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Comparing 3D-Printed and Conventional Hearing Aid Ear Tips

This study is looking at how comfortable and effective different types of ear tips are for people who use hearing aids. We are comparing three types of custom ear tips: a standard 'Third-party' type and two 3D-printed types called 'FlexResin' and 'Resin'. Participants will wear each type of ear tip for one week. We want to see if the 3D-printed ear tips work as well as or better than the standard ones for sound quality, comfort, and fit. This study is for adults aged 18 to 89 who have hearing loss in both ears (bilateral sensorineural hearing loss) and can speak English. We will measure comfort using a questionnaire and check how well the hearing aids work with Real Ear Measures.

Study design
This is an interventional study planning to enroll 32 participants. It is not specified if it is randomized or blinded.
What's involved
You would wear three different types of custom ear tips, each for one week. Your hearing aids will be programmed to your specific hearing loss.
Compensation
Not stated in the trial record.
Follow-up
Your comfort and hearing aid performance will be measured throughout the study, which is expected to last an average of three weeks (one week per ear tip type).

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NCT07228845

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

Recruiting
NAAges 18–89InterventionalTreatment
University of Arizona
~32 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested: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)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Outer EAR comfort questionnaire
Measured over through study completion, an average of 1 week
+1 more outcome measured

Conditions

Hearing Aids
Hearing Loss, Bilateral Sensorineural
3D Printing

Explore related trials

Hearing Loss

Where it's being run

1 sites across 1 states
Arizona1

Who to contact

Bryan Wong, AuD, PhD
[email protected]
16025270359 · ext. 5206268549
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Outer EAR comfort questionnairethrough study completion, an average of 1 week

    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.

  • Real Ear Measuresthrough study completion, an average of 1 week

    Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party, in-house\_Resin, in-house\_FlexResin). 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.