hearing loss):&#xD;
&#xD;
          1. Non-English speaker [Speech perception materials are presented in English]&#xD;
&#xD;
          2. Medical condition considered a contraindication to undergoing cochlear implantation&#xD;
&#xD;
          3. Conductive hearing loss in either ear&#xD;
&#xD;
          4. Compromised auditory nerve, including those with a history of vestibular schwannoma&#xD;
&#xD;
          5. Ossification&#xD;
&#xD;
          6. Inability to participate in follow-up procedures (i.e., unwillingness, geographic&#xD;
             location)&#xD;
&#xD;
          7. History of meningitis, autoimmune disease, or any medical condition that&#xD;
             contraindicate middle or inner ear surgery or anesthesia&#xD;
&#xD;
          8. Meniere's disease with intractable vertigo&#xD;
&#xD;
          9. Trauma that precludes inner ear surgery&#xD;
&#xD;
         10. Case of sudden sensorineural hearing loss that has not been first evaluated by a&#xD;
             physician&#xD;
&#xD;
         11. Pregnancy [Subjects who are pregnant or become pregnant prior to surgery are excluded&#xD;
             due to the potential risk of anesthesia to an unborn child. Subjects who become&#xD;
             pregnant after surgery may continue to participate in study procedures]&#xD;
&#xD;
         12. Tinnitus as the primary purpose for seeking cochlear implantation&#xD;
&#xD;
         13. Subject obtains a severe or catastrophic score on the Tinnitus Handicap Inventory&#xD;
             (Newman, Jacobson &amp; Spitzer, 1996).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margaret Dillon, AuD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011 Jan;32(1):39-47. doi: 10.1097/MAO.0b013e3181fcf271.</citation>
    <PMID>21068690</PMID>
  </reference>
  <reference>
    <citation>Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012 Oct;33(8):1339-46. doi: 10.1097/MAO.0b013e318268d52d.</citation>
    <PMID>22935813</PMID>
  </reference>
  <reference>
    <citation>Hansen MR, Gantz BJ, Dunn C. Outcomes after cochlear implantation for patients with single-sided deafness, including those with recalcitrant Meniere's disease. Otol Neurotol. 2013 Dec;34(9):1681-7. doi: 10.1097/MAO.0000000000000102.</citation>
    <PMID>24232066</PMID>
  </reference>
  <reference>
    <citation>Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13.</citation>
    <PMID>19005250</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>April 20, 2022</results_first_submitted>
  <results_first_submitted_qc>July 20, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 25, 2022</results_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Unilateral hearing loss</keyword>
  <keyword>Single Sided Deafness</keyword>
  <keyword>Asymmetric hearing loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 10, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT02203305/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cochlear Implant: Unilateral Hearing Loss Group</title>
          <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>A control group without the study intervention (cochlear implantation) will complete the test battery.&#xD;
Control Group: Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD.</description>
        </group>
        <group group_id="P3">
          <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
          <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Deafness Group</title>
          <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used as a treatment for single-sided deafness/unilateral hearing loss and/or asymmetric hearing loss</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>A control group without the study intervention (cochlear implantation) will complete the test battery.&#xD;
Control Group: Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD.</description>
        </group>
        <group group_id="B3">
          <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
          <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used as a treatment for single-sided deafness/unilateral hearing loss and/or asymmetric hearing loss</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age (years) at the time of cochlear implantation for treatment groups (unilateral hearing loss/single-sided deafness and asymmetric hearing loss). Age (years) at the time of testing for the control group</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50" spread="12"/>
                    <measurement group_id="B2" value="45" spread="3"/>
                    <measurement group_id="B3" value="70" spread="7"/>
                    <measurement group_id="B4" value="58" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Hearing Loss</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="20"/>
                    <count group_id="B4" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3" spread="2"/>
                    <measurement group_id="B2" value="4" spread="2"/>
                    <measurement group_id="B3" value="3" spread="3"/>
                    <measurement group_id="B4" value="3" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Word Recognition in Quiet Over Time</title>
        <description>Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Word Recognition in Quiet Over Time</title>
          <description>Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use.</description>
          <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval.</population>
          <units>percentage of words correctly repeated</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="7"/>
                    <measurement group_id="O2" value="8" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="1"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36" spread="18"/>
                    <measurement group_id="O2" value="32" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" spread="19"/>
                    <measurement group_id="O2" value="40" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="1"/>
                    <measurement group_id="O2" value="0" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51" spread="15"/>
                    <measurement group_id="O2" value="47" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" spread="19"/>
                    <measurement group_id="O2" value="49" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" spread="18"/>
                    <measurement group_id="O2" value="55" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded 50-word consonant-nucleus-consonant (CNC) words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Percent correct converted to rationalized arcsine units (RAU) prior to analysis.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and condition (p&lt;0.001). Interaction: Interval and condition (p&lt;0.001).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded 50-word CNC words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Percent correct converted to rationalized arcsine units (RAU) prior to analysis.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and condition (p&lt;0.001). Interaction: interval and condition (p&lt;0.001).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>ANOVA</method>
            <method_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of word recognition between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.429</p_value>
            <p_value_desc>A logit transformation was applied to proportion correct data prior to analysis.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and group (p=0.429). Interaction: group and interval (p=0.387).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time</title>
        <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time</title>
          <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.</description>
          <population>Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67" spread="19"/>
                    <measurement group_id="O2" value="76" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" spread="19"/>
                    <measurement group_id="O2" value="79" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" spread="19"/>
                    <measurement group_id="O2" value="52" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68" spread="18"/>
                    <measurement group_id="O2" value="77" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" spread="8"/>
                    <measurement group_id="O2" value="48" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68" spread="18"/>
                    <measurement group_id="O2" value="79" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" spread="7"/>
                    <measurement group_id="O2" value="43" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" spread="19"/>
                    <measurement group_id="O2" value="78" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" spread="6"/>
                    <measurement group_id="O2" value="41" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67" spread="18"/>
                    <measurement group_id="O2" value="79" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" spread="6"/>
                    <measurement group_id="O2" value="40" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.019</p_value>
            <p_value_desc>The Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.19) and condition (p&lt;0.001). Interaction: interval and condition (p&lt;0.019).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.012</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.012) and condition (p&lt;0.001). Interaction: interval and condition (p=0.004).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Association of age at implantation and sound source localization (RMS) at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>correlation</non_inferiority_desc>
            <p_value>=0.033</p_value>
            <method>bivariate pearson correlation</method>
            <param_type>bivariate pearson correlation</param_type>
            <param_value>0.42</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of sound source localization between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.249</p_value>
            <p_value_desc>There were significant main effects of group (p&lt;0.001) and interval (p&lt;0.001). There was a non-significant interaction between group and interval (p=0.249).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: group (p&lt;0.001) and interval (p&lt;0.001). Interaction: group and interval (p=0.249).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time</title>
        <description>Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time</title>
          <description>Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.</description>
          <population>Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>before surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="1"/>
                    <measurement group_id="O2" value="4" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" spread="2"/>
                    <measurement group_id="O2" value="5" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" spread="2"/>
                    <measurement group_id="O2" value="6" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="1"/>
                    <measurement group_id="O2" value="6" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="1"/>
                    <measurement group_id="O2" value="6" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="1"/>
                    <measurement group_id="O2" value="6" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Responses on the Speech, Spatial, &amp; Qualities of hearing scale (SSQ) as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.056</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.448</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and subscale (p&lt;0.001). Interaction: interval and subscale (p=0.488).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.299</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: subscale (p&lt;0.001) and interval (p=0.072). Interaction: subscale and interval (p=0.299).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ Speech pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.018</p_value>
            <p_value_desc>There were significant main effects of interval (p&lt;0.001) and pragmatic subscale (p&lt;0.001), and their interaction (p&lt;0.018).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and pragmatic subscale (p&lt;0.001). Interaction: interval and pragmatic subscale (p&lt;0.018).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ Spatial pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.767</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and pragmatic subscale (p=0.767). Interaction: interval and pragmatic subscale (p=0.542).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ Qualities of Hearing pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.242</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.003) and pragmatic subscale (p&lt;0.001). Interaction: interval and pragmatic subscale (p=0.242).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bivariate pearson correlation</non_inferiority_desc>
            <p_value>0.370</p_value>
            <method>bivariate pearson correlation</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation</non_inferiority_desc>
            <p_value>=0.865</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>bivariate pearson correlation</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation</non_inferiority_desc>
            <p_value>=0.005</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>bivariate pearson correlation</method>
            <param_type>bivariate pearson correlation</param_type>
            <param_value>0.60</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation</non_inferiority_desc>
            <p_value>=0.006</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>bivariate pearson correlation</method>
            <param_type>bivariate pearson correlation</param_type>
            <param_value>0.67</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation</non_inferiority_desc>
            <p_value>=0.152</p_value>
            <method>bivariate pearson correlation</method>
            <param_type>bivariate pearson correlation</param_type>
            <param_value>-0.33</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation</non_inferiority_desc>
            <p_value>=0.761</p_value>
            <method>bivariate pearson correlation</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation</non_inferiority_desc>
            <p_value>=0.315</p_value>
            <method>bivariate pearson correlation</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation</non_inferiority_desc>
            <p_value>=0.666</p_value>
            <method>bivariate pearson correlation</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of subjective benefit between groups (UHL/SSD and AHL) on the speech, spatial, and qualities of hearing subscales during the post-activation intervals (1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.175</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: cohort (p=0.912), interval (p=0.463), and subscale (p=0.483). Interactions: 2-way or 3-way (p&gt;0.175).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear</title>
        <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the normal/better hearing ear. Scored as the percent correctly repeated.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear</title>
          <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the normal/better hearing ear. Scored as the percent correctly repeated.</description>
          <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.</population>
          <units>percentage of words correctly repeated</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" spread="13"/>
                    <measurement group_id="O2" value="3" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" spread="14"/>
                    <measurement group_id="O2" value="5" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40" spread="16"/>
                    <measurement group_id="O2" value="8" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="16"/>
                    <measurement group_id="O2" value="3" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" spread="19"/>
                    <measurement group_id="O2" value="10" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" spread="18"/>
                    <measurement group_id="O2" value="2" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" spread="16"/>
                    <measurement group_id="O2" value="15" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="17"/>
                    <measurement group_id="O2" value="2" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52" spread="18"/>
                    <measurement group_id="O2" value="15" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" spread="19"/>
                    <measurement group_id="O2" value="4" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53" spread="21"/>
                    <measurement group_id="O2" value="22" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.161</p_value>
            <p_value_desc>Significant effect of interval (p=0.046) and of condition (p&lt;0.001) and a non-significant interaction (p=0.161).&#xD;
Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.046) and condition (p&lt;0.001). Interaction: interval and condition (p=0.161).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.107</p_value>
            <p_value_desc>Significant effect of condition (p&lt;0.001) and the interaction (p&lt;0.001). Non-significant effect of interval (p=0.107).&#xD;
Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: condition (p&lt;0.001) and interval p=0.107). Interaction of condition and interval (p&lt;0.001).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Association of age at implantation and speech recognition in noise at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation</non_inferiority_desc>
            <p_value>=0.580</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>bivariate pearson correlation</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of speech recognition between groups (UHL/SSD and AHL) for the three masker configurations (noise towards the better hearing ear, noise towards the poorer hearing ear, and noise from the front) and signal-to-noise ratio (SNR; 0, 5, or 10 dB SNR) over the post-activation intervals (1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.743</p_value>
            <p_value_desc>A logit transformation was applied to proportion correct data prior to analysis.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Effects: SNR (p=0.026) &amp; masker condition (p&lt;0.001). Interactions: cohort &amp; condition (p&lt;0.001), interval &amp; condition (p=0.015). Others (p&gt;0.140).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>pearson correlation</non_inferiority_desc>
            <p_value>=0.036</p_value>
            <p_value_desc>Percent correct converted to rationalized arcsine units (RAU) prior to analysis.</p_value_desc>
            <method>bivariate pearson correlation</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Localization Results (Measured in Variable Error) Over Time</title>
        <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in variable error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Localization Results (Measured in Variable Error) Over Time</title>
          <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in variable error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.</description>
          <population>Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" spread="16"/>
                    <measurement group_id="O2" value="29" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" spread="18"/>
                    <measurement group_id="O2" value="25" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" spread="10"/>
                    <measurement group_id="O2" value="35" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" spread="16"/>
                    <measurement group_id="O2" value="23" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" spread="7"/>
                    <measurement group_id="O2" value="33" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" spread="14"/>
                    <measurement group_id="O2" value="23" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" spread="7"/>
                    <measurement group_id="O2" value="28" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="14"/>
                    <measurement group_id="O2" value="23" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="7"/>
                    <measurement group_id="O2" value="29" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" spread="15"/>
                    <measurement group_id="O2" value="24" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="7"/>
                    <measurement group_id="O2" value="27" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.183</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effect: interval (p=0.183) and condition (p=0.012). Interaction: interval and condition (p=0.081).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.196</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effect: interval (p=0.010) and condition (p=0.100). Interaction: interval and condition (p=0.196).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.056</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.210</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Localization Results (Measured in Constant Error) Over Time</title>
        <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Localization Results (Measured in Constant Error) Over Time</title>
          <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.</description>
          <population>Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59" spread="23"/>
                    <measurement group_id="O2" value="67" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" spread="24"/>
                    <measurement group_id="O2" value="73" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" spread="18"/>
                    <measurement group_id="O2" value="37" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" spread="21"/>
                    <measurement group_id="O2" value="71" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" spread="6"/>
                    <measurement group_id="O2" value="33" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" spread="23"/>
                    <measurement group_id="O2" value="74" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" spread="7"/>
                    <measurement group_id="O2" value="31" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62" spread="23"/>
                    <measurement group_id="O2" value="72" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="5"/>
                    <measurement group_id="O2" value="29" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" spread="22"/>
                    <measurement group_id="O2" value="73" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" spread="5"/>
                    <measurement group_id="O2" value="28" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.071</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.071) and condition (p&lt;0.001). Interaction: interval and condition (p&lt;0.051)</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.109</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.109) and condition (p&lt;0.001). Interaction: interval and condition (p=0.052).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Localization Results (Measured in Adjusted Constant Error) Over Time</title>
        <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in adjusted constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Localization Results (Measured in Adjusted Constant Error) Over Time</title>
          <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in adjusted constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.</description>
          <population>Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" spread="9"/>
                    <measurement group_id="O2" value="48" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" spread="11"/>
                    <measurement group_id="O2" value="53" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" spread="10"/>
                    <measurement group_id="O2" value="30" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46" spread="12"/>
                    <measurement group_id="O2" value="52" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="5"/>
                    <measurement group_id="O2" value="29" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" spread="12"/>
                    <measurement group_id="O2" value="52" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" spread="5"/>
                    <measurement group_id="O2" value="27" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" spread="12"/>
                    <measurement group_id="O2" value="53" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" spread="5"/>
                    <measurement group_id="O2" value="26" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46" spread="12"/>
                    <measurement group_id="O2" value="53" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" spread="5"/>
                    <measurement group_id="O2" value="25" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.024</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.018) and condition (p&lt;0.001). Interaction: interval and condition (p=0.024).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.219</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.187) and condition (p&lt;0.001). Interaction: interval and condition (p=0.219).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time</title>
        <description>Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time</title>
          <description>Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.</description>
          <population>Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>before surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" spread="19"/>
                    <measurement group_id="O2" value="52" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" spread="13"/>
                    <measurement group_id="O2" value="32" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" spread="9"/>
                    <measurement group_id="O2" value="28" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" spread="8"/>
                    <measurement group_id="O2" value="31" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" spread="8"/>
                    <measurement group_id="O2" value="29" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="9"/>
                    <measurement group_id="O2" value="28" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Responses on the Abbreviated Profile of Hearing Aid Benefit (APHAB) as measured with the global score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.011</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses were compared to responses over the post-activation period (1, 3, 6, 9, and 12 months) with the cochlear implant using a repeated-measures ANOVA.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.264</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.023</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.005) and subscales (p=0.001). Interaction: interval and subscales (p=0.023).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.643</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.643) and subscale (p=0.005). Interaction: interval and subscale (p=0.480).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation (one-tailed)</non_inferiority_desc>
            <p_value>=0.947</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>bivariate pearson correlation</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.500</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>bivariate pearson correlation</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation</non_inferiority_desc>
            <p_value>=0.023</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>bivariate pearson correlation</method>
            <param_type>bivariate pearson correlation</param_type>
            <param_value>-0.51</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation</non_inferiority_desc>
            <p_value>=0.033</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>bivariate pearson correlation</method>
            <param_type>bivariate pearson correlation</param_type>
            <param_value>-0.55</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of subjective benefit between groups (UHL/SSD and AHL) on the ease of communication, background noise, and reverberation subscales over the post-activation intervals (1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.208</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: cohort (p=0.541), interval (p=0.446), and subscale (p=0.208). Interactions: 2-way or 3-way (p&gt;0.287).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time</title>
        <description>Subjects completed subjective questionnaires to order to evaluate the perceived benefits of cochlear implantation. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time</title>
          <description>Subjects completed subjective questionnaires to order to evaluate the perceived benefits of cochlear implantation. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.</description>
          <population>Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>before surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="17"/>
