<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/NCT04496791</url>
  </required_header>
  <id_info>
    <org_study_id>Sonova2020_26</org_study_id>
    <nct_id>NCT04496791</nct_id>
  </id_info>
  <brief_title>Quality Control of CE-Certified Phonak Hearing Aids - 2020_26</brief_title>
  <official_title>Quality Control of CE-Certified Phonak Hearing Aids - 2020_26</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sonova AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sonova AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phonak Hearing Devices pass through different development and study phases. At an early&#xD;
      stage, feasibility studies are conducted to investigate new algorithms, features and&#xD;
      functions in an isolated manner. If the benefit is proven, their performance is then&#xD;
      investigated regarding interdependency between all available algorithms, features and&#xD;
      functions running in parallel in a hearing aid (pivotal/pre-validation studies) and,&#xD;
      resulting from the pre-validation studies, they get optimized. Prior to product launch, the&#xD;
      Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials.&#xD;
      This is a validation study, investigating improved algorithms, features, functions and&#xD;
      wearing comfort. This will be a clinical investigation which will be conducted mono centric&#xD;
      at Sonova AG Headquarters based in Stäfa (Switzerland).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will investigate the combination of the features to determine if the audiological&#xD;
      performance and quality of the new successor of the Marvel family shows an improved benefit&#xD;
      over Phonak Audéo Marvel before going into the System Validation. Therefore this study will&#xD;
      be a comparative study. The study will determine if hearing impaired users wearing the&#xD;
      successor hearing aids, have better initial acceptance with the new precalculation, better&#xD;
      sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud&#xD;
      environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another&#xD;
      objective of the study is to compare the listening effort with the two different study&#xD;
      devices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">August 7, 2020</completion_date>
  <primary_completion_date type="Actual">August 7, 2020</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rating of the sound quality for the new and the comparative HI</measure>
    <time_frame>4 weeks</time_frame>
    <description>Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after one week home trial. The home trial is randomized. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Speech intelligibility in noisy situations (only test device)</measure>
    <time_frame>4 week</time_frame>
    <description>Evaluating the speech intelligibility with the test device, using a speech in noise test, Oldenburger Satztest (OLSA) after the subject set the noise cancellation via an App on an individual limit. The results of the test are the word recognition score in SNR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech intelligibility in quiet situations</measure>
    <time_frame>4 week</time_frame>
    <description>Evaluating and comparing the speech intelligibility in a quiet test situation of the test device and the Marvel device. Using the &quot;Reimtest nach Wallenberg und Kollmeier (WaKo ) (%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech intelligibility in noisy situations</measure>
    <time_frame>4 weeks</time_frame>
    <description>Evaluating and comparing the speech intelligibility in a noisy test situation of the test device and competitor. Using the OLSA (word recognition score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rating of sound quality</measure>
    <time_frame>1 week</time_frame>
    <description>Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after the First Fit. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Successor of Phonak Audéo M-90</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phonak Hearing instrument (HI) with modified precalculation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phonak Audéo M-90</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Phonak Audéo M-90 is the most recent RIC device from Phonak which will be fitted to the participants individual hearing loss.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)</intervention_name>
    <description>HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication</description>
    <arm_group_label>Phonak Audéo M-90</arm_group_label>
    <arm_group_label>Successor of Phonak Audéo M-90</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hearing Loss range: N3-N4&#xD;
&#xD;
          -  experienced hearing aid user&#xD;
&#xD;
          -  willingness to wear behind the ear hearing aids&#xD;
&#xD;
          -  Informed Consent as documented by signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the audiogram is not in the fitting range of the intended hearing aid&#xD;
&#xD;
          -  first time user&#xD;
&#xD;
          -  limited mobility and not in the position to attend weekly appointments in Stäfa&#xD;
             (Switzerland)&#xD;
&#xD;
          -  participant is not able to describe experiences and hearing impressions&#xD;
&#xD;
          -  allergies against the material of the hearing aid&#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>Sonova AG</name>
      <address>
        <city>Stäfa</city>
        <zip>8712</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>September 9, 2020</last_update_submitted>
  <last_update_submitted_qc>September 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04496791
org study id: Sonova2020_26
nct id: NCT04496791
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Phonak Hearing Devices pass through different development and study phases. At an early
      stage, feasibility studies are conducted to investigate new algorithms, features and
      functions in an isolated manner. If the benefit is proven, their performance is then
      investigated regarding interdependency between all available algorithms, features and
      functions running in parallel in a hearing aid (pivotal/pre-validation studies) and,
      resulting from the pre-validation studies, they get optimized. Prior to product launch, the
      Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials.
      This is a validation study, investigating improved algorithms, features, functions and
      wearing comfort. This will be a clinical investigation which will be conducted mono centric
      at Sonova AG Headquarters based in Stäfa (Switzerland).
This study will investigate the combination of the features to determine if the audiological
      performance and quality of the new successor of the Marvel family shows an improved benefit
      over Phonak Audéo Marvel before going into the System Validation. Therefore this study will
      be a comparative study. The study will determine if hearing impaired users wearing the
      successor hearing aids, have better initial acceptance with the new precalculation, better
      sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud
      environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another
      objective of the study is to compare the listening effort with the two different study
      devices.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Rating of the sound quality for the new and the comparative HI
time frame: 4 weeks
description: Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after one week home trial. The home trial is randomized. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)
measure: Speech intelligibility in noisy situations (only test device)
time frame: 4 week
description: Evaluating the speech intelligibility with the test device, using a speech in noise test, Oldenburger Satztest (OLSA) after the subject set the noise cancellation via an App on an individual limit. The results of the test are the word recognition score in SNR.
measure: Speech intelligibility in quiet situations
time frame: 4 week
description: Evaluating and comparing the speech intelligibility in a quiet test situation of the test device and the Marvel device. Using the "Reimtest nach Wallenberg und Kollmeier (WaKo ) (%).
measure: Speech intelligibility in noisy situations
time frame: 4 weeks
description: Evaluating and comparing the speech intelligibility in a noisy test situation of the test device and competitor. Using the OLSA (word recognition score)
measure: Rating of sound quality
time frame: 1 week
description: Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after the First Fit. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)
arm group label: Successor of Phonak Audéo M-90
arm group type: Experimental
description: Phonak Hearing instrument (HI) with modified precalculation.
arm group label: Phonak Audéo M-90
arm group type: Active Comparator
description: Phonak Audéo M-90 is the most recent RIC device from Phonak which will be fitted to the participants individual hearing loss.
intervention type: Device
intervention name: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)
description: HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication
arm group label: Phonak Audéo M-90
arm group label: Successor of Phonak Audéo M-90
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hearing Loss