<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/NCT02189798</url>
  </required_header>
  <id_info>
    <org_study_id>CR0114</org_study_id>
    <nct_id>NCT02189798</nct_id>
  </id_info>
  <brief_title>Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness</brief_title>
  <official_title>Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advanced Bionics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Advanced Bionics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing&#xD;
      sensitivity can be preserved in newly implanted adults with partial deafness (considerable&#xD;
      low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural&#xD;
      hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™&#xD;
      Mid-Scala electrode to support the development of electro-acoustic stimulation technology&#xD;
      (EAS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Thirty-six subjects wore the EAS processor for as long as 84 months without any significant&#xD;
    safety issues. Sufficient data gained to support EAS technology development for safe use in&#xD;
    subjects with residual low-frequency acoustic hearing sensitivity.&#xD;
  </why_stopped>
  <start_date type="Actual">October 21, 2014</start_date>
  <completion_date type="Actual">March 29, 2022</completion_date>
  <primary_completion_date type="Actual">March 29, 2022</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>Parallel Assignment</intervention_model>
    <intervention_model_description>The two main arms are conducted in parallel. The third arm is optional for subjects who complete either of the two main arms using the EAS sound processor.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Unaided pure-tone hearing threshold measurements</measure>
    <time_frame>Three months</time_frame>
    <description>Unaided pure tone hearing threshold measurement in the implanted ear 3 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech perception testing</measure>
    <time_frame>Up to 19 months</time_frame>
    <description>Speech perception testing (in quiet and noise) in the treated ear compared to pre-implant speech perception testing (in quiet and noise)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Questionnaire data</measure>
    <time_frame>Up to 19 months</time_frame>
    <description>Speech, Spatial Qualities (SSQ) questionnaire, Abbreviated Profile of Hearing Aid Benefits (APHAB) and Sponsored Development questionnaires post-implant compared to pre-implant condition</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hearing Loss</condition>
  <condition>Partial Deafness</condition>
  <condition>Hearing Disorders</condition>
  <condition>Ear Diseases</condition>
  <condition>Otorhinolaryngologic Diseases</condition>
  <arm_group>
    <arm_group_label>Newly Implanted Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Existing Implanted Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EAS Extended Use Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adults who are unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness and completed the 12 Month visit using the EAS sound processor in either the Newly Implanted Group or Existing Implanted Group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode</intervention_name>
    <description>HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).</description>
    <arm_group_label>Newly Implanted Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EAS sound processor</intervention_name>
    <description>Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.</description>
    <arm_group_label>EAS Extended Use Arm</arm_group_label>
    <arm_group_label>Existing Implanted Group</arm_group_label>
    <arm_group_label>Newly Implanted Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria: Newly Implanted Group:&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  No previous cochlear implant experience in either ear&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone&#xD;
             average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural&#xD;
             hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000,&#xD;
             4,000, and 8,000 Hz) in the ear to be implanted&#xD;
&#xD;
          -  Aided CNC word recognition score up to 50% in ear to be implanted&#xD;
&#xD;
          -  Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone&#xD;
             average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural&#xD;
             hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000,&#xD;
             4,000, and 8,000 Hz) in the contralateral (non-implanted) ear&#xD;
&#xD;
          -  Aided CNC word recognition score up to 80% in the contralateral ear&#xD;
&#xD;
          -  English language proficiency&#xD;
&#xD;
          -  Willingness to use an ear-level sound processor postoperatively for the duration of&#xD;
             the study trial&#xD;
&#xD;
          -  Willingness to participate in all scheduled procedures outlined in the protocol&#xD;
&#xD;
        Exclusion Criteria: Newly Implanted Group:&#xD;
&#xD;
          -  Preoperative audiometric conductive overlay of 15 dB or greater at two frequencies or&#xD;
             more in range of 500-1000 Hz in the ear to be implanted&#xD;
&#xD;
          -  Congenital hearing loss (for purpose of this study, onset prior to age 2 years*).&#xD;
             *Based on critical period for speech and language development&#xD;
&#xD;
          -  Duration greater than 30 years of severe-to-profound high-frequency hearing loss&#xD;
&#xD;
          -  Cochlear malformation or obstruction that would preclude full insertion of electrode&#xD;
             array in the ear to be implanted&#xD;
&#xD;
          -  Medical or psychological conditions that contraindicate surgery or impact the ability&#xD;
             to manage an implanted device or the study related procedures as determined by the&#xD;
             investigator&#xD;
&#xD;
          -  Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of&#xD;
             auditory neuropathy/dys-synchrony in either the ear to be implanted or the&#xD;
             contralateral ear&#xD;
&#xD;
          -  Active middle-ear disease/infection in the ear to be implanted&#xD;
&#xD;
          -  Unrealistic expectations regarding potential benefits, risks and limitations inherent&#xD;
             to implant surgical procedures as determined by the investigator&#xD;
&#xD;
          -  Unwillingness or inability of subject to comply with all investigational requirements&#xD;
             as determined by the investigator&#xD;
&#xD;
        EAS Fitting Inclusion Criteria: Newly Implanted and Existing Implanted Groups&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  18 years of age or older, unilaterally implanted with HiRes90K™ Advantage cochlear&#xD;
             implant with HiFocus™ Mid-Scala electrode and fit with an ear-level sound processor&#xD;
             (i.e. Naída family device)&#xD;
&#xD;
          -  Postoperative unaided low frequency audiometric hearing thresholds in the treated ear&#xD;
             up to 80 dB HL for at least one frequency from 125 - 1000 Hz&#xD;
&#xD;
          -  English Language Proficiency&#xD;
&#xD;
          -  Willingness to participate in all scheduled procedures outlined in the study protocol&#xD;
&#xD;
        EAS Fitting Exclusion Criteria: Newly Implanted and Existing Implanted Groups&#xD;
&#xD;
          -  Unilaterally implanted with HiRes 90K™ Advantage cochlear implant with HiFocus™ Helix®&#xD;
             and HiFocus™ 1j electrode&#xD;
&#xD;
          -  Exclusive use of a body worn external sound processor&#xD;
&#xD;
          -  Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of&#xD;
             auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear&#xD;
&#xD;
          -  Postoperative unaided low frequency audiometric hearing thresholds in the treated ear&#xD;
             exceeding 80 dB HL at each frequency from 125 - 1000 Hz Unwillingness or inability of&#xD;
             subject to comply with all investigational requirements as determined by the&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Georgetown University School of Medicine</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa Bay Hearing and Balance Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Medical Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Ear Institute/St. Luke's Health System</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Ear Institute</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Bill Wilkerson Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Ear, Nose &amp; Throat Clinic</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 15, 2022</last_update_submitted>
  <last_update_submitted_qc>July 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cochlear Implant</keyword>
  <keyword>HiRes™ 90K Advantage implant</keyword>
  <keyword>Cochlear Implantation</keyword>
  <keyword>HiFocus™ Mid-Scala electrode</keyword>
  <keyword>Listening Benefits</keyword>
  <keyword>Adults</keyword>
  <keyword>Cochlear Implant Benefit</keyword>
  <keyword>Electrical Stimulation</keyword>
  <keyword>Electro-Acoustic Stimulation (EAS)</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>Ear Diseases</mesh_term>
    <mesh_term>Hearing Disorders</mesh_term>
    <mesh_term>Otorhinolaryngologic Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Imidacloprid</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02189798
org study id: CR0114
nct id: NCT02189798
lead sponsor: 
has dmc: No
The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing
      sensitivity can be preserved in newly implanted adults with partial deafness (considerable
      low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural
      hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™
      Mid-Scala electrode to support the development of electro-acoustic stimulation technology
      (EAS).
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The two main arms are conducted in parallel. The third arm is optional for subjects who complete either of the two main arms using the EAS sound processor.
primary purpose: Treatment
masking: None (Open Label)
measure: Unaided pure-tone hearing threshold measurements
time frame: Three months
description: Unaided pure tone hearing threshold measurement in the implanted ear 3 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)
measure: Speech perception testing
time frame: Up to 19 months
description: Speech perception testing (in quiet and noise) in the treated ear compared to pre-implant speech perception testing (in quiet and noise)
measure: Questionnaire data
time frame: Up to 19 months
description: Speech, Spatial Qualities (SSQ) questionnaire, Abbreviated Profile of Hearing Aid Benefits (APHAB) and Sponsored Development questionnaires post-implant compared to pre-implant condition
arm group label: Newly Implanted Group
arm group type: Experimental
description: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor.
arm group label: Existing Implanted Group
arm group type: Experimental
description: Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor.
arm group label: EAS Extended Use Arm
arm group type: Experimental
description: Adults who are unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness and completed the 12 Month visit using the EAS sound processor in either the Newly Implanted Group or Existing Implanted Group.
intervention type: Device
intervention name: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode
description: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).
arm group label: Newly Implanted Group
intervention type: Device
intervention name: EAS sound processor
description: Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.
arm group label: EAS Extended Use Arm
arm group label: Existing Implanted Group
arm group label: Newly Implanted Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Ear Diseases
mesh term: Hearing Disorders
mesh term: Otorhinolaryngologic Diseases
mesh term: Imidacloprid