Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing in the Normal Range
NCT ID: NCT07216937
Last Updated: 2025-11-10
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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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-11-07
2026-05-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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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
ear tips fabricated using biocompatible resin
BTE hearing aid with compatible earmolds
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.
Third-party control
ear tips fabricated by third party manufacturer using biocompatible resin
BTE hearing aid with compatible earmolds
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.
In-house Study group_FlexibleResin
ear tips fabricated using biocompatible flexible resin
BTE hearing aid with compatible earmolds
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.
Interventions
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BTE hearing aid with compatible earmolds
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.
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
* history of extensive outer or middle ear surgery.
* history of neurological or cognitive disorder.
18 Years
89 Years
ALL
Yes
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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Bryan Wong, AuD, PhD
Role: primary
Other Identifiers
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00005737
Identifier Type: -
Identifier Source: org_study_id