Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing in the Normal Range
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BTE hearing aid with compatible earmolds.
- Who it may be relevant to
- Registry conditions: Hearing Aids, 3D Printing. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device BTE hearing aid with compatible earmolds
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 outcome measures
- Real Ear Measures [Time frame: 2nd listening session appointment (15 minutes)]
- Outer EAR comfort questionnaire [Time frame: 2nd listening session appointment (10 minutes)]
Secondary outcome measures (2)
- Cost [Time frame: Prior to second listening session appointment (15 minutes)]
- Time [Time frame: Prior to second listening appointment (15 minutes)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Arizona Hearing Clinic — Tucson
Identifiers
NCT: NCT07216937 · 00005737