<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/NCT02259192</url>
  </required_header>
  <id_info>
    <org_study_id>CI for SSD adults</org_study_id>
    <nct_id>NCT02259192</nct_id>
  </id_info>
  <brief_title>Cochlear Implants for Adults With Single-sided Deafness</brief_title>
  <acronym>SSD</acronym>
  <official_title>Cochlear Implantation for Single-Sided Deafness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Robert Shannon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Med-El Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>House Clinic, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this investigation is to determine the safety and preliminary efficacy of&#xD;
      implanting a cochlear implant (CI) in the profoundly deaf ear of an adult with one normal&#xD;
      hearing (NH) ear (termed &quot;single-sided deaf&quot; person, or SSD). The potential subjects will&#xD;
      have been deafened post-lingually, thus, at one point the now deafened ear did conduct sound&#xD;
      from the periphery. The MED-EL CI system will be implanted in ten (10) SSD patients.The&#xD;
      long-term goal of this research program is to determine whether the CI, in combination with&#xD;
      the NH ear, may provide improved localization ability and better speech understanding in&#xD;
      noise, relative to performance before cochlear implantation (i.e., with the NH ear alone). A&#xD;
      secondary long-term goal is to determine whether CI stimulation may reduce tinnitus severity,&#xD;
      compared to tinnitus experienced prior to cochlear implantation or when the CI is turned off,&#xD;
      after implantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pure-tone threshold average (dB)</measure>
    <time_frame>6 months post-activation</time_frame>
    <description>Change in 3-frequency pure-tone threshold average (dB) in the normal hearing ear.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hearing in Noise Test (signal-to-noise ratio)</measure>
    <time_frame>6 months post-activation</time_frame>
    <description>Change in Hearing in Noise Test signal-to-noise ratio in the normal hearing ear.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>1-month post-implantation</time_frame>
    <description>Number of unexpected serious adverse events across all 10 subjects.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Single-sided Deafness</condition>
  <arm_group>
    <arm_group_label>Open-label</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cochlear Implant</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MED-EL Maestro Cochlear Implant</intervention_name>
    <description>cochlear implant</description>
    <arm_group_label>Open-label</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is an adult (18 years of age or older)&#xD;
&#xD;
          -  English as the primary language&#xD;
&#xD;
          -  Able to undergo general anesthesia, as determined by physical examination and written&#xD;
             report from the physician&#xD;
&#xD;
          -  Receives pneumovax vaccine within 2 weeks of surgery and provides documentation to the&#xD;
             principal investigator&#xD;
&#xD;
          -  Profoundly/severely deaf in one ear (&quot;implant ear&quot;), as defined by:&#xD;
&#xD;
               -  3-frequency pure-tone average≥70 dB Hearing Loss&#xD;
&#xD;
               -  Bone conduction thresholds consistent with air conduction thresholds (i.e., no&#xD;
                  conductive component to the hearing loss)&#xD;
&#xD;
               -  HINT sentence recognition score ≤40% correct, 60 dBA presentation level&#xD;
&#xD;
               -  Post-lingual onset of hearing loss, i.e., after age 6 years of age&#xD;
&#xD;
               -  Hearing loss occurred &lt;10 years prior, as obtained by history&#xD;
&#xD;
          -  Normal hearing in one ear (&quot;non-implant ear&quot;), as defined by:&#xD;
&#xD;
               -  3-frequency PTA ≤25 dB HL&#xD;
&#xD;
               -  No tested frequency air conduction threshold &gt;35 dB HL&#xD;
&#xD;
               -  Bone conduction thresholds consistent with air conduction thresholds&#xD;
&#xD;
               -  Word recognition score ≥80% correct, 60 dBA presentation level&#xD;
&#xD;
               -  HINT sentence recognition score ≥ 80%, 60 dBA presentation level&#xD;
&#xD;
          -  Provides informed consent&#xD;
&#xD;
          -  Willing and able to follow the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Retrocochlear pathology resulting from Neurofibromatosis 2, or other types of cranial&#xD;
             nerve/brainstem tumors&#xD;
&#xD;
          -  Co-existing medical conditions that require radiotherapy of the brainstem and/or&#xD;
             auditory cortex&#xD;
&#xD;
          -  Any medical contraindication precluding safe administration of general anesthesia,&#xD;
             e.g.,&#xD;
&#xD;
               -  Cardiopulmonary disease&#xD;
&#xD;
               -  Renal disease&#xD;
&#xD;
          -  Otologic conditions which contraindicate surgery&#xD;
&#xD;
               -  Active middle ear infection&#xD;
&#xD;
               -  Tympanic membrane perforation&#xD;
&#xD;
          -  Anatomic abnormalities detected on CT preventing appropriate placement of the&#xD;
             stimulator housing in the bone of the skull or placement of the electrode array in the&#xD;
             cochlea (e.g., ossification)&#xD;
&#xD;
          -  Psychological conditions contraindicating surgery&#xD;
&#xD;
          -  Skin or scalp conditions that may preclude attachment of the coil or that may&#xD;
             interfere with the use of the coil&#xD;
&#xD;
          -  Chronic pain in or around the head&#xD;
&#xD;
          -  Current or previous use of an active hearing implant (e.g., bone-anchored hearing&#xD;
             aids, cochlear implant, etc.)&#xD;
&#xD;
          -  Developmental delays or organic brain dysfunction&#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>Robert Shannon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keck School of Medicine of USC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keck School of Medicine of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>House Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>April 18, 2017</last_update_submitted>
  <last_update_submitted_qc>April 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Robert Shannon</investigator_full_name>
    <investigator_title>Professor of Research, Otolaryngology - Head and Neck Surgery</investigator_title>
  </responsible_party>
  <keyword>deaf adult</keyword>
  <keyword>single-sided</keyword>
  <keyword>cochlear implant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss</mesh_term>
  </condition_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/NCT02259192
org study id: CI for SSD adults
nct id: NCT02259192
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this investigation is to determine the safety and preliminary efficacy of
      implanting a cochlear implant (CI) in the profoundly deaf ear of an adult with one normal
      hearing (NH) ear (termed "single-sided deaf" person, or SSD). The potential subjects will
      have been deafened post-lingually, thus, at one point the now deafened ear did conduct sound
      from the periphery. The MED-EL CI system will be implanted in ten (10) SSD patients.The
      long-term goal of this research program is to determine whether the CI, in combination with
      the NH ear, may provide improved localization ability and better speech understanding in
      noise, relative to performance before cochlear implantation (i.e., with the NH ear alone). A
      secondary long-term goal is to determine whether CI stimulation may reduce tinnitus severity,
      compared to tinnitus experienced prior to cochlear implantation or when the CI is turned off,
      after implantation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Pure-tone threshold average (dB)
time frame: 6 months post-activation
description: Change in 3-frequency pure-tone threshold average (dB) in the normal hearing ear.
measure: Hearing in Noise Test (signal-to-noise ratio)
time frame: 6 months post-activation
description: Change in Hearing in Noise Test signal-to-noise ratio in the normal hearing ear.
measure: Adverse Events
time frame: 1-month post-implantation
description: Number of unexpected serious adverse events across all 10 subjects.
arm group label: Open-label
arm group type: Experimental
description: Cochlear Implant
intervention type: Device
intervention name: MED-EL Maestro Cochlear Implant
description: cochlear implant
arm group label: Open-label
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Shannon, PhD
role: Principal Investigator
affiliation: Keck School of Medicine of USC
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Southern California
investigator full name: Robert Shannon
investigator title: Professor of Research, Otolaryngology - Head and Neck Surgery
mesh term: Deafness
mesh term: Hearing Loss