Trials / Completed
CompletedNCT05000047
Clinical Performance Evaluation of 3D Ear Canal Scanning Technology
3D Ear Scanner-Workflow Timing and Preferences Compared to Traditional Silicone Earmold Impressions
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- Sonova AG · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 3D ear scanner | 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. |
| OTHER | Conventional silicon ear impressions | 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. |
Timeline
- Start date
- 2021-05-17
- Primary completion
- 2021-06-30
- Completion
- 2021-07-15
- First posted
- 2021-08-11
- Last updated
- 2023-06-01
- Results posted
- 2023-05-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05000047. Inclusion in this directory is not an endorsement.