RecruitingNCT07380269

Cochlear Implant Recipients: Comprehensive Longitudinal Evaluation

Comprehensive Follow-up and Evaluation for Cochlear Implant Patients for All Ages

Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

300 participants

Start Date

Aug 22, 2025

Study Type

OBSERVATIONAL

Conditions

Cochlear Implantation Hearing Loss Deafness Speech Perception Hearing Loss, Sensorineural

Summary

This study aims to assess hearing and speech perception, as well as quality of life, in deaf patients of all ages before and after cochlear implantation, and to explore differences across age groups and treatment subtypes, thereby providing evidence for personalized hearing and speech rehabilitation.

Eligibility

Inclusion Criteria6

Patients with severe or greater hearing loss (≥65 dB) scheduled to receive cochlear implant (CI) treatment.
No restrictions on age or gender.
Native language is Mandarin Chinese.
The subject and/or their legal guardian must provide informed consent prior to the study, voluntarily sign a written informed consent form, and be willing to undergo follow-up assessments at the specified time points.
Ability to communicate effectively with the researcher with the help of a guardian and comply with the researcher's requirements. For young children without mature language skills, ability to cooperate with the help of a guardian.
The subject's guardian has a correct understanding of the trial and realistic expectations of potential benefits.

Exclusion Criteria5

Presence of other severe diseases unsuitable for cochlear implantation surgery.
Significant psychological problems or mood disorders (e.g., notable anxiety, depression, or behavioral disorders) that would preclude cooperation with training and follow-up.
Neurological diseases (e.g., epilepsy, cerebral palsy) that may affect auditory processing ability.
Concurrent participation in other interventional studies involving drugs or behavioral interventions that may affect auditory rehabilitation during the study period.
Any other condition considered by the investigator to make the subject unsuitable for participation in this clinical study.

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Interventions

PROCEDURECochlear Implantation

cochlear implantation - a surgical procedure designed to provide auditory perception to individuals with severe-to-profound sensorineural hearing loss who receive limited to no benefits from conventional amplification.