Status:
RECRUITING
Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Age-related Hearing Loss
Hearing Loss, Sensorineural
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief 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 rand...
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06882889
Start Date
October 24 2024
End Date
December 31 2025
Last Update
August 13 2025
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 5100000