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

NCT ID: NCT07228845

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2027-04-15

Brief Summary

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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

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Conditions

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Hearing Aids Hearing Loss, Bilateral Sensorineural 3D Printing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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In-house Study group_Resin

participants will initially receive ear tips fabricated using biocompatible resin

Group Type EXPERIMENTAL

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

Intervention Type 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

Third-party Manufactured

participants will initially receive ear tips fabricated by third party manufacturer using biocompatible resin

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

In-house Study group_FlexibleResin

Participants will initially receive ear tips fabricated using biocompatible flexible resin

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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

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.

Intervention Type DEVICE

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

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Bryan Wong

Assistant Professor of Practice

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of Arizona Hearing Clinic

Tucson, Arizona, United States

Site Status

Countries

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United States

Central Contacts

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Bryan Wong, AuD, PhD

Role: CONTACT

16025270359 ext. 5206268549

Facility Contacts

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Bryan Wong, AuD, PhD

Role: primary

5206268549

Other Identifiers

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5737

Identifier Type: -

Identifier Source: org_study_id

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