                    <measurement group_id="O2" value="18" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" spread="10"/>
                    <measurement group_id="O2" value="4" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="7"/>
                    <measurement group_id="O2" value="2" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="5"/>
                    <measurement group_id="O2" value="4" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="6"/>
                    <measurement group_id="O2" value="2" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="5"/>
                    <measurement group_id="O2" value="4" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers &quot;yes&quot; (4 points), &quot;sometimes&quot; (2 points), or &quot;no&quot; (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.221</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers &quot;yes&quot; (4 points), &quot;sometimes&quot; (2 points), or &quot;no&quot; (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.538</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of subjective benefit between groups (UHL/SSD and AHL) on the Tinnitus Handicap Inventory over the post-activation intervals (1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.218</p_value>
            <p_value_desc>There were no significant main effects of cohort (p=0.265) or interval (p=0.430). There was no significant interaction between cohort and interval (p=0.218).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: cohort (p=0.265) or interval (p=0.430). Interaction: cohort and interval (p=0.218).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)</title>
        <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as the percent correctly repeated.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)</title>
          <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as the percent correctly repeated.</description>
          <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.</population>
          <units>percentage of words correctly repeated</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83" spread="10"/>
                    <measurement group_id="O2" value="40" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" spread="9"/>
                    <measurement group_id="O2" value="53" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" spread="7"/>
                    <measurement group_id="O2" value="49" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" spread="9"/>
                    <measurement group_id="O2" value="39" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" spread="8"/>
                    <measurement group_id="O2" value="41" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" spread="9"/>
                    <measurement group_id="O2" value="29" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" spread="7"/>
                    <measurement group_id="O2" value="38" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" spread="15"/>
                    <measurement group_id="O2" value="38" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" spread="9"/>
                    <measurement group_id="O2" value="42" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" spread="11"/>
                    <measurement group_id="O2" value="38" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" spread="11"/>
                    <measurement group_id="O2" value="42" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.322</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effect: interval (p=0.084) and condition (p=0.322). Interaction: interval and condition (p=0.125).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.317</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.014) and condition (p=0.317). Interaction: interval and condition (p=0.118).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.017</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.292</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>pearson correlation</non_inferiority_desc>
            <p_value>&gt;0.185</p_value>
            <method>bivariate pearson correlation</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front</title>
        <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 10-talker masker from the front speaker. Scored as the percent correctly repeated.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front</title>
          <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 10-talker masker from the front speaker. Scored as the percent correctly repeated.</description>
          <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.</population>
          <units>percentage of words correctly repeated</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" spread="11"/>
                    <measurement group_id="O2" value="18" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39" spread="8"/>
                    <measurement group_id="O2" value="23" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41" spread="8"/>
                    <measurement group_id="O2" value="28" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43" spread="10"/>
                    <measurement group_id="O2" value="17" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" spread="15"/>
                    <measurement group_id="O2" value="23" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" spread="13"/>
                    <measurement group_id="O2" value="21" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" spread="10"/>
                    <measurement group_id="O2" value="26" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" spread="15"/>
                    <measurement group_id="O2" value="20" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" spread="12"/>
                    <measurement group_id="O2" value="25" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" spread="12"/>
                    <measurement group_id="O2" value="22" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" spread="11"/>
                    <measurement group_id="O2" value="24" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.581</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effect: interval (p=0.039) and condition (p=0.007). Interaction: interval and condition (p=0.581).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.817</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: condition (p=0.005) and interval (p=0.528). Interaction: condition and interval (p=0.817).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.008</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.009</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Association of age at implantation and performance at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate correlation</non_inferiority_desc>
            <p_value>=0.049</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.&#xD;
This correlation was no longer significant when controlling for the hearing threshold at 8000 Hz.</p_value_desc>
            <method>bivariate pearson correlation</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>pearson correlation</non_inferiority_desc>
            <p_value>&gt;0.185</p_value>
            <method>bivariate pearson correlation</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front</title>
        <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 4-talker masker from the front speaker. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower numbers indicate better performance (range -7.5 to 23.5 dB SNR).</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front</title>
          <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 4-talker masker from the front speaker. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower numbers indicate better performance (range -7.5 to 23.5 dB SNR).</description>
          <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.</population>
          <units>signal-to-noise ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="1.4"/>
                    <measurement group_id="O2" value="4.2" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="1.2"/>
                    <measurement group_id="O2" value="3.3" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.5"/>
                    <measurement group_id="O2" value="2.6" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="1.3"/>
                    <measurement group_id="O2" value="3.6" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.7"/>
                    <measurement group_id="O2" value="2.6" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="2.4"/>
                    <measurement group_id="O2" value="3.1" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.4"/>
                    <measurement group_id="O2" value="1.8" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.4"/>
                    <measurement group_id="O2" value="2.7" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="1.4"/>
                    <measurement group_id="O2" value="1.4" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.2"/>
                    <measurement group_id="O2" value="3.9" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.7"/>
                    <measurement group_id="O2" value="3.4" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.440</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.070) and condition (p=0.440). Interaction: interval and condition (p=0.047).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.379</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: condition (p&lt;0.001) and interval (p=0.250). Interaction: interval and condition (p=0.379).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.021</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear</title>
        <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the normal/better hearing ear. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. A lower value indicates better performance (range -7.5 to 23.5 dB SNR).</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear</title>
          <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the normal/better hearing ear. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. A lower value indicates better performance (range -7.5 to 23.5 dB SNR).</description>
          <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.</population>
          <units>signal-to-noise ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.3"/>
                    <measurement group_id="O2" value="7.1" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.8"/>
                    <measurement group_id="O2" value="6.8" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="2.2"/>
                    <measurement group_id="O2" value="5.2" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.9"/>
                    <measurement group_id="O2" value="6.9" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="2.5"/>
                    <measurement group_id="O2" value="4.6" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.7"/>
                    <measurement group_id="O2" value="6.9" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.1"/>
                    <measurement group_id="O2" value="3.9" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="2.0"/>
                    <measurement group_id="O2" value="6.2" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="1.7"/>
                    <measurement group_id="O2" value="4.2" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.4"/>
                    <measurement group_id="O2" value="6.9" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="2.2"/>
                    <measurement group_id="O2" value="4.4" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.639</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effect: condition (p&lt;0.001) and interval (p=0.639). Interaction: interval and condition (p=0.280).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.637</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: condition (p&lt;0.001) and interval (p=0.637). Interaction: interval and condition (p=0.450).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.002</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)</title>
        <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower values indicate better performance (range -7.5 to 23.5 dB SNR).</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)</title>
          <description>Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower values indicate better performance (range -7.5 to 23.5 dB SNR).</description>
          <population>Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.</population>
          <units>signal-to-noise ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" spread="1.6"/>
                    <measurement group_id="O2" value="1.4" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="1.0"/>
                    <measurement group_id="O2" value="0.4" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="1.5"/>
                    <measurement group_id="O2" value="0.5" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.2" spread="1.6"/>
                    <measurement group_id="O2" value="1.4" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.0" spread="1.5"/>
                    <measurement group_id="O2" value="1.7" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.9" spread="1.3"/>
                    <measurement group_id="O2" value="1.4" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="1.5"/>
                    <measurement group_id="O2" value="1.3" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.5" spread="1.2"/>
                    <measurement group_id="O2" value="0.5" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.9" spread="1.1"/>
                    <measurement group_id="O2" value="0.8" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.7" spread="1.8"/>
                    <measurement group_id="O2" value="2.3" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery, aided (cochlear implant)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" spread="1.7"/>
                    <measurement group_id="O2" value="2.4" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.671</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.020) and condition (p=0.406). Interaction: interval and condition (p=0.671).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.124</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p=0.124) and condition (p=0.845). Interaction: interval and condition (p=0.960).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.025</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.442</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)</title>
        <description>Results on recorded speech perception materials: aided word recognition. Recorded 50-word CNC words were evaluated preoperatively with a conventional hearing aid. Performance was compared to the CI alone at the 12 month interval. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores &lt;20%).</description>
