Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL

August 12, 2025 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 5100000
        • Recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 60 years and ≤ 85 years;
  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:

  1. Exclusion of noise-induced hearing loss, hereditary hearing loss, drug-induced hearing loss, etc.;
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The experimental group
The experimental group will use domestic hearing aids.
Device: 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.
Active Comparator: The control group
The control group will use imported hearing aids.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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
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.
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.
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.

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.
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.
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.
The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Study Chair: Yang Haidi, PhD, SunYatSunU2H

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2024-761-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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