RecruitingNot ApplicableNCT06882889

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

Sponsor

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

Enrollment

80 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 60 YearsMax Age: 85 Years

Inclusion Criteria6

Age ≥ 60 years and ≤ 85 years;
Diagnosed with age-related hearing Loss, which is characterized by bilateral, symmetrical, and gradually progressive hearing loss primarily affecting high frequencies, along with a decline in speech recognition ability, as referenced in the "Expert Consensus on Diagnosis and Intervention of Age-Related Hearing Loss" (2019 edition);
Age-related hearing Loss is of moderate to severe or severe sensorineural hearing loss, with moderate to severe defined as 50 to <65 dB HL, and severe defined as 65 to <80 dB HL;
Chinese nationality, able to complete all assessments in the Chinese language;
Right-handed;
No significant neurological diseases, severe systemic diseases, family history of genetic disorders, or major psychiatric conditions;

Exclusion Criteria5

Exclusion of noise-induced hearing loss, hereditary hearing loss, drug-induced hearing loss, etc.;
Inability to use hearing aids ;
Presence of dementia, Parkinson's disease, or other neurodegenerative diseases that may affect study compliance;
History of cerebrovascular accidents, stroke, epilepsy, or other central nervous system disorders;
Other conditions deemed by the investigator to be exclusionary.

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Interventions

DEVICEDomestic 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.

DEVICEImported 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.