Comparing 3D-Printed and Conventional Ear Tips for Hearing Aids

This study is comparing how comfortable and effective 3D-printed ear tips are compared to traditional ear tips for hearing aids. Researchers want to see if 3D-printed ear tips work just as well, or even better, in terms of sound quality, comfort, and how well they fit. They will also look at how long each type takes to make and its cost. You may be able to join if you are between 18 and 89 years old, have normal hearing, and clear ear canals. The study will measure how well the ear tips work using Real Ear Measures (a way to check sound in your ear) and ask about your comfort using a questionnaire. This study is currently unclear on its recruitment status and plans to enroll 30 people.

Study design
This is an interventional study comparing three different types of customized ear tips for hearing aids. It plans to enroll 30 participants.
What's involved
You would wear each type of ear tip for 20 minutes during a listening session. There will be a second listening session appointment where Real Ear Measures and a comfort questionnaire will be completed.
Compensation
Not stated in the trial record.
Follow-up
Your comfort and Real Ear Measures will be assessed at the second listening session appointment.

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NCT07216937

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

Recruiting
NAAges 18–89InterventionalTreatment
University of Arizona
~30 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:BTE hearing aid with compatible earmolds

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Real Ear Measures
Measured over 2nd listening session appointment (15 minutes)
+1 more outcome measured
Hearing Aids
3D Printing
1 sites across 1 states
Arizona1

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Eligibility criteria

Inclusion

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

history of extensive or current outer or middle ear pathology.
history of extensive outer or middle ear surgery.
history of neurological or cognitive disorder.
  • Real Ear Measures2nd listening session appointment (15 minutes)

    Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party control, in-house\_Resin, in-house\_FlexResin). Then, a thin microphone tube is placed in the ear canal to measure the average amount gain (dB SPL) across various frequencies (250-8000Hz) while the participant sits in front of a speaker playing sound samples. Results are recorded in gain (dB SPL) across frequencies. Once complete, the eartip type is changed and recording is repeated until all eartip material types have been tested for each individual.

  • Outer EAR comfort questionnaire2nd listening session appointment (10 minutes)

    A validated questionnaire, Outer EAR, will be used to elicit patient perception of physical comfort, acoustic comfort, quality of voice, and overall self-perceived satisfaction. Includes 6 items (5 levels) , with 5 representing best possible function/rating.