Clinical Performance Evaluation of 3D Ear Canal Scanning Technology

Completed

• Conditions: Ear Mold Impression Procedure
• Interventions: Device: 3D ear scanner; Other: Conventional silicon ear impressions

• Registration Number: NCT05000047
• Lead Sponsor: Sonova AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-17
• Study First Submitted: 2021-06-09
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-15
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-11
• Results First Submitted: 2022-07-04
• Results First Submitted QC: 2022-07-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Results First Posted: 2023-05-06
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Elapsed Time in Minutes to Complete Bilateral Ear Impressions	Day one	The total time in minutes, required for sub-investigators to complete each impression methodology on each participant, according to a standard of care procedure . For the silicone impressions, time was started after otoscopy and cerumen management of both ears, and just before prepping and placing the otoblocks. The timer stopped after the audiologist was satisfied with both ear impressions and placed them in box. For the ear scan, time was started after otoscopy of both ears, and just before prepping the headset and hand-held scanner. The timer stopped after the 3D scan was reviewed for each ear and audiologist satisfied with result. The time reported is how long it took for clinician to finish one complete set of impressions, which included a right and a left ear impression. Separate times for each ear was not recorded.

Secondary Outcome Measures

Name	Time	Method
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).	Day 1	Sub-investigators answered a question after each procedure on each participant they saw- "How confident are you that the method of impression/scanning will yield a quality custom product?" on a scale from 1 (not at all confident) to 3 (very confident).
Subjective Feedback, Pleasantness of Experience	Day one	Each participant answered the question "How pleasant do you rate the impression/scanning procedure?" after each procedure. Participants rated the the pleasantness on a scale from 1 (very pleasant) to 5 (very unpleasant).
Sub-investigator Clinician Subjective Rating of Ease of Procedure on a Scale From 1 (Not at All Easy) to 10 (Most Ease)	Day 1	Sub-investigators answered a question after each procedure on each participant- "How easy was it to perform the procedure? on a scale from 1 (not at all easy) to 10(most ease).
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)	Day 1	Sub-investigators answered a question after each procedure on each participant they saw- "Do you feel like there was any potential for improvement when performing this procedure?". Each sub-investigator rated their own potential for improvement on a scale from 1(no potential for improvement, clinician was very satisfied with impression) to 3 (a lot of potential for improvement, clinician felt impression was inferior).
Subjective Feedback on the Perceived Improvement of Actual Device Fitting Using Each Impression Procedure Compared to a Non-custom Hearing Aid Fitting	Day one	Each participant answered the question at the end of each procedure- "Compared to a non-custom fitting, do you feel that the method of impression/scanning improves the hearing aid process for you?", and rated on a scale from 1 (very improved) to 5 (much worse).
Clinician Subjective Rating of Overall Experience of Each Procedure.	Day 1	Clinicians answered a question after each procedure on each participant they saw- "How would you rate the overall experience of performing this procedure?" using a scale from 1 (worst) to 5 (best).
Subjective Feedback of Overall Experience of Both Ear Impression Procedures	Day one	Each participant answered the question "How do you rate your experience of the recently performed ear canal impression/scanning?" after each procedure. Participants rated their overall experience on a scale from 1 (worst) to 5 (best).

Trial Locations

Locations (1)

Phonak Audiology Research Center; 🇺🇸 Aurora, Illinois, United States