        <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
        <population>One asymmetric hearing loss participant withdrew prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)</title>
          <description>Results on recorded speech perception materials: aided word recognition. Recorded 50-word CNC words were evaluated preoperatively with a conventional hearing aid. Performance was compared to the CI alone at the 12 month interval. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores &lt;20%).</description>
          <population>One asymmetric hearing loss participant withdrew prior to the 12-month interval.</population>
          <units>percentage of words correct</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>preop, hearing aid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="7"/>
                    <measurement group_id="O2" value="8" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month post-activation, cochlear implant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" spread="18"/>
                    <measurement group_id="O2" value="55" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Percent correct values were converted to rationalized arcsine units prior to analysis.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)</title>
        <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus with a bone-conduction device. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants in the asymmetric group did not complete testing at the 9-month interval. One participant did not complete testing with the CI on at the 12-month interval. Three participants did not complete testing in the with the bone conduction device at the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)</title>
          <description>Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus with a bone-conduction device. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance.</description>
          <population>Three participants in the asymmetric group did not complete testing at the 9-month interval. One participant did not complete testing with the CI on at the 12-month interval. Three participants did not complete testing in the with the bone conduction device at the 12-month interval.</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>preoperative, bone-conduction device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" spread="19"/>
                    <measurement group_id="O2" value="76" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month, cochlear implant</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" spread="19"/>
                    <measurement group_id="O2" value="52" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month, cochlear implant</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" spread="8"/>
                    <measurement group_id="O2" value="48" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-month, cochlear implant</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" spread="7"/>
                    <measurement group_id="O2" value="43" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9-month, cochlear implant</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" spread="6"/>
                    <measurement group_id="O2" value="41" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, cochlear implant</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" spread="6"/>
                    <measurement group_id="O2" value="40" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, bone conduction device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" spread="19"/>
                    <measurement group_id="O2" value="80" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Participants listened with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Participants listening with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)</title>
        <description>Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.</description>
        <time_frame>preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)</time_frame>
        <population>Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)</title>
          <description>Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.</description>
          <population>Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>before surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" spread="19"/>
                    <measurement group_id="O2" value="52" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" spread="13"/>
                    <measurement group_id="O2" value="32" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" spread="9"/>
                    <measurement group_id="O2" value="28" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" spread="8"/>
                    <measurement group_id="O2" value="31" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" spread="8"/>
                    <measurement group_id="O2" value="29" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="9"/>
                    <measurement group_id="O2" value="28" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and subscales (p&lt;0.001). Interaction: interval and subscales (p&lt;0.001).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.010</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and subscales (p=0.010). Interaction: interval and subscales (p=0.001).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)</title>
        <description>Subjects completed subjective questionnaires. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.</description>
        <time_frame>Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)</time_frame>
        <population>Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)</title>
          <description>Subjects completed subjective questionnaires. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.</description>
          <population>Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>before surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="17"/>
                    <measurement group_id="O2" value="18" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" spread="10"/>
                    <measurement group_id="O2" value="4" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="7"/>
                    <measurement group_id="O2" value="2" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="5"/>
                    <measurement group_id="O2" value="4" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="6"/>
                    <measurement group_id="O2" value="2" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="5"/>
                    <measurement group_id="O2" value="4" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers &quot;yes&quot; (4 points), &quot;sometimes&quot; (2 points), or &quot;no&quot; (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers &quot;yes&quot; (4 points), &quot;sometimes&quot; (2 points), or &quot;no&quot; (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.003</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)</title>
        <description>Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.</description>
        <time_frame>preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)</time_frame>
        <population>Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)</title>
          <description>Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.</description>
          <population>Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>before surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="1"/>
                    <measurement group_id="O2" value="4" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" spread="2"/>
                    <measurement group_id="O2" value="5" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" spread="2"/>
                    <measurement group_id="O2" value="6" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="1"/>
                    <measurement group_id="O2" value="6" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="1"/>
                    <measurement group_id="O2" value="6" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months after surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="1"/>
                    <measurement group_id="O2" value="6" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ as measured with the subscales (speech, spatial, &amp; qualities) were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>There were significant main effects of interval (p&lt;0.001) and subscale (p&lt;0.001) and interaction (p=0.001).&#xD;
A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and subscale (p&lt;0.001). Interaction: interval and subscale (p=0.001).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ as measured with the subscales (speech, spatial, &amp; qualities) were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.034</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and subscale (p&lt;0.001). Interaction: interval and subscale (p=0.034).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and pragmatic subscale (p&lt;0.001). Interaction: interval and pragmatic subscale (p&lt;0.001).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.192</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effect: interval (p&lt;0.001) and pragmatic subscale (p=0.192). Interaction: interval and pragmatic subscale (p=0.001).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and pragmatic subscale (p&lt;0.001). Interaction: interval and pragmatic subscale (p&lt;0.001).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.479</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and pragmatic subscale (p&lt;0.001). Interaction: interval and pragmatic subscale (p=0.479).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.804</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effect: interval (p&lt;0.001) and pragmatic subscale (p=0.804). Interaction: interval and pragmatic subscale (p=0.090).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.005</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effects: interval (p&lt;0.001) and pragmatic subscale (p&lt;0.001). Interaction: interval and pragmatic subscale (p=0.005).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)</title>
        <description>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</description>
        <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
        <population>One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Seven participants were tested at a different signal-to-noise ratio at the preoperative interval. Four participants were tested at a different signal-to-noise ratio.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)</title>
          <description>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</description>
          <population>One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Seven participants were tested at a different signal-to-noise ratio at the preoperative interval. Four participants were tested at a different signal-to-noise ratio.</population>
          <units>percent correct</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-op, bone-conduction device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32" spread="17"/>
                    <measurement group_id="O2" value="17" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month post-activation, cochlear implant</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" spread="11"/>
                    <measurement group_id="O2" value="24" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.034</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)</title>
        <description>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</description>
        <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
        <population>One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Seven participants were tested at a different signal-to-noise ratio at the preoperative interval. Four participants were tested at a different signal-to-noise ratio.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)</title>
          <description>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</description>
          <population>One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Seven participants were tested at a different signal-to-noise ratio at the preoperative interval. Four participants were tested at a different signal-to-noise ratio.</population>
          <units>percent correct</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-op, bone-conduction device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61" spread="28"/>
                    <measurement group_id="O2" value="24" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month post-activation, cochlear implant</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" spread="11"/>
                    <measurement group_id="O2" value="42" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.037</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)</title>
        <description>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</description>
        <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
        <population>One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Seven participants were tested at a different signal-to-noise ratio at the preoperative interval. Four participants were tested at a different signal-to-noise ratio.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)</title>
          <description>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</description>
          <population>One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Seven participants were tested at a different signal-to-noise ratio at the preoperative interval. Four participants were tested at a different signal-to-noise ratio.</population>
          <units>percent correct</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-op, bone-conduction device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="18"/>
                    <measurement group_id="O2" value="6" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month post-activation, cochlear implant</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53" spread="21"/>
                    <measurement group_id="O2" value="22" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)</title>
        <description>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).</description>
        <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
        <population>One asymmetric hearing loss participant withdrew prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)</title>
          <description>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).</description>
          <population>One asymmetric hearing loss participant withdrew prior to the 12-month interval.</population>
