Clinical Performance Evaluation of 3D Ear Canal Scanning Technology

Sonova

Status: Completed

Conditions: Ear Mold Impression Procedure

Treatments: Other: Conventional silicon ear impressions; Device: 3D ear scanner

Study type: Observational

Funder types: Industry

Identifiers

NCT05000047

SRF-371

Details and patient eligibility

About

Study participants will undergo ear canal impressions in a standard of care protocol utilizing two methodologies: 3D ear scanning using a commercially-available ear scanning device, and conventional silicone impression material. The elapsed time of each procedure will be captured for each participant, and the average duration of the two methodologies will be compared.

Enrollment: 30 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hearing impairment (any degree, type, and configuration)

Exclusion criteria

• Absent or abnormal external auditory canal and/or external auditory meatus.
• Positive history of external/middle ear surgery.

Trial design

30 participants in 1 patient group

All participants

Description:

All study participants who have bilateral earmold impressions completed using both a 3D ear scanner and the conventional procedure using silicone impression material.

Treatment:

Device: 3D ear scanner

Other: Conventional silicon ear impressions