Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL
NCT ID: NCT06882889
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
80 participants
INTERVENTIONAL
2024-10-24
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cognitive Function and EEG Brain Network Remodeling Among Users of Hearing Aids With ARHL
NCT06893432
A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids
NCT05694039
Auditory-Cognitive Dual-Task Intervention for Older Adults With Hearing Loss
NCT06486285
Investigating Hearing Aid Frequency Response Curves 2
NCT05828017
Computer-Assisted Speech Training for Hearing Aid Users
NCT02092337
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The experimental group
The experimental group will use domestic hearing aids.
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.
The control group
The control group will use imported hearing aids.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
60 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yang Haidi, PhD
Role: STUDY_CHAIR
SunYatSunU2H
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SYSKY-2024-761-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.