Status:
COMPLETED
Benchmark Ear Impression Techniques
Lead Sponsor:
Sonova AG
Conditions:
Ear Anatomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 benc...
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- Only adult participants ≥ 18 years
- Informed consent form as documented by signature
- Ability to fill in a questionnaire conscientious
- Healthy outer ear (Pinna and ear canal, w/o previous surgical procedures)
Exclusion
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03303183
Start Date
October 23 2017
End Date
December 15 2018
Last Update
November 26 2019
Active Locations (1)
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1
Sonova AG
Stäfa, Switzerland