<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/NCT03253003</url>
  </required_header>
  <id_info>
    <org_study_id>Sonova2017_27</org_study_id>
    <nct_id>NCT03253003</nct_id>
  </id_info>
  <brief_title>Quality Control of CE-Certified Phonak Hearing Aids - 2017_27</brief_title>
  <official_title>Quality Control of CE-Certified Phonak Hearing Aids - 2017_27</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sonova AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sonova AG</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted&#xD;
      on hard of participants with a hearing loss to grant quality control prior to product launch.&#xD;
      The aim of the investigation series is to ensure a stable overall performance of the new&#xD;
      hearing systems, a good sound quality during phone calls as well as maximum benefit for the&#xD;
      participant with the devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phonak Hearing Systems pass through different development and study stages. 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, as a&#xD;
      result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing&#xD;
      Systems undergo a final quality control in terms of clinical trials in the way as planned for&#xD;
      this study (&quot;phase of final inspection&quot;). This will be a clinical evaluation which will be&#xD;
      conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">August 25, 2017</completion_date>
  <primary_completion_date type="Actual">August 25, 2017</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>
    <intervention_model_description>A line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stable performance in daily life</measure>
    <time_frame>Three weeks</time_frame>
    <description>The data, serving as primary outcomes are collected in a series of home trials, taking place between the lab trial appointments. The stable performance in daily life (that means: no significant interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. Descriptive statistics will be executed. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phone call - Sound Quality</measure>
    <time_frame>One week</time_frame>
    <description>The data serving as primary outcomes are collected in a lab appointment. The participants will be asked to have a phone call with the investigator in the lab. The sound quality will be subjectively assessed by the participants and additionally by the investigators on given scales. Descriptive statistics will be executed. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Hearing Loss, Bilateral Sensorineural, Progressive</condition>
  <arm_group>
    <arm_group_label>Audéo B hearing aid line extension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Line extension of the Phonak Audéo B product family</intervention_name>
    <description>The line extension of Phonak Audéo B product family will be fitted to the participants individual hearing loss.</description>
    <arm_group_label>Audéo B hearing aid line extension</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult hearing impaired persons (minimum age: 18 years) with and without (experience&#xD;
             with) hearing aids&#xD;
&#xD;
          -  Good written and spoken (Swiss) German language skills&#xD;
&#xD;
          -  Healthy outer ear&#xD;
&#xD;
          -  Ability to fill in a questionnaire (p/eCRF) conscientiously&#xD;
&#xD;
          -  Informed Consent as documented by signature&#xD;
&#xD;
          -  Smartphone user&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to&#xD;
             the investigational product&#xD;
&#xD;
          -  Limited mobility and not in the position to attend weekly appointments in Stäfa&#xD;
             (Switzerland)&#xD;
&#xD;
          -  Limited ability to describe listening impressions/experiences and the use of the&#xD;
             hearing aid&#xD;
&#xD;
          -  Inability to produce a reliable hearing test result&#xD;
&#xD;
          -  Massively limited dexterity&#xD;
&#xD;
          -  Known psychological problems&#xD;
&#xD;
          -  Central hearing disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simone Ebbing, B. Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sonova AG</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sonova AG</name>
      <address>
        <city>Stäfa</city>
        <state>Zürich</state>
        <zip>8712</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>September 21, 2017</last_update_submitted>
  <last_update_submitted_qc>September 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</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>
    <mesh_term>Hearing Loss, Bilateral</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/NCT03253003
org study id: Sonova2017_27
nct id: NCT03253003
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted
      on hard of participants with a hearing loss to grant quality control prior to product launch.
      The aim of the investigation series is to ensure a stable overall performance of the new
      hearing systems, a good sound quality during phone calls as well as maximum benefit for the
      participant with the devices.
Phonak Hearing Systems pass through different development and study stages. 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, as a
      result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing
      Systems undergo a final quality control in terms of clinical trials in the way as planned for
      this study ("phase of final inspection"). This will be a clinical evaluation which will be
      conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.
primary purpose: Other
masking: None (Open Label)
measure: Stable performance in daily life
time frame: Three weeks
description: The data, serving as primary outcomes are collected in a series of home trials, taking place between the lab trial appointments. The stable performance in daily life (that means: no significant interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. Descriptive statistics will be executed. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
measure: Phone call - Sound Quality
time frame: One week
description: The data serving as primary outcomes are collected in a lab appointment. The participants will be asked to have a phone call with the investigator in the lab. The sound quality will be subjectively assessed by the participants and additionally by the investigators on given scales. Descriptive statistics will be executed. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
arm group label: Audéo B hearing aid line extension
arm group type: Experimental
description: The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.
intervention type: Device
intervention name: Line extension of the Phonak Audéo B product family
description: The line extension of Phonak Audéo B product family will be fitted to the participants individual hearing loss.
arm group label: Audéo B hearing aid line extension
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Simone Ebbing, B. Sc.
role: Principal Investigator
affiliation: Sonova AG
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Hearing Loss, Bilateral
sharing ipd: No