Status:
COMPLETED
Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss
Lead Sponsor:
Duke University
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Hearing Loss
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This study aims to evaluate the benefit of bilateral hearing aid use compared to a unilateral hearing aid. Patients with mild to moderate bilateral hearing loss who are considering the purchase of a c...
Detailed Description
Primary objectives: 1. To compare the hearing-aid benefit of unilateral versus bilateral fittings of commercially-available hearing aids that incorporate a dome coupling (open or closed dome as requi...
Eligibility Criteria
Inclusion
- 50+ years of age
- Ability to read and understand English
- Mild to moderate sensorineural hearing loss (defined by a pure-tone average at 500, 1000, and 2000 Hz of \<55 dB HL in each ear, and the 3000 Hz and 4000 Hz threshold \<80 in each ear), based on a hearing test obtained within the last 6 months by a licensed audiologist.
- Symmetrical hearing loss defined by \<20 dB difference between the pure-tone average of 500, 1000, and 2000 Hz between ears)
- Interested in purchasing hearing aids, but is open minded about trying one or two hearing aids
- No prior hearing aid use longer than 3 months (as documented via self-report)
- Adequate literacy to complete questionnaires
- Willing to purchase study-specific hearing aid(s)
- Access to a smart phone and the internet
Exclusion
- Concerns for middle ear pathology (e.g., air bone gap of \>15 dB at 2 consecutive octave frequencies in either ear)
- Concerns for retrocochlear pathology by audiologist (e.g unilateral tinnitus or ear fullness, referral to ENT/Auditory Brainstem Response testing to r/o acoustic neuroma)
- Severe tinnitus as the reason for seeking amplification
- Co-morbid condition that would interfere with study (e.g., dementia, blindness, neurologic pathology)
- History of fluctuating hearing loss
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2024
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT04739436
Start Date
April 26 2021
End Date
September 20 2024
Last Update
April 10 2025
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232