Recruiting

3D-Printed Ear Tips

Sponsor:

University of Arizona

Code:

NCT07228845

Conditions

Hearing Aids

Hearing Loss, Bilateral Sensorineural

3D Printing

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin)

BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin)

BTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes)

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 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.

Conditions

Hearing Aids

Hearing Loss, Bilateral Sensorineural

3D Printing

Study ID

NCT07228845

Start date

Mar 15, 2026

Status verified date

Apr, 2026

Completion date

Apr 25, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Bilateral, symmetric, sensorineural hearing loss, with thresholds between normal and severe degree of hearing loss
  • Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
  • English speaking.

Exclusion Criteria:

  • Self reported history of extensive or current outer or middle ear pathology.
  • Self reported history of extensive outer or middle ear surgery.
  • Self reported history of neurological or cognitive disorder.
  • Active ear infection

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Bryan Wong, AuD, PhD

16025270359bryanwong@arizona.edu

Locations

The University of Arizona Hearing Clinic

Recruiting

Tucson, Arizona, United States, 85721

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 loss

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.