Clinical Trial

Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL

Recruiting
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Record status
This record was last updated August 13, 2025 (before its estimated August 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study compares the hearing improvement effects of domestic hearing aids and imported hearing aids in 80 patients with moderate to severe and severe age-related hearing loss. Patients will be randomly assigned to either the experimental group (domestic hearing aids) or the control group (imported hearing aids) and will undergo a 30-minute trial. Pure Tone Average (PTA) and Speech Recognition Threshold (SRT) will be measured both before and after the trial. The improvements in PTA and SRT will be calculated.The market prices of the hearing aids and the degree of hearing improvement in decibels will be recorded. These data will be used to conduct a comprehensive cost-effectiveness analysis. After the trial, the International Outcome Inventory for Hearing Aids (IOI-HA) and the Abbreviated Profile of Hearing Aid Benefit (APHAB) will be used to assess the benefits of the hearing aids.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-18.
Trial Details
NCT Number NCT06882889
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions Age-related Hearing Loss, Hearing Loss, Sensorineural
Enrollment 80 participants
Start Date 2024-10-24
Primary Completion 2025-08-30 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-13