          <units>signal-to-noise ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-op, bone-conduction device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="2.0"/>
                    <measurement group_id="O2" value="4.9" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month post-activation, cochlear implant</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.7"/>
                    <measurement group_id="O2" value="3.4" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) with a bone-conduction device (preoperative interval) and 2) with the cochlear implant (CI) at the 12-month post-activation interval. Results are reported in dB SNR, where a lower value indicates better performance. A paired samples t-test compared the performance with the two devices.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.004</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.004</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)</title>
        <description>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).</description>
        <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
        <population>One asymmetric hearing loss participant withdrew prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)</title>
          <description>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).</description>
          <population>One asymmetric hearing loss participant withdrew prior to the 12-month interval.</population>
          <units>signal-to-noise ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-op, bone-conduction device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="2.4"/>
                    <measurement group_id="O2" value="2.7" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month post-activation, cochlear implant</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" spread="1.7"/>
                    <measurement group_id="O2" value="2.4" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.727</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)</title>
        <description>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).</description>
        <time_frame>preoperative interval and 12 month post-activation interval</time_frame>
        <population>One asymmetric hearing loss participant withdrew prior to the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)</title>
          <description>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).</description>
          <population>One asymmetric hearing loss participant withdrew prior to the 12-month interval.</population>
          <units>signal-to-noise ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-op, bone-conduction device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="2.3"/>
                    <measurement group_id="O2" value="6.1" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month post-activation, cochlear implant</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="2.2"/>
                    <measurement group_id="O2" value="4.4" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.090</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)</title>
        <description>The speech perception (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 10-talker masker at 0 dB SNR with the target speech presented from the front and the masker (1) presented from the front (SoNo), (2) presented towards the implanted ear (SoNbc), and (3) presented towards the acoustic ear (SoNnh). Performance was scored as the percent of words correctly repeated, with higher values indicating better performance. The task was completed with the participants listening with their bone-conduction device on versus off.</description>
        <time_frame>Assessment completed after 12 months of implantable bone-conduction listening experience</time_frame>
        <population>Performance on measures of speech perception</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group: Recipients of a Bone-conduction Device on the Affected Side</title>
            <description>Recipients of an implantable bone-conduction device with at least 12 months of listening experience. Participants were adults (18 years of age or older) with a duration of moderate-to-profound hearing loss of 5 years or less at the time of implantation with a bone-conduction device and normal hearing to mild hearing loss in the contralateral ear.</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)</title>
          <description>The speech perception (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 10-talker masker at 0 dB SNR with the target speech presented from the front and the masker (1) presented from the front (SoNo), (2) presented towards the implanted ear (SoNbc), and (3) presented towards the acoustic ear (SoNnh). Performance was scored as the percent of words correctly repeated, with higher values indicating better performance. The task was completed with the participants listening with their bone-conduction device on versus off.</description>
          <population>Performance on measures of speech perception</population>
          <units>percentage of words correctly repeated</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SoNo, device on</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32" lower_limit="30" upper_limit="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SoNbc, device on</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" lower_limit="68" upper_limit="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SoNnh, device on</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="5" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SoNo, device off</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" lower_limit="18" upper_limit="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SoNbc, device off</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" lower_limit="69" upper_limit="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SoNnh, device off</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="5" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Speech Recognition in Noise for a Control Group: BKB-SIN Test</title>
        <description>The speech perception outcomes in the study population (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 4-talker masker with the target speech presented from the front and the masker (1) presented from the front, (2) presented towards the implanted ear, and (3) presented towards the acoustic ear. Performance was scored as the dB SNR when the participant understood 50% correct, with lower values indicating better performance. Participants completed the task with the device on and off.</description>
        <time_frame>Assessment completed after 12 months of implantable bone-conduction listening experience</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group: Recipients of a Bone-conduction Device on the Affected Side</title>
            <description>Recipients of an implantable bone-conduction device with at least 12 months of listening experience. Participants were adults (18 years of age or older) with a duration of moderate-to-profound hearing loss of 5 years or less at the time of implantation with a bone-conduction device and normal hearing to mild hearing loss in the contralateral ear.</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Recognition in Noise for a Control Group: BKB-SIN Test</title>
          <description>The speech perception outcomes in the study population (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 4-talker masker with the target speech presented from the front and the masker (1) presented from the front, (2) presented towards the implanted ear, and (3) presented towards the acoustic ear. Performance was scored as the dB SNR when the participant understood 50% correct, with lower values indicating better performance. Participants completed the task with the device on and off.</description>
          <units>signal-to-noise ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SoNo, device on</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" lower_limit="-1" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SoNbc, device on</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" lower_limit="-4.5" upper_limit="-2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SoNnh, device on</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="-1" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SoNo, device off</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" lower_limit="-2" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SoNbc, device off</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" lower_limit="-6" upper_limit="-4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SoNnh, device off</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1.5" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Localization for a Control Group</title>
        <description>Subjects were asked to identify the noise source from an 11-speaker array with the bone-conduction device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Subjects in the control group were implantable bone-conduction device recipients (alternative treatment option) with at least 12 months of listening experience with their implanted bone-conduction device. Participants completed the task with their device on and off.</description>
        <time_frame>Assessment completed after 12 months of implantable bone-conduction listening experience</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group: Recipients of a Bone-conduction Device on the Affected Side</title>
            <description>Recipients of an implantable bone-conduction device with at least 12 months of listening experience. Participants were adults (18 years of age or older) with a duration of moderate-to-profound hearing loss of 5 years or less at the time of implantation with a bone-conduction device and normal hearing to mild hearing loss in the contralateral ear.</description>
          </group>
        </group_list>
        <measure>
          <title>Localization for a Control Group</title>
          <description>Subjects were asked to identify the noise source from an 11-speaker array with the bone-conduction device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Subjects in the control group were implantable bone-conduction device recipients (alternative treatment option) with at least 12 months of listening experience with their implanted bone-conduction device. Participants completed the task with their device on and off.</description>
          <units>degrees</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>device on</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63" lower_limit="61" upper_limit="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>device off</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="50" upper_limit="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)</title>
        <description>Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the average responses across questions for each subscale (Speech Hearing, Spatial Hearing, and Qualities of Hearing). Results are also reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.&#xD;
Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.</description>
        <time_frame>Assessment completed after 12 months of implantable bone-conduction listening experience</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group: Recipients of a Bone-conduction Device on the Affected Side</title>
            <description>Recipients of an implantable bone-conduction device with at least 12 months of listening experience. Participants were adults (18 years of age or older) with a duration of moderate-to-profound hearing loss of 5 years or less at the time of implantation with a bone-conduction device and normal hearing to mild hearing loss in the contralateral ear.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)</title>
          <description>Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the average responses across questions for each subscale (Speech Hearing, Spatial Hearing, and Qualities of Hearing). Results are also reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.&#xD;
Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>speech hearing subscale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="3.7" upper_limit="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>spatial hearing subscale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="1.1" upper_limit="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>qualities of hearing subscale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="5.0" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="3.5" upper_limit="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)</title>
        <description>Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Results are reported as the average responses for each of the four subscales: ease of communication, reverberation, effectiveness in background noise, and reverberation. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.&#xD;
Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.</description>
        <time_frame>Assessment completed after 12 months of implantable bone-conduction listening experience</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group: Recipients of a Bone-conduction Device on the Affected Side</title>
            <description>Recipients of an implantable bone-conduction device with at least 12 months of listening experience. Participants were adults (18 years of age or older) with a duration of moderate-to-profound hearing loss of 5 years or less at the time of implantation with a bone-conduction device and normal hearing to mild hearing loss in the contralateral ear.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)</title>
          <description>Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Results are reported as the average responses for each of the four subscales: ease of communication, reverberation, effectiveness in background noise, and reverberation. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.&#xD;
Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>global score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.3" lower_limit="12.3" upper_limit="45.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ease of communication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="12.3" upper_limit="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>reverberation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.5" lower_limit="12.3" upper_limit="54.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>effectiveness in background noise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.7" lower_limit="12.3" upper_limit="62.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>aversiveness to sounds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" lower_limit="4.7" upper_limit="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Pitch Perception With the Cochlear Implant Over the Post-activation Period</title>
        <description>Participants completed an adaptive pitch matching task that compared the pitch of acoustic stimulation presented to their normal hearing ear with the perception of stimulation from the cochlear implant. Two stimuli were used: clicks &amp; tones. Pitch perception was evaluated for the 5 most apical electrodes. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / frequency information presented by the electrode. Results are reported as the averaged normalized score for clicks &amp; tones for each electrode (electrodes 1-5) at each interval (1, 3, 6, and 12 months post-activation). A value of 1.0 indicates the participant perceived the same frequency as the center frequency presented by the electrode. A value &lt; 1.0 indicates a lower perceived pitch and a value &gt; 1.0 indicates a higher perceived pitch than the electric frequency information.</description>
        <time_frame>post-activation period (1, 3, 6, and 12 months post-activation)</time_frame>
        <population>19 of the 20 participants in the single-sided deafness/unilateral hearing loss group elected to complete the pitch matching task on the five most apical electrodes. One participant missed the 1-month and 3-month intervals. Another participant missed the 6-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Single-sided Deafness/Unilateral Hearing Loss Cohort</title>
            <description>participants with a cochlear implant in the affected ear and normal to near-normal hearing in the contralateral ear</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pitch Perception With the Cochlear Implant Over the Post-activation Period</title>
          <description>Participants completed an adaptive pitch matching task that compared the pitch of acoustic stimulation presented to their normal hearing ear with the perception of stimulation from the cochlear implant. Two stimuli were used: clicks &amp; tones. Pitch perception was evaluated for the 5 most apical electrodes. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / frequency information presented by the electrode. Results are reported as the averaged normalized score for clicks &amp; tones for each electrode (electrodes 1-5) at each interval (1, 3, 6, and 12 months post-activation). A value of 1.0 indicates the participant perceived the same frequency as the center frequency presented by the electrode. A value &lt; 1.0 indicates a lower perceived pitch and a value &gt; 1.0 indicates a higher perceived pitch than the electric frequency information.</description>
          <population>19 of the 20 participants in the single-sided deafness/unilateral hearing loss group elected to complete the pitch matching task on the five most apical electrodes. One participant missed the 1-month and 3-month intervals. Another participant missed the 6-month interval.</population>
          <units>normalized score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1-month: electrode 1, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month: electrode 1, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month: electrode 2, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month: electrode 2, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month: electrode 3, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month: electrode 3, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month: electrode 4, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month: electrode 4, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month: electrode 5, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month: electrode 5, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month: electrode 1, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month: electrode 1, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month: electrode 2, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month: electrode 2, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month: electrode 3, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month: electrode 3, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month: electrode 4, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month: electrode 4, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month: electrode 5, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month: electrode 5, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-month: electrode 1, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-month: electrode 1, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-month: electrode 2, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-month: electrode 2, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-month: electrode 3, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-month: electrode 3, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-month: electrode 4, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-month: electrode 4, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-month: electrode 5, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-month: electrode 5, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month: electrode 1, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month: electrode 1, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month: electrode 2, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month: electrode 2, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month: electrode 3, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month: electrode 3, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month: electrode 4, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month: electrode 4, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month: electrode 5, click</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month: electrode 5, tone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>A linear mixed effects model compared the main effects of target stimulus (click, tone), electrode (1-5), and interval (1, 3, 6, and 12 months) on the normalized pitch match.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.923</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effect: electrode (p&lt;0.001), target stimulus (p=0.923), and interval (p=0.226). Interaction: electrode and interval (p=0.496).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Correlation between pitch perception (normalized mean pitch match) and word recognition with the CI alone.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.164</p_value>
            <method>bivariate pearson correlation</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Correlation between pitch perception (normalized mean pitch match) and speech recognition in noise (masker from the front, masker towards the better hearing ear, and masker towards the poorer hearing ear).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation</non_inferiority_desc>
            <p_value>&gt;0.367</p_value>
            <method>bivariate pearson correlation</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Correlation between pitch perception (normalized mean pitch match) and sound source localization (RMS error).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>bivariate pearson correlation</non_inferiority_desc>
            <p_value>&gt;0.349</p_value>
            <method>bivariate pearson correlation</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Unaided Hearing in the Implanted Ear Over the Study Period.</title>
        <description>The unaided hearing thresholds were measured preoperatively and post-operatively/post-activation. Twenty-five participants with SSD or AHL had an unaided threshold at 125 Hz of 80 dB HL or better. Their unaided thresholds were reviewed with respect to hearing preservation. The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array.</description>
        <time_frame>pre-operative, initial activation, and post-activation intervals (1, 3, 6, 9, and 12-months).</time_frame>
        <population>Participants in the SSD/UHL and AHL groups that presented with an unaided threshold at 125 Hz of 80 dB HL or better (n=25). A value of 100 dB HL was entered for cases of no response.&#xD;
Nine participants had a threshold of 95 dB HL or better at initial activation and were reviewed over the post-activation period. Two participants did not complete the 9-month and one participant did not complete the 12-month.</population>
        <group_list>
          <group group_id="O1">
            <title>Single-sided Deafness/Unilateral Hearing Loss and Asymmetric Hearing Loss Groups Combined</title>
            <description>The data from both groups (SSD and AHL) were combined.</description>
          </group>
        </group_list>
        <measure>
          <title>Unaided Hearing in the Implanted Ear Over the Study Period.</title>
          <description>The unaided hearing thresholds were measured preoperatively and post-operatively/post-activation. Twenty-five participants with SSD or AHL had an unaided threshold at 125 Hz of 80 dB HL or better. Their unaided thresholds were reviewed with respect to hearing preservation. The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array.</description>
          <population>Participants in the SSD/UHL and AHL groups that presented with an unaided threshold at 125 Hz of 80 dB HL or better (n=25). A value of 100 dB HL was entered for cases of no response.&#xD;
Nine participants had a threshold of 95 dB HL or better at initial activation and were reviewed over the post-activation period. Two participants did not complete the 9-month and one participant did not complete the 12-month.</population>
          <units>decibel hearing level</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>preoperative</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>initial activation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-month post-activation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-month post-activation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-month post-activation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9-month post-activation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month post-activation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Comparison of the unaided threshold at 125 Hz at the preoperative and initial activation intervals for the 25 participants with unaided threshold of 80 dB HL or better at the preoperative interval.&#xD;
The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Comparison of the unaided threshold at 125 Hz from the initial activation to the 12-month post-activation interval for the 9 participants with an unaided threshold of 95 dB HL or better at the initial activation interval.&#xD;
The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.47</p_value>
            <method>ANOVA</method>
            <method_desc>generalized linear mixed-effects model</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Localization With a Bone-conduction Device Over Time, Measured in Root-mean-squared (RMS) Error</title>
        <description>Subjects were asked to identify the noise source from an 11-speaker array. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined. Performance was measured with a bone conduction device preoperatively and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source.</description>
        <time_frame>preoperative and 12-month intervals</time_frame>
        <population>Three participants in the asymmetric hearing loss group did not complete the task at the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Localization With a Bone-conduction Device Over Time, Measured in Root-mean-squared (RMS) Error</title>
          <description>Subjects were asked to identify the noise source from an 11-speaker array. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined. Performance was measured with a bone conduction device preoperatively and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source.</description>
          <population>Three participants in the asymmetric hearing loss group did not complete the task at the 12-month interval.</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>preoperative</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" spread="19"/>
                    <measurement group_id="O2" value="76" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" spread="19"/>
                    <measurement group_id="O2" value="80" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.739</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.553</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Speech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentences</title>
        <description>Speech recognition with a bone-conduction device was compared at the preoperative and 12-month intervals. Performance was evaluated for the AzBio sentences in a 10-talker masker (0 dB SNR) presented with the target and masker from the front, the target from the front and masker to the acoustic hearing, and target from the front and masker towards the affected ear.</description>
        <time_frame>preoperative and 12-month intervals</time_frame>
        <population>Thirteen participants with asymmetric hearing loss completed the task at the preoperative and 12-month intervals at 0 dB SNR.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentences</title>
          <description>Speech recognition with a bone-conduction device was compared at the preoperative and 12-month intervals. Performance was evaluated for the AzBio sentences in a 10-talker masker (0 dB SNR) presented with the target and masker from the front, the target from the front and masker to the acoustic hearing, and target from the front and masker towards the affected ear.</description>
          <population>Thirteen participants with asymmetric hearing loss completed the task at the preoperative and 12-month intervals at 0 dB SNR.</population>
          <units>percent correct</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>preoperative, speech front and noise front</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32" spread="17"/>
                    <measurement group_id="O2" value="17" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>preoperative, speech front and noise to the acoustic ear</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="18"/>
                    <measurement group_id="O2" value="6" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>preoperative, speech front and noise to the affected ear</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61" spread="28"/>
                    <measurement group_id="O2" value="24" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, speech front and noise front</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" spread="16"/>
                    <measurement group_id="O2" value="16" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, speech front and noise to the acoustic ear</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" spread="18"/>
                    <measurement group_id="O2" value="1" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, speech front and noise to the affected ear</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" spread="18"/>
                    <measurement group_id="O2" value="31" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.345</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Main effect: interval (p=0.027) and masker condition (p&lt;0.001). Interaction: interval and masker condition (p=0.345).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.577</p_value>
            <p_value_desc>Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Main effect: masker condition (p&lt;0.001) and interval (p=0.577). Interaction: interval and masker condition (p=0.055).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Pitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategy</title>
        <description>9 participants repeated the pitch perception task at the 12-month interval while listening to the CIS strategy. FS4 &amp; CIS strategies differ in whether or not fine structure cues are provided on the 4 most apical electrodes; there is no difference in the cues provided by electrode 5. An adaptive task compared the pitch of acoustic stimulation presented to the normal hearing ear with the stimulation from the cochlear implant. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / presented frequency information. Results are reported as the averaged normalized score for clicks &amp; tones for each electrode. A value of 1.0 indicates the perceived frequency was the same as the electric frequency information. A value &lt; 1.0 indicates a lower perceived pitch and a value &gt; 1.0 indicates a higher perceived pitch than the electric frequency information.</description>
        <time_frame>12-month interval</time_frame>
        <population>One participant did not complete testing for electrode 5</population>
        <group_list>
          <group group_id="O1">
            <title>Single-sided Deafness/Unilateral Hearing Loss Cohort</title>
            <description>participants with a cochlear implant in the affected ear and normal to near-normal hearing in the contralateral ear</description>
          </group>
        </group_list>
        <measure>
          <title>Pitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategy</title>
          <description>9 participants repeated the pitch perception task at the 12-month interval while listening to the CIS strategy. FS4 &amp; CIS strategies differ in whether or not fine structure cues are provided on the 4 most apical electrodes; there is no difference in the cues provided by electrode 5. An adaptive task compared the pitch of acoustic stimulation presented to the normal hearing ear with the stimulation from the cochlear implant. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / presented frequency information. Results are reported as the averaged normalized score for clicks &amp; tones for each electrode. A value of 1.0 indicates the perceived frequency was the same as the electric frequency information. A value &lt; 1.0 indicates a lower perceived pitch and a value &gt; 1.0 indicates a higher perceived pitch than the electric frequency information.</description>
          <population>One participant did not complete testing for electrode 5</population>
          <units>normalized score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>electrode 1, FS4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>electrode 1, CIS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>electrode 2, FS4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>electrode 2, CIS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>electrode 3, FS4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>electrode 3, CIS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>electrode 4, FS4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>electrode 4, CIS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>electrode 5, FS4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>electrode 5, CIS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>A linear mixed effect model assessed the main effects of stimulus, electrode, and coding strategy, and their interactions.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.023</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Main effect: coding strategy (p=0.023). Interaction: coding strategy and electrode (p=0.044). All other main effects and interactions were p&gt;0.160.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Paired samples t-tests evaluated whether pitch perception (mean normalized pitch) differed between coding strategy for each electrode.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.035</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>Pitch perception for electrode 1 (p=0.035). All other comparisons were p&gt;0.318.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Localization in the Unaided Condition and With a Bone-conduction Device, Measured in Root-mean-squared Error.</title>
        <description>Subjects were asked to identify the noise source from an 11-speaker array with a bone-conductive device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined. Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared at the preoperative and 12-month post-activation intervals.</description>
        <time_frame>preoperative and 12-month post-activation intervals.</time_frame>
        <population>One participant in the asymmetric group withdrew before the 12-month interval. Two additional participants in the asymmetric hearing loss group did not complete the procedure with the bone-conduction device at the 12-month interval.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Localization in the Unaided Condition and With a Bone-conduction Device, Measured in Root-mean-squared Error.</title>
          <description>Subjects were asked to identify the noise source from an 11-speaker array with a bone-conductive device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined. Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared at the preoperative and 12-month post-activation intervals.</description>
          <population>One participant in the asymmetric group withdrew before the 12-month interval. Two additional participants in the asymmetric hearing loss group did not complete the procedure with the bone-conduction device at the 12-month interval.</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>before surgery, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66" spread="20"/>
                    <measurement group_id="O2" value="76" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>before surgery, bone conduction device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" spread="19"/>
                    <measurement group_id="O2" value="76" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, unaided</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68" spread="18"/>
                    <measurement group_id="O2" value="79" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, bone conduction device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" spread="19"/>
                    <measurement group_id="O2" value="80" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.084</p_value>
            <method>ANOVA</method>
            <method_desc>Main effects: condition (p=0.960) and interval (p=0.084). Interaction: condition and interval (p=0.433).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.434</p_value>
            <method>ANOVA</method>
            <method_desc>Main effect: condition (p=0.434) or interval (p=0.687). Interaction: condition and interval (p=0.678).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Speech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences</title>
        <description>Speech recognition in noise with the AzBio sentences in 3 masker conditions (masker from the front, masker towards the better hearing ear, and masker towards the poorer hearing ear) at the preoperative and 12-month intervals in the unaided condition and with a bone-conduction device. Percent correct results were converted to rationalized arcsine units (RAUs) which helps to control for floor and ceiling effects in the perception correct data (e.g., &lt;20% correct).</description>
        <time_frame>preoperative interval and 12-month post-activation interval.</time_frame>
        <population>All participants in the UHL/SSD group completed the task at 0 dB SNR. Not all participants in the AHL group completed the task at 0 dB SNR.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
            <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
          <group group_id="O2">
            <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
            <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences</title>
          <description>Speech recognition in noise with the AzBio sentences in 3 masker conditions (masker from the front, masker towards the better hearing ear, and masker towards the poorer hearing ear) at the preoperative and 12-month intervals in the unaided condition and with a bone-conduction device. Percent correct results were converted to rationalized arcsine units (RAUs) which helps to control for floor and ceiling effects in the perception correct data (e.g., &lt;20% correct).</description>
          <population>All participants in the UHL/SSD group completed the task at 0 dB SNR. Not all participants in the AHL group completed the task at 0 dB SNR.</population>
          <units>rationalized arcsine units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>preop, unaided, masker towards better ear</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" spread="21"/>
                    <measurement group_id="O2" value="-13" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>preop, bone-conduction, masker towards better ear</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" spread="26"/>
                    <measurement group_id="O2" value="-5" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, unaided, masker towards better ear</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="23"/>
                    <measurement group_id="O2" value="-14" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, bone-conduction, masker towards better ear</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" spread="20"/>
                    <measurement group_id="O2" value="-18" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>preop, unaided, masker from front</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" spread="11"/>
                    <measurement group_id="O2" value="14" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>preop, bone-conduction, masker from front</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" spread="22"/>
                    <measurement group_id="O2" value="13" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, unaided, masker from front</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" spread="11"/>
                    <measurement group_id="O2" value="20" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, bone-conduction, masker from front</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" spread="17"/>
                    <measurement group_id="O2" value="12" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>preop, unaided, masker towards poorer ear</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" spread="12"/>
                    <measurement group_id="O2" value="40" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>preop, bone-conduction, masker towards poorer ear</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61" spread="33"/>
                    <measurement group_id="O2" value="22" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, unaided, masker towards poorerear</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86" spread="15"/>
                    <measurement group_id="O2" value="37" spread="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month, bone-conduction, masker from towards poorer ear</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" spread="10"/>
                    <measurement group_id="O2" value="29" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.935</p_value>
            <p_value_desc>Percent correct converted to rationalized arcsine units (RAU) prior to analysis.</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Main effects: condition (p=0.018), interval (p=0.012), and masker (p&lt;0.001). Interactions: interval and masker (p&lt;0.001). Other interactions: p&gt;0.117.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.977</p_value>
            <p_value_desc>A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Effects: interval (p=0.012) and masker (p&lt;0.001). Interactions: interval&amp;masker (p=0.020) &amp; condition, interval, &amp;masker (p=0.035). Others: (p&gt;0.131).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months post-activation</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group</title>
          <description>Cochlear implantation of the affected ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
        </group>
        <group group_id="E2">
          <title>Cochlear Implant: Asymmetric Hearing Loss Group</title>
          <description>Cochlear implantation of the poorer hearing ear&#xD;
Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss</description>
        </group>
        <group group_id="E3">
          <title>Control Group (Recipients of a Bone-conduction Device)</title>
          <description>Recipients of a bone-conduction device (alternative treatment technology) with at least 12 months of device use.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>vertigo / dizziness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>light-headedness &amp; nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>imbalance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>nystagmus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>drainage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>facial stimulation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>bleeding at surgical site</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>short circuit</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Unable to reach maximum enrollment in the control group (bone conduction device users).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Margaret Dillon</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>9199665251</phone>
      <email>mdillon@med.unc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02203305
org study id: 14-1544
nct id: NCT02203305
lead sponsor: 
collaborator: 
The primary goal of this project is to determine whether subjects with Single-Sided Deafness
      (SSD) experience an improvement in speech perception, localization, and quality of life with
      a cochlear implant as compared to an unaided listening condition.
