Benchmark Ear Impression Techniques

Not Applicable

Completed

• Conditions: Ear Anatomy
• Interventions: Device: Standard Impression technique; Device: Direct Ear Scanner

• Registration Number: NCT03303183
• Lead Sponsor: Sonova AG

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 benchmarking the outcome of each impression technique on custom product dummies on participants.

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 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.

Study Timeline

• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-05
• Study Start: 2017-10-23
• Primary Completion: 2018-12-15
• Study Completion: 2018-12-15
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-25
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Silicone Ear impression	Standard Impression technique	Impression via silicone
Direct Ear Scanner	Direct Ear Scanner	Digitale impression via direct ear scanner

Primary Outcome Measures

Name	Time	Method
Deviation of Direct ear scanner compared to silicone impressions	1 year	Deviation of the scan of Direct ear scanner compared to silicone impressions with two viscosities \[mm\]

Trial Locations

Locations (1)

Sonova AG; 🇨🇭 Stäfa, Switzerland