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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 over a prolonged duration in a sample of individuals with bilateral hearing loss. 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 | participants will initially receive ear tips fabricated using biocompatible resin |
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| Third-party Manufactured | Active Comparator | participants will initially receive ear tips fabricated by third party manufacturer using biocompatible resin |
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| In-house Study group_FlexibleResin | Experimental | Participants will initially receive ear tips fabricated using biocompatible flexible resin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin) | Device | Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Third-party, FlexResin, Resin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 week |
| Real Ear Measures | Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party, in-house_Resin, in-house_FlexResin). 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. | through study completion, an average of 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Cost | The total raw cost ($, dollars US) | through study completion, an average of week |
| Time | Time-to-subject for each ear tip type | through study completion, an average of week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bryan Wong, AuD, PhD | Contact | 16025270359 | 5206268549 | bryanwong@arizona.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona Hearing Clinic | Recruiting | Tucson | Arizona | 85721 | United States |
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|
| BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin) | Device | Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Resin, Third-party, FlexResin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group |
|
| BTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes) | Device | Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Resin, Third-party, FlexResin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group |
|
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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