NCT04739436

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Hearing amplification	Bilateral vs. unilateral hearing aids for hearing loss

Timeline

• Start date: 2021-04-26
• Primary completion: 2024-07-12
• Completion: 2024-09-20
• First posted: 2021-02-04
• Last updated: 2025-04-10
• Results posted: 2025-04-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study