Ear Mold Impression Procedure
Conditions
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.
Interventions
DEVICE3D 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.
OTHERConventional 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.
Sponsors
Sonova AG
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elapsed Time in Minutes to Complete Bilateral Ear Impressions | 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
| Measure | Time frame | Description |
|---|---|---|
| Subjective Feedback, Pleasantness of Experience | 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). |
| Subjective Feedback on the Perceived Improvement of Actual Device Fitting Using Each Impression Procedure Compared to a Non-custom Hearing Aid Fitting | 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). |
| 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-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). |
| Subjective Feedback of Overall Experience of Both Ear Impression Procedures | 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). |
| 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 | 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. | 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). |
| 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 | 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). |
Countries
United States
Participant flow
Pre-assignment details
Of 30 enrolled participants, 30 met inclusion criteria and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 71.4 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 participants | — |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: Day one
Population: All earmold impression sets (right ear, left ear) that were taken by sub-investigator using both silicone and 3D scanning technologies.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Set of Ear Impressions Taken Using 3D Scanner | Elapsed Time in Minutes to Complete Bilateral Ear Impressions | 8.15 Minutes |
| Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique | Elapsed Time in Minutes to Complete Bilateral Ear Impressions | 6.28 Minutes |
Secondary
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Set of Ear Impressions Taken Using 3D Scanner | Clinician Subjective Rating of Overall Experience of Each Procedure. | 4.2 score on a scale |
| Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique | Clinician Subjective Rating of Overall Experience of Each Procedure. | 4.5 score on a scale |
Secondary
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Set of Ear Impressions Taken Using 3D Scanner | 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 |
| Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique | Sub-investigator Clinician Subjective Rating of Ease of Procedure on a Scale From 1 (Not at All Easy) to 10 (Most Ease) | 9.27 score on a scale |
Secondary
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Set of Ear Impressions Taken Using 3D Scanner | 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 |
| Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique | 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). | 2.9 score on a scale |
Secondary
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Set of Ear Impressions Taken Using 3D Scanner | 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 |
| Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique | 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) | 1.2 score on a scale |
Secondary
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).
Time frame: Day one
Population: All participants who have both silicone and scanned ear impressions completed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Set of Ear Impressions Taken Using 3D Scanner | Subjective Feedback of Overall Experience of Both Ear Impression Procedures | 4.6 score on a scale |
| Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique | Subjective Feedback of Overall Experience of Both Ear Impression Procedures | 3.9 score on a scale |
Secondary
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).
Time frame: Day one
Population: All participants who had both silicone and scanned ear impressions completed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Set of Ear Impressions Taken Using 3D Scanner | 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 |
| Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique | Subjective Feedback on the Perceived Improvement of Actual Device Fitting Using Each Impression Procedure Compared to a Non-custom Hearing Aid Fitting | 2.13 score on a scale |
Secondary
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).
Time frame: Day one
Population: All participants who had both silicone and scanned ear impressions completed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Set of Ear Impressions Taken Using 3D Scanner | Subjective Feedback, Pleasantness of Experience | 1.73 score on a scale |
| Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique | Subjective Feedback, Pleasantness of Experience | 2.4 score on a scale |