N/A N=276 Randomized Treatment

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

Hearing Loss

Bottom Line

View on ClinicalTrials.gov: NCT04739436 ↗

Enrolled (actual)

276

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB) — -19.74; -14.41 score on a scale — p=0.003

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Hearing amplification (Device)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)	-17.76; -15.7	0.264
SECONDARY Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP)	87.61; 88.25; 62.64; 59.08; 15.56; 19.91	0.584
SECONDARY Change in Hearing Aid Benefit as Measured by Bamford-Kowal-Bench Speech in Noise (BKB SIN) Test	-1.51; -1.37	0.946
SECONDARY Change in Hearing Aid Benefit as Measured by the Abbreviated Word Auditory Recognition and Recall Measure (WARRM)	15.56; 14.48; 3.01; 4.72	0.490
SECONDARY Hearing Aid Satisfaction as Measured by Satisfaction With Amplification in Daily Life (SADL) Survey	5.71; 5.7; 5.63; 5.64	0.933
SECONDARY Change in Hearing Related Quality Life as Measured by Hearing Handicap Inventory for Elderly (HHIE) Survey Completion	-16.89; -14.7; -19.14; -15.22	—
SECONDARY Change in Complex Ecological Listening as Measured by the Speech Spatial Qualities (SSQ) Survey	0.96; 0.58; 0.83; 0.85	0.015 sig
SECONDARY Hours of Hearing Aid Use	10.09; 10.87; 10.01; 10.35	0.137
SECONDARY Hearing Aid Expectations as Measured by the Expected Consequences of Hearing Aid Ownership (ECHO) Survey	5.01; 5.05	—
SECONDARY Global Hearing Aid Outcomes as Measured by the International Outcome Inventory for Hearing Aids (IOI_HA) Survey	29.81; 29.06; 29.88; 29.89	0.108
SECONDARY Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire	11; 28; 24; 37; 92; 53	—
SECONDARY Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids	1; 1; 26; 48; 107; 77	—
SECONDARY Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)	-17.76; -15.7	0.264

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.

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04739436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.