Clinical trial Recruiting at 1 site Interventional Ages 18 to 89

3D-printed versus conventional hearing-aid ear tips for comfort and fit

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

Run by University of Arizona · NCT07228845 · Data updated 2026-11-12

This study will test whether 3D-printed hearing-aid ear tips are as comfortable, fit as well, and sound as good as standard ear tips for people with bilateral sensorineural hearing loss, and will compare how long each takes to make and how much each costs.

Quick facts

Study typeInterventional
Ages18 Years to 89 Years
SexAll
Enrollment32 (estimated)
SponsorUniversity of Arizona
Academic / other
Locations1 site (Tucson, Arizona)
StatusRecruiting
StartedMarch 15, 2026
Main results expectedApril 15, 2027
Study endsApril 25, 2027
Registry record updatedMay 1, 2026
Trial IDNCT07228845 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are English-speaking adults with bilateral, symmetric sensorineural hearing loss and normal otoscopy who meet the clinic's inclusion criteria.

Probably not a fit

People with active outer or middle ear disease, a history of extensive ear surgery, neurological or cognitive disorders, or asymmetric hearing loss are unlikely to benefit from this comparison.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with bilateral, symmetric sensorineural hearing loss will be fitted with behind-the-ear (BTE) hearing aids using either 3D-printed or conventional ear tips and followed over a prolonged period. Participants will experience different ear-tip types so researchers can compare perceived sound quality, comfort, and fit using standard subjective and objective measures. The study will also record the manufacturing time and direct costs for each ear-tip method. Results will be used to compare user experience and resource implications between 3D-printed and standard ear tips.

Why it matters

Potential benefit: If successful, 3D-printed ear tips could provide a faster, lower-cost, and more personalized option that matches conventional ear tips for comfort and sound quality.

How similar studies have gone: Early pilot studies and commercial use of 3D-printed ear molds indicate comparable fit and cost advantages to conventional molds, but long-term comfort and sound-quality comparisons are still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • The University of Arizona Hearing Clinic
    Tucson, Arizona, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.