Comparing domestic and imported hearing aids for age-related hearing loss
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
This study is testing whether hearing aids made in the U.S. work better than imported ones for older adults with age-related hearing loss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06882889 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are Chinese individuals aged 60 to 85 with moderate to severe age-related sensorineural hearing loss.
Not a fit: Patients with noise-induced, hereditary, or drug-induced hearing loss, or those unable to use hearing aids will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help patients make informed choices about hearing aids based on their effectiveness and cost.
How similar studies have performed: Previous studies have shown varying results in comparing different hearing aid brands, but this specific comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.