Perceptual evaluation and rehabilitation program for congenital hearing loss

Is this trial a fit for you?

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

What this trial studies

The team will upgrade existing materials and develop a multimodal, gamified software platform with age‑stratified difficulty to test and train auditory speech perception, music perception, and spatial hearing. Participants will include people with congenital sensorineural hearing loss (who have hearing aids, cochlear implants, or gene therapy) and matched normal‑hearing controls. The platform will combine interactive tasks and rehabilitation exercises and will be validated across age groups from young children to adults. Outcome measures will focus on reliability, validity, and improvements in perceptual function after targeted training.

Why it matters

Who can join: the full rules

Inclusion Criteria:

For Congenital Deafness Group: Patients with congenital hearing loss with hearing thresholds ≥65 dB who have received hearing aids, cochlear implantation, or gene therapy; Age between 1 and 35 years old, regardless of gender.

For Healthy Controls Group: Participants with normal hearing thresholds (≤20 dB) whose age and gender matched to the patient group.

Mandarin Chinese as the native language. Participants and/or their guardians must provide informed consent before the trial, voluntarily sign a written consent form, and commit to receive evaluation at specified time points.

Capable of effective communication with researchers under the guardian's assistance and willing to cooperate and comply with the researchers' requirements.

Participants and/or their guardians should have a correct understanding of the trial and appropriate expectations regarding potential benefits.

Exclusion Criteria:

Presence of other otological disorders that may interfere with the surgical outcome or interpretation of study endpoints, such as otitis media, Meniere's disease, etc.

Presence of other severe congenital diseases, such as congenital heart disease. Presence of severe systemic diseases or in the acute onset of diseases, such as pulmonary tuberculosis, active hepatitis B or C infection, active herpes zoster infection, pancreatitis, renal insufficiency, etc.

Individuals with low immunity, a history of immune deficiency or organ transplantation.

Individuals with a history of neurological, mental disorders, or moderate-to-severe cognitive dysfunction, such as epilepsy, dementia, autism spectrum disorders, etc.

Any other conditions for which the investigators consider the subject unsuitable for participation in this clinical study.

Where it's running

• Eye & ENT Hospital of Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Yilai Shu, M.D.& Ph.D.
• Email: yilai_shu@fudan.edu.cn
• Phone: +86 21 6437 7134

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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.