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RECRUITING
NCT06882889
NA

Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-10-24

Completion Date

2025-12-31

Last Updated

2025-08-13

Healthy Volunteers

No

Interventions

DEVICE

Domestic hearing aids

The domestic hearing aids used in this study are from the Bigsound brand. Using domestic hearing aids for intervention, one first evaluates the patient's hearing condition through pure-tone audiometry. Subsequently, by thoroughly understanding the patient's hearing needs, lifestyle, and other relevant factors, the most suitable type and functions of hearing aids are selected to best meet the individual's specific situation.

DEVICE

Imported hearing aids

The imported hearing aids used in this study are from the Phonak brand. Using imported hearing aids for intervention, one first evaluates the patient's hearing condition through pure-tone audiometry. Then, by thoroughly understanding the patient's hearing needs, lifestyle, and other relevant factors, the most suitable type and functions of hearing aids are selected to best meet the individual's specific situation.

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China