N/A
N=30
Clinical Performance Evaluation of 3D Ear Canal Scanning Technology
Ear Mold Impression Procedure
Bottom Line
View on ClinicalTrials.gov: NCT05000047 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Elapsed Time in Minutes to Complete Bilateral Ear Impressions — 8.15; 6.28 Minutes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 3D ear scanner (Device); Conventional silicon ear impressions (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sonova AG
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Elapsed Time in Minutes to Complete Bilateral Ear Impressions |
8.15; 6.28 | — |
| SECONDARY Subjective Feedback of Overall Experience of Both Ear Impression Procedures |
4.6; 3.9 | — |
| SECONDARY Subjective Feedback, Pleasantness of Experience |
1.73; 2.4 | — |
| SECONDARY Subjective Feedback on the Perceived Improvement of Actual Device Fitting Using Each Impression Procedure Compared to a Non-custom Hearing Aid Fitting |
1.77; 2.13 | — |
| SECONDARY Sub-investigator Clinician Subjective Rating of Ease of Procedure on a Scale From 1 (Not at All Easy) to 10 (Most Ease) |
8.13; 9.27 | — |
| SECONDARY Sub-investigator Clinician Subjective Rating of Individual Potential for Improvement When Performing Each Procedure 1 (no Potential for Improvement) to 3 (a Lot of Potential for Improvement) |
1.6; 1.2 | — |
| SECONDARY Sub-investigator Clinician Subjective Rating of Individual Confidence That Method of Impression Will Yield a Quality Custom Product for the Participant on a Scale From 1 (Not at All Confident) to 3 (Very Confident). |
2.6; 2.9 | — |
| SECONDARY Clinician Subjective Rating of Overall Experience of Each Procedure. |
4.2; 4.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05000047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.