<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/NCT03780374</url>
  </required_header>
  <id_info>
    <org_study_id>Sonova2018_37</org_study_id>
    <nct_id>NCT03780374</nct_id>
  </id_info>
  <brief_title>Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application</brief_title>
  <official_title>Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application</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 novel sound changing principles in CE-labelled Sonova brand&#xD;
      hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing&#xD;
      impaired. These sound changing principles are enabled by respective hearing instrument&#xD;
      algorithms. The aim of the study is to investigate and asses strength and weaknesses of these&#xD;
      novel sound changing principles in terms of hearing performance to determine their&#xD;
      application in hearing instruments (Phase of development). Both, objective laboratory&#xD;
      measurements as well as subjective evaluations in real life environment will be carried out.&#xD;
      This will be a controlled, single blinded and randomized active comparator clinical&#xD;
      evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">March 15, 2019</completion_date>
  <primary_completion_date type="Actual">January 15, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>Each participant will be treated with sound principle 1, 2 and 3 in a crossover design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The participant's will not know which intervention will be applied.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Speech Intelligibility in Noise</measure>
    <time_frame>4 weeks</time_frame>
    <description>The speech intelligibility in noise with the three different sound processing principles will be assessed with the aid of the Oldenburg Sentence Test. The result will be shown in dB (decibel) SRT (Speech Reception Threshold).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sound Quality - Overall</measure>
    <time_frame>16 weeks</time_frame>
    <description>The overall sound quality of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire.&#xD;
The results are ratings on a numeric scale, ranging from 0 (bad) to 10 (excellent).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loudness - Laboratory</measure>
    <time_frame>8 weeks</time_frame>
    <description>The loudness of sounds with the three different sound processing principles will be assessed in laboratory with the aid of a MUSHRA (Multi-Stimulus Test with Hidden Reference and Anchor) test.&#xD;
The results are ratings on a numeric scale, ranging from 0 (very soft), 50 (just right) to 100 (very loud).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loudness - Daily Life</measure>
    <time_frame>16 weeks</time_frame>
    <description>The loudness of sounds with the three different sound processing principles will be assessed in daily life with the aid of a questionnaire.&#xD;
The results are ratings on a numeric scale, ranging from 0 (very soft) to 10 (very loud).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clarity - Daily Life</measure>
    <time_frame>16 weeks</time_frame>
    <description>The clarity of sounds with the three sound processing principles will be assessed with the aid of a questionnaire.&#xD;
The results are ratings on a numeric scale, ranging from 0 (very unclear) to 10 (very clear).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preferred Sound Processing Principle</measure>
    <time_frame>16 weeks</time_frame>
    <description>The preferred sound processing principle will be assessed with the aid of a questionnaire.&#xD;
The results will be a ranking, ranging from 1 (most preferred) to 3 (least preferred).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Naturalness - Daily Life</measure>
    <time_frame>16 weeks</time_frame>
    <description>The sound quality with the three different sound processing principles will be assessed with the aid of a questionnaire.&#xD;
The results are ratings on a numeric scale, ranging from 0 (unnatural) to 10 (natural).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Localization - Daily Life</measure>
    <time_frame>16 weeks</time_frame>
    <description>The ability to localize sounds with the three different sound processing principles will be assessed with the aid of a questionnaire.&#xD;
The results are ratings on a numeric scale, ranging from 0 (not at all locatable) to 10 (very well locatable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reverberation - Daily Life</measure>
    <time_frame>16 weeks</time_frame>
    <description>The reverberation of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire.&#xD;
The results are ratings on a numeric scale, ranging from 0 (not at all reverberant) to 10 (very reverberant).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction - Overall in Daily Life</measure>
    <time_frame>16 weeks</time_frame>
    <description>The overall satisfaction in daily life with the three different sound processing principles will be assessed with the aid of a questionnaire.&#xD;
The results are ratings on a numeric scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Sound Processing Principle 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sound Processing Principle 1 will be applied in the hearing aid.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sound Processing Principle 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sound Processing Principle 2 will be applied in the hearing aid.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sound Processing Principle 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sound Processing Principle 3 will be applied in the hearing aid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phonak Audéo L2M with Sound Processing Principle 1</intervention_name>
    <description>Compensation of a hearing loss with Sound Processing Principle 1.</description>
    <arm_group_label>Sound Processing Principle 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phonak Audéo L2M with Sound Processing Principle 2</intervention_name>
    <description>Compensation of a hearing loss with Sound Processing Principle 2.</description>
    <arm_group_label>Sound Processing Principle 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phonak Audéo L2M with Sound Processing Principle 3</intervention_name>
    <description>Compensation of a hearing loss with Sound Processing Principle 3.</description>
    <arm_group_label>Sound Processing Principle 3</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;
          -  Healthy outer ear (without previous surgical procedures)&#xD;
&#xD;
          -  Ability to fill in a questionnaire conscientiously&#xD;
&#xD;
          -  Informed Consent as documented by signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to the medical device in this study, e.g. known hypersensitivity or&#xD;
             allergy to the investigational product&#xD;
&#xD;
          -  Limited mobility and not in the position to attend weekly appointments&#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;
          -  Known 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>Zurich</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>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 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>
  <!-- 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/NCT03780374
org study id: Sonova2018_37
nct id: NCT03780374
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand
      hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing
      impaired. These sound changing principles are enabled by respective hearing instrument
      algorithms. The aim of the study is to investigate and asses strength and weaknesses of these
      novel sound changing principles in terms of hearing performance to determine their
      application in hearing instruments (Phase of development). Both, objective laboratory
      measurements as well as subjective evaluations in real life environment will be carried out.
