Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to develop a new system to better evaluate and help people born with hearing loss. It focuses on improving how patients understand speech, enjoy music, and perceive sounds around them. This system uses fun, game-like software tailored to different age groups to both test and train these hearing abilities. It will be especially helpful for those who have already used hearing aids, cochlear implants, or new gene therapy treatments.

People who may join this study are children and young adults between 1 and 35 years old who have significant hearing loss from birth and have received one of these treatments. Healthy individuals of similar ages and backgrounds may also participate for comparison. Participants will need to speak Mandarin Chinese and be able to communicate well with the research team, with help from a guardian if needed. Those interested will be asked to give consent and commit to attending scheduled evaluations. The study is not yet recruiting, and certain health conditions or other hearing problems may exclude someone from joining. Overall, this trial aims to create a helpful tool that supports better hearing and communication for people with congenital hearing loss.

Gender

ALL

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 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.