Clinical Performance Evaluation of 3D Ear Canal Scanning Technology

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

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.

Study Overview

• Status: Completed
• Conditions: Ear Mold Impression Procedure
• Intervention / Treatment: Other: Conventional silicon ear impressions; Device: 3D ear scanner

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Phonak Audiology Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults with anatomically typical external auditory canals/meatus who have any degree, type, and configuration of hearing impairment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants; All study participants who have bilateral earmold impressions completed using both a 3D ear scanner and the conventional procedure using silicone impression material.	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.; 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.

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Sonova AG
• Investigators: Principal Investigator: Kevin Seitz-Paquette, Sonova USCS

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Silicon
• Other Study ID Numbers: SRF-371

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes