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

NCT ID: NCT04739436

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-26
• Study Completion Date: 2024-09-20

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bilateral hearing aid fitting group

Group Type: OTHER

Hearing amplification

Intervention Type: DEVICE

Bilateral vs. unilateral hearing aids for hearing loss

Unilateral hearing aid fitting group

Group Type: ACTIVE_COMPARATOR

Hearing amplification

Intervention Type: DEVICE

Bilateral vs. unilateral hearing aids for hearing loss

Interventions

Hearing amplification

Bilateral vs. unilateral hearing aids for hearing loss

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherri Smith, AuD,PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Duke University Medical Center

Durham, North Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PCORI-HL-2019C1-16059

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00106077

Identifier Type: -

Identifier Source: org_study_id