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NCT Number: NCT07216937

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

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.

Recruiting

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Key information

Conditions

Hearing Aids 3D Printing

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Arizona Hearing Clinic

Tucson, Arizona, 85719, United States

Location status: Recruiting

Location contact

Bryan Wong, AuD, PhD

CONTACT

[email protected]

5206268549

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Real Ear Measures

    Time frame: 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.

  2. Outer EAR comfort questionnaire

    Time frame: 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 outcomes

  1. Cost

    Time frame: Prior to second listening session appointment (15 minutes)

    The total raw cost ($, dollars US)

  2. Time

    Time frame: Prior to second listening appointment (15 minutes)

    time-to-subject for each eartip type

Study contacts

Contact information is provided by the study sponsor or research team.

Bryan Wong, AuD, PhD

CONTACT

[email protected]

520-626-8549

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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