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NCT Number: NCT07228845

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

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.

Recruiting

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Key information

Conditions

Hearing Aids 3D Printing Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Bilateral Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

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, 85721, United States

Location status: Recruiting

Location contact

Bryan Wong, AuD, PhD

CONTACT

[email protected]

5206268549

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

BTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin)

Device

Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Third-party, FlexResin, Resin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group.

BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin)

Device

Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Resin, Third-party, FlexResin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group

BTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes)

Device

Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Resin, Third-party, FlexResin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group

Primary outcomes

  1. Outer EAR comfort questionnaire

    Time frame: 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.

  2. Real Ear Measures

    Time frame: 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.

Secondary outcomes

  1. Cost

    Time frame: through study completion, an average of week

    The total raw cost ($, dollars US)

  2. Time

    Time frame: through study completion, an average of week

    Time-to-subject for each ear tip type

Study contacts

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

Bryan Wong, AuD, PhD

CONTACT

[email protected]

16025270359 ext. 5206268549

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 14, 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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