Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing Loss
1 other identifier
interventional
32
1 country
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2025
CompletedFirst Posted
Study publicly available on registry
November 14, 2025
CompletedStudy Start
First participant enrolled
March 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 25, 2027
May 1, 2026
April 1, 2026
1.1 years
November 7, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
through study completion, an average of 1 week
Real Ear Measures
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.
through study completion, an average of 1 week
Secondary Outcomes (2)
Cost
through study completion, an average of week
Time
through study completion, an average of week
Study Arms (3)
In-house Study group_Resin
EXPERIMENTALparticipants will initially receive ear tips fabricated using biocompatible resin
Third-party Manufactured
ACTIVE COMPARATORparticipants will initially receive ear tips fabricated by third party manufacturer using biocompatible resin
In-house Study group_FlexibleResin
EXPERIMENTALParticipants will initially receive ear tips fabricated using biocompatible flexible resin
Interventions
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.
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Arizona Hearing Clinic
Tucson, Arizona, 85721, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
November 7, 2025
First Posted
November 14, 2025
Study Start
March 15, 2026
Primary Completion (Estimated)
April 15, 2027
Study Completion (Estimated)
April 25, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share