Single-sided deafness (SSD) can be defined as moderate-to-profound sensorineural hearing loss
      with limited speech perception benefit in one ear and normal hearing in the contralateral
      ear. Though one ear is within the normal hearing limits, SSD may result in reduced speech
      perception in noise, variable abilities on localization tasks, increased subjective report of
      hearing handicap, and reduced quality of life.

      This patient population cannot utilize conventional amplification due to the severity of the
      hearing loss and poor speech discrimination abilities in the affected ear. Current treatment
      options include: contralateral routing of the signal (CROS) hearing aids, and bone-conduction
      devices. A CROS hearing aid is a two-part system that includes a microphone/transmitter on
      the affected ear and a receiver on the normal hearing ear. The microphone/transmitter sends
      the acoustic signal from the affected ear to the receiver, which is presented to the normal
      hearing ear. Bone-conduction devices utilize a percutaneous, implanted titanium abutment to
      send the acoustic signal from the affected side to the normal hearing ear via vibrations. The
      goal of both of these technologies is to send the signal from the affected side to the normal
      hearing side, thereby leaving the patient in a unilateral listening condition.

      Though CROS hearing aids and bone-conduction devices provide the patient with auditory
      information from both sides to the better hearing ear, the ability to use binaural cues for
      speech perception in noise is variable.

      It is of interest whether cochlear implantation of the affected ear would benefit the SSD
      population. A cochlear implant is a two-part system, including the internal electrode array
      and external speech processor. The internal electrode array is surgically implanted into the
      affected cochlea. The external speech processor receives sounds and transmits this signal to
      the internal portion. The electrode array presents the acoustic signal via electrical pulses
      within the cochlea, which is interpreted by the brain as sound.

      Presumably, cochlear implantation may provide the SSD population improvements in speech
      perception in the affected ear, which cannot benefit from appropriately fit hearing aids.
      Cochlear implantation may provide a benefit over current treatment options in the SSD
      population, as it stimulates the auditory pathway on the affected side, thus allowing for
      ipsilateral representation of acoustic signals arriving to each ear independently.

      The primary goal of this project is to determine whether subjects with SSD experience an
      improvement in speech perception, localization, and quality of life with a cochlear implant
      as compared to an unaided listening condition. Secondary aims include: 1) a comparison of
      speech perception, localization, and quality of life outcomes in the study population to a
      SSD control group with long-term listening experience with a current treatment option (i.e.
      bone-conduction device), and 2) a within-subject comparison of speech perception and
      localization abilities with cochlear implantation versus the bone-conduction test device.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Word Recognition in Quiet Over Time
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use.
measure: Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.
measure: Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.
measure: Change in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the normal/better hearing ear. Scored as the percent correctly repeated.
measure: Change in Localization Results (Measured in Variable Error) Over Time
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in variable error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.
measure: Change in Localization Results (Measured in Constant Error) Over Time
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.
measure: Change in Localization Results (Measured in Adjusted Constant Error) Over Time
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in adjusted constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.
measure: Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.
measure: Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Subjects completed subjective questionnaires to order to evaluate the perceived benefits of cochlear implantation. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.
measure: Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as the percent correctly repeated.
measure: Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 10-talker masker from the front speaker. Scored as the percent correctly repeated.
measure: Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 4-talker masker from the front speaker. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower numbers indicate better performance (range -7.5 to 23.5 dB SNR).
measure: Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the normal/better hearing ear. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. A lower value indicates better performance (range -7.5 to 23.5 dB SNR).
measure: Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower values indicate better performance (range -7.5 to 23.5 dB SNR).
measure: Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)
time frame: preoperative interval and 12 month post-activation interval
description: Results on recorded speech perception materials: aided word recognition. Recorded 50-word CNC words were evaluated preoperatively with a conventional hearing aid. Performance was compared to the CI alone at the 12 month interval. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores <20%).
measure: Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus with a bone-conduction device. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance.
measure: Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)
time frame: preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)
description: Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.
measure: Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)
time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
description: Subjects completed subjective questionnaires. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.
measure: Subjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)
time frame: preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)
description: Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.
measure: Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)
time frame: preoperative interval and 12 month post-activation interval
description: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.
measure: Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)
time frame: preoperative interval and 12 month post-activation interval
description: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.
measure: Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)
time frame: preoperative interval and 12 month post-activation interval
description: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.
measure: Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)
time frame: preoperative interval and 12 month post-activation interval
description: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).
measure: Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)
time frame: preoperative interval and 12 month post-activation interval
description: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).
measure: Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)
time frame: preoperative interval and 12 month post-activation interval
description: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).
measure: Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)
time frame: Assessment completed after 12 months of implantable bone-conduction listening experience
description: The speech perception (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 10-talker masker at 0 dB SNR with the target speech presented from the front and the masker (1) presented from the front (SoNo), (2) presented towards the implanted ear (SoNbc), and (3) presented towards the acoustic ear (SoNnh). Performance was scored as the percent of words correctly repeated, with higher values indicating better performance. The task was completed with the participants listening with their bone-conduction device on versus off.
measure: Speech Recognition in Noise for a Control Group: BKB-SIN Test
time frame: Assessment completed after 12 months of implantable bone-conduction listening experience
description: The speech perception outcomes in the study population (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 4-talker masker with the target speech presented from the front and the masker (1) presented from the front, (2) presented towards the implanted ear, and (3) presented towards the acoustic ear. Performance was scored as the dB SNR when the participant understood 50% correct, with lower values indicating better performance. Participants completed the task with the device on and off.
measure: Localization for a Control Group
time frame: Assessment completed after 12 months of implantable bone-conduction listening experience
description: Subjects were asked to identify the noise source from an 11-speaker array with the bone-conduction device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Subjects in the control group were implantable bone-conduction device recipients (alternative treatment option) with at least 12 months of listening experience with their implanted bone-conduction device. Participants completed the task with their device on and off.
measure: Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)
time frame: Assessment completed after 12 months of implantable bone-conduction listening experience
description: Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the average responses across questions for each subscale (Speech Hearing, Spatial Hearing, and Qualities of Hearing). Results are also reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.
Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.
measure: Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)
time frame: Assessment completed after 12 months of implantable bone-conduction listening experience
description: Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Results are reported as the average responses for each of the four subscales: ease of communication, reverberation, effectiveness in background noise, and reverberation. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.
Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.
measure: Change in Pitch Perception With the Cochlear Implant Over the Post-activation Period
time frame: post-activation period (1, 3, 6, and 12 months post-activation)
description: Participants completed an adaptive pitch matching task that compared the pitch of acoustic stimulation presented to their normal hearing ear with the perception of stimulation from the cochlear implant. Two stimuli were used: clicks & tones. Pitch perception was evaluated for the 5 most apical electrodes. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / frequency information presented by the electrode. Results are reported as the averaged normalized score for clicks & tones for each electrode (electrodes 1-5) at each interval (1, 3, 6, and 12 months post-activation). A value of 1.0 indicates the participant perceived the same frequency as the center frequency presented by the electrode. A value < 1.0 indicates a lower perceived pitch and a value > 1.0 indicates a higher perceived pitch than the electric frequency information.
arm group label: Cochlear Implant
arm group type: Experimental
description: Cochlear implantation of the affected ear
arm group label: Control Group
arm group type: Other
description: A control group without the study intervention (cochlear implantation) will complete the test battery.
arm group label: Cochlear Implant: Asymmetric hearing loss
arm group type: Experimental
description: Cochlear implantation of the poorer hearing ear
intervention type: Device
intervention name: Cochlear Implant
description: cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss
arm group label: Cochlear Implant
arm group label: Cochlear Implant: Asymmetric hearing loss
other name: MED-EL CONCERT cochlear implant system
other name: MED-EL SYNCHRONY cochlear implant system
intervention type: Other
intervention name: Control Group
description: Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD.
arm group label: Control Group
other name: bone-conduction device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Margaret Dillon, AuD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
citation: Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011 Jan;32(1):39-47. doi: 10.1097/MAO.0b013e3181fcf271.
PMID: 21068690
citation: Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012 Oct;33(8):1339-46. doi: 10.1097/MAO.0b013e318268d52d.
PMID: 22935813
citation: Hansen MR, Gantz BJ, Dunn C. Outcomes after cochlear implantation for patients with single-sided deafness, including those with recalcitrant Meniere's disease. Otol Neurotol. 2013 Dec;34(9):1681-7. doi: 10.1097/MAO.0000000000000102.
PMID: 24232066
citation: Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13.
PMID: 19005250
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Unable to reach maximum enrollment in the control group (bone conduction device users).
point of contact: 