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

Not Applicable

Not yet recruiting

• Conditions: Hearing Aids; Hearing Loss, Bilateral Sensorineural; 3D Printing

• Registration Number: NCT07228845
• Lead Sponsor: University of Arizona

Brief 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 over a prolonged duration in a sample of individuals with bilateral hearing loss. It will also compare how long each method takes to make and how much each costs.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-07
• Study First Submitted QC: 2025-11-13
• Last Update Submitted: 2025-11-13
• Study First Posted: 2025-11-14
• Last Update Posted: 2025-11-14
• Study Start: 2026-01-15
• Primary Completion: 2027-01-15
• Study Completion: 2027-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Real Ear Measures	through 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.
Outer EAR comfort questionnaire	through 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.

Secondary Outcome Measures

Name	Time	Method
Cost	through study completion, an average of week	The total raw cost ($, dollars US)
Time	through study completion, an average of week	Time-to-subject for each ear tip type

Trial Locations

Locations (1)

The University of Arizona Hearing Clinic; 🇺🇸 Tucson, Arizona, United States