Trial Outcomes & Findings for Clinical Performance Evaluation of 3D Ear Canal Scanning Technology (NCT NCT05000047)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

Day one

Results posted on

2023-06-01

Participant Flow

Of 30 enrolled participants, 30 met inclusion criteria and completed the study.

Participant milestones

Participant milestones
Measure	All Participants All participants who have bilateral impressions taken with both methodologies. 1. 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. 2. 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.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=30 Participants All participants who have bilateral impressions taken with both methodologies. 1. 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. 2. 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.
Age, Continuous	71.4 years n=30 Participants
Sex: Female, Male Female	15 Participants n=30 Participants
Sex: Female, Male Male	15 Participants n=30 Participants
Region of Enrollment United States	30 participants n=30 Participants

PRIMARY outcome

Timeframe: Day one

Population: All earmold impression sets (right ear, left ear) that were taken by sub-investigator using both silicone and 3D scanning technologies.

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.

Outcome measures

Outcome measures
Measure	Set of Ear Impressions Taken Using 3D Scanner n=30 Set of earmold impressions Set (right ear, left ear) of impressions completed via a commercially available 3D ear scanner, which is used according to standard of care.	Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique n=30 Set of earmold impressions Set (right ear, left ear) of impressions taken using a two part silicon impression material which fills the ear and produces a physical cast of the ear canal. The procedure is standard of care.
Elapsed Time in Minutes to Complete Bilateral Ear Impressions	8.15 Minutes Interval 5.55 to 14.4	6.28 Minutes Interval 5.75 to 8.73

SECONDARY outcome

Timeframe: Day one

Population: All participants who have both silicone and scanned ear impressions completed

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).

Outcome measures

Outcome measures
Measure	Set of Ear Impressions Taken Using 3D Scanner n=30 Participants Set (right ear, left ear) of impressions completed via a commercially available 3D ear scanner, which is used according to standard of care.	Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique n=30 Participants Set (right ear, left ear) of impressions taken using a two part silicon impression material which fills the ear and produces a physical cast of the ear canal. The procedure is standard of care.
Subjective Feedback of Overall Experience of Both Ear Impression Procedures	4.6 score on a scale Interval 2.0 to 5.0	3.9 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Day one

Population: All participants who had both silicone and scanned ear impressions completed

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).

Outcome measures

Outcome measures
Measure	Set of Ear Impressions Taken Using 3D Scanner n=30 Participants Set (right ear, left ear) of impressions completed via a commercially available 3D ear scanner, which is used according to standard of care.	Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique n=30 Participants Set (right ear, left ear) of impressions taken using a two part silicon impression material which fills the ear and produces a physical cast of the ear canal. The procedure is standard of care.
Subjective Feedback, Pleasantness of Experience	1.73 score on a scale Interval 1.0 to 3.0	2.4 score on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Day one

Population: All participants who had both silicone and scanned ear impressions completed

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).

Outcome measures

Outcome measures
Measure	Set of Ear Impressions Taken Using 3D Scanner n=30 Participants Set (right ear, left ear) of impressions completed via a commercially available 3D ear scanner, which is used according to standard of care.	Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique n=30 Participants Set (right ear, left ear) of impressions taken using a two part silicon impression material which fills the ear and produces a physical cast of the ear canal. The procedure is standard of care.
Subjective Feedback on the Perceived Improvement of Actual Device Fitting Using Each Impression Procedure Compared to a Non-custom Hearing Aid Fitting	1.77 score on a scale Interval 1.0 to 3.0	2.13 score on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Day 1

Population: All earmold impression sets (right ear, left ear) that were taken by sub-investigators using both silicone and 3D scanning technologies. Sub-investigators were not considered enrolled but contributed to this assessment.

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).

Outcome measures

Outcome measures
Measure	Set of Ear Impressions Taken Using 3D Scanner n=30 set of earmold impressions Set (right ear, left ear) of impressions completed via a commercially available 3D ear scanner, which is used according to standard of care.	Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique n=30 set of earmold impressions Set (right ear, left ear) of impressions taken using a two part silicon impression material which fills the ear and produces a physical cast of the ear canal. The procedure is standard of care.
Sub-investigator Clinician Subjective Rating of Ease of Procedure on a Scale From 1 (Not at All Easy) to 10 (Most Ease)	8.13 score on a scale Interval 2.0 to 10.0	9.27 score on a scale Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: Day 1

Population: All earmold impression sets (right ear, left ear) that were taken by clinician using both silicone and 3D scanning technologies. Sub-investigator clinicians were not considered enrolled but did contribute to this assessment.

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).

Outcome measures

Outcome measures
Measure	Set of Ear Impressions Taken Using 3D Scanner n=30 set of earmold impressions Set (right ear, left ear) of impressions completed via a commercially available 3D ear scanner, which is used according to standard of care.	Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique n=30 set of earmold impressions Set (right ear, left ear) of impressions taken using a two part silicon impression material which fills the ear and produces a physical cast of the ear canal. The procedure is standard of care.
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 score on a scale Interval 1.0 to 3.0	1.2 score on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: Day 1

Population: All earmold impression sets (right ear, left ear) that were taken by clinician using both silicone and 3D scanning technologies. Clinicians were not considered enrolled but did contribute to this assessment.

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).

Outcome measures

Outcome measures
Measure	Set of Ear Impressions Taken Using 3D Scanner n=30 set of earmold impressions Set (right ear, left ear) of impressions completed via a commercially available 3D ear scanner, which is used according to standard of care.	Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique n=30 set of earmold impressions Set (right ear, left ear) of impressions taken using a two part silicon impression material which fills the ear and produces a physical cast of the ear canal. The procedure is standard of care.
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 score on a scale Interval 1.0 to 3.0	2.9 score on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: Day 1

Population: All earmold impression sets (right ear, left ear) that were taken by clinician using both silicone and 3D scanning technologies. Clinicians were not considered enrolled but did contribute to this assessment.

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).

Outcome measures

Outcome measures
Measure	Set of Ear Impressions Taken Using 3D Scanner n=30 Earmold impression sets Set (right ear, left ear) of impressions completed via a commercially available 3D ear scanner, which is used according to standard of care.	Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique n=30 Earmold impression sets Set (right ear, left ear) of impressions taken using a two part silicon impression material which fills the ear and produces a physical cast of the ear canal. The procedure is standard of care.
Clinician Subjective Rating of Overall Experience of Each Procedure.	4.2 score on a scale Interval 2.0 to 5.0	4.5 score on a scale Interval 3.0 to 5.0

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator, Director of Research

Sonova USCS

Phone: 630-821-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place