Long-term hearing and speech outcomes after cochlear implants
Comprehensive Follow-up and Evaluation for Cochlear Implant Patients for All Ages
This project will see if cochlear implants improve hearing, speech understanding, and quality of life in Mandarin-speaking patients of all ages before and after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07380269 on ClinicalTrials.gov |
What this trial studies
This is a longitudinal observational study that follows patients with severe or greater hearing loss who are scheduled to receive cochlear implants at the Eye & ENT Hospital of Fudan University. Participants will complete standardized hearing, speech perception, and quality-of-life measures before surgery and at multiple follow-up visits after implantation. Outcomes will be compared across age cohorts and clinical subtypes to identify patterns in recovery and benefit. The goal is to generate data that can inform more individualized auditory and speech rehabilitation approaches.
Who should consider this trial
Good fit: Ideal candidates are native Mandarin speakers of any age with severe or greater hearing loss (≥65 dB) who are scheduled for cochlear implantation and can attend follow-up visits and provide informed consent.
Not a fit: Patients with other severe medical conditions that make cochlear implantation unsafe, significant unmanaged psychiatric disorders, or who are not native Mandarin speakers are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help tailor post-implant rehabilitation to improve speech and hearing outcomes and quality of life for future patients.
How similar studies have performed: Many prior studies show cochlear implants improve hearing and speech in children and adults, but comprehensive longitudinal Mandarin-language data across all ages are relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.