<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/NCT01715948</url>
  </required_header>
  <id_info>
    <org_study_id>CDHA-RS/2013-118</org_study_id>
    <nct_id>NCT01715948</nct_id>
  </id_info>
  <brief_title>A Comparison Between Wireless CROS and Bone-anchored Hearing Devices for Single-Sided Deafness: A Pilot Study</brief_title>
  <official_title>A Comparison Between Wireless CROS and Bone-anchored Hearing Devices for Single-Sided Deafness: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manohar Bance</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dalhousie University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      People with single-sided deafness (SSD) have significant hearing loss in one ear and normal&#xD;
      or near normal hearing in the other ear. Those living with SSD experience several&#xD;
      communication difficulties, particularly when listening to speech in the presence of&#xD;
      background noise. This problem is worse in situations where the noise is on the side of the&#xD;
      good ear and the speech is on the side of the poor ear.&#xD;
&#xD;
      The Bone-anchored hearing device (BAHD) and the Contralateral Routing of Signals (CROS)&#xD;
      hearing aid are two intervention methods designed to improve hearing in people who have&#xD;
      significant hearing loss in one ear only. The BAHD is a surgically implanted device which&#xD;
      also includes an external processor; sounds from the poor ear are transmitted to the good ear&#xD;
      through skull vibrations. The CROS does not involve surgery; instead a hearing aid is fitted&#xD;
      behind each ear, and the sounds on the side of the poor ear are wirelessly transmitted to the&#xD;
      good ear.&#xD;
&#xD;
      The majority of previous studies comparing the BAHD to the CROS have used older CROS models&#xD;
      with basic technology and a wire along the neck to send sounds from the poor ear to the good&#xD;
      ear. There is a lack of studies comparing newer digital wireless CROS hearing aids to the&#xD;
      BAHD. The current research will compare the effect of the BAHD and CROS hearing aid on speech&#xD;
      perception scores when listening to speech in quiet and in noise. The research will also&#xD;
      investigate participants' reported benefits with each device during everyday situations. In&#xD;
      order to compare the BAHD and CROS, individuals who already have been implanted with a BAHD&#xD;
      will be given a trial period with a new wireless digital CROS hearing aid.&#xD;
&#xD;
      The research hypothesis states that the CROS hearing aid will be as equally beneficial or&#xD;
      greater than the BAHD in improving hearing and participant benefit. If the findings support&#xD;
      the hypothesis that the CROS offers just as much benefits as the BAHD, or is an even better&#xD;
      alternative, more individuals with SSD may choose to avoid surgery and decide to receive a&#xD;
      CROS hearing aid instead.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Users of the BAHD will be given a 2-week trial period with the Unitron Tandem CROS hearing&#xD;
      aid. Participants will be randomly assigned to wear either their BAHD for two weeks or the&#xD;
      trial CROS for two weeks. There will be a total of three visits made to the clinic.&#xD;
&#xD;
      During each visit:&#xD;
&#xD;
        -  Participants' hearing will be tested (either with the BAHD, the CROS, or without wearing&#xD;
           any device).&#xD;
&#xD;
        -  Speech perception ability will be tested in quiet and in noise conditions (either while&#xD;
           wearing the BAHD, the CROS, or no device).&#xD;
&#xD;
        -  Participants will be asked to complete two standardized questionnaires on the perceived&#xD;
           benefits that the BAHD or the CROS provides.&#xD;
&#xD;
      In addition, participants will be asked to fill out a short diary form every day, for a&#xD;
      two-week period, to report the situations in which they wore the device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>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>Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise</measure>
    <time_frame>The QuickSIN unaided was administered at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested).</time_frame>
    <description>One speech-in-noise test (QuickSIN) presented four lists of six pre-recorded sentences at 50 dB hearing level (HL) in soundfield. Multitalker noise was presented together with the target sentence and increased at a fixed number of dB with the completion of each sentence. The multitalker noise was initially presented at 25 dB HL (signal-to-noise ratio - SNR of 25 dB), and increased by 5 dB after each sentence until the multitalker noise was of equal intensity with the final sentence (SNR of 0 dB). In one condition, two lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the poor ear. In the other condition, two different lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the better ear. The two scores derived from the two different lists of sentences presented within each condition were averaged. A low score indicates better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Words Recognized</measure>
    <time_frame>Word recognition testing (unaided) occurred at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested)..</time_frame>
