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Recruiting NCT07024524

Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss

Trial Parameters

Condition Congenital Hearing Loss
Sponsor Eye & ENT Hospital of Fudan University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 210
Sex ALL
Min Age 1 Year
Max Age 35 Years
Start Date 2025-07-04
Completion 2028-01-01
Interventions
Rehabilitation training

Brief Summary

This study aims to establish a novel multimodal evaluation and precision rehabilitation system for patients with congenital hearing loss who have received hearing aids, cochlear implantation, or emerging gene therapy. The proposed system will integrate age-stratified difficulty levels, combined with a gamified interaction platform or software designed to assess and train three core perceptual domains: auditory speech perception, music perception, and spatial hearing capabilities.

Eligibility Criteria

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 o

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