Clinical Performance Evaluation of 3D Ear Canal Scanning Technology

Study Overview
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Brief Summary
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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.

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

Conditions
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Ear Mold Impression Procedure

Intervention / Treatment
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* Device: 3D ear scanner
* Other: Conventional silicon ear impressions


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>All study participants who have bilateral earmold impressions completed using both a 3D ear scanner and the conventional procedure using silicone impression material. | Device: 3D ear scanner<br>* 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.<br>Other: Conventional silicon ear impressions<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elapsed Time in Minutes to Complete Bilateral Ear Impressions | 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. | Day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Feedback of Overall Experience of Both Ear Impression Procedures | 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). | Day one | 
| Subjective Feedback, Pleasantness of Experience | 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). | Day one | 
| Subjective Feedback on the Perceived Improvement of Actual Device Fitting Using Each Impression Procedure Compared to a Non-custom Hearing Aid Fitting | 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). | Day one | 
| Sub-investigator Clinician Subjective Rating of Ease of Procedure on a Scale From 1 (Not at All Easy) to 10 (Most Ease) | 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). | Day 1 | 
| 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) | 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). | Day 1 | 
| 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). | 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). | Day 1 | 
| Clinician Subjective Rating of Overall Experience of Each Procedure. | 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). | Day 1 |