iotaMotion, Inc, creator of iotaSOFT, an FDA cleared robotic-assisted cochlear implant insertion system, today announced FDA 510(k) clearance for expanded pediatric use of its iotaSOFT Insertion System. The system is now cleared for use in patients four years of age and older, extending access to robotic-assisted cochlear implantation for school-aged children.
The iotaSOFT Insertion System enables controlled electrode array insertion during one of the most delicate steps of cochlear implant surgery. By standardizing this critical step, iotaSOFT is designed to help preserve delicate cochlear structures, a consideration that is often central to decision-making.
The iotaSOFT Insertion System enables precise and controlled electrode array insertion during one of the most delicate steps of cochlear implant surgery. By standardizing this critical step, iotaSOFT is designed to help preserve delicate cochlear structures, a consideration that is often central to decision-making.
Cincinnati Children's Hospital has become the first dedicated pediatric center to adopt the iotaSOFT Insertion System. Cincinnati Children's joins over 35 leading cochlear implant centers across the U.S., including nearly half of U.S. neurotology fellowship training programs, that have adopted this technology.
