Actively Recruiting

Phase Not Applicable
Age: 18Years - 89Years
All Genders
ID07228845

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

Led by University of Arizona · Updated on 2026-05-01

32

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether 3D-printed ear tips perform as well as or better than standard ear tips in terms of sound quality, comfort, and fit for individuals with bilateral sensorineural hearing loss. The study aims to address challenges in affordable and timely hearing healthcare by comparing the effectiveness, cost, and production time of these ear tips. Participants will receive behind-the-ear (BTE) hearing aids fitted with three different types of customized ear tips made from biocompatible resin or flexible resin. Each ear tip will be worn for one week in a randomized order, either starting with third-party manufactured, flexible resin, or resin ear tips. Hearing aids will be programmed to match participants' hearing loss from 250-8000Hz, and a short washout period will follow testing with each ear tip group. During the study, participants will complete comfort questionnaires and undergo real ear measurements after each week of ear tip use. Researchers will also track the cost and time required to produce each type of ear tip. The study will last approximately three weeks per participant, covering the use of all three ear tips and follow-up assessments to evaluate comfort and sound quality.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Bilateral, symmetric sensorineural hearing loss ranging from normal to severe
  • Normal ear canals and eardrums with aerated middle ear on both sides
  • English speaking
Not Eligible

You will not qualify if you...

  • History of extensive or current outer or middle ear problems
  • History of extensive outer or middle ear surgery
  • History of neurological or cognitive disorders
  • Current active ear infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Approximately 3 to 4 weeks

Participants will wear three different types of customized ear tips with their hearing aids, each for 1 week in a crossover design. Hearing aids will be programmed to fit their hearing loss. A short washout period will follow completion of testing with each ear tip group.

Weekly visits for up to 4 weeks

Trial Site Locations

Total: 1 location

1

The University of Arizona Hearing Clinic

Tucson, Arizona, United States, 85721

Actively Recruiting

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Research Team

B

Bryan Wong, AuD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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