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

Not Applicable

Not yet recruiting

• Conditions: Hearing Aids; 3D Printing

• Registration Number: NCT07216937
• 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. It will also compare how long each method takes to make and how much each costs.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-10
• Study First Submitted QC: 2025-10-13
• Last Update Submitted: 2025-10-14
• Study First Posted: 2025-10-15
• Last Update Posted: 2025-10-16
• Study Start: 2025-10-24
• Primary Completion: 2026-04-14
• Study Completion: 2026-05-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Normal hearing thresholds (<25 dB HL) at octave frequencies from 250-8000Hz.
• Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
• English speaking.

Exclusion Criteria

• history of extensive or current outer or middle ear pathology.
• history of extensive outer or middle ear surgery.
• history of neurological or cognitive disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Real Ear Measures	2nd listening session appointment (15 minutes)	Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party control, in-house\_Resin, in-house\_FlexResin). Then, 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. Once complete, the eartip type is changed and recording is repeated until all eartip material types have been tested for each individual.
Outer EAR comfort questionnaire	2nd listening session appointment (10 minutes)	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	Prior to second listening session appointment (15 minutes)	The total raw cost ($, dollars US)
Time	Prior to second listening appointment (15 minutes)	time-to-subject for each eartip type

Trial Locations

Locations (1)

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