CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
3D ear scanner +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05000047
NCT05000047N/ACompleted

3D Ear Scanner-Workflow Timing and Preferences Compared to Traditional Silicone Earmold Impressions

Sonova AG·observational·Posted Aug 11, 2021·Updated Jun 1, 2023

In Brief

An observational study evaluating 3D ear scanner and Conventional silicon ear impressions for Ear Mold Impression Procedure. Completed, enrolled 30 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 11, 2021
Enrollment StartMay 17, 2021
Primary CompletionJun 30, 2021
Study CompletionJul 15, 2021
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 4.9 years ago

Interventions

3D ear scannerdevice

A commercially-available ear scanning device used according to standard of care. A hand-held device is used and is considered less invasive than conventional earmold impressions.

Conventional silicon ear impressionsother

A two part silicon impression material that is used to fill the ear and produce a physical cast of the ear canal. The procedure is standard of care.