Age-related Hearing LossNCT06882889
Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL
A study testing Domestic hearing aids and Imported hearing aids in people with Age-related Hearing Loss and Hearing Loss, Sensorineural, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Age-related Hearing Loss, Hearing Loss, Sensorineural
- What is being tested?
- Domestic hearing aids and Imported hearing aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
- Other conditions deemed by the investigator to be exclusionary.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 5100000
Haidi Yang, PhD, 13178821663, yanghaidi1978@163.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Domestic hearing aids, Imported hearing aids
- Keywords
- Age-related hearing loss, Hearing Aids, Randomized Controlled Trial
- Medical subject headings
- Presbycusis, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Domestic hearing aidsDevice
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 aidsDevice
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 group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | The experimental group will use domestic hearing aids. Receives: Device: Domestic hearing aids |
| The control group | Active comparator | The control group will use imported hearing aids. Receives: Device: Imported hearing aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start24 Oct 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Hearing LossStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group will use domestic hearing aids, and the control group will use imported hearing aids.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Haidi, PhD, Study chair, SunYatSunU2H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882889
- Sponsor's protocol ID
- SYSKY-2024-761-02
- Status last verified
- Aug 2025
- First submitted
- 11 Feb 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06882889
- Acronym / sponsor ID
- SYSKY-2024-761-02
- Keywords
- Age-related hearing loss, Hearing Aids, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The experimental group will use domestic hearing aids, and the control group will use imported hearing aids.
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Device: Domestic hearing aidsThe experimental group will use domestic hearing aids. |
| The control group | Active comparator | Device: Imported hearing aidsThe control group will use imported hearing aids. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
- Other conditions deemed by the investigator to be exclusionary.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Domestic hearing aidsThe 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. | Device | The experimental group |
| Imported hearing aidsThe 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. | Device | The control group |
Primary outcome
Improvement in Pure Tone Average (ΔPTA)
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 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
4 secondary outcomes
Improvement in Speech Recognition Threshold (ΔSRT)
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)
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)
Time frame: The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.
Cost-Effectiveness Analysis (CEA):
Time frame: The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yang Haidi, PhD study chair
SunYatSunU2H
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domestic hearing aids and Imported hearing aids in people with Age-related Hearing Loss and Hearing Loss, Sensorineural, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Haidi, PhD (13178821663, yanghaidi1978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Pure Tone Average (ΔPTA) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.