FDA OKs iotaMotion’s Robotic-Assisted Cochlear Implant Insertion for Kids Age 4 and Up

iotaMotion, creator of the iotaSOFT robotic-assisted cochlear implant insertion system, has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded pediatric use of its iotaSOFT system. It’s now cleared to use in patients aged four and older.

iotaSOFT enables precise, controlled electrode array insertion during one of the most delicate steps in cochlear implant surgery. Standardizing this step aims to help preserve delicate cochlear structures, which is often central to decision-making in these surgeries.

As part of this milestone, Cincinnati Children’s Hospital has become the first dedicated pediatric center to adopt iotaSOFT. It joins over 35 leading cochlear implant centers across the U.S. that have adopted the technology.

In pediatric patients, early access to sound is critical for speech, language, and educational development. However, concerns around hearing preservation and surgical variability can delay intervention.

A 2025 clinical cohort study published in The Laryngoscope (Khan et al.) 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, according to its authors.

“Robotic assistance in cochlear implantation is about precision and consistency,” said Marlan Hansen, MD, co-founder and chief medical officer of iotaMotion. “With the expanded pediatric indication for iotaSOFT, supported by growing clinical evidence, families can have greater confidence that controlled, standardized insertion is designed to protect the cochlea and preserve its structure and function. This 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.”