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iotaMotion's FDA Approval for Pediatric iotaSOFT® Usage

On January 15, 2026, iotaMotion, Inc., the innovator behind iotaSOFT®, which is the first and only FDA-approved robotic-assisted cochlear implant insertion system, announced a significant development. The company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the pediatric use of the iotaSOFT® system. This clearance permits the use of the device for children aged four and older, thereby enhancing access to robotic-assisted cochlear implantation for school-age children.

The iotaSOFT® Robotic-Assisted Cochlear Implant Insertion System exemplifies cutting-edge surgical technology by providing slow, consistent, and controlled insertion of electrodes, which helps to protect the delicate intracochlear structures. Currently, less than 5% of the 60 million eligible patients worldwide receive cochlear implants, despite over 430 million individuals suffering from disabling hearing loss according to the World Health Organization. With this new approval, there lies a potential to significantly increase the number of eligible pediatric patients who can benefit from cochlear implants through this advanced technology.

Mike Lobinsky, the CEO of iotaMotion, remarked on the importance of this FDA approval, stating, "Obtaining pediatric authorization is a major milestone for iotaMotion and families faced with the decision of cochlear implantation. By standardizing one of the most intricate steps in cochlear implantation surgery, iotaSOFT helps reduce variability, which may give parents increased confidence when considering hearing implants for their children."

The system precisely manages electrode insertion during one of the most challenging phases of cochlear implantation surgery. The iotaSOFT system is designed to standardize this critical step by ensuring the protection of fragile cochlear structures, a central aspect often influencing decision-making in regards to cochlear implantation.

Recognizing the groundbreaking advancements in this area, Cincinnati Children’s Hospital, a nationally recognized pediatric medical center noted in U.S. News & World Report for 2025-2026, has become the first pediatric center to implement the iotaSOFT insertion system. They have joined over 35 leading cochlear implant centers in the U.S., nearly half of which have neurotology training and research programs that have adopted this innovative technology.

Dr. Daniel Choo, Director of Clinical Development at Cincinnati Children’s Hospital, expressed their commitment to delivering exceptional care while integrating beneficial innovations for their patients. He noted, "The robotic-assisted cochlear implantation represents a significant leap in our program in this field."

Globally, cochlear implant use remains alarmingly low, with approximately 5% of eligible patients receiving implants. Early sound perception is crucial for pediatric patients in developing speech, language skills, and education. However, concerns regarding auditory preservation and surgical variability can often delay intervention. Findings from a 2025 clinical cohort study published in The Laryngoscope indicated that 85% of patients who underwent robotic-assisted insertion preserved their hearing after one year, compared to 71% in the manual insertion group.

Dr. Marlan Hansen, co-founder and medical director of iotaMotion, emphasized, "The robotic assistance in cochlear implantation optimizes precision and consistency. Supported by growing clinical evidence, the clearance of iotaSOFT for pediatric use provides families with the assurance that the standardized and controlled insertion is designed to safeguard cochlea and maintain its structure and function. This is particularly vital for children who may benefit from new therapeutic advances, including gene and regenerative auditory technologies, for which success likely depends on atraumatic cochlear implant placement early in life."

About iotaMotion

iotaMotion, Inc. is a medical technology company based in Saint Paul, Minnesota, dedicated to enhancing cochlear implantation surgery beyond human capabilities through robotic-assisted solutions. Its flagship technology, the iotaSOFT® Insertion System, is designed to preserve intricate intracochlear structures via slow and steady electrode array insertion. It is currently marketed in the United States and undergoing clinical studies in other global markets. For more information, please visit www.iotamotion.com or follow them on LinkedIn, X, Facebook, or YouTube.