<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/NCT03755453</url>
  </required_header>
  <id_info>
    <org_study_id>Sonova2018_34</org_study_id>
    <nct_id>NCT03755453</nct_id>
  </id_info>
  <brief_title>Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application - Sonova2018_34</brief_title>
  <official_title>Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application</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>
      A methodical evaluation of novel measurement and fitting methods for individualizing&#xD;
      CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to&#xD;
      be conducted on hearing impaired participants. The aim of the study is to investigate and&#xD;
      asses strength and weaknesses of these novel measurement and fitting methods in terms of&#xD;
      optimizing hearing performance and experience and/or usability of the hearing aids and&#xD;
      accessories. Both laboratory measurements as well as evaluations in real life environments&#xD;
      will be carried out. This will be a controlled and randomised active comparator clinical&#xD;
      evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Stäfa.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2018</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</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>Single Group Assignment</intervention_model>
    <intervention_model_description>All participants will receive a hearing aid fitted with fitting method A and afterwards fitted with fitting method B.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of fitting method A versus B in regard to sound quality</measure>
    <time_frame>2 months</time_frame>
    <description>The number of subjects who prefer the hearing aid setting achieved with hearing aid fitting method A versus B will be measured in the lab with the aid of sounds presented via loudspeakers. This will be measured with the Multiple Stimuli with Hidden Reference and Anchor (MUSHRA) method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of fitting method A versus B in regard to speech intelligibility in noise</measure>
    <time_frame>2 months</time_frame>
    <description>The speech intelligibility in noise with hearing aid fitting method A versus B will be measured with the aid of the Oldenburg sentence test in dB Speech Reception Treshold (SRT).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Audéo B-Direct fitted with fitting method A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional standard fitting method which do not include adjustments from the participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Audéo B-Direct fitted with fitting method B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alternative fitting method which includes additional adjustments from the participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hearing aid: Phonak Audéo B90-Direct</intervention_name>
    <description>Hearing aids will be fitted to the participants individual hearing loss.</description>
    <arm_group_label>Audéo B-Direct fitted with fitting method A</arm_group_label>
    <arm_group_label>Audéo B-Direct fitted with fitting method B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Participants fulfilling all of the following inclusion criteria are eligible for the study:&#xD;
&#xD;
          -  Adult hearing impaired persons (minimum age: 18 years) with and without (experience&#xD;
             with) hearing aids&#xD;
&#xD;
          -  Healthy outer ear (without previous surgical procedures)&#xD;
&#xD;
          -  Ability to fill in a questionnaire (p/eCRF) conscientiously&#xD;
&#xD;
          -  Informed Consent as documented by signature&#xD;
&#xD;
        The presence of any one of the following exclusion criteria will lead to exclusion of the&#xD;
        participant:&#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 appointments&#xD;
&#xD;
          -  Limited ability to describe listening impressions or to use hearing aids/ accessories&#xD;
&#xD;
          -  Inability to produce a reliable hearing test result&#xD;
&#xD;
          -  Massively limited dexterity&#xD;
&#xD;
          -  Known psychological problems&#xD;
&#xD;
          -  Known central hearing disorders&#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>
        <state>Zürich</state>
        <zip>8712</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>May 7, 2019</last_update_submitted>
  <last_update_submitted_qc>May 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2019</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/NCT03755453
org study id: Sonova2018_34
nct id: NCT03755453
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A methodical evaluation of novel measurement and fitting methods for individualizing
      CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to
      be conducted on hearing impaired participants. The aim of the study is to investigate and
      asses strength and weaknesses of these novel measurement and fitting methods in terms of
      optimizing hearing performance and experience and/or usability of the hearing aids and
      accessories. Both laboratory measurements as well as evaluations in real life environments
      will be carried out. This will be a controlled and randomised active comparator clinical
      evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Stäfa.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: All participants will receive a hearing aid fitted with fitting method A and afterwards fitted with fitting method B.
primary purpose: Treatment
masking: Single (Participant)
measure: Comparison of fitting method A versus B in regard to sound quality
time frame: 2 months
description: The number of subjects who prefer the hearing aid setting achieved with hearing aid fitting method A versus B will be measured in the lab with the aid of sounds presented via loudspeakers. This will be measured with the Multiple Stimuli with Hidden Reference and Anchor (MUSHRA) method.
measure: Comparison of fitting method A versus B in regard to speech intelligibility in noise
time frame: 2 months
description: The speech intelligibility in noise with hearing aid fitting method A versus B will be measured with the aid of the Oldenburg sentence test in dB Speech Reception Treshold (SRT).
arm group label: Audéo B-Direct fitted with fitting method A
arm group type: Active Comparator
description: Traditional standard fitting method which do not include adjustments from the participants.
arm group label: Audéo B-Direct fitted with fitting method B
arm group type: Experimental
description: Alternative fitting method which includes additional adjustments from the participants.
intervention type: Device
intervention name: Hearing aid: Phonak Audéo B90-Direct
description: Hearing aids will be fitted to the participants individual hearing loss.
arm group label: Audéo B-Direct fitted with fitting method A
arm group label: Audéo B-Direct fitted with fitting method B
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
sharing ipd: No