Clinical trial NCT06882889: Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age-related Hearing Loss
Hearing Loss, Sensorineural
Keywords: Age-related hearing loss
Hearing Aids
Randomized Controlled Trial
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group will use domestic hearing aids, and the control group will use imported hearing aids.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Pure Tone Average (ΔPTA)
timeFrame: 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:
measure: Improvement in Speech Recognition Threshold (ΔSRT)
timeFrame: 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.
measure: International Outcome Inventory for Hearing Aids (IOI-HA)
timeFrame: The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.
measure: Cost-Effectiveness Analysis (CEA):
timeFrame: The assessment will be conducted only after the patient has used the hearing aid for 0.5 hours.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: SunYatSunU2H
name: Yang Haidi, PhD
role: STUDY_CHAIR
References: