<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/NCT01670006</url>
  </required_header>
  <id_info>
    <org_study_id>CAM5397</org_study_id>
    <nct_id>NCT01670006</nct_id>
  </id_info>
  <brief_title>Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cochlear</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cochlear</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this feasibility study is to obtain preliminary safety and efficacy data&#xD;
      associated with cochlear implantation in individuals with severe to profound sensorineural&#xD;
      hearing loss contralateral to an ear with normal, or near-normal, hearing. The hypothesis is&#xD;
      that restoration of hearing in the deafened ear will result in improved speech perception in&#xD;
      the treated ear and advantages related to restoration of hearing to both ears.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects With Adverse Events</measure>
    <time_frame>12 months</time_frame>
    <description>Device and procedure-related anticipated and unanticipated aderse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hearing in Noise Test (HINT)Score</measure>
    <time_frame>12 months</time_frame>
    <description>To access speech perception performance using Hearing in noise test sentences in noise was measured at 12 months post activation. Recorded HINT sentences were presented to participants at 60dBA pre-operatively and 12 months post activation. Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome.</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>Cochlear Implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cochlear Nucleus Cochlear Implant System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cochlear Nucleus Cochlear Implant System</intervention_name>
    <arm_group_label>Cochlear Implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to provide informed consent.&#xD;
&#xD;
          2. Eighteen years-of-age or older at the time of implantation.&#xD;
&#xD;
          3. Presence of single-sided deafness as follows:&#xD;
&#xD;
               1. Poorer ear (ear to be implanted):&#xD;
&#xD;
                    -  severe to profound sensorineural hearing loss, defined as pure-tone&#xD;
                       thresholds 80 dB HL or greater for the frequencies 500, 1000, 2000, 3000,&#xD;
                       and 4000 Hz.&#xD;
&#xD;
                    -  Monosyllabic word understanding, as measured using the CNC Word Test at 60&#xD;
                       dBA under earphones, less than or equal to 10%.&#xD;
&#xD;
               2. Better ear (contralateral ear):&#xD;
&#xD;
                    -  Normal or near-normal hearing, defined as pure-tone thresholds no poorer&#xD;
                       than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer than 40 dB&#xD;
                       HL at 4000 Hz.&#xD;
&#xD;
                    -  Monosyllabic word understanding, as measured using the CNC Word Test at 60&#xD;
                       dBA under earphones, of greater than or equal to 90%.&#xD;
&#xD;
          4. Duration of severe to profound sensorineural hearing loss of at least 6 months (to&#xD;
             ensure stability of hearing loss) but no greater than 10 years.&#xD;
&#xD;
          5. English spoken as a primary language.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Alleviation of tinnitus as the stated primary or sole motivation for seeking&#xD;
             implantation by the subject and/or investigator.&#xD;
&#xD;
          2. Actively using an implantable device in the poorer ear.&#xD;
&#xD;
          3. Onset of severe to profound hearing loss &lt; 6 years-of-age.&#xD;
&#xD;
          4. Evidence of active middle-ear pathology based on otologic examination and/or&#xD;
             immittance testing.&#xD;
&#xD;
          5. Medical or psychological conditions that contraindicate undergoing surgery.&#xD;
&#xD;
          6. Ossification or any other cochlear anomaly at the implant ear that might prevent&#xD;
             complete insertion of the electrode array.&#xD;
&#xD;
          7. Hearing loss of neural or central origin, including auditory neuropathy.&#xD;
&#xD;
          8. Unrealistic expectations on the part of the subject regarding the possible benefits,&#xD;
             risks, and limitations inherent to the surgical procedure and prosthetic device.&#xD;
&#xD;
          9. Unwillingness and/or inability of the candidate to comply with all investigational&#xD;
             requirements including, but not limited to, study protocol and surgical procedure, as&#xD;
             determined by the 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>New York University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <results_first_submitted>June 29, 2022</results_first_submitted>
  <results_first_submitted_qc>August 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 22, 2022</results_first_posted>
  <last_update_submitted>August 31, 2022</last_update_submitted>
  <last_update_submitted_qc>August 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Single sided deafness</keyword>
  <keyword>Unilateral deafness</keyword>
  <keyword>Unilateral hearing loss</keyword>
  <keyword>Cochlear implantation</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Subjects With Single-Sided Deafness and a Cochlear Implant</title>
          <description>Ten subjects with Single-Sided Deafness (SSD) were implanted with a Cochlear Nucleus Cochlear Implant System and followed for 12 months after device activation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Subjects With Single-Sided Deafness and a Cochlear Implant</title>
          <description>Ten subjects with Single-Sided Deafness (SSD) were implanted with a Cochlear Nucleus Cochlear Implant System and followed for 12 months after device activation.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.8" spread="11.3"/>
                  </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="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="3"/>
                  </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_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Adverse Events</title>
        <description>Device and procedure-related anticipated and unanticipated aderse events.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Subjects With Single-Sided Deafness and a Cochlear Implant</title>
            <description>Ten subjects with Single-Sided Deafness (SSD) were implanted with a Cochlear Nucleus Cochlear Implant System and followed for 12 months after device activation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Adverse Events</title>
          <description>Device and procedure-related anticipated and unanticipated aderse events.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hearing in Noise Test (HINT)Score</title>
        <description>To access speech perception performance using Hearing in noise test sentences in noise was measured at 12 months post activation. Recorded HINT sentences were presented to participants at 60dBA pre-operatively and 12 months post activation. Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Subjects With Single-Sided Deafness and a Cochlear Implant</title>
            <description>Ten subjects with Single-Sided Deafness (SSD) were implanted with a Cochlear Nucleus Cochlear Implant System and followed for 12 months after device activation.</description>
          </group>
        </group_list>
        <measure>
          <title>Hearing in Noise Test (HINT)Score</title>
          <description>To access speech perception performance using Hearing in noise test sentences in noise was measured at 12 months post activation. Recorded HINT sentences were presented to participants at 60dBA pre-operatively and 12 months post activation. Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome.</description>
          <units>percentage of correct words.</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <desc>Suspected allergic response to a drug used during the anesthesia procedure.</desc>
      <group_list>
        <group group_id="E1">
          <title>Subjects With Single-Sided Deafness and a Cochlear Implant</title>
          <description>Ten subjects with Single-Sided Deafness (SSD) were implanted with a Cochlear Nucleus Cochlear Implant System and followed for 12 months after device activation.</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="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Sudden ventilation restriction upon induction of anesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>PRS Specialist, Clinical Affairs</name_or_title>
      <organization>Cochlear</organization>
      <phone>+612 9428 6555</phone>
      <email>cltd-prs-admin@cochlear.com</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/NCT01670006
org study id: CAM5397
nct id: NCT01670006
lead sponsor: 
has dmc: No
is fda regulated device: Yes
The objective of this feasibility study is to obtain preliminary safety and efficacy data
      associated with cochlear implantation in individuals with severe to profound sensorineural
      hearing loss contralateral to an ear with normal, or near-normal, hearing. The hypothesis is
      that restoration of hearing in the deafened ear will result in improved speech perception in
      the treated ear and advantages related to restoration of hearing to both ears.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Subjects With Adverse Events
time frame: 12 months
description: Device and procedure-related anticipated and unanticipated aderse events.
measure: Hearing in Noise Test (HINT)Score
time frame: 12 months
description: To access speech perception performance using Hearing in noise test sentences in noise was measured at 12 months post activation. Recorded HINT sentences were presented to participants at 60dBA pre-operatively and 12 months post activation. Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome.
arm group label: Cochlear Implantation
arm group type: Experimental
description: Cochlear Nucleus Cochlear Implant System
intervention type: Device
intervention name: Cochlear Nucleus Cochlear Implant System
arm group label: Cochlear Implantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Deafness
mesh term: Hearing Loss
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 