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NOT YET RECRUITING
NCT07018882
NA

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

Sponsor: Todoc

View on ClinicalTrials.gov

Summary

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

Official title: 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.

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-06

Completion Date

2026-12-31

Last Updated

2025-06-13

Healthy Volunteers

No

Interventions

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.