Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.

NCT ID: NCT07018882

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-12-31

Brief Summary

The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study

Detailed Description

This study is a clinical trial designed to examine the auditory performance improvement in patients with bilateral severe sensorineural hearing loss (70 dB HL or greater) by comparing auditory performance before and after cochlear implant surgery.

Cochlear implants, both imported and domestically manufactured, have already been approved and are in use in the country. These existing devices have also undergone clinical research, comparing and analyzing auditory performance before and after implantation. Therefore, this study is designed as a prospective, single-arm, open-label clinical trial.

Patients who are clinically eligible for cochlear implant surgery and can tolerate the surgery will be asked for their consent and then undergo the cochlear implant procedure. The outcome of the cochlear implant surgery will be evaluated through auditory performance assessments.

Additionally, adverse effects will be monitored to assess the efficacy and safety of the cochlear implants on auditory function.

Conditions

Hearing Loss, Sensorineural

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sullivan

Group Type: EXPERIMENTAL

Sullivan

Intervention Type: DEVICE

Patients who are clinically eligible for cochlear implant surgery and can tolerate the surgery will be asked for their consent and then undergo the cochlear implant procedure. The outcome of the cochlear implant surgery will be evaluated through auditory performance assessments. Additionally, adverse effects will be monitored to assess the efficacy and safety of the cochlear implants on auditory function.

Interventions

Sullivan

Patients who are clinically eligible for cochlear implant surgery and can tolerate the surgery will be asked for their consent and then undergo the cochlear implant procedure. The outcome of the cochlear implant surgery will be evaluated through auditory performance assessments. Additionally, adverse effects will be monitored to assess the efficacy and safety of the cochlear implants on auditory function.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with sensorineural hearing loss of 1 side or both sides (70 dBHL) or higher, aged 19 years or older
• No previous cochlear implantation history in the ear scheduled for surgery
• No contraindications to surgery, such as cochlear agenesis or auditory nerve agenesis, as determined by imaging tests
• Patients without cancer, autoimmune disease, or neurological disease
• Patients with a general condition that allows general anesthesia
• Patients with no abnormalities in personality, depression, anxiety, sociality, or problem drinking tests
• Use Korean
• Patients who agree to participate in the clinical trial and sign a written consent form However, if the patient is unable to sign, the patient (if able to sign) and guardian (or agent) voluntarily agree to participate in the clinical trial and sign an informed consent form

Exclusion Criteria

• Cases where electrode insertion is difficult due to severe internal malformation, cochlear ossification, etc.
• Cases with cancer or autoimmune disease
• Cases with a general condition that makes it difficult to tolerate general anesthesia
• Cases with moderate or higher mental disability or where auditory training is difficult due to the absence of parents or supporters to assist with rehabilitation education
• Cases deemed inappropriate for this test by the clinical trial manager

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: collaborator

Todoc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Sullivan

Identifier Type: -

Identifier Source: org_study_id