Recruiting

3D-Printed Ear Tips

Sponsor:

University of Arizona

Code:

NCT07216937

Conditions

Hearing Aids

3D Printing

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

BTE hearing aid with compatible earmolds

Study Details

Brief summary:

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.

Conditions

Hearing Aids

3D Printing

Study ID

NCT07216937

Start date

Nov 7, 2025

Status verified date

Apr, 2026

Completion date

Jun 14, 2026

Anticipated

Primary completion date

May 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Normal hearing thresholds (<25 dB HL) at octave frequencies from 250-8000Hz.
  • Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
  • English speaking.

Exclusion Criteria:

  • history of extensive or current outer or middle ear pathology.
  • history of extensive outer or middle ear surgery.
  • history of neurological or cognitive disorder.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

  • Real Ear Measures [ Time Frame: 2nd listening session appointment (15 minutes) ]
  • Outer EAR comfort questionnaire [ Time Frame: 2nd listening session appointment (10 minutes) ]

Central Contacts and Locations

Central contacts

Bryan Wong, AuD, PhD

520-626-8549bryanwong@arizona.edu

Locations

The University of Arizona Hearing Clinic

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Bryan Wong, AuD, PhD

5206268549bryanwong@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • hearing aids
  • 3D printing
  • hearing healthcare accessibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-05-01.