<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/NCT03007472</url>
  </required_header>
  <id_info>
    <org_study_id>CLTD5685</org_study_id>
    <nct_id>NCT03007472</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults</brief_title>
  <acronym>SME</acronym>
  <official_title>Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults</official_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_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear&#xD;
      implant, and CP1000 (Nucleus 7) sound processor&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound&#xD;
      processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant&#xD;
      location. Speech perception testing as well as subjective questionnaires will be administered&#xD;
      over 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">March 6, 2020</completion_date>
  <primary_completion_date type="Actual">December 3, 2018</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>Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone</measure>
    <time_frame>Preoperatively and 6 months post sound processor activation</time_frame>
    <description>Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone</measure>
    <time_frame>Preoperatively and 6 months post sound processor activation</time_frame>
    <description>Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)</measure>
    <time_frame>Preoperatively and 6 months post sound processor activaton</time_frame>
    <description>Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Frequency Specific Thresholds and Speech Recognition in Noise or Quiet</measure>
    <time_frame>12 months post-activation</time_frame>
    <description>Frequency-specific thresholds at standard audiometric frequencies for each ear, and speech recognition in quiet (CNC words) or noise (AzBio sentences) in best unilateral and/or electric alone.</description>
  </other_outcome>
  <other_outcome>
    <measure>Speech Perception in Quiet and Noise With Change in Cochlear Implant Programming</measure>
    <time_frame>Following 12-month study visit but prior to 36-month interval.</time_frame>
    <description>Two optional study visits to evaluate whether a change in cochlear implant programming, specifically an increase in the number of channels will improve subject speech perception in quiet and noise.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Hearing Loss, Sensorineural</condition>
  <arm_group>
    <arm_group_label>CI532/N7 study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CI532</intervention_name>
    <description>Cochlear implant</description>
    <arm_group_label>CI532/N7 study group</arm_group_label>
    <other_name>Slim Modiolar Electrode</other_name>
    <other_name>532</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nucleus 7</intervention_name>
    <description>Sound processor</description>
    <arm_group_label>CI532/N7 study group</arm_group_label>
    <other_name>N7</other_name>
    <other_name>CP1000</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing&#xD;
             loss.&#xD;
&#xD;
          2. Limited benefit from amplification as defined by test scores of 40% correct or less in&#xD;
             the ear to be implanted and 50% or less in the contralateral ear on a recorded&#xD;
             monosyllabic word test I. Consistent with the Minimum Speech Test Battery (2011), it&#xD;
             is required that all subjects be evaluated at 60 dBA presentation level.&#xD;
&#xD;
          3. Bilateral moderate sloping to profound hearing loss&#xD;
&#xD;
          4. Minimum of 30 days experience with appropriately fit bilateral amplification, fit&#xD;
             using the standardized National Acoustics Laboratory (NAL) fitting method&#xD;
&#xD;
          5. Proficient in English&#xD;
&#xD;
          6. Ability to complete testing -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous cochlear implantation&#xD;
&#xD;
          2. Pre-linguistically deafened (onset of hearing loss at less than two years of age)&#xD;
&#xD;
          3. Ossification or any other cochlear anomaly that might prevent complete insertion of&#xD;
             the electrode array&#xD;
&#xD;
          4. Duration of severe to profound hearing loss greater than 20 years&#xD;
&#xD;
          5. Diagnosis of retro-cochlear pathology&#xD;
&#xD;
          6. Diagnosis of auditory neuropathy&#xD;
&#xD;
          7. Unrealistic expectations on the part of the subject regarding the possible benefits,&#xD;
             risks, and limitations that are inherent to the surgical procedure and use of the&#xD;
             prosthetic device&#xD;
&#xD;
          8. Unwillingness or inability to comply with all investigational requirements&#xD;
&#xD;
          9. Additional cognitive, medical or social handicaps that would prevent completion of all&#xD;
             study requirements-&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jillian Crosson, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Senior Manager of Clinical Services</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Megan Mears, AuD</last_name>
    <role>Study Director</role>
    <affiliation>Clinical Project Manager</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rocky Mountain Ear Center</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Hearing and Balance Disorders</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Ear Institute</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</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>New York University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>13212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hearts for Hearing</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas Ear Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Grutters JP, Joore MA, van der Horst F, Verschuure H, Dreschler WA, Anteunis LJ. Choosing between measures: comparison of EQ-5D, HUI2 and HUI3 in persons with hearing complaints. Qual Life Res. 2007 Oct;16(8):1439-49. doi: 10.1007/s11136-007-9237-x. Epub 2007 Jul 24.</citation>
    <PMID>17647093</PMID>
  </reference>
  <reference>
    <citation>Hiller W, Goebel G. Factors influencing tinnitus loudness and annoyance. Arch Otolaryngol Head Neck Surg. 2006 Dec;132(12):1323-30. doi: 10.1001/archotol.132.12.1323.</citation>
    <PMID>17178943</PMID>
  </reference>
  <reference>
    <citation>Meinert,C(1986).ClinicalTrials:Design,Conduct,andAnalysis.OxfordUniversityPress,NewYork.</citation>
  </reference>
  <reference>
    <citation>Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.</citation>
    <PMID>15817019</PMID>
  </reference>
  <reference>
    <citation>PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.</citation>
    <PMID>14485785</PMID>
  </reference>
  <reference>
    <citation>Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.</citation>
    <PMID>21829134</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>November 9, 2020</results_first_submitted>
  <results_first_submitted_qc>November 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 3, 2020</results_first_posted>
  <last_update_submitted>December 4, 2020</last_update_submitted>
  <last_update_submitted_qc>December 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cochlear implant, sound processor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03007472/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03007472/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CI532/N7 Study Group</title>
          <description>All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor&#xD;
CI532: Cochlear implant&#xD;
Nucleus 7: Sound processor</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not have aidable contralateral thresholds at the time</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Loss to Follow Up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CI532/N7 Study Group</title>
          <description>All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor&#xD;
CI532: Cochlear implant&#xD;
Nucleus 7: Sound processor</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="96"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.39" lower_limit="23" upper_limit="91"/>
                  </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="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                  </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="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ipsilateral Ear Mean - Duration of Hearing Loss</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.7" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Contralateral Ear Mean - Duration of Hearing Loss</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.7" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone</title>
        <description>Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores.</description>
        <time_frame>Preoperatively and 6 months post sound processor activation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CI532/N7 Study Group</title>
            <description>All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor&#xD;
CI532: Cochlear implant&#xD;
Nucleus 7: Sound processor</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone</title>
          <description>Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores.</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="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Ipsilateral Aided</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month CI/Best Unilateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.9" spread="21.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone</title>
        <description>Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.</description>
        <time_frame>Preoperatively and 6 months post sound processor activation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CI532/N7 Study Group</title>
            <description>All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor&#xD;
CI532: Cochlear implant&#xD;
Nucleus 7: Sound processor</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone</title>
          <description>Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.</description>
          <units>percentage of correct AzBio sentences</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Ipsilateral Aided +10 SNR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.8" spread="17.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month CI/Best Unilateral +10 SNR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" spread="26.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)</title>
        <description>Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).</description>
        <time_frame>Preoperatively and 6 months post sound processor activaton</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CI532/N7 Study Group</title>
            <description>All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor&#xD;
CI532: Cochlear implant&#xD;
Nucleus 7: Sound processor</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)</title>
          <description>Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="0.197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Frequency Specific Thresholds and Speech Recognition in Noise or Quiet</title>
        <description>Frequency-specific thresholds at standard audiometric frequencies for each ear, and speech recognition in quiet (CNC words) or noise (AzBio sentences) in best unilateral and/or electric alone.</description>
        <time_frame>12 months post-activation</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Speech Perception in Quiet and Noise With Change in Cochlear Implant Programming</title>
        <description>Two optional study visits to evaluate whether a change in cochlear implant programming, specifically an increase in the number of channels will improve subject speech perception in quiet and noise.</description>
        <time_frame>Following 12-month study visit but prior to 36-month interval.</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CI532/N7 Study Group</title>
          <description>All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor&#xD;
CI532: Cochlear implant&#xD;
Nucleus 7: Sound processor</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation requiring Ablation Procedure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory failure</sub_title>
                <description>Death secondary to cardio-respiratory failure, presistent tachycardia secondary to myotonic distrophy, stage Y3 N0 colon carcinoma, sepsis, VRE, acidosis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Heart Attack</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Active Meniere's Disease/Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Coxsackievirus, subsequent labyrinthitis/vestibular neuritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Decreased Hearing in Non-Implanted Ear</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acid Reflux</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Alcoholic cirrhosis of the liver</sub_title>
                <description>Death-complications</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Electrode Tip Foldover</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Tip Rollover</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>CI Explanted Due to Non-Auditory Stimulation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Diagnosed with prostate cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>CVA (cerebrovascular accident)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>TIA/Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>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="26" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="96"/>
              </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 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>
    <point_of_contact>
      <name_or_title>Cochlear Clinical Studies</name_or_title>
      <organization>Cochlear</organization>
      <phone>(303) 790-9010</phone>
      <email>clinicalstudies@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/NCT03007472
org study id: CLTD5685
nct id: NCT03007472
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear
      implant, and CP1000 (Nucleus 7) sound processor
Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound
      processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant
      location. Speech perception testing as well as subjective questionnaires will be administered
      over 12 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone
time frame: Preoperatively and 6 months post sound processor activation
description: Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores.
measure: Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone
time frame: Preoperatively and 6 months post sound processor activation
description: Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.
measure: Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)
time frame: Preoperatively and 6 months post sound processor activaton
description: Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).
measure: Frequency Specific Thresholds and Speech Recognition in Noise or Quiet
time frame: 12 months post-activation
description: Frequency-specific thresholds at standard audiometric frequencies for each ear, and speech recognition in quiet (CNC words) or noise (AzBio sentences) in best unilateral and/or electric alone.
measure: Speech Perception in Quiet and Noise With Change in Cochlear Implant Programming
time frame: Following 12-month study visit but prior to 36-month interval.
description: Two optional study visits to evaluate whether a change in cochlear implant programming, specifically an increase in the number of channels will improve subject speech perception in quiet and noise.
arm group label: CI532/N7 study group
arm group type: Experimental
description: All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor
intervention type: Device
intervention name: CI532
description: Cochlear implant
arm group label: CI532/N7 study group
other name: Slim Modiolar Electrode
other name: 532
intervention type: Device
intervention name: Nucleus 7
description: Sound processor
arm group label: CI532/N7 study group
other name: N7
other name: CP1000
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jillian Crosson, PhD
role: Study Director
affiliation: Senior Manager of Clinical Services
last name: Megan Mears, AuD
role: Study Director
affiliation: Clinical Project Manager
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Grutters JP, Joore MA, van der Horst F, Verschuure H, Dreschler WA, Anteunis LJ. Choosing between measures: comparison of EQ-5D, HUI2 and HUI3 in persons with hearing complaints. Qual Life Res. 2007 Oct;16(8):1439-49. doi: 10.1007/s11136-007-9237-x. Epub 2007 Jul 24.
PMID: 17647093
citation: Hiller W, Goebel G. Factors influencing tinnitus loudness and annoyance. Arch Otolaryngol Head Neck Surg. 2006 Dec;132(12):1323-30. doi: 10.1001/archotol.132.12.1323.
PMID: 17178943
citation: Meinert,C(1986).ClinicalTrials:Design,Conduct,andAnalysis.OxfordUniversityPress,NewYork.
citation: Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
PMID: 15817019
citation: PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.
PMID: 14485785
citation: Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.
PMID: 21829134
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Hearing Loss, Sensorineural
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 