[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652498":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":37,"locations":43,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":85,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Hearing-aid intervention","EXPERIMENTAL","Participants in the hearing-aid intervention group will receive standardized bilateral fitting of behind-the-ear (BTE) hearing aids, and their parents will be instructed to ensure consistent daily use for 12 months and be provided with essential knowledge regarding hearing aid maintenance and proper usage. In addition, the same hearing-care education sessions will also be delivered to this group.",[13,14],"Device: Behind-the-ear (BTE) hearing aids","Other: Hearing-care educational sessions",{"label":16,"type":6,"description":17,"interventionNames":18},"Hearing-care education","Participants in the hearing-care education control group will not receive hearing aids, but will receive standardized hearing-care educational sessions at each follow-up visit.",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","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.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"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.",[9,16],[31,35],{"name":32,"affiliation":33,"role":34},"Hao Wu","Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":36},"STUDY_CHAIR",[38],{"name":39,"role":40,"phone":41,"phoneExt":25,"email":42},"Zhili Wang","CONTACT","+86-21-53314064","zhili_w@163.com",[44],{"facility":45,"status":25,"city":46,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011","Shanghai","China","CN",{"type":50,"coordinates":51},"Point",[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56],{"name":57,"role":40,"phone":41,"phoneExt":25,"email":42},"Zhili Wang Zhili Wang Zhili Wang",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100652498","hearing-intervention-effects-on-brain-and-language-development-in-children-with-bilateral-mild-hearing-loss-100652498",false,"NCT07774728","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","HBD-RCT","Inclusion Criteria:\n\n* Age: ≥0.5 years and \\\u003C4 years\n* 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\u002FAd type) on acoustic immittance testing\n* Without previous hearing aid intervention\n\nExclusion Criteria:\n\n* Premature and low birth weight infants: gestational age less than 37 weeks, or birth weight below 2500 grams\n* Participants diagnosed with enlarged vestibular aqueduct (EVA) by imaging (CT, MRI) or genetic testing\n* 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\n* Families who refused to participate in this study, or have already decided whether the participant will wear hearing aids or not (refused to randomization).\n* Participants who refused\u002Fwas unable to undergo study assessments as scheduled.","ALL","6 Months","4 Years",{"count":72,"type":73},236,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.",[79],"Hearing Loss, Bilateral",[81,82,83,84],"Mild hearing loss","Hearing aids","Brain development","Children","NOT_YET_RECRUITING","2026-08-17",{"date":88,"type":89},"2026-08-19","ACTUAL",{"date":91,"type":73},"2026-08-31",{"date":93,"type":73},"2028-08-31",{"name":5,"class":6},1]