Actively Recruiting
A Non-Inferiority, Single-Blind, Randomized Controlled Trial Comparing the Efficacy of Domestic Versus Imported Hearing Aids in Patients With Moderate to Severe and Severe Age-Related Hearing Loss
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-08-13
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the hearing improvement effects of domestic versus imported hearing aids in patients with moderate to severe and severe age-related hearing loss. This non-inferiority, single-blind, randomized controlled trial involves 80 patients who will be randomly assigned to use either domestic hearing aids from the Bigsound brand or imported hearing aids from the Phonak brand. The study aims to compare hearing improvements and cost-effectiveness between the two types of hearing aids. Participants will use their assigned hearing aids for a 30-minute trial. Both domestic and imported hearing aids include behind-the-ear, neck-worn, and in-the-ear styles, with the domestic devices being rechargeable. The study collects data on Pure Tone Average (PTA) and Speech Recognition Threshold (SRT) before and after the trial, and records the market price and degree of hearing improvement in decibels. After the trial, patient benefits are assessed using the International Outcome Inventory for Hearing Aids (IOI-HA) and the Abbreviated Profile of Hearing Aid Benefit (APHAB). During the study, participants will undergo hearing tests before and after using the hearing aids. Researchers will analyze hearing and speech improvements, patient satisfaction, and adaptation in various listening environments. The study also includes a cost-effectiveness analysis of the hearing aids. The total participation time includes the 30-minute hearing aid trial and post-trial assessments, with the study ending by December 2025.
CONDITIONS
Brief Title
Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 60 and 85 years
- Diagnosed with moderate to severe or severe age-related hearing loss as defined by specific hearing loss levels
- Bilateral, symmetrical, and gradually progressive hearing loss primarily affecting high frequencies with speech recognition decline
- Chinese nationality and able to complete all assessments in Chinese
- Right-handed
- No significant neurological, systemic, genetic, or major psychiatric diseases
You will not qualify if you...
- Hearing loss caused by noise exposure, heredity, drugs, or other non-age-related causes
- Unable to use hearing aids
- Presence of dementia, Parkinson's disease, or other neurodegenerative diseases affecting compliance
- History of cerebrovascular accidents, stroke, epilepsy, or central nervous system disorders
- Any other conditions deemed exclusionary by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 minutes
Participants are fitted with either domestic or imported hearing aids after an initial hearing assessment. They will try the hearing aids during a 30-minute trial period to evaluate hearing improvement and satisfaction.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 5100000
Actively Recruiting
Research Team
Y
Yang Haidi, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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