3D Ear Scanner-Workflow Timing and Preferences Compared to Traditional Silicone Earmold Impressions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ear Mold Impression Procedure
- Sponsor
- Sonova AG
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Elapsed Time in Minutes to Complete Bilateral Ear Impressions
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- 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)
- Subjective Feedback, Pleasantness of Experience(Day one)
- 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-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)
- Subjective Feedback on the Perceived Improvement of Actual Device Fitting Using Each Impression Procedure Compared to a Non-custom Hearing Aid Fitting(Day one)
- Clinician Subjective Rating of Overall Experience of Each Procedure.(Day 1)
- Subjective Feedback of Overall Experience of Both Ear Impression Procedures(Day one)