<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/NCT02228148</url>
  </required_header>
  <id_info>
    <org_study_id>CEL5332</org_study_id>
    <nct_id>NCT02228148</nct_id>
  </id_info>
  <brief_title>Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)</brief_title>
  <official_title>Comparison of Fitting Methods Using Cochlear Clinical Care Innovation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cochlear</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>numerics data GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cochlear</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate if the new and simplified fitting method with&#xD;
      Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the&#xD;
      Clinical Care Innovation) provides Cochlear Implants Recipients with the same hearing outcome&#xD;
      as the current and established clinical fitting method with Cochlear Nucleus Custom SoundTM&#xD;
      Suite. The Clinical Care Innovation method reduces fitting to simple volume, bass and trebles&#xD;
      adjustments, operations which are familiar to anyone who has used an audio player.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds</measure>
    <time_frame>3 months after implantation</time_frame>
    <description>Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds</measure>
    <time_frame>6 months after implantation</time_frame>
    <description>Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds</measure>
    <time_frame>9 months after implantation</time_frame>
    <description>Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds</measure>
    <time_frame>12 months after implantation</time_frame>
    <description>Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds</measure>
    <time_frame>15 months after implantation</time_frame>
    <description>Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests</measure>
    <time_frame>3 months after implantation</time_frame>
    <description>Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests</measure>
    <time_frame>6 months after implantation</time_frame>
    <description>Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests</measure>
    <time_frame>9 months after implantation</time_frame>
    <description>Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests</measure>
    <time_frame>12 months after implantation</time_frame>
    <description>Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests</measure>
    <time_frame>15 months after implantation</time_frame>
    <description>Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)</measure>
    <time_frame>before first fitting post-implantation (1 day)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)</measure>
    <time_frame>3 months after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)</measure>
    <time_frame>6 months after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)</measure>
    <time_frame>9 months after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)</measure>
    <time_frame>12 months after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)</measure>
    <time_frame>15 months after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire</measure>
    <time_frame>after each fitting (4 weeks after implantation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire</measure>
    <time_frame>after each fitting (3 months after implantation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire</measure>
    <time_frame>after each fitting (6 months after implantation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire</measure>
    <time_frame>after each fitting (9 months after implantation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire</measure>
    <time_frame>after each fitting (12 months after implantation)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>NFS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cochlear Nucleus Fitting Software</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cochlear Nucleus Custom SoundTM Suite</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NFS</intervention_name>
    <description>Cochlear Nucleus Fitting Software</description>
    <arm_group_label>NFS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CSS</intervention_name>
    <description>Cochlear Nucleus Custom SoundTM Suite</description>
    <arm_group_label>CSS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly implanted subjects with available Nucleus Cochlear Implants compatible with&#xD;
             CP900 series sound processors (excluding Cochlear Nucleus Hybrid)&#xD;
&#xD;
          -  Post linguistically deafened adults (≥ 18 years)&#xD;
&#xD;
          -  Unilaterally implanted&#xD;
&#xD;
          -  ≤ 15 years of severe to profound deafness prior to implantation&#xD;
&#xD;
          -  Subjects who are capable and willing to participate in speech perception tests in&#xD;
             local language&#xD;
&#xD;
          -  Subjects who are able to provide feedback in form of a written questionnaire (e.g.&#xD;
             Speech Spatial Hearing Qualities questionnaire)&#xD;
&#xD;
          -  Subjects willing to give their consent to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Additional handicaps that would prevent participation in evaluations (e.g. visual&#xD;
             impairment, blindness)&#xD;
&#xD;
          -  Unrealistic expectations on the part of the subject, regarding the possible benefits,&#xD;
             risks and limitations that are inherent to the procedure/fitting method&#xD;
&#xD;
          -  Bilateral implantation&#xD;
&#xD;
          -  Hybrid-L (not supported by Nucleus Fitting Software)&#xD;
&#xD;
          -  Subjects who already have hearing experience with a Cochlear Implant (e.g.&#xD;
             reimplantation, contralateral Cochlear Implant)&#xD;
&#xD;
          -  Subjects with single-sided deafness&#xD;
&#xD;
          -  Known cochlea malformations&#xD;
&#xD;
          -  Subjects who lost their hearing due to meningitis&#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>Bart Volckaerts, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cochlear</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Deutsches HörZentrum Hannover der HNO-Klinik der MHH</name>
      <address>
        <city>Hannover</city>
        <state>Niedersachsen</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Hals, Nasen-, Ohrenheilkunde, Kopf und Halschirurgie</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital</name>
      <address>
        <city>Zurich</city>
        <state>Kanton Zurich</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>January 9, 2018</last_update_submitted>
  <last_update_submitted_qc>January 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Post linguistically deafness, severe to profound deafness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02228148
org study id: CEL5332
nct id: NCT02228148
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate if the new and simplified fitting method with
      Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the
      Clinical Care Innovation) provides Cochlear Implants Recipients with the same hearing outcome
      as the current and established clinical fitting method with Cochlear Nucleus Custom SoundTM
      Suite. The Clinical Care Innovation method reduces fitting to simple volume, bass and trebles
      adjustments, operations which are familiar to anyone who has used an audio player.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
time frame: 3 months after implantation
description: Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
time frame: 6 months after implantation
description: Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
time frame: 9 months after implantation
description: Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
time frame: 12 months after implantation
description: Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
time frame: 15 months after implantation
description: Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
time frame: 3 months after implantation
description: Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
time frame: 6 months after implantation
description: Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
time frame: 9 months after implantation
description: Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
time frame: 12 months after implantation
description: Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
measure: Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
time frame: 15 months after implantation
description: Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
measure: Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
time frame: before first fitting post-implantation (1 day)
measure: Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
time frame: 3 months after implantation
measure: Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
time frame: 6 months after implantation
measure: Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
time frame: 9 months after implantation
measure: Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
time frame: 12 months after implantation
measure: Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
time frame: 15 months after implantation
measure: Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
time frame: after each fitting (4 weeks after implantation)
measure: Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
time frame: after each fitting (3 months after implantation)
measure: Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
time frame: after each fitting (6 months after implantation)
measure: Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
time frame: after each fitting (9 months after implantation)
measure: Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
time frame: after each fitting (12 months after implantation)
arm group label: NFS
arm group type: Experimental
description: Cochlear Nucleus Fitting Software
arm group label: CSS
arm group type: Active Comparator
description: Cochlear Nucleus Custom SoundTM Suite
intervention type: Device
intervention name: NFS
description: Cochlear Nucleus Fitting Software
arm group label: NFS
intervention type: Device
intervention name: CSS
description: Cochlear Nucleus Custom SoundTM Suite
arm group label: CSS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bart Volckaerts, PhD
role: Study Director
affiliation: Cochlear
facility: 
facility: 
facility: 
country: Germany
country: Switzerland
responsible party type: Sponsor
mesh term: Hearing Loss