<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/NCT03303183</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH Nr.2014-0326</org_study_id>
    <nct_id>NCT03303183</nct_id>
  </id_info>
  <brief_title>Benchmark Ear Impression Techniques</brief_title>
  <official_title>Benchmark Ear Impression Techniques</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the scan quality of the direct ear scanner&#xD;
      concerning consistency, accuracy and reliability and to compare the data to common silicone&#xD;
      ear impressions by benchmarking the outcome of each impression technique on custom product&#xD;
      dummies on participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Today's standard for ear impression techniques is the impression taking process with silicone&#xD;
      impression material. To use the silicone impression for a hearing aid manufacturing process&#xD;
      the geometry of the impression is needed. Modern processes scan the silicone ear impression&#xD;
      with specific scanners. Afterwards the digitalized ear impression is uploaded in the modeling&#xD;
      software for further proceed. A new ear impression technique is now provided with the direct&#xD;
      ear scanner technology. The direct ear scanner can create a digital scan of the outer ear and&#xD;
      ear canal. The scan than can directly transferred to the modeling software. The research&#xD;
      question of this study is to determine the scan quality of the direct ear scanner concerning&#xD;
      consistency, accuracy and reliability and to compare the data to common silicone ear&#xD;
      impressions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Actual">December 15, 2018</completion_date>
  <primary_completion_date type="Actual">December 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Deviation of Direct ear scanner compared to silicone impressions</measure>
    <time_frame>1 year</time_frame>
    <description>Deviation of the scan of Direct ear scanner compared to silicone impressions with two viscosities [mm]</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Ear Anatomy</condition>
  <arm_group>
    <arm_group_label>Direct Ear Scanner</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Digitale impression via direct ear scanner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Silicone Ear impression</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Impression via silicone</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Impression technique</intervention_name>
    <description>Silicone impression technique</description>
    <arm_group_label>Silicone Ear impression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Direct Ear Scanner</intervention_name>
    <description>Direct Ear Scanner to scan the ear anatomy</description>
    <arm_group_label>Direct Ear Scanner</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Only adult participants ≥ 18 years&#xD;
&#xD;
          -  Informed consent form as documented by signature&#xD;
&#xD;
          -  Ability to fill in a questionnaire conscientious&#xD;
&#xD;
          -  Healthy outer ear (Pinna and ear canal, w/o previous surgical procedures)&#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;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sonova AG</name>
      <address>
        <city>Stäfa</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>November 25, 2019</last_update_submitted>
  <last_update_submitted_qc>November 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 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/NCT03303183
org study id: KEK-ZH Nr.2014-0326
nct id: NCT03303183
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to determine the scan quality of the direct ear scanner
      concerning consistency, accuracy and reliability and to compare the data to common silicone
      ear impressions by benchmarking the outcome of each impression technique on custom product
      dummies on participants.
Today's standard for ear impression techniques is the impression taking process with silicone
      impression material. To use the silicone impression for a hearing aid manufacturing process
      the geometry of the impression is needed. Modern processes scan the silicone ear impression
      with specific scanners. Afterwards the digitalized ear impression is uploaded in the modeling
      software for further proceed. A new ear impression technique is now provided with the direct
      ear scanner technology. The direct ear scanner can create a digital scan of the outer ear and
      ear canal. The scan than can directly transferred to the modeling software. The research
      question of this study is to determine the scan quality of the direct ear scanner concerning
      consistency, accuracy and reliability and to compare the data to common silicone ear
      impressions.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Deviation of Direct ear scanner compared to silicone impressions
time frame: 1 year
description: Deviation of the scan of Direct ear scanner compared to silicone impressions with two viscosities [mm]
arm group label: Direct Ear Scanner
arm group type: Active Comparator
description: Digitale impression via direct ear scanner
arm group label: Silicone Ear impression
arm group type: Active Comparator
description: Impression via silicone
intervention type: Device
intervention name: Standard Impression technique
description: Silicone impression technique
arm group label: Silicone Ear impression
intervention type: Device
intervention name: Direct Ear Scanner
description: Direct Ear Scanner to scan the ear anatomy
arm group label: Direct Ear Scanner
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor