Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Key facts
- Where
- Foshan, Guangzhou, Jiangyin, Kunming, Liuzhou, Nanjing, Shanghai, Sichuan, Taizhou, and Yan’an, ChinaSee the 12 sites
Where in China
- The First People's Hospital of FoshanFoshan, ChinaContact: Dr. YuNo longer taking part
- Guangzhou Women and Children's Medical Center, Guangzhou Medical UniversityGuangzhou, ChinaContact: Dr. WangNo longer taking part
- Jiangyin People's HospitalJiangyin, ChinaContact: Dr. ChenNo longer taking part
- Children's Hospital of Kunming Medical UniversityKunming, ChinaContact: Dr. MaNo longer taking part
- Liuzhou Maternal and Child Health HospitalLiuzhou, ChinaContact: Dr. TangNo longer taking part
- Children's Hospital of Nanjing Medical UniversityNanjing, ChinaContact: Zhili WangNo longer taking part
- Shanghai Children's Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaContact: Dr. NiNo longer taking part
- Shanghai Children's Medical Center, Shanghai Jiao Tong University School of MedicineShanghai, ChinaContact: Dr. JiaoNo longer taking part
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011Shanghai, ChinaContact: Dr. WangNo longer taking part
- West China Hospital，Sichuan UniversitySichuan, ChinaContact: Dr. MengNo longer taking part
- Taizhou People's HospitalTaizhou, ChinaContact: Dr. PangNo longer taking part
- Affiliated Hospital of Yan'an UniversityYan’an, ChinaContact: Dr. SongNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Trial code
- NCT07774728
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
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: 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: 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; 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; 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.