Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL
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
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 24, 2024
CompletedFirst Submitted
Initial submission to the registry
February 11, 2025
CompletedFirst Posted
Study publicly available on registry
March 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedAugust 13, 2025
August 1, 2025
10 months
February 11, 2025
August 12, 2025
Conditions
Keywords
Outcome Measures
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
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 (4)
Improvement in Speech Recognition Threshold (ΔSRT)
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 assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.
Abbreviated Profile of Hearing Aid Benefit (APHAB)
The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.
Cost-Effectiveness Analysis (CEA):
The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.
Study Arms (2)
The experimental group
EXPERIMENTALThe experimental group will use domestic hearing aids.
The control group
ACTIVE COMPARATORThe control group will use imported hearing aids.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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;
- Right-handed;
- No significant neurological diseases, severe systemic diseases, family history of genetic disorders, or major psychiatric conditions;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 5100000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yang Haidi, PhD
SunYatSunU2H
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2025
First Posted
March 19, 2025
Study Start
October 24, 2024
Primary Completion
August 30, 2025
Study Completion
December 31, 2025
Last Updated
August 13, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share