<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/NCT04496271</url>
  </required_header>
  <id_info>
    <org_study_id>Sonova2020_06</org_study_id>
    <nct_id>NCT04496271</nct_id>
  </id_info>
  <brief_title>Quality Control of CE-Certified Phonak Hearing Aids - 2020_06</brief_title>
  <official_title>Quality Control of CE-Certified Phonak Hearing Aids - 2020_06</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">January 13, 2020</start_date>
  <completion_date type="Actual">April 8, 2020</completion_date>
  <primary_completion_date type="Actual">March 16, 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 Hearing aid</measure>
    <time_frame>5 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 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>Rating sound quality of own voice</measure>
    <time_frame>5 weeks</time_frame>
    <description>Evaluating subjectively the HI regarding to the naturalness of the own voice. Participant will be ask in the first visit for spontaneous acceptance, regarding to the quality of their own voice, by rating scales. They have to rate the clarity, dullness etc. of their own voice. Also they will be ask after the hometrial how satisfy they are with the sound quality of their own voice.They have to rate it by rating scales in percentage. (e.g. very satisfy = 100%, very unsatisfy = 0%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating listening effort</measure>
    <time_frame>5 weeks</time_frame>
    <description>Evaluating listening effort by a special feature. The participants will be in a noisy test situation and have to listen to words, which they should repeat. After each group of words they will be ask to rate how difficult it was to understand by a rating scala (very difficult-difficult-somewhat-easy-very easy). The participants have to do that with the new and the old RIC device. The test will be randomized and single blinded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</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 aid 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 Receiver In Canal hearing aid by 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 channel)- device</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;
          -  Self-reported confidence to using Bluetooth smartphone&#xD;
&#xD;
          -  Hearing Loss range: moderate and moderate/ severe&#xD;
&#xD;
          -  experienced hearing aid user&#xD;
&#xD;
          -  willingness and interest in testing new features&#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;
          -  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;
          -  participant has finger movement disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 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>April 2020</verification_date>
  <study_first_submitted>February 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>November 24, 2022</last_update_submitted>
  <last_update_submitted_qc>November 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2022</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04496271
org study id: Sonova2020_06
nct id: NCT04496271
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 Hearing aid
time frame: 5 weeks
description: Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)
measure: Rating sound quality of own voice
time frame: 5 weeks
description: Evaluating subjectively the HI regarding to the naturalness of the own voice. Participant will be ask in the first visit for spontaneous acceptance, regarding to the quality of their own voice, by rating scales. They have to rate the clarity, dullness etc. of their own voice. Also they will be ask after the hometrial how satisfy they are with the sound quality of their own voice.They have to rate it by rating scales in percentage. (e.g. very satisfy = 100%, very unsatisfy = 0%)
measure: Evaluating listening effort
time frame: 5 weeks
description: Evaluating listening effort by a special feature. The participants will be in a noisy test situation and have to listen to words, which they should repeat. After each group of words they will be ask to rate how difficult it was to understand by a rating scala (very difficult-difficult-somewhat-easy-very easy). The participants have to do that with the new and the old RIC device. The test will be randomized and single blinded.
arm group label: Successor of Phonak Audéo M-90
arm group type: Experimental
description: Phonak Hearing aid with modified precalculation.
arm group label: Phonak Audéo M-90
arm group type: Active Comparator
description: Phonak Audéo M-90 is the most recent Receiver In Canal hearing aid by Phonak which will be fitted to the participants individual hearing loss.
intervention type: Device
intervention name: RIC (Receiver in channel)- device
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: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hearing Loss
sharing ipd: No