#FDA Clearance #iotaMotion #iotaSOFT®

iotaMotion's Innovative Advancement in Pediatric Cochlear Implant Surgery

In a groundbreaking development for pediatric healthcare, iotaMotion, Inc. has announced that its cutting-edge product, the iotaSOFT® Robotic-Assisted Cochlear Implant Insertion System, has received FDA clearance for expanded use in children aged four years and older. This notable update not only streamlines the process of cochlear implantation for young patients, but also significantly enhances the prospects for those suffering from severe hearing loss.

Previously, the iotaSOFT system was primarily intended for older patients. However, with the FDA’s recent approval, the technology is set to improve the quality of life for countless children. School-aged children will now have improved access to robotic-assisted cochlear implants, allowing them to experience sound at a crucial stage of speech and emotional development.

Dr. Mike Lobinsky, CEO of iotaMotion, expressed his enthusiasm about this important milestone. He stated, “Receiving FDA clearance for expanded pediatric use marks a significant milestone for iotaMotion and for families navigating cochlear implant decisions.” This underlines the company’s commitment to providing innovative solutions that alleviate the difficulties faced by families considering cochlear implants for their children.

The iotaSOFT system represents a leap forward in medical technology, allowing for slow, consistent, and controlled electrode insertion, which helps preserve fragile intracochlear structures. This meticulous approach minimizes variability in surgical outcomes, an aspect that can often cause anxiety for parents deliberating over such decisions. Enhanced control during surgery means families can feel more confident about the procedure and its potential outcomes.

With its FDA approval, the iotaSOFT system is now available to a wider network of institutions. Notably, Cincinnati Children's Hospital has become the first dedicated pediatric center to incorporate this advanced technology into its cochlear implant program. Dr. Daniel Choo, a leading figure at Cincinnati Children’s, stated that robotic-assisted cochlear implantation represents a meaningful advancement in their surgical offerings. This partnership opens doors to improved healthcare standards in pediatric ENT practices across the nation.

Currently, the World Health Organization reports that only a small fraction of eligible individuals receive cochlear implants—less than 5% of 60 million people worldwide. This is particularly concerning given that over 430 million individuals suffer from disabling hearing loss, a number that grows alarmingly with each passing year. Early intervention, especially in the pediatric population, is essential for linguistic and cognitive development.

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