N/A
N=30
Investigations of Ear Tip Performance, Perceptions, and Experiences
Hearing Aids
Bottom Line
View on ClinicalTrials.gov: NCT05725824 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Real Ear Measures — 61.23; 60.23; 60.5; 64.53 dB SPL — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BTE hearing aid with compatible earmolds (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arizona
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Real Ear Measures |
61.23; 60.23; 60.5; 64.53; 66.5; 66.23 | <0.05 sig |
| PRIMARY Outer Effectiveness of Auditory Rehabilitation (EAR) Questionnaire |
3.6; 3.77; 3.6; 3.17; 3.43; 3.3 | <0.05 sig |
| PRIMARY Physical Dimensions |
27.19; 27.73; 27.39; 21.42; 22.50; 22.23 | <0.05 sig |
| PRIMARY Production Variable |
59.95; 1.29; 0.04 | <0.05 sig |
Summary
Normal hearing participants will be fit with a hearing aid and different types of customized earmolds. Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. Objective acoustic real ear measures and subjective ratings of sound quality and physical comfort will be evaluated and compared between earmolds. Findings will help researchers to better understand the impacts of different earmolds and how each might affect overall point-of-care.
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 as primary spoken language.
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.
Data sourced from ClinicalTrials.gov (NCT05725824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.