iotaMotion Receives FDA Clearance for Pediatric Cochlear Implant Robot, Expanding Access for Children
Key Insights
iotaMotion (search) received FDA 510(k) clearance to expand its iotaSOFT (search) robotic-assisted cochlear implant insertion system for use in patients four years of age and older.
Clinical evidence shows 85% of patients maintained hearing preservation at one year with robotic-assisted insertion compared to 71% with manual insertion.
Cincinnati Children's Hospital (search) became the first dedicated pediatric center to adopt the technology, joining over 35 leading cochlear implant centers across the United States.
iotaMotion (search) has received FDA 510(k) clearance for expanded pediatric use of its iotaSOFT (search) robotic-assisted cochlear implant insertion system, marking a significant milestone for the Minnesota-based medical technology company. 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 (search) Insertion System, claimed to be the first FDA-approved robotic cochlear implant system, enables precise and controlled electrode array insertion during one of the most delicate steps of cochlear implant surgery. The system is designed to preserve delicate intracochlear structures through slow and consistent electrode array insertion, standardizing a critical surgical step that can significantly impact patient outcomes.
Clinical Evidence Supporting Pediatric Expansion
Recent clinical data has demonstrated the potential benefits of robotic-assisted cochlear implant insertion. A 2025 clinical cohort study published in The Laryngoscope found that 85% of patients in the robotic-assisted insertion group maintained hearing preservation at one year, compared with 71% in the manual insertion group.
"Robotic assistance in cochlear implantation is about precision and consistency," said Dr. Marlan Hansen, co-founder and chief medical officer of iotaMotion (search). "With the expanded pediatric indication for iotaSOFT (search), supported by growing clinical evidence, families can have greater confidence that controlled, standardized insertion is designed to protect the cochlea (search) and preserve its structure and function."
First Pediatric Center Adoption
Cincinnati Children's Hospital (search), a nationally ranked pediatric medical center and U.S. News & World Report Honor Roll member for 2025–2026, has become the first dedicated pediatric center to adopt the iotaSOFT (search) Insertion System. The hospital joins over 35 leading cochlear implant centers across the United States, including nearly half of U.S. neurotology fellowship training programs, that have adopted this technology.
"At Cincinnati Children's, our focus is delivering the highest standard of care while thoughtfully integrating innovations that benefit our patients," said Dr. Daniel Choo, chief clinical growth officer and professor of otolaryngology–head and neck surgery. "Robotic-assisted cochlear implantation represents a meaningful advancement in our cochlear implant program."
Addressing Critical Unmet Medical Need
The pediatric expansion addresses a significant global healthcare challenge. According to the World Health Organization, fewer than 5% of eligible cochlear implant candidates receive an implant, despite more than 430 million people worldwide experiencing disabling hearing loss (search). In pediatric patients, early access to sound is critical for speech, language and educational development, yet concerns around hearing preservation and surgical variability can delay intervention.
"Receiving FDA clearance for expanded pediatric use marks a significant milestone for iotaMotion (search) and for families navigating cochlear implant decisions," said Mike Lobinsky, CEO of iotaMotion. "By standardizing one of the most delicate steps in cochlear implant surgery, iotaSOFT (search) helps reduce variability which could provide parents greater confidence as they consider cochlear implantation for their children."
Technology and Future Implications
Electrode arrays in cochlear implants are the structures that electrically stimulate the auditory nerve (search), bypassing damaged hair cells and sending sound signals to the brain in patients with hearing loss (search). The precision offered by robotic assistance may be particularly important for children who may benefit from emerging therapeutic advances.
Dr. Hansen noted that the technology is "especially important for children who may benefit from emerging therapeutic advances, including gene-based and regenerative hearing technologies, which will likely depend on atraumatic, cochlear implant array placement early in life."
The company previously received its initial FDA clearance for iotaSOFT (search) in 2020 and raised $12 million from a Series A financing round in 2023 to speed up commercial expansion. According to GlobalData analysis, the global surgical robotics market is growing at a CAGR of 6.2% and projected to reach a valuation of $16.2 billion in 2034, up from $8.89 billion in 2024.