Cochlear Implant Recipients: Comprehensive Longitudinal Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cochlear Implantation.
- Who it may be relevant to
- Registry conditions: Hearing Loss, Hearing Loss, Sensorineural, Deafness, Cochlear Implantation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comprehensive Follow-up and Evaluation for Cochlear Implant Patients for All Ages
Overview
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.
Detailed description
The study aims to conduct a comprehensive evaluation of auditory and speech perception abilities, as well as overall quality of life, in patients with hearing loss across all age groups undergoing cochlear implantation. By comparing pre- and post-operative outcomes, the study will investigate how different age cohorts and subtype groups respond to cochlear implantation treatment. The findings are expected to provide critical evidence to guide the development of individualized auditory and speech rehabilitation strategies.
Interventions
- Procedure Cochlear 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.
Primary outcome measures
- Evaluation of Auditory Function [Time frame: From enrollment until the end of the 5-year follow-up. Assessments are conducted preoperatively, at device activation, and post-activation at 4 weeks, 13 weeks, 26 weeks, 52 weeks, 2 years, 3 years, and 5 years.]
Secondary outcome measures (2)
- Evaluation of Speech Function [Time frame: From enrollment until the end of the 5-year follow-up. Assessments are conducted preoperatively, at device activation, and post-activation at 4 weeks, 13 weeks, 26 weeks, 52 weeks, 2 years, 3 years, and 5 years.]
- Assessment of Psychosocial and Functional Outcomes [Time frame: From enrollment until the end of the 5-year follow-up. Assessments are conducted preoperatively, at device activation, and post-activation at 4 weeks, 13 weeks, 26 weeks, 52 weeks, 2 years, 3 years, and 5 years.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Eye & ENT Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT07380269 · 2025192