Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss

Duke University

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Hearing amplification

Study type: Interventional

Funder types: Other

Identifiers

NCT04739436

Pro00106077

PCORI-HL-2019C1-16059 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 required by degree of hearing loss, or custom coupling if clinically indicated), which represents the most popular style used for mild to moderate hearing loss.
2. To compare other multi-dimensional outcomes including hearing-related quality of life, hearing aid satisfaction in patient-nominated goals, ecological hearing aid outcomes, and hearing aid use.

Secondary objectives:

1. To compare performance outcomes for unilateral versus bilateral hearing aid fittings
2. To explore the differences in long-term patient reported outcomes for their final hearing aid configuration choice
3. To explore patient experiences in each group (unilateral vs bilateral), and patient preference in regards to their choice of final hearing aid configuration.

This study is being conducted at Duke and Vanderbilt Medical Centers, with Duke functioning as the main coordinating center. Study participants will pay out of pocket for the hearing aid(s), but will be able to extend the hearing aid fitting trial period from 60 days (standard of care) to 180 days (6 months). Participants will be given the opportunity to change their hearing aid configuration and/or return their hearing aid(s) for a refund after 3 months, and again at the end of the 6 month study period.

Enrollment: 278 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 participants in 2 patient groups

Bilateral hearing aid fitting group

Other group

Treatment:

Device: Hearing amplification

Unilateral hearing aid fitting group

Active Comparator group

Treatment:

Device: Hearing amplification