Benchmark Ear Impression Techniques

Ear Anatomy Clinical Trial

Official title:

Benchmark Ear Impression Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03303183
• Other study ID #: KEK-ZH Nr.2014-0326
• Status: Completed
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: December 15, 2018

Study information

• Verified date: November 2019
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 15, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ear Anatomy

Intervention

Device:
• Standard Impression technique
Silicone impression technique
• Direct Ear Scanner
Direct Ear Scanner to scan the ear anatomy

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deviation of Direct ear scanner compared to silicone impressions	Deviation of the scan of Direct ear scanner compared to silicone impressions with two viscosities [mm]	1 year