Phonak Audiology Research Center
Aurora, Illinois, 60504, United States
Completed
NCT Number: NCT05000047
Clinical Performance Evaluation of 3D Ear Canal Scanning Technology
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.
Completed
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Conditions
Age range
18 year–100 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
3D ear scanner
DeviceA 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.
Conventional silicon ear impressions
OtherA 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.
Primary outcomes
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Elapsed Time in Minutes to Complete Bilateral Ear Impressions
Time frame: 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 outcomes
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Subjective Feedback of Overall Experience of Both Ear Impression Procedures
Time frame: 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).
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Subjective Feedback, Pleasantness of Experience
Time frame: 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).
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Subjective Feedback on the Perceived Improvement of Actual Device Fitting Using Each Impression Procedure Compared to a Non-custom Hearing Aid Fitting
Time frame: 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).
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Sub-investigator Clinician Subjective Rating of Ease of Procedure on a Scale From 1 (Not at All Easy) to 10 (Most Ease)
Time frame: 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).
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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)
Time frame: 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).
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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).
Time frame: 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).
-
Clinician Subjective Rating of Overall Experience of Each Procedure.
Time frame: 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).
Sponsors and collaborators
Lead sponsor
Sonova AG
Industry
Registry information
Official study title
3D Ear Scanner-Workflow Timing and Preferences Compared to Traditional Silicone Earmold Impressions
Important dates
- Study start
- 2021
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Aug 11, 2021
- Registry last updated
- Jun 1, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.