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iotaMotion announced that the U.S. Food and Drug Administration granted 510(k) clearance to expand pediatric use of its iotaSOFT robotic-assisted cochlear implant insertion system, allowing use in patients aged four years and older. The system is intended to assist surgeons during the electrode insertion step of cochlear implant surgery by providing controlled, automated movement. According to their press release, Cincinnati Children’s Hospital is the first pediatric center to adopt the system under the expanded clearance, and the company reports use at more than 35 cochlear implant centers nationwide. The release references previously published research comparing robotic-assisted and manual insertion techniques, without detailing study methodology or outcomes, and situates the clearance within broader context on pediatric cochlear implantation and access to hearing care.
Read the full press release here.
