iotaSOFT® Insertion System

The iotaSOFT Insertion System is a powered surgical device that assists surgeons in placing cochlear implant electrode arrays into the inner ear by controlling insertion speed. It consists of a sterile single-use drive unit and a reusable touch-screen console with footpedal control, and is compatible with electrode arrays from all three major U.S. cochlear implant manufacturers. The device is indicated for patients aged 4 years and older undergoing cochlear implantation via round window or cochleostomy approach.

The subject device is identical to the predicate device in design, materials, software, and technological characteristics, with no changes to features or parameter settings. The only modification is an expansion of the indicated patient age range from 12 years and older down to 4 years and older, with the same drive unit systems available for all eligible candidates.

ISO 10993-1 (biocompatibility classification and testing), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation), ISO 10993-11 (acute systemic toxicity and pyrogenicity), ISO 11135 (sterilization validation by ethylene oxide), ISO 10993-7 (ethylene oxide residuals), and IEC 62366-1 (usability engineering).