Behind-the-ear (BTE) hearing aids: Bilateral BTE hearing aids will be uniformly provided by the project team and fitted and verified by experienced audiologists at participating sites, with settings adjusted to achieve optimal hearing status according to individual needs. The devices will be selected from mainstream BTE hearing aid brands and models that are already commercially available in China and widely used in pediatric populations.
Hearing-care educational sessions: Standardized educational sessions covering children hearing and speech development, pediatric hearing care, routine monitoring and detection, and appropriate family support and parent-child interaction delivered by trained researchers during each follow-up visit.
Study summary
This is a multicenter, prospective, randomized controlled clinical trial to evaluate the effects of hearing aid intervention on brain and language development in children with bilateral mild sensorineural hearing loss. Eligible participants will be randomly assigned (1:1) to either the hearing aid intervention group or the control group. The primary outcome is the general developmental quotient of the Griffiths Development Scales-Chinese Edition (GDS-C) at 12 months. Secondary outcomes include auditory and speech development, language development, adaptive behavior, and brain structure and function assessed by MRI. Follow-up assessments will be conducted at baseline, 6 months, and 12 months.
Eligibility
Sex
ALL
Min age
6 Months
Max age
4 Years
Healthy volunteers
No
Inclusion Criteria:
* Age: ≥0.5 years and \<4 years
* Diagnosed with bilateral mild sensorineural hearing loss by objective hearing tests: bilateral click-ABR ≥35 dB nHL and ≤50 dB nHL, with bilateral type A tympanogram (including As/Ad type) on acoustic immittance testing
* Without previous hearing aid intervention
Exclusion Criteria:
* Premature and low birth weight infants: gestational age less than 37 weeks, or birth weight below 2500 grams
* Participants diagnosed with enlarged vestibular aqueduct (EVA) by imaging (CT, MRI) or genetic testing
* Participants with complicated medical problems or significant disabilities affecting growth and development (such as autism, recurrent epilepsy, severe heart disease requiring multiple surgeries, etc.) and considered unsuitable for this study by the investigators
* Families who refused to participate in this study, or have already decided whether the participant will wear hearing aids or not (refused to randomization).
* Participants who refused/was unable to undergo study assessments as scheduled.
Primary outcome measure(s)
Children overall development, as measured by General Developmental Quotient (GDQ) from the Griffiths Development Scales - Chinese Edition (GDS-C) — From enrollment to 12 months, with assessments at 0, 6, and 12 months. The GDS-C was adapted from the 2006 Griffiths Mental Development Scales - Extended Revised (GMDS-ER) and standardized with Chinese norms for children aged 0-8 years. It evaluates six subdomains: (A) Locomotor, (B) Personal-Social, (C) Language, (D) Eye \& Hand Coordination, (E) Performance, and (F) Practical Reasoning. The General Developmental Quotient (GDQ) is derived as:(developmental age ÷ chronological age) × 100. Higher scores indicate better overall developmental status.
Trial sites (1)
Facility
City
Region
Status
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011
Shanghai
China
More Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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