    <description>Word recognition was tested with the recorded version of the Central Institute for the Deaf (CID) W-22 (Auditec of St. Louis), with a different list of 25 monosyllabic words presented at 50 dB HL in three randomized listening conditions. In the first condition, one list was presented at 50 dB HL at 90 degrees to the poor ear in quiet. In the second condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was presented at 45 dB HL at 90 degrees to the poor ear. In the final condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was delivered at 45 dB HL at 90 degrees to the better ear.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech Spatial Qualities Questionnaire (SSQ)</measure>
    <time_frame>Administered at the end of a 2 week trial with the CROS and at the end of a 2 week use of the BAHD.</time_frame>
    <description>The Speech Spatial Qualities Questionnaire (SSQ) was given to assess the self-perceived benefits provided by the device that was worn the previous 2 weeks. The SSQ requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (&quot;Not at all&quot;) to 10 (&quot;Perfectly&quot;). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. Therefore, a lower score indicated poorer self-perceived benefit from the device (representing a worse outcome), while a higher score indicated greater self-perceived benefit from the device (representing a better outcome). To obtain individual scores for the SSQ questionnaire, the ratings for each listening scenario were summed. The mean, minimum and maximum scores for each subscale of the SSQ across all participants were also determined.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Unilateral Hearing Loss</condition>
  <condition>Unilateral Deafness</condition>
  <arm_group>
    <arm_group_label>CROS hearing aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted with a retainer earhook on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to a slim tube and open ear tip. The CROS does not amplify sound but rather transmits sound from the side of the unaidable ear to the contralateral ear, overcoming the head shadow effect that presents with SSD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bone-anchored hearing device (BAHD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The BAHD (such as the Baha by Cochlear or Bone-Bridge by MED-EL) also helps to alleviate the negative effect of head shadow and the difficulty with speech perception in noise that present with SSD. Also known as an osseointegrated aural prosthesis, the BAHD is implanted in individuals with SSD to stimulate the ear with the normal cochlea. The BAHD requires that a titanium screw be surgically implanted in the temporal bone on the side of the poor ear. This titanium screw is connected to a percutaneous abutment. An electromechanical sound processor (external transducer) is coupled onto the abutment and can be removed when necessary. Sound can now be routed to the better ear by transcranial bone conduction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CROS hearing aid</intervention_name>
    <description>Participants were randomly assigned to be fitted with the CROS hearing aid either at the end of the first visit or at the end of the second visit. They were given a 2-week trial with the CROS and asked to refrain from wearing their BAHD during that time. At the end of the first visit, four participants were fitted with the CROS hearing aid and were subsequently tested with this device on their second visit, at which time they were instructed to use the BAHD for the next 2 weeks. This protocol was reversed in the other four participants, with testing after each device experience. Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries.</description>
    <arm_group_label>CROS hearing aid</arm_group_label>
    <other_name>Unitron Tandem 4 CROS hearing aid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bone-anchored hearing device (BAHD)</intervention_name>
    <description>All participants had received BAHD implantation prior to the study. They were randomly selected to continue wearing their BAHD for 2 weeks following the end of the first visit or the end of the second visit. Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries.</description>
    <arm_group_label>Bone-anchored hearing device (BAHD)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with unilateral deafness (hearing loss in only one ear) who received BAHD&#xD;
             surgery less than 3 years ago&#xD;
&#xD;
          -  Severe to profound hearing loss in the poor ear and normal hearing in the good ear&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults who underwent BAHD surgery more than 3 years ago&#xD;
&#xD;
          -  Adults with hearing loss in both ears&#xD;
&#xD;
          -  Adults who received a BAHD to treat a condition other than unilateral deafness (such&#xD;
             as bilateral conductive hearing loss)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manohar Bance, FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Capital Health, Canada</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rachel Caissie, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dalhousie University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Finbow, B.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dalhousie University</affiliation>
  </overall_official>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <results_first_submitted>September 9, 2015</results_first_submitted>
  <results_first_submitted_qc>March 7, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 5, 2016</results_first_posted>
  <last_update_submitted>March 7, 2016</last_update_submitted>
  <last_update_submitted_qc>March 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Manohar Bance</investigator_full_name>
    <investigator_title>Staff Physician Division of Otolaryngology</investigator_title>
  </responsible_party>
  <keyword>CROS hearing aid</keyword>
  <keyword>Bone-anchored hearing device</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>
