Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing Loss

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT07228845
Status
Recruiting
Apply to this trial

Conditions

  • 3D Printing
  • Hearing Aids
  • Hearing Loss, Bilateral Sensorineural

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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

Study Details

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.

Key Dates

Start date
Mar 15, 2026
Status verified
Apr 2026
Primary completion
Apr 15, 2027
Completion
Apr 25, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: In-house Study group_Resin
    participants will initially receive ear tips fabricated using biocompatible resin
  • Active Comparator: Third-party Manufactured
    participants will initially receive ear tips fabricated by third party manufacturer using biocompatible resin
  • Experimental: In-house Study group_FlexibleResin
    Participants will initially receive ear tips fabricated using biocompatible flexible resin

Primary Outcome Measure

Outer EAR comfort questionnaire [ Time Frame: through study completion, an average of 1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Arizona Hearing ClinicTucsonArizona85721
Bryan Wong, AuD, PhD
[email protected]
5206268549

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By research site
The University of Arizona Hearing Clinic· Tucson, AZ

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