Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing Loss
NCT ID: NCT07228845
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
32 participants
INTERVENTIONAL
2026-01-15
2027-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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In-house Study group_Resin
participants will initially receive ear tips fabricated using biocompatible resin
BTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes)
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
Third-party Manufactured
participants will initially receive ear tips fabricated by third party manufacturer using biocompatible resin
BTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin)
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.
In-house Study group_FlexibleResin
Participants will initially receive ear tips fabricated using biocompatible flexible resin
BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin)
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
Interventions
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BTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin)
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.
BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin)
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)
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
Eligibility Criteria
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Inclusion Criteria
* Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
* English speaking.
Exclusion Criteria
* Self reported history of extensive outer or middle ear surgery.
* Self reported history of neurological or cognitive disorder.
* Active ear infection
18 Years
89 Years
ALL
No
Sponsors
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University of Arizona
OTHER
Responsible Party
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Bryan Wong
Assistant Professor of Practice
Locations
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The University of Arizona Hearing Clinic
Tucson, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5737
Identifier Type: -
Identifier Source: org_study_id
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