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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D ear scanner | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with anatomically typical external auditory canals/meatus who have any degree, type, and configuration of hearing impairment.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Seitz-Paquette | Sonova USCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phonak Audiology Research Center | Aurora | Illinois | 60504 | United States |
Of 30 enrolled participants, 30 met inclusion criteria and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants who have bilateral impressions taken with both methodologies.
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who have bilateral impressions taken with both methodologies.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age range from 40 to 88 years, with a mean age of 71.4 years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All earmold impression sets (right ear, left ear) that were taken by sub-investigator using both silicone and 3D scanning technologies. | Posted | Mean | Full Range | Minutes | Day one | Set of earmold impressions | Set of earmold impressions |
|
up to 30 days after participant was seen for impressions.
Any adverse events that occur at time of appointment are documented on adverse event template form (TPL-518) and follow up continues with participant for 30 days or until event is resolved, or a referral has been made to appropriate medical professional.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants will have bilateral impressions taken with both methodologies.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator, Director of Research | Sonova USCS | 630-821-5000 | phonakaudiologyresearch@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2021 | Jul 1, 2022 | Prot_SAP_000.pdf |
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| Conventional silicon ear impressions | Other | 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. |
|
| 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 |
| Mean |
| Full Range |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Description |
|---|
| OG000 | Set of Ear Impressions Taken Using 3D Scanner | Set (right ear, left ear) of impressions completed via a commercially available 3D ear scanner, which is used according to standard of care. |
| OG001 | Set of Impressions Taken Using Traditional Silicone Ear Impression Material and Technique | Set (right ear, left ear) of impressions taken using a two part silicon impression material which fills the ear and produces a physical cast of the ear canal. The procedure is standard of care. |
|
|
| 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). | All participants who have both silicone and scanned ear impressions completed | Posted | Mean | Full Range | score on a scale | Day one |
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| 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). | All participants who had both silicone and scanned ear impressions completed | Posted | Mean | Full Range | score on a scale | Day one |
|
|
|
| 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). | All participants who had both silicone and scanned ear impressions completed | Posted | Mean | Full Range | score on a scale | Day one |
|
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| 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). | 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. | Posted | Mean | Full Range | score on a scale | Day 1 | set of earmold impressions | set of earmold impressions |
|
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| 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). | 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. | Posted | Mean | Full Range | score on a scale | Day 1 | set of earmold impressions | set of earmold impressions |
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| 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). | 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. | Posted | Mean | Full Range | score on a scale | Day 1 | set of earmold impressions | set of earmold impressions |
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| 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). | 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. | Posted | Mean | Full Range | score on a scale | Day 1 | Earmold impression sets | Earmold impression sets |
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| 0 |
| 30 |
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| 30 |
| 0 |
| 30 |
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