FDA clears expanded pediatric use of robotic-assisted cochlear implant insertion system

On January 14, 2026, the FDA granted 510(k) clearance for expanded pediatric use of the iotaSOFT Insertion System, allowing use in patients aged 4 years and older. The system, developed by iotaMotion, Inc., is the first FDA-cleared robotic-assisted technology designed to standardize electrode array insertion during cochlear implant surgery, a step associated with risk of intracochlear trauma and loss of residual hearing.¹

“Receiving FDA clearance for expanded pediatric use marks a significant milestone for iotaMotion 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 helps reduce variability which could provide parents greater confidence as they consider cochlear implantation for their children.”¹

The iotaSOFT system is designed to deliver slow, controlled, and consistent insertion of cochlear implant electrode arrays. Variability in insertion speed and force during manual implantation has been associated with trauma to intracochlear structures, which can compromise hearing preservation. Concerns related to surgical variability and hearing preservation may contribute to delays in cochlear implantation, particularly in pediatric patients, despite evidence that early auditory access is critical for speech, language, and educational development.¹

Cincinnati Children’s Hospital has become the first dedicated pediatric center to adopt the system following the expanded clearance. “At Cincinnati Children's, our focus is delivering the highest standard of care while thoughtfully integrating innovations that benefit our patients,” said Daniel Choo, MD, 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.”¹

Evidence supporting robotic-assisted insertion includes both preclinical and clinical studies. In a cadaveric study published in Otology & Neurotology, Claussen and colleagues compared robotic-assisted and manual electrode insertions performed by experienced neurotologists using fresh-frozen human cadaveric heads.² Robotics-assisted insertion resulted in significantly lower intracochlear trauma scores than manual insertion (mean trauma score, 1.3 vs 2.2; P<.05), with fewer high-grade trauma events and a greater number of atraumatic insertions. The authors concluded that robotic assistance enabled more standardized insertions across surgeons and experience levels, supporting further clinical evaluation of this approach.

Clinical outcomes were further evaluated in a 2025 cohort study published in The Laryngoscope by Khan and colleagues.³ The study compared 27 adults undergoing robotic-assisted cochlear implantation using the iotaSOFT system with 24 adults receiving manual insertion. Functional acoustic hearing, defined as a low-frequency pure-tone average below 80 dB HL, was preserved at 1 year in 85% of patients in the robotic-assisted group compared with 71% in the manual insertion group. Although the difference did not reach statistical significance, the absolute risk reduction of 14% corresponded to a number needed to treat of 7 to prevent one additional case of loss of functional acoustic hearing.³

Robotic-assisted insertion was also associated with more stable hearing thresholds over time. Notably, delayed hearing loss occurred only in the manual insertion group, whereas all losses in the robotic-assisted group occurred at initial activation. Speech perception outcomes were similar between groups, but patients who retained residual hearing demonstrated better performance in challenging listening environments.³

“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.”¹

Globally, fewer than 5% of individuals who are candidates for cochlear implantation receive an implant, despite more than 430 million people experiencing disabling hearing loss worldwide. In pediatric populations, the ability to preserve cochlear structures may have implications beyond current outcomes, including potential eligibility for future regenerative or gene-based hearing therapies that may depend on atraumatic early implantation.¹

Together, preclinical and clinical data suggest that robotic-assisted electrode insertion may reduce insertion-related trauma and improve rates of hearing preservation. With FDA clearance now extending use to school-aged children, robotic-assisted cochlear implantation may represent an additional tool to support consistent surgical technique and informed decision-making in pediatric hearing care.^1-3

References

1. iotaMotion Inc. iotaMotion Receives FDA Clearance for Expanded Pediatric Use of iotaSOFT® Robotic-Assisted Cochlear Implant Insertion System. PR Newswire. January 14, 2026. Accessed January 14, 2026. https://www.prnewswire.com/news-releases/iotamotion-receives-fda-clearance-for-expanded-pediatric-use-of-iotasoft-robotic-assisted-cochlear-implant-insertion-system-302660678.html
2. Claussen AD, Shibata SB, Kaufmann CR, Henslee A, Hansen MR. Comparative Analysis of Robotics-Assisted and Manual Insertions of Cochlear Implant Electrode Arrays. Otol Neurotol. 2022;43(10):1155-1161. doi:10.1097/MAO.0000000000003707
3. Khan UA, Dunn CC, Scheperle RA, et al. Robotic-Assisted Electrode Array Insertion Improves Rates of Hearing Preservation. Laryngoscope. 2025;135(11):4364-4371. doi:10.1002/lary.32318