NCT03303183

Benchmark Ear Impression Techniques

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Sonova AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ear Anatomy

Interventions

Type	Name	Description
DEVICE	Standard Impression technique	Silicone impression technique
DEVICE	Direct Ear Scanner	Direct Ear Scanner to scan the ear anatomy

Timeline

• Start date: 2017-10-23
• Primary completion: 2018-12-15
• Completion: 2018-12-15
• First posted: 2017-10-05
• Last updated: 2019-11-26

Locations

1 site across 1 country: Switzerland