Clinical trial Recruiting at 1 site Observational Ages Any age to 18

Hearing and Brain Development in Children and Teens

Official title: A Longitudinal Cohort Study of Hearing and Brain Development in Children and Adolescents With Hearing Loss Across Different Hearing Management Pathways and in Normal-Hearing Controls

Run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · NCT07625462 · Data updated 2026-11-12

This observational study tests how hearing care paths (like hearing aids, cochlear implants, brainstem implants, gene therapy, or no intervention) relate to hearing, speech, language, and brain development in kids and teens, with a normal-hearing group for comparison.

Quick facts

Study typeObservational
AgesAny age to 18 Years
SexAll
Enrollment5000 (estimated)
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedMay 20, 2026
Main results expectedDecember 31, 2030
Study endsDecember 31, 2030
Registry record updatedJune 4, 2026
Trial IDNCT07625462 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children and adolescents up to 18 years old with hearing loss, including those using hearing aids, cochlear implants, auditory brainstem implants, gene therapy, or those managed with follow-up or normal-hearing controls.

Probably not a fit

Children who cannot participate in study testing or who have conditions that obscure developmental assessments may not benefit from the findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort will follow children and adolescents with hearing loss across multiple management pathways and compare them to a normal-hearing group. Participants will undergo repeated assessments of hearing, speech and language skills, neurodevelopment, and multimodal brain function over time. The study aims to map development trajectories and how different interventions may influence outcomes. It does not assign treatments but observes existing management choices and their associations with outcomes.

Why it matters

Potential benefit: If successful, the study could help identify which management pathways are associated with the best developmental outcomes in children with hearing loss.

How similar studies have gone: Previous observational cohorts have provided insights into hearing development, but this study’s broad, bidirectional design across multiple interventions is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Inability to cooperate with study testing procedures.

Where it's running

  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, China
    Recruiting

Study contacts

  • Principal investigator: Hao Wu — Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
  • Study coordinator: Yun Li
  • Email: liyuncmm@126.com
  • Phone: +86-21-53314064

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.