This bidirectional observational cohort study aims to establish a Hearing and Brain Development (HBD) cohort in children and adolescents with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up without intervention, as well as in a normal-hearing control group. Participants will undergo longitudinal assessments of hearing, speech, language, neurodevelopment, and multimodal brain function.
Age no more than 18 years.
For the HA/CI/ABI/GT/FU groups: behavioral or pure-tone hearing threshold >=20 dB HL, or air-conduction ABR >=35 dB nHL; For the normal-hearing control group: participants diagnosed as normal hearing by experienced physicians.
Inability to cooperate with study testing procedures.
The study population consists of children and adolescents aged 0 to 18 years who are evaluated and/or managed at the Department of Otolaryngology-Head and Neck Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. The cohort includes participants with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up without intervention, as well as a normal-hearing control group.
Cohort
Prospective
Not listed
6
Trial groupsSee each trial group below.
Change in Categories of Auditory Performance-II Score
The Categories of Auditory Performance-II scale will be used to assess auditory performance. Scores range from 0 to 9, with higher scores indicating better auditory performance. Change is calculated as the value at follow-up minus the baseline value.
Change in Speech Intelligibility Rating Score
The Speech Intelligibility Rating scale will be used to assess speech intelligibility. Scores range from 1 to 5, with higher scores indicating better speech intelligibility. Change is calculated as the value at follow-up minus the baseline value.
Change in MRI-derived Brain Development Deviation Composite Score
The MRI-derived Brain Development Deviation Composite Score will be calculated from pre-specified multimodal brain magnetic resonance imaging measures using age-adjusted normative models. All pre-specified MRI measures will be combined into a single standardized composite score before analysis. The score summarizes the magnitude of deviation from age-expected brain development. Higher values indicate greater deviation from age-expected brain development. Change is calculated as the value at follow-up minus the baseline value.
Change in Parent-Child Interaction Quality Composite Score
The Parent-Child Interaction Quality Composite Score will be used to assess parent-child interaction quality based on a pre-specified observational coding scheme. The composite score summarizes overall interaction quality during recorded parent-child interaction tasks. Higher scores indicate better parent-child interaction quality. Change is calculated as the value at follow-up minus the baseline value.
Change in Griffiths Mental Development Scales General Development Score
The Griffiths Mental Development Scales will be used to assess general developmental level. The general development score reflects overall developmental functioning across multiple developmental domains. Higher scores indicate better general developmental functioning. Change is calculated as the value at follow-up minus the baseline value.
Change in Ages and Stages Questionnaires: Social-Emotional, Second Edition Total Score
The Ages and Stages Questionnaires: Social-Emotional, Second Edition will be used to assess social-emotional development. Total scores vary by age-specific form, with higher scores indicating greater social-emotional concern. Change is calculated as the value at follow-up minus the baseline value.
Change in Adaptive Behavior Assessment System, Second Edition General Adaptive Composite Score
The Adaptive Behavior Assessment System, Second Edition will be used to assess adaptive behavior. The General Adaptive Composite score summarizes overall adaptive functioning across daily living, communication, social, and practical adaptive skill areas. Higher scores indicate better adaptive functioning. Change is calculated as the value at follow-up minus the baseline value.
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