Cochlear Implant Recipients: Comprehensive Longitudinal Evaluation

NCT07380269 | Recruiting DMC

• 1 other identifier: 2025192
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Loss; Hearing Loss, Sensorineural; Deafness; Cochlear Implantation; Speech Perception

Keywords

Cochlear Implant; Pediatric Cochlear Implantation; Adult Cochlear Implantation; Auditory Rehabilitation; Speech Recognition; Quality of Life; Cognitive Function; Observational Cohort

Outcome Measures

Primary Outcomes (1)

• Evaluation of Auditory Function

  A comprehensive assessment of auditory sensitivity and daily listening abilities. Objective measures include electrophysiological tests (Auditory Brainstem Response, ABR; Auditory Steady-State Response, ASSR) for threshold estimation, particularly in non-communicative subjects. Behavioral audiometry and sound-field testing determine hearing thresholds in dB HL. Distortion Product Otoacoustic Emissions (DPOAE) assess cochlear outer hair cell function. Subjective auditory performance is evaluated using standardized questionnaires: the Categories of Auditory Performance (CAP, range 0-7, higher is better).The Parents' Evaluation of Aural/oral performance of Children (PEACH), consists of 12 core items, each rated on a 5-point scale from 0 to 4. Total scores are calculated to a percentage, ranging from 0% to 100%. A higher percent indicates better auditory and communication performance.

  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 Outcomes (2)

• Evaluation of Speech Function

  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

  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.

Study Arms (1)

Cochlear Implant Recipients

Procedure: Cochlear Implantation

Interventions

Cochlear Implantation PROCEDURE

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.

Cochlear Implant Recipients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A single-center, observational cohort of patients across all age groups (children and adults) with severe-to-profound hearing loss who are candidates for and receive cochlear implantation.

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, 200031, China

RECRUITING

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural; Deafness

Interventions

Cochlear Implantation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation

Central Study Contacts

Yilai Shu, M.D.& Ph.D.

CONTACT

+86 21 6437 7134; yilai_shu@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: February 2, 2026
• Study Start: August 22, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: February 2, 2026

Record last verified: 2025-09

Locations

CN (1)