NCT06882889

Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study aims to conduct a non-inferiority, single-blind, randomized controlled trial to compare the hearing improvement effects of domestic hearing aids versus imported hearing aids in patients with moderate to severe and severe age-related hearing loss. A total of 80 patients meeting the inclusion and exclusion criteria will be randomly assigned to either the experimental group (domestic hearing aids) or the control group (imported hearing aids). The domestic hearing aids used in this study are from the Bigsound brand and include behind-the-ear (BTE), neck-worn, and in-the-ear (ITE) styles. All of these hearing aids are rechargeable.The imported hearing aids used in this study are from the Phonak brand and include behind-the-ear (BTE), neck-worn, and in-the-ear (ITE) styles. Each group will undergo a 30-minute trial with their respective hearing aids. Pure Tone Average (PTA) and Speech Recognition Threshold (SRT) before and after the 30-minute trial will be collected, and the improvements in PTA and SRT will be calculated.The market price of the hearing aids and the degree of hearing improvement in decibels for each patient will be recorded, and a comprehensive cost-effectiveness analysis will be performed. Additionally, after the 30-minute 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. Statistical analyses will be conducted to determine whether the domestic hearing aids are non-inferior to the imported hearing aids in terms of hearing and speech improvement. The analysis will also evaluate patient satisfaction, performance in different listening environments, and adaptation to the hearing aids for both the domestic hearing aids and imported hearing aids.

Conditions

• Age-related Hearing Loss
• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-24
• Primary completion: 2025-08-30
• Completion: 2025-12-31
• First posted: 2025-03-19
• Last updated: 2025-08-13

Locations

1 site across 1 country: China