NCT07018882

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

Single-Center, Single-arm, Open, Prospective, Pivotal Clinical Trial for Evaluating the Audiological Efficacy and Safety of Sullivan Cochlear Implantation in Patients With Severe to Profound Bilateral Hearing Loss.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Todoc · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-06-13
• Last updated: 2025-06-13