Actively Recruiting

Phase Not Applicable
Age: 60Years - 85Years
All Genders
NCT06882889

Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-08-13

80

Participants Needed

1

Research Sites

61 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL

Who Can Participate

Age: 60Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 to 85 years
  • Diagnosed with moderate to severe or severe age-related hearing loss characterized by bilateral, symmetrical, and gradually progressive high-frequency sensorineural hearing loss with declined speech recognition
  • Chinese nationality and able to complete assessments in Chinese
  • Right-handed
  • No significant neurological diseases, severe systemic diseases, family history of genetic disorders, or major psychiatric conditions
Not Eligible

You will not qualify if you...

  • Hearing loss caused by noise, heredity, drugs, or other non-age-related causes
  • Unable to use hearing aids
  • Presence of dementia, Parkinson's disease, or other neurodegenerative diseases affecting study compliance
  • History of cerebrovascular accidents, stroke, epilepsy, or central nervous system disorders
  • Other conditions judged by the investigator to be exclusionary

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Guangzhou, Guangdong, China, 5100000

Actively Recruiting

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Research Team

Y

Yang Haidi, PhD

CONTACT

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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