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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT07216937
Status
Recruiting
Apply to this trial

Conditions

  • 3D Printing
  • Hearing Aids

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

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. It will also compare how long each method takes to make and how much each costs.

Key Dates

Start date
Nov 7, 2025
Status verified
Apr 2026
Primary completion
May 20, 2026
Completion
Jun 14, 2026

Study Design

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

Arms

  • Experimental: In-house Study group_Resin
    ear tips fabricated using biocompatible resin
  • Active Comparator: Third-party control
    ear tips fabricated by third party manufacturer using biocompatible resin
  • Experimental: In-house Study group_FlexibleResin
    ear tips fabricated using biocompatible flexible resin

Primary Outcome Measure

Real Ear Measures [ Time Frame: 2nd listening session appointment (15 minutes) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Arizona Hearing ClinicTucsonArizona85719
Bryan Wong, AuD, PhD
[email protected]
5206268549

Find similar trials in Tucson, AZ

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

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