Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss

Effects of Hearing Aid Intervention on Brain and Language Development in Children With Bilateral Mild Hearing Loss: A Multicenter Randomized Controlled Trial

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.

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.