Multicenter Randomized Controlled Trial Comparing Surgical Approaches to the Cochlea for the Slim Modiolar Electrode: Assessing Intracochlear Trauma and Hearing Preservation

What this Trial Is About

Researchers are conducting a multinational randomized controlled trial to compare two surgical methods for cochlear implant insertion: cochleostomy (CO) and extended round window (eRW). The study focuses on adults with severe to profound sensorineural hearing loss who are candidates for cochlear implantation with the Nucleus CI632 slim modiolar electrode. The goal is to see how each surgical approach affects the preservation of residual hearing, intracochlear trauma, and electrode placement. Participants will be randomly assigned to receive the cochlear implant using either the cochleostomy approach, which involves drilling an opening near the round window membrane, or the extended round window approach, where the scala tympani is accessed by extending the round window margin. Both approaches use the same type of electrode array. The study will last about one year for each participant, including preoperative assessments and follow-ups at 1 week, 3 months, and 12 months after surgery. During the study, researchers will monitor hearing preservation using pure tone audiometry and assess intracochlear trauma through intraoperative electrocochleography (ECochG) at various surgery stages. Imaging will be used to evaluate electrode position three months after surgery. Participants will undergo multiple assessments to track outcomes and safety throughout the year-long study period.

Clinical Trial to Compare Two Surgical Approaches to the Cochlea