Clinical Performance Evaluation of 3D Ear Canal Scanning Technology
NCT ID: NCT05000047
Last Updated: 2023-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
30 participants
OBSERVATIONAL
2021-05-17
2021-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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All participants
All study participants who have bilateral earmold impressions completed using both a 3D ear scanner and the conventional procedure using silicone impression material.
3D ear scanner
A commercially-available ear scanning device used according to standard of care. A hand-held device is used and is considered less invasive than conventional earmold impressions.
Conventional silicon ear impressions
A two part silicon impression material that is used to fill the ear and produce a physical cast of the ear canal. The procedure is standard of care.
Interventions
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3D ear scanner
A commercially-available ear scanning device used according to standard of care. A hand-held device is used and is considered less invasive than conventional earmold impressions.
Conventional silicon ear impressions
A two part silicon impression material that is used to fill the ear and produce a physical cast of the ear canal. The procedure is standard of care.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Positive history of external/middle ear surgery.
18 Years
100 Years
ALL
No
Sponsors
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Sonova AG
INDUSTRY
Responsible Party
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Principal Investigators
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Kevin Seitz-Paquette
Role: PRINCIPAL_INVESTIGATOR
Sonova USCS
Locations
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Phonak Audiology Research Center
Aurora, Illinois, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SRF-371
Identifier Type: -
Identifier Source: org_study_id
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