An interventional study of Domestic hearing aids and Imported hearing aids in Age-related Hearing Loss and Hearing Loss, Sensorineural, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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.
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 with moderate to severe and severe age-related hearing loss.
A total of 80 patients meeting the inclusion and exclusion criteria will be randomly assigned to either the experimental group (domestic hearing aids) or the control group (imported hearing aids).
The domestic hearing aids used in this study are from the Bigsound brand and include behind-the-ear (BTE), neck-worn, and in-the-ear (ITE) styles. All of these hearing aids are rechargeable.The imported hearing aids used in this study are from the Phonak brand and include behind-the-ear (BTE), neck-worn, and in-the-ear (ITE) styles.
Each group will undergo a 30-minute trial with their respective hearing aids. Pure Tone Average (PTA) and Speech Recognition Threshold (SRT) before and after the 30-minute trial will be collected, and the improvements in PTA and SRT will be calculated.The market price of the hearing aids and the degree of hearing improvement in decibels for each patient will be recorded, and a comprehensive cost-effectiveness analysis will be performed. Additionally, after the 30-minute 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.
Statistical analyses will be conducted to determine whether the domestic hearing aids are non-inferior to the imported hearing aids in terms of hearing and speech improvement. The analysis will also evaluate patient satisfaction, performance in different listening environments, and adaptation to the hearing aids for both the domestic hearing aids and imported hearing aids.
66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 45 interventional studies indexed under Presbycusis.
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Exclusion Criteria:
The experimental group will use domestic hearing aids.
Device: Domestic hearing aids
The control group will use imported hearing aids.
Device: Imported 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.
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.
Improvement in Pure Tone Average (ΔPTA)
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
Time frame: 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 Speech Recognition Threshold (ΔSRT)
Improvement in Speech Recognition Threshold (ΔSRT): The improvement in Speech Recognition Threshold (ΔSRT) will be assessed by measuring the lowest sound intensity at which 50% of spondee words are correctly identified by patients with moderate to severe and severe age-related hearing loss , both before and after hearing aid fitting. This will be done using speech audiometry and sound field speech audiometry. The measurements will be recorded as pre-fitting SRT and post-fitting SRT. Improvement in Speech Recognition Threshold (ΔSRT)= post-fitting SRT - pre-fitting SRT
Time frame: 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.
International Outcome Inventory for Hearing Aids (IOI-HA)
The International Outcome Inventory for Hearing Aids (IOI-HA) scale will be used to evaluate the usage experience and satisfaction of patients with moderate to severe and severe age-related hearing loss after wearing domestic hearing aids and imported hearing aids for 30 minutes.
Time frame: The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Abbreviated Profile of Hearing Aid Benefit (APHAB) : The Abbreviated Profile of Hearing Aid Benefit (APHAB) scale will be used to evaluate the hearing performance of patients with moderate to severe and severe age-related hearing loss in different listening situations after wearing domestic hearing aids and imported hearing aids for 0.5 hours. This assessment aims to understand the effectiveness of the hearing aids in various listening environments and the patients' adaptation to the hearing aids.
Time frame: The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.
Cost-Effectiveness Analysis (CEA):
Cost-Effectiveness Analysis (CEA) will be used to evaluate the estimated costs of domestic hearing aids and imported hearing aids. The degree of hearing loss in decibels (dB) for patients with moderate to severe and severe age-related hearing loss will be recorded. The cost-effectiveness ratio will be calculated by dividing the total costs by the number of dB of hearing improvement. The measurement will be in Chinese Yuan (CNY) per dB.
Time frame: The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.
Plan to share: No
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