    <mesh_term>Hearing Loss, Unilateral</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Contralateral Routing of Signals (CROS) Hearing Aid</title>
          <description>Participants who have been implanted with a bone-anchored hearing device (BAHD) over the past three years will be given a two-week trial period with a Contralateral Routing of Signals (CROS) hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.&#xD;
Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>A Comparison Between Wireless CROS and BAHD for SSD</title>
          <description>Participants who have been implanted with a BAHD over the past three years will be given a two-week trial period with a CROS hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.&#xD;
CROS hearing aid: BAHD users will be fitted with the CROS hearing aid for a two-week trial period. Their hearing abilities with the CROS hearing aid will be compared to their hearing abilities with their BAHD over a two-week period.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54" lower_limit="44" upper_limit="66"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise</title>
        <description>One speech-in-noise test (QuickSIN) presented four lists of six pre-recorded sentences at 50 dB hearing level (HL) in soundfield. Multitalker noise was presented together with the target sentence and increased at a fixed number of dB with the completion of each sentence. The multitalker noise was initially presented at 25 dB HL (signal-to-noise ratio - SNR of 25 dB), and increased by 5 dB after each sentence until the multitalker noise was of equal intensity with the final sentence (SNR of 0 dB). In one condition, two lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the poor ear. In the other condition, two different lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the better ear. The two scores derived from the two different lists of sentences presented within each condition were averaged. A low score indicates better performance.</description>
        <time_frame>The QuickSIN unaided was administered at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>QuickSIN Noise to Better Ear Unaided</title>
            <description>Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing no device. The multitalker noise increases with each sentence presentation such that the signal-to-noise ratio decreases from 25 to 0 dB, in 5-dB steps, over the six sentences.</description>
          </group>
          <group group_id="O2">
            <title>QuickSIN Noise to Better Ear With BAHD</title>
            <description>Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the BAHD.</description>
          </group>
          <group group_id="O3">
            <title>QuickSIN Noise to Better Ear With CROS</title>
            <description>Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the CROS.</description>
          </group>
          <group group_id="O4">
            <title>QuickSIN Noise to Poorer Ear Unaided</title>
            <description>Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing no device.</description>
          </group>
          <group group_id="O5">
            <title>QuickSIN Noise to Poorer Ear With BAHD</title>
            <description>Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the BAHD.</description>
          </group>
          <group group_id="O6">
            <title>QuickSIN Noise to Poorer Ear With CROS</title>
            <description>Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the CROS.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise</title>
          <description>One speech-in-noise test (QuickSIN) presented four lists of six pre-recorded sentences at 50 dB hearing level (HL) in soundfield. Multitalker noise was presented together with the target sentence and increased at a fixed number of dB with the completion of each sentence. The multitalker noise was initially presented at 25 dB HL (signal-to-noise ratio - SNR of 25 dB), and increased by 5 dB after each sentence until the multitalker noise was of equal intensity with the final sentence (SNR of 0 dB). In one condition, two lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the poor ear. In the other condition, two different lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the better ear. The two scores derived from the two different lists of sentences presented within each condition were averaged. A low score indicates better performance.</description>
          <units>words</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.44" lower_limit="4.461" upper_limit="6.419"/>
                    <measurement group_id="O2" value="3.5" lower_limit="2.646" upper_limit="4.354"/>
                    <measurement group_id="O3" value="4.75" lower_limit="3.815" upper_limit="5.685"/>
                    <measurement group_id="O4" value="-1.75" lower_limit="-2.346" upper_limit="-1.154"/>
                    <measurement group_id="O5" value="0.75" lower_limit="-0.089" upper_limit="1.589"/>
                    <measurement group_id="O6" value="2.38" lower_limit="1.786" upper_limit="2.974"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Words Recognized</title>
        <description>Word recognition was tested with the recorded version of the Central Institute for the Deaf (CID) W-22 (Auditec of St. Louis), with a different list of 25 monosyllabic words presented at 50 dB HL in three randomized listening conditions. In the first condition, one list was presented at 50 dB HL at 90 degrees to the poor ear in quiet. In the second condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was presented at 45 dB HL at 90 degrees to the poor ear. In the final condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was delivered at 45 dB HL at 90 degrees to the better ear.</description>
        <time_frame>Word recognition testing (unaided) occurred at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested)..</time_frame>
        <population>The researchers chose not to include a condition with words presented at 90 degrees to the better ear in quiet.</population>
        <group_list>
          <group group_id="O1">
            <title>WRS Noise to Better Ear</title>
            <description>Word recognition was tested with words presented from the front and multitalker noise (at 45 dB HL) at 90 degrees azimuth to the better ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.</description>
          </group>
          <group group_id="O2">
            <title>WRS Noise to Poorer Ear</title>
            <description>Word recognition was tested with words presented from the front and multitalker noise (at 45 dB HL) at 90 degrees azimuth to the poorer ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.</description>
          </group>
          <group group_id="O3">
            <title>WRS in Quiet to Poorer Ear</title>
            <description>Word recognition was tested with no noise (quiet) with words presented at 90 degrees azimuth to the poorer ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Words Recognized</title>
          <description>Word recognition was tested with the recorded version of the Central Institute for the Deaf (CID) W-22 (Auditec of St. Louis), with a different list of 25 monosyllabic words presented at 50 dB HL in three randomized listening conditions. In the first condition, one list was presented at 50 dB HL at 90 degrees to the poor ear in quiet. In the second condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was presented at 45 dB HL at 90 degrees to the poor ear. In the final condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was delivered at 45 dB HL at 90 degrees to the better ear.</description>
          <population>The researchers chose not to include a condition with words presented at 90 degrees to the better ear in quiet.</population>
          <units>Percentage of words perceived correctly</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unaided Condition</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.5" lower_limit="42.23" upper_limit="54.77"/>
                    <measurement group_id="O2" value="78" lower_limit="74.56" upper_limit="81.44"/>
                    <measurement group_id="O3" value="96" lower_limit="94.25" upper_limit="97.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BAHD Condition</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5" lower_limit="55.81" upper_limit="69.19"/>
                    <measurement group_id="O2" value="77" lower_limit="70.97" upper_limit="83.03"/>
                    <measurement group_id="O3" value="97" lower_limit="94.77" upper_limit="99.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CROS Condition</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62" lower_limit="57.48" upper_limit="66.52"/>
                    <measurement group_id="O2" value="66.5" lower_limit="60.22" upper_limit="72.78"/>
                    <measurement group_id="O3" value="94.5" lower_limit="91.85" upper_limit="97.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Speech Spatial Qualities Questionnaire (SSQ)</title>
        <description>The Speech Spatial Qualities Questionnaire (SSQ) was given to assess the self-perceived benefits provided by the device that was worn the previous 2 weeks. The SSQ requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (&quot;Not at all&quot;) to 10 (&quot;Perfectly&quot;). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. Therefore, a lower score indicated poorer self-perceived benefit from the device (representing a worse outcome), while a higher score indicated greater self-perceived benefit from the device (representing a better outcome). To obtain individual scores for the SSQ questionnaire, the ratings for each listening scenario were summed. The mean, minimum and maximum scores for each subscale of the SSQ across all participants were also determined.</description>
        <time_frame>Administered at the end of a 2 week trial with the CROS and at the end of a 2 week use of the BAHD.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SSQ Subscale - Speech (BAHD)</title>
            <description>Participants rated the effectiveness of the BAHD for listening situations included in the Speech subscale of the SSQ on a 10-point scale.</description>
          </group>
          <group group_id="O2">
            <title>SSQ Subscale - Speech (CROS)</title>
            <description>Participants rated the effectiveness of the CROS for listening situations included in the Speech subscale of the SSQ on a 10-point scale.</description>
          </group>
          <group group_id="O3">
            <title>SSQ Subscale - Spatial (BAHD)</title>
            <description>Participants rated the effectiveness of the BAHD for listening situations included in the Spatial subscale of the SSQ on a 10-point scale.</description>
          </group>
          <group group_id="O4">
            <title>SSQ Subscale - Spatial (CROS)</title>
            <description>Participants rated the effectiveness of the CROS for listening situations included in the Spatial subscale of the SSQ on a 10-point scale.</description>
          </group>
          <group group_id="O5">
            <title>SSQ Subscale - Qualities (BAHD)</title>
            <description>Participants rated the effectiveness of the BAHD for listening situations included in the Qualities subscale of the SSQ on a 10-point scale.</description>
          </group>
          <group group_id="O6">
            <title>SSQ Subscale - Qualities (CROS)</title>
            <description>Participants rated the effectiveness of the CROS for listening situations included in the Qualities subscale of the SSQ on a 10-point scale.</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Spatial Qualities Questionnaire (SSQ)</title>
          <description>The Speech Spatial Qualities Questionnaire (SSQ) was given to assess the self-perceived benefits provided by the device that was worn the previous 2 weeks. The SSQ requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (&quot;Not at all&quot;) to 10 (&quot;Perfectly&quot;). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. Therefore, a lower score indicated poorer self-perceived benefit from the device (representing a worse outcome), while a higher score indicated greater self-perceived benefit from the device (representing a better outcome). To obtain individual scores for the SSQ questionnaire, the ratings for each listening scenario were summed. The mean, minimum and maximum scores for each subscale of the SSQ across all participants were also determined.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.56" lower_limit="5.112" upper_limit="6.008"/>
                    <measurement group_id="O2" value="5.79" lower_limit="5.365" upper_limit="6.215"/>
                    <measurement group_id="O3" value="4.24" lower_limit="3.727" upper_limit="4.753"/>
                    <measurement group_id="O4" value="4.45" lower_limit="3.702" upper_limit="5.198"/>
                    <measurement group_id="O5" value="6.89" lower_limit="6.431" upper_limit="7.349"/>
                    <measurement group_id="O6" value="7.12" lower_limit="6.43" upper_limit="7.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>BAHD</title>
          <description>The intervention during which the BAHD was trialed as part of the cross-over design</description>
        </group>
        <group group_id="E2">
          <title>CROS Aid</title>
          <description>The intervention during which the CROS aid was trialed as part of the cross-over design</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>The sample size was small and included only one male. The trial period of two weeks was short and may not have provided enough time for participants to adjust to the new CROS. The long-term benefit of both hearing devices needs to be assessed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Manohar Bance</name_or_title>
      <organization>Capital Health</organization>
      <phone>902-473-5975</phone>
      <email>m.bance@dal.ca</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/NCT01715948
org study id: CDHA-RS/2013-118
nct id: NCT01715948
lead sponsor: 
collaborator: 
has dmc: No
People with single-sided deafness (SSD) have significant hearing loss in one ear and normal
      or near normal hearing in the other ear. Those living with SSD experience several
      communication difficulties, particularly when listening to speech in the presence of
      background noise. This problem is worse in situations where the noise is on the side of the
      good ear and the speech is on the side of the poor ear.

      The Bone-anchored hearing device (BAHD) and the Contralateral Routing of Signals (CROS)
      hearing aid are two intervention methods designed to improve hearing in people who have
      significant hearing loss in one ear only. The BAHD is a surgically implanted device which
      also includes an external processor; sounds from the poor ear are transmitted to the good ear
      through skull vibrations. The CROS does not involve surgery; instead a hearing aid is fitted
      behind each ear, and the sounds on the side of the poor ear are wirelessly transmitted to the
      good ear.

      The majority of previous studies comparing the BAHD to the CROS have used older CROS models
      with basic technology and a wire along the neck to send sounds from the poor ear to the good
      ear. There is a lack of studies comparing newer digital wireless CROS hearing aids to the
      BAHD. The current research will compare the effect of the BAHD and CROS hearing aid on speech
      perception scores when listening to speech in quiet and in noise. The research will also
      investigate participants' reported benefits with each device during everyday situations. In
      order to compare the BAHD and CROS, individuals who already have been implanted with a BAHD
      will be given a trial period with a new wireless digital CROS hearing aid.

      The research hypothesis states that the CROS hearing aid will be as equally beneficial or
      greater than the BAHD in improving hearing and participant benefit. If the findings support
      the hypothesis that the CROS offers just as much benefits as the BAHD, or is an even better
      alternative, more individuals with SSD may choose to avoid surgery and decide to receive a
      CROS hearing aid instead.
Users of the BAHD will be given a 2-week trial period with the Unitron Tandem CROS hearing
      aid. Participants will be randomly assigned to wear either their BAHD for two weeks or the
      trial CROS for two weeks. There will be a total of three visits made to the clinic.

      During each visit:

        -  Participants' hearing will be tested (either with the BAHD, the CROS, or without wearing
           any device).

        -  Speech perception ability will be tested in quiet and in noise conditions (either while
           wearing the BAHD, the CROS, or no device).

        -  Participants will be asked to complete two standardized questionnaires on the perceived
           benefits that the BAHD or the CROS provides.

      In addition, participants will be asked to fill out a short diary form every day, for a
      two-week period, to report the situations in which they wore the device.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise
time frame: The QuickSIN unaided was administered at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested).
description: One speech-in-noise test (QuickSIN) presented four lists of six pre-recorded sentences at 50 dB hearing level (HL) in soundfield. Multitalker noise was presented together with the target sentence and increased at a fixed number of dB with the completion of each sentence. The multitalker noise was initially presented at 25 dB HL (signal-to-noise ratio - SNR of 25 dB), and increased by 5 dB after each sentence until the multitalker noise was of equal intensity with the final sentence (SNR of 0 dB). In one condition, two lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the poor ear. In the other condition, two different lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the better ear. The two scores derived from the two different lists of sentences presented within each condition were averaged. A low score indicates better performance.
measure: Percentage of Words Recognized
time frame: Word recognition testing (unaided) occurred at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested)..
description: Word recognition was tested with the recorded version of the Central Institute for the Deaf (CID) W-22 (Auditec of St. Louis), with a different list of 25 monosyllabic words presented at 50 dB HL in three randomized listening conditions. In the first condition, one list was presented at 50 dB HL at 90 degrees to the poor ear in quiet. In the second condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was presented at 45 dB HL at 90 degrees to the poor ear. In the final condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was delivered at 45 dB HL at 90 degrees to the better ear.
measure: Speech Spatial Qualities Questionnaire (SSQ)
time frame: Administered at the end of a 2 week trial with the CROS and at the end of a 2 week use of the BAHD.
description: The Speech Spatial Qualities Questionnaire (SSQ) was given to assess the self-perceived benefits provided by the device that was worn the previous 2 weeks. The SSQ requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 ("Not at all") to 10 ("Perfectly"). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. Therefore, a lower score indicated poorer self-perceived benefit from the device (representing a worse outcome), while a higher score indicated greater self-perceived benefit from the device (representing a better outcome). To obtain individual scores for the SSQ questionnaire, the ratings for each listening scenario were summed. The mean, minimum and maximum scores for each subscale of the SSQ across all participants were also determined.
arm group label: CROS hearing aid
arm group type: Experimental
description: The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted with a retainer earhook on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to a slim tube and open ear tip. The CROS does not amplify sound but rather transmits sound from the side of the unaidable ear to the contralateral ear, overcoming the head shadow effect that presents with SSD.
arm group label: Bone-anchored hearing device (BAHD)
arm group type: Experimental
description: The BAHD (such as the Baha by Cochlear or Bone-Bridge by MED-EL) also helps to alleviate the negative effect of head shadow and the difficulty with speech perception in noise that present with SSD. Also known as an osseointegrated aural prosthesis, the BAHD is implanted in individuals with SSD to stimulate the ear with the normal cochlea. The BAHD requires that a titanium screw be surgically implanted in the temporal bone on the side of the poor ear. This titanium screw is connected to a percutaneous abutment. An electromechanical sound processor (external transducer) is coupled onto the abutment and can be removed when necessary. Sound can now be routed to the better ear by transcranial bone conduction.
intervention type: Device
intervention name: CROS hearing aid
description: Participants were randomly assigned to be fitted with the CROS hearing aid either at the end of the first visit or at the end of the second visit. They were given a 2-week trial with the CROS and asked to refrain from wearing their BAHD during that time. At the end of the first visit, four participants were fitted with the CROS hearing aid and were subsequently tested with this device on their second visit, at which time they were instructed to use the BAHD for the next 2 weeks. This protocol was reversed in the other four participants, with testing after each device experience. Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries.
arm group label: CROS hearing aid
other name: Unitron Tandem 4 CROS hearing aid
intervention type: Device
intervention name: Bone-anchored hearing device (BAHD)
description: All participants had received BAHD implantation prior to the study. They were randomly selected to continue wearing their BAHD for 2 weeks following the end of the first visit or the end of the second visit. Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries.
arm group label: Bone-anchored hearing device (BAHD)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Manohar Bance, FRCS
role: Principal Investigator
affiliation: Capital Health, Canada
last name: Rachel Caissie, Ph.D.
role: Principal Investigator
affiliation: Dalhousie University
last name: Jennifer Finbow, B.Sc.
role: Principal Investigator
affiliation: Dalhousie University
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Manohar Bance
investigator title: Staff Physician Division of Otolaryngology
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Unilateral
sharing ipd: Yes
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The sample size was small and included only one male. The trial period of two weeks was short and may not have provided enough time for participants to adjust to the new CROS. The long-term benefit of both hearing devices needs to be assessed.
point of contact: 