      This will be a controlled, single blinded and randomized active comparator clinical
      evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Each participant will be treated with sound principle 1, 2 and 3 in a crossover design.
primary purpose: Treatment
masking: Single (Participant)
masking description: The participant's will not know which intervention will be applied.
measure: Speech Intelligibility in Noise
time frame: 4 weeks
description: The speech intelligibility in noise with the three different sound processing principles will be assessed with the aid of the Oldenburg Sentence Test. The result will be shown in dB (decibel) SRT (Speech Reception Threshold).
measure: Sound Quality - Overall
time frame: 16 weeks
description: The overall sound quality of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (bad) to 10 (excellent).
measure: Loudness - Laboratory
time frame: 8 weeks
description: The loudness of sounds with the three different sound processing principles will be assessed in laboratory with the aid of a MUSHRA (Multi-Stimulus Test with Hidden Reference and Anchor) test.
The results are ratings on a numeric scale, ranging from 0 (very soft), 50 (just right) to 100 (very loud).
measure: Loudness - Daily Life
time frame: 16 weeks
description: The loudness of sounds with the three different sound processing principles will be assessed in daily life with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (very soft) to 10 (very loud).
measure: Clarity - Daily Life
time frame: 16 weeks
description: The clarity of sounds with the three sound processing principles will be assessed with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (very unclear) to 10 (very clear).
measure: Preferred Sound Processing Principle
time frame: 16 weeks
description: The preferred sound processing principle will be assessed with the aid of a questionnaire.
The results will be a ranking, ranging from 1 (most preferred) to 3 (least preferred).
measure: Naturalness - Daily Life
time frame: 16 weeks
description: The sound quality with the three different sound processing principles will be assessed with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (unnatural) to 10 (natural).
measure: Localization - Daily Life
time frame: 16 weeks
description: The ability to localize sounds with the three different sound processing principles will be assessed with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (not at all locatable) to 10 (very well locatable).
measure: Reverberation - Daily Life
time frame: 16 weeks
description: The reverberation of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (not at all reverberant) to 10 (very reverberant).
measure: Satisfaction - Overall in Daily Life
time frame: 16 weeks
description: The overall satisfaction in daily life with the three different sound processing principles will be assessed with the aid of a questionnaire.
The results are ratings on a numeric scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).
arm group label: Sound Processing Principle 1
arm group type: Active Comparator
description: Sound Processing Principle 1 will be applied in the hearing aid.
arm group label: Sound Processing Principle 2
arm group type: Experimental
description: Sound Processing Principle 2 will be applied in the hearing aid.
arm group label: Sound Processing Principle 3
arm group type: Experimental
description: Sound Processing Principle 3 will be applied in the hearing aid.
intervention type: Device
intervention name: Phonak Audéo L2M with Sound Processing Principle 1
description: Compensation of a hearing loss with Sound Processing Principle 1.
arm group label: Sound Processing Principle 1
intervention type: Device
intervention name: Phonak Audéo L2M with Sound Processing Principle 2
description: Compensation of a hearing loss with Sound Processing Principle 2.
arm group label: Sound Processing Principle 2
intervention type: Device
intervention name: Phonak Audéo L2M with Sound Processing Principle 3
description: Compensation of a hearing loss with Sound Processing Principle 3.
arm group label: Sound Processing Principle 3
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