3D-printed versus conventional hearing-aid ear tips for comfort and fit
Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing Loss
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT07228845 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults with bilateral, symmetric sensorineural hearing loss and normal otoscopy who meet the clinic's inclusion criteria.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tucson, Arizona
- The University of Arizona Hearing Clinic — Tucson, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Bryan Wong, AuD, PhD
- Email: bryanwong@arizona.edu
- Phone: 16025270359
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.