Safety Study of the iotaSOFT Insertion System for Cochlear Implant Surgery in People 12 Years and Older

What this Trial Is About

Researchers are evaluating the continued safety of the iotaSOFT Insertion System, a device used by surgeons to assist in inserting cochlear implant electrode arrays in one ear per participant. The study includes participants aged 12 years and older who have sensorineural hearing loss and are receiving or have received cochlear implants. The goal is to collect additional safety data and understand procedural details such as device performance and implant functionality. The study involves two groups a retrospective review of patient records and a prospective collection of data from subjects receiving a cochlear implant with the robotic-assisted iotaSOFT Insertion System. The study focuses on the commercial use of this device as intended for cochlear implant surgery. Researchers will gather information on device deficiencies, insertion speed, tip fold-over rates, and measures related to cochlear implant function. Participants will be monitored through follow-up visits, with researchers assessing adverse events related to device use up to one month after activation of the implant. Safety data and procedural characteristics will be recorded to evaluate the use of the device. The total participation time includes both retrospective data review and prospective follow-up after surgery, ensuring comprehensive monitoring of outcomes and any device-related issues.

Post-Market Clinical Investigation of the IotaSOFT Insertion System