NCT07216937

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

Access to affordable and timely hearing healthcare remains a major challenge for many individuals, partly due to the high cost and long turnaround time. This study will explore whether 3D-printed ear tips perform as well as or better than standard ear tips in terms of sound quality, comfort, and fit. It will also compare how long each method takes to make and how much each costs.

Conditions

• Hearing Aids
• 3D Printing

Interventions

Type	Name	Description
DEVICE	BTE hearing aid with compatible earmolds	Hearing aids will be fit with three different types of customized ear tips. They will only wear each ear tip group for the duration of the test (total = 20 minutes). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 40 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear ear tip group.

Timeline

• Start date: 2025-11-07
• Primary completion: 2026-04-14
• Completion: 2026-05-14
• First posted: 2025-10-15
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study