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

NCT07216937 | Recruiting FDA Device

• 1 other identifier: 00005737
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Aids; 3D Printing

Keywords

hearing aids; 3D printing; hearing healthcare accessibility

Outcome Measures

Primary Outcomes (2)

• Real Ear Measures

  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.

  2nd listening session appointment (15 minutes)

• Outer EAR comfort questionnaire

  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.

  2nd listening session appointment (10 minutes)

Secondary Outcomes (2)

• Cost

  Prior to second listening session appointment (15 minutes)

• Time

  Prior to second listening appointment (15 minutes)

Study Arms (3)

In-house Study group_Resin

EXPERIMENTAL

ear tips fabricated using biocompatible resin

Device: BTE hearing aid with compatible earmolds

Third-party control

ACTIVE COMPARATOR

ear tips fabricated by third party manufacturer using biocompatible resin

Device: BTE hearing aid with compatible earmolds

In-house Study group_FlexibleResin

EXPERIMENTAL

ear tips fabricated using biocompatible flexible resin

Device: BTE hearing aid with compatible earmolds

Interventions

BTE hearing aid with compatible earmolds DEVICE

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.

In-house Study group_FlexibleResin; In-house Study group_Resin; Third-party control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

The University of Arizona Hearing Clinic

Tucson, Arizona, 85719, United States

RECRUITING

Central Study Contacts

Bryan Wong, AuD, PhD

CONTACT

520-626-8549; bryanwong@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Practice

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: October 15, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): June 14, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)