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Recruiting NCT07228845

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

No phase Interventional Hearing Aids Hearing Loss, Bilateral Sensorineural 3D Printing

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 aids with compatible ear tips (Third-party, FlexResin, Resin), BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin), BTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes).
Who it may be relevant to
Registry conditions: Hearing Aids, Hearing Loss, Bilateral Sensorineural, 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 →

Unsure about the terms? Read our patient guide →

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 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.

Interventions

  • Device 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.
  • 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
  • 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

Primary outcome measures

  • Outer EAR comfort questionnaire [Time frame: through study completion, an average of 1 week]
  • Real Ear Measures [Time frame: through study completion, an average of 1 week]
Secondary outcome measures (2)
  • Cost [Time frame: through study completion, an average of week]
  • Time [Time frame: through study completion, an average of week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

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: NCT07228845 · 5737

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