Domestic 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.
Imported 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.
Study 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
Sex
ALL
Min age
60 Years
Max age
85 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Improvement in Pure Tone Average (ΔPTA) — The initial assessment will be conducted prior to the use of the hearing aid, and the follow-up assessment will be performed 0.5 hours after the hearing aid is used. Improvement in Pure Tone Average (ΔPTA):
The improvement in Pure Tone Average (ΔPTA) will be assessed by measuring the average of the lowest sound intensities detectable at 0.5 kHz, 1 kHz, 2 kHz, and 4 kHz in the better ear of patients with moderate to severe and severe age-related hearing loss both before and after hearing aid fitting, using pure tone audiometry and sound field audiometry. These measurements will be recorded as pre-fitting PTA and post-fitting PTA.
Improvement in Pure Tone Average (ΔPTA) = post-fitting PTA - pre-fitting PTA
Trial sites (1)
Facility
City
Region
Status
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou
Guangdong
Recruiting
More Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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