Comparing domestic and imported hearing aids for age-related hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effectiveness of domestic hearing aids from the Bigsound brand with imported hearing aids from the Phonak brand in patients aged 60 to 85 with moderate to severe age-related hearing loss. Eighty participants will be randomly assigned to either group and will undergo a 30-minute trial with their respective hearing aids. Hearing improvements will be measured using Pure Tone Average (PTA) and Speech Recognition Threshold (SRT) before and after the trial, and a cost-effectiveness analysis will be conducted based on the market prices and hearing improvements. Additionally, patient-reported outcomes will be assessed using standardized questionnaires.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 60 years and ≤ 85 years;
2. 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);
3. 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;
4. Chinese nationality, able to complete all assessments in the Chinese language;
5. Right-handed;
6. No significant neurological diseases, severe systemic diseases, family history of genetic disorders, or major psychiatric conditions;

Exclusion Criteria:

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

Where it's running

• Sun Yat-sen Memorial Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yang Haidi, PhD
• Email: yanghaidi1978@163.com
• Phone: 13178821663

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.