Clinical Research Directory
Browse clinical research sites, groups, and studies.
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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.
Official title: Effects of Hearing Aid Intervention on Brain and Language Development in Children With Bilateral Mild Hearing Loss: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
6 Months - 4 Years
Study Type
INTERVENTIONAL
Enrollment
258
Start Date
2026-09-30
Completion Date
2028-09-30
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (12)
The First People's Hospital of Foshan
Foshan, China
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, China
Jiangyin People's Hospital
Jiangyin, China
Children's Hospital of Kunming Medical University
Kunming, China
Liuzhou Maternal and Child Health Hospital
Liuzhou, China
Children's Hospital of Nanjing Medical University
Nanjing, China
Shanghai Children's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011
Shanghai, China
West China Hospital, Sichuan University
Sichuan, China
Taizhou People's Hospital
Taizhou, China
Affiliated Hospital of Yan'an University
Yan’an, China