Evaluating Cochlear Insertion Trauma and Hearing Preservation After Cochlear Implantation: A Randomized Single-blind Controlled Trial

What this Trial Is About

Researchers are evaluating the best surgical approach and implant type to preserve residual hearing in patients with sensorineural hearing loss (SNHL) who are receiving a cochlear implant (CI). The study aims to find whether combining the round window approach with a lateral wall electrode array reduces insertion trauma and improves hearing outcomes compared to other combinations. This randomized single-blind controlled trial explores how different methods affect hearing preservation after CI surgery. Participants are randomly assigned to one of four groups that combine two surgical approaches and two types of electrode arrays. The surgical approaches include insertion through the round window or cochleostomy, while the electrode arrays are either a lateral wall design or a pre-curved perimodiolar design. The devices used are made by Advanced Bionics. Each participant receives one of these combinations during the CI surgery. During the 12 months following surgery, researchers will assess hearing preservation as the primary outcome. They will also evaluate the position of the electrode array, electrocochleography results, and speech perception. Participants will undergo hearing tests and other evaluations to monitor the effects of the different surgical and implant approaches. The study provides detailed monitoring to understand how these factors influence hearing outcomes after cochlear implantation.

Hearing Preservation in Cochlear Implantation Surgery