Actively Recruiting
Comprehensive Follow-up and Evaluation for Cochlear Implant Patients for All Ages
Led by Eye & ENT Hospital of Fudan University · Updated on 2026-02-02
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating hearing and speech perception as well as quality of life in patients with severe hearing loss who are undergoing cochlear implantation. The study includes participants of all ages and investigates how different age groups and treatment subtypes respond to cochlear implants. The goal is to gather evidence that can help develop personalized hearing and speech rehabilitation strategies. Participants will receive cochlear implantation, a surgical procedure aimed at providing auditory perception to those with severe-to-profound sensorineural hearing loss who benefit little or not at all from traditional hearing aids. The study follows patients from before the surgery through multiple post-activation timepoints, including 4 weeks, 13 weeks, 26 weeks, 52 weeks, and at 2, 3, and 5 years after device activation. During the study, researchers will assess auditory function, speech function, and psychosocial and functional outcomes at each scheduled visit. These evaluations start preoperatively and continue through the entire 5-year follow-up period. Participants will undergo various assessments to monitor their progress and quality of life related to hearing and speech abilities.
CONDITIONS
Brief Title
Cochlear Implant Recipients: Comprehensive Longitudinal Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to device activation
Participants undergo preoperative assessments including auditory and speech perception evaluations as well as quality of life measurements.
1 visit preoperatively
Duration - Surgery day and immediate recovery period
Participants receive cochlear implantation surgery and immediate post-operative care.
1 visit for surgery
Duration - 5 years
Participants are evaluated after device activation with assessments of auditory and speech function and psychosocial outcomes.
Visits at device activation, 4 weeks, 13 weeks, 26 weeks, 52 weeks, 2 years, 3 years, and 5 years post-activation
Trial Site Locations
Total: 1 location
1
Eye & ENT Hospital of Fudan University
Shanghai, China, 200031
Actively Recruiting
Research Team
Y
Yilai Shu, M.D.& Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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