Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss (NCT04739436) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss
United States278 participantsStarted 2021-04-26
Plain-language 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 commercially available hearing aid will be considered for participation. Eligible participants will be randomized to one of the following treatment arms: (1) a bilateral hearing aid fitting group, and (2) a unilateral hearing aid fitting group.
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)