<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/NCT03751891</url>
  </required_header>
  <id_info>
    <org_study_id>Sonova2018_05</org_study_id>
    <nct_id>NCT03751891</nct_id>
  </id_info>
  <brief_title>Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05</brief_title>
  <official_title>Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05</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 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. This is a validation&#xD;
      study, investigating optimized algorithms, features, functions and wearing comfort. This will&#xD;
      be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based&#xD;
      in Stäfa (Switzerland).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study a comparison with a CE-labeled Phonak Receiver-in-the-canal (RIC) device&#xD;
      (active comparator) and two CE-labeled competitor devices (RIC) is done. All study devices&#xD;
      contain direct connectivity functionality which will be compared in terms of streamed Audio&#xD;
      quality, streaming stability and Usability preferences of all available functions and&#xD;
      features. This will be a clinical evaluation which will be conducted mono centric at Sonova&#xD;
      AG Headquarters based in Stäfa (Switzerland).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2018</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">April 13, 2018</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participant masking was only done for laboratory measurements. For home trial testing no masking was done.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the speech intelligibiltity of phone calls via direct streaming</measure>
    <time_frame>6 weeks</time_frame>
    <description>The primary outcome meaurement of this study is the comparison of Phonak's direct connectivity solution against two competitors in terms of subjective speech intelligibility of streamed audio signals via smartphone. The subjective speech intelligibilty will be measured via interview (sound quality rating, satisfaction rating of speech intelligibility) from far-end talker and near-end talker.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigation of Bluetooth Connection losses between Hearing Aid and smart phone during a phone call (number of reported interruptions during a phone call which will be streamed via bluetooth from Smartphone to Hearing Aid)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The secondary outcome measurement of this study is to investigate the number of (Bluetooth-) Connection losses between Hearing Aid and Smartphone during a phone call stream. The bluetooth connection losses will be investigated by counting the reported interruptions of a streamed phone call between smartphone and Hearing Aid in relation to the amount of conducted phone calls during two weeks of home trial for the investigational device and the comparative devices.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Comparison of the subjective Sound Quality rating of TV-Audiostream via direct connectivity</measure>
    <time_frame>6 weeks</time_frame>
    <description>Another outcome measurement of this study is the comparison of streamed audio signals from TV in terms of sound quality (measured via satisfaction rating).</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparison of the Usability of remote controls via direct connectivity</measure>
    <time_frame>6 weeks</time_frame>
    <description>Another outcome measurement of this study is the comparison of the usability of a remote control via interview during and after home trial.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Hearing Loss, Sensorineural</condition>
  <arm_group>
    <arm_group_label>Phonak Audéo B90-Direct</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HearingAid_A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>HearingAid_A is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer_A which will be fitted to the participants individual Hearing loss.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HearingAid_B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>HearingAid_B is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer_B which will be fitted to the participants individual Hearing loss.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phonak Audéo B90-Direct</intervention_name>
    <description>The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.</description>
    <arm_group_label>Phonak Audéo B90-Direct</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HearingAid_A</intervention_name>
    <description>HearingAid_A is the most recent Receiver-in-the-canal Hearing aid from manufacturer_A which will be fitted to the participants individual Hearing loss.</description>
    <arm_group_label>HearingAid_A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HearingAid_B</intervention_name>
    <description>HearingAid_B is the most recent Receiver-in-the-canal Hearing aid from manufacturer_B which will be fitted to the participants individual Hearing loss.</description>
    <arm_group_label>HearingAid_B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss)&#xD;
             without hearing aid experience&#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;
          -  willingness to wear Receiver in the canal hearing aids&#xD;
&#xD;
          -  Informed Consent as documented by signature&#xD;
&#xD;
          -  owning an iPhone 6 or higher&#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;
          -  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>
  <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>November 2018</verification_date>
  <study_first_submitted>September 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</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, Sensorineural</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/NCT03751891
org study id: Sonova2018_05
nct id: NCT03751891
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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. This is a validation
      study, investigating optimized algorithms, features, functions and wearing comfort. This will
      be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based
      in Stäfa (Switzerland).
In this study a comparison with a CE-labeled Phonak Receiver-in-the-canal (RIC) device
      (active comparator) and two CE-labeled competitor devices (RIC) is done. All study devices
      contain direct connectivity functionality which will be compared in terms of streamed Audio
      quality, streaming stability and Usability preferences of all available functions and
      features. This will be a clinical evaluation which will be conducted mono centric at Sonova
      AG Headquarters based in Stäfa (Switzerland).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Participant masking was only done for laboratory measurements. For home trial testing no masking was done.
measure: Comparison of the speech intelligibiltity of phone calls via direct streaming
time frame: 6 weeks
description: The primary outcome meaurement of this study is the comparison of Phonak's direct connectivity solution against two competitors in terms of subjective speech intelligibility of streamed audio signals via smartphone. The subjective speech intelligibilty will be measured via interview (sound quality rating, satisfaction rating of speech intelligibility) from far-end talker and near-end talker.
measure: Investigation of Bluetooth Connection losses between Hearing Aid and smart phone during a phone call (number of reported interruptions during a phone call which will be streamed via bluetooth from Smartphone to Hearing Aid)
time frame: 6 weeks
description: The secondary outcome measurement of this study is to investigate the number of (Bluetooth-) Connection losses between Hearing Aid and Smartphone during a phone call stream. The bluetooth connection losses will be investigated by counting the reported interruptions of a streamed phone call between smartphone and Hearing Aid in relation to the amount of conducted phone calls during two weeks of home trial for the investigational device and the comparative devices.
measure: Comparison of the subjective Sound Quality rating of TV-Audiostream via direct connectivity
time frame: 6 weeks
description: Another outcome measurement of this study is the comparison of streamed audio signals from TV in terms of sound quality (measured via satisfaction rating).
measure: Comparison of the Usability of remote controls via direct connectivity
time frame: 6 weeks
description: Another outcome measurement of this study is the comparison of the usability of a remote control via interview during and after home trial.
arm group label: Phonak Audéo B90-Direct
arm group type: Experimental
description: The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss.
arm group label: HearingAid_A
arm group type: Active Comparator
description: HearingAid_A is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer_A which will be fitted to the participants individual Hearing loss.
arm group label: HearingAid_B
arm group type: Active Comparator
description: HearingAid_B is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer_B which will be fitted to the participants individual Hearing loss.
intervention type: Device
intervention name: Phonak Audéo B90-Direct
description: The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.
arm group label: Phonak Audéo B90-Direct
intervention type: Device
intervention name: HearingAid_A
description: HearingAid_A is the most recent Receiver-in-the-canal Hearing aid from manufacturer_A which will be fitted to the participants individual Hearing loss.
arm group label: HearingAid_A
intervention type: Device
intervention name: HearingAid_B
description: HearingAid_B is the most recent Receiver-in-the-canal Hearing aid from manufacturer_B which will be fitted to the participants individual Hearing loss.
arm group label: HearingAid_B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Hearing Loss, Sensorineural