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

Launched by TODOC · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a new device called the Sullivan Cochlear Implant for people with hearing loss. It is designed for individuals aged 19 and older who have a specific type of hearing loss called sensorineural hearing loss, which means there's a problem with the inner ear or hearing nerve. To be eligible, participants should not have had a cochlear implant in the ear that will be treated, and they should not have certain medical conditions that could complicate surgery, like cancer or autoimmune diseases.

The trial will take place at one location and includes a group of participants who will receive the cochlear implant. They will be monitored over time to see how well the device works and whether it is safe to use. Before joining, participants will need to agree to be part of the study and sign a consent form. It's important to note that the trial is not yet recruiting participants, so interested individuals will need to wait until it officially begins.

Gender

ALL

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