Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Domestic hearing aids
DeviceThe 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
DeviceThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: The experimental groupExperimental treatment 1 intervention
Group B: The control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov