<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/NCT03774030</url>
  </required_header>
  <id_info>
    <org_study_id>2017-02051-2</org_study_id>
    <nct_id>NCT03774030</nct_id>
  </id_info>
  <brief_title>Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 2</brief_title>
  <acronym>HEAR3D_CE2</acronym>
  <official_title>Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sonova AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss Commission for Technology and Innovation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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 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 participants. These sound changing principles are enabled by respective hearing&#xD;
      instrument technologies and hearing instrument algorithms. The aim of the study is to&#xD;
      investigate and assess strengths and weaknesses of these novel sound changing principles in&#xD;
      terms of hearing performance to determine their application in hearing instruments (Phase of&#xD;
      development). Both, objective laboratory measurements as well as subjective evaluations in&#xD;
      real life environment will be carried out. This will be a controlled, single blinded and&#xD;
      randomised active comparator clinical evaluation which will be conducted mono centric at the&#xD;
      University Hospital of Zürich.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2018</start_date>
  <completion_date type="Actual">January 21, 2019</completion_date>
  <primary_completion_date type="Actual">January 21, 2019</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 group of hearing-impaired particpants with mild or severe hearing loss</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Head movements measured with head tracker</measure>
    <time_frame>6 weeks</time_frame>
    <description>The participant starts the acoustic stimulus, tries to identify the direction of the stimulus as precise as possible and validates the final position. This is interpreted as reaction time with regard to spatial quality in seconds [s].</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Ability, Spatial</condition>
  <arm_group>
    <arm_group_label>hearing impaired participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hearing impaired participants with mild or severe hearing loss</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>several virtual 3-D complex audio environments</intervention_name>
    <description>The focus is a comparison of 3 hearing aid algorithms in a virtual 3-D complex audio Environment.</description>
    <arm_group_label>hearing impaired participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult persons (minimum age: 18 years) with Hearing loss&#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 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&#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>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Norbert Dillier, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT03514758?term=sonova&amp;draw=3&amp;rank=21</url>
    <description>link to first part of study</description>
  </link>
  <results_reference>
    <citation>Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.</citation>
    <PMID>15035561</PMID>
  </results_reference>
  <results_reference>
    <citation>Choisel S, Wickelmaier F. Evaluation of multichannel reproduced sound: scaling auditory attributes underlying listener preference. J Acoust Soc Am. 2007 Jan;121(1):388-400. doi: 10.1121/1.2385043.</citation>
    <PMID>17297794</PMID>
  </results_reference>
  <results_reference>
    <citation>Mueller MF, Meisenbacher K, Lai WK, Dillier N. Sound localization with bilateral cochlear implants in noise: how much do head movements contribute to localization? Cochlear Implants Int. 2014 Jan;15(1):36-42. doi: 10.1179/1754762813Y.0000000040. Epub 2013 Nov 25.</citation>
    <PMID>23684420</PMID>
  </results_reference>
  <results_reference>
    <citation>Catic J, Santurette S, Dau T. The role of reverberation-related binaural cues in the externalization of speech. J Acoust Soc Am. 2015 Aug;138(2):1154-67. doi: 10.1121/1.4928132.</citation>
    <PMID>26328729</PMID>
  </results_reference>
  <results_reference>
    <citation>Simon LS, Zacharov N, Katz BF. Perceptual attributes for the comparison of head-related transfer functions. J Acoust Soc Am. 2016 Nov;140(5):3623. doi: 10.1121/1.4966115.</citation>
    <PMID>27908072</PMID>
  </results_reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 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>
  <!-- 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/NCT03774030
org study id: 2017-02051-2
nct id: NCT03774030
lead sponsor: 
collaborator: 
has dmc: No
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 participants. These sound changing principles are enabled by respective hearing
      instrument technologies and hearing instrument algorithms. The aim of the study is to
      investigate and assess strengths 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
      randomised active comparator clinical evaluation which will be conducted mono centric at the
      University Hospital of Zürich.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: a group of hearing-impaired particpants with mild or severe hearing loss
primary purpose: Other
masking: None (Open Label)
measure: Head movements measured with head tracker
time frame: 6 weeks
description: The participant starts the acoustic stimulus, tries to identify the direction of the stimulus as precise as possible and validates the final position. This is interpreted as reaction time with regard to spatial quality in seconds [s].
arm group label: hearing impaired participants
arm group type: Experimental
description: Hearing impaired participants with mild or severe hearing loss
intervention type: Procedure
intervention name: several virtual 3-D complex audio environments
description: The focus is a comparison of 3 hearing aid algorithms in a virtual 3-D complex audio Environment.
arm group label: hearing impaired participants
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Norbert Dillier, Professor
role: Principal Investigator
affiliation: University Hospital
facility: 
country: Switzerland
url: https://clinicaltrials.gov/ct2/show/NCT03514758?term=sonova&draw=3&rank=21
description: link to first part of study
citation: Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.
PMID: 15035561
citation: Choisel S, Wickelmaier F. Evaluation of multichannel reproduced sound: scaling auditory attributes underlying listener preference. J Acoust Soc Am. 2007 Jan;121(1):388-400. doi: 10.1121/1.2385043.
PMID: 17297794
citation: Mueller MF, Meisenbacher K, Lai WK, Dillier N. Sound localization with bilateral cochlear implants in noise: how much do head movements contribute to localization? Cochlear Implants Int. 2014 Jan;15(1):36-42. doi: 10.1179/1754762813Y.0000000040. Epub 2013 Nov 25.
PMID: 23684420
citation: Catic J, Santurette S, Dau T. The role of reverberation-related binaural cues in the externalization of speech. J Acoust Soc Am. 2015 Aug;138(2):1154-67. doi: 10.1121/1.4928132.
PMID: 26328729
citation: Simon LS, Zacharov N, Katz BF. Perceptual attributes for the comparison of head-related transfer functions. J Acoust Soc Am. 2016 Nov;140(5):3623. doi: 10.1121/1.4966115.
PMID: 27908072
responsible party type: Sponsor