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Access to affordable and timely hearing healthcare remains a major challenge for many individuals, partly due to the high cost and long turnaround time. This study will explore whether 3D-printed ear tips perform as well as or better than standard ear tips in terms of sound quality, comfort, and fit. It will also compare how long each method takes to make and how much each costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-house Study group_Resin | Experimental | ear tips fabricated using biocompatible resin |
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| Third-party control | Active Comparator | ear tips fabricated by third party manufacturer using biocompatible resin |
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| In-house Study group_FlexibleResin | Experimental | ear tips fabricated using biocompatible flexible resin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTE hearing aid with compatible earmolds | Device | Hearing aids will be fit with three different types of customized ear tips. They will only wear each ear tip group for the duration of the test (total = 20 minutes). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 40 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear ear tip group. |
| Measure | Description | Time Frame |
|---|---|---|
| Real Ear Measures | Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party control, in-house_Resin, in-house_FlexResin). Then, a thin microphone tube is placed in the ear canal to measure the average amount gain (dB SPL) across various frequencies (250-8000Hz) while the participant sits in front of a speaker playing sound samples. Results are recorded in gain (dB SPL) across frequencies. Once complete, the eartip type is changed and recording is repeated until all eartip material types have been tested for each individual. | 2nd listening session appointment (15 minutes) |
| Outer EAR comfort questionnaire | A validated questionnaire, Outer EAR, will be used to elicit patient perception of physical comfort, acoustic comfort, quality of voice, and overall self-perceived satisfaction. Includes 6 items (5 levels) , with 5 representing best possible function/rating. | 2nd listening session appointment (10 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Cost | The total raw cost ($, dollars US) | Prior to second listening session appointment (15 minutes) |
| Time | time-to-subject for each eartip type |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bryan Wong, AuD, PhD | Contact | 520-626-8549 | bryanwong@arizona.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona Hearing Clinic | Recruiting | Tucson | Arizona | 85719 | United States |
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| Prior to second listening appointment (15 minutes) |