RecruitingNot ApplicableNCT07228845

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


Sponsor

University of Arizona

Enrollment

32 participants

Start Date

Mar 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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

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Interventions

DEVICEBTE 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.

DEVICEBTE 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

DEVICEBTE 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


Locations(1)

The University of Arizona Hearing Clinic

Tucson, Arizona, United States

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NCT07228845


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