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

NCT04739436 | Completed Results FDA Device

• 2 other identifiers: Pro00106077PCORI-HL-2019C1-16059
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 2

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)

  The APHAB score ranges from 1 to 99. The change in APHAB score was calculated as the difference between scores at 3 months and baseline, so the range of possible values for the change score is -98 to 98. A lower APHAB score indicates a better benefit; a negative change score indicates greater benefit at 3 months than at baseline.

  Baseline, 3 months

Secondary Outcomes (12)

• Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP)

  3 months

• Change in Hearing Aid Benefit as Measured by Bamford-Kowal-Bench Speech in Noise (BKB SIN) Test

  Baseline, 3 months

• Change in Hearing Aid Benefit as Measured by the Abbreviated Word Auditory Recognition and Recall Measure (WARRM)

  Baseline, 3 months

• Hearing Aid Satisfaction as Measured by Satisfaction With Amplification in Daily Life (SADL) Survey

  3 months , 6 months

• Change in Hearing Related Quality Life as Measured by Hearing Handicap Inventory for Elderly (HHIE) Survey Completion

  Baseline, 3 months, 6 months

Study Arms (2)

Bilateral hearing aid fitting group

OTHER

Device: Hearing amplification

Unilateral hearing aid fitting group

ACTIVE COMPARATOR

Device: Hearing amplification

Interventions

Hearing amplification DEVICE

Bilateral vs. unilateral hearing aids for hearing loss

Bilateral hearing aid fitting group; Unilateral hearing aid fitting group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sherri L. Smith, PhD, AuD, CCC-A
• Organization: Duke University Medical Center

sherri.smith@duke.edu

(919) 684-2426

Study Officials

• Sherri Smith, AuD,PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 4, 2021
• Study Start: April 26, 2021
• Primary Completion: July 12, 2024
• Study Completion: September 20, 2024
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (2)