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iotaMotion's Breakthrough in Pediatric Cochlear Surgeries

iotaMotion, Inc. has made significant strides in cochlear implant technology with its iotaSOFT® robotic system. Recently, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the extended pediatric use of this groundbreaking system, allowing it to be utilized for patients as young as four years old. This new approval aims to improve accessibility to robotic-assisted cochlear implants, particularly for children of school age, who could greatly benefit from early intervention.

The iotaSOFT® system is the first and only FDA-approved robotic-assisted cochlear implant insertion system. It facilitates slow, controlled, and consistent insertion of electrode arrays, addressing one of the most delicate phases of cochlear implant surgeries. The core objective is to preserve fragile structures within the cochlea, significantly enhancing the chances of successful hearing restoration.

According to Mike Lobinsky, CEO of iotaMotion, “The FDA approval for pediatric use is a significant milestone for iotaMotion and families facing the decision for cochlear implants. By standardizing one of the most critical steps in the cochlear implantation procedure, iotaSOFT helps to reduce variations, likely instilling greater confidence in parents considering this option for their children.”

More than just a technological advancement, the iotaSOFT system marks a paradigm shift in pediatric cochlear implants. Current research indicates that the global rate of cochlear implantation is alarmingly low, with fewer than 5% of the 60 million eligible patients worldwide actually receiving implants. The World Health Organization highlights a staggering figure: over 430 million people globally suffer from disabling hearing loss, many of whom are children who would benefit enormously from early cochlear implant placements.

In a landmark collaboration, Cincinnati Children's Hospital has become the first specialized pediatric center to implement the iotaSOFT system, joining over 35 leading cochlear implant centers in the U.S., including top neurotology residency programs. Dr. Daniel Choo, the hospital’s head of clinical growth and an ear, nose, and throat professor, stated, “At Cincinnati Children's, our focus is on delivering the best care while thoughtfully integrating innovations that benefit our patients. The robotic cochlear implantation represents a significant advancement in our cochlear implant program.”

The importance of timely access to sound for pediatric patients cannot be overstated; it is crucial for language, speech, and educational development. Concerns surrounding the preservation of hearing and variability in surgical techniques can lead to delays in intervention. A recent clinical cohort study published in The Laryngoscope underscores this challenge, revealing that 85% of patients who received robotic-assisted implants retained their hearing after a year, compared to 71% who underwent manual implantation.

Dr. Marlan Hansen, co-founder and chief medical director of iotaMotion, emphasizes that “Robotic cochlear implantation focuses on precision and consistency. With the expanded pediatric indication for iotaSOFT, backed by emerging clinical evidence, families can be more confident that controlled, standardized implantations are designed to protect the cochlea while maintaining its structure and function. This is particularly pivotal for children who may benefit from new therapeutic advancements such as gene-based and regenerative hearing technologies, which are likely contingent on the early, minimally traumatic placement of cochlear implant arrays.”

As iotaMotion continues to innovate in the field, the company remains committed to improving the landscape of cochlear implant surgery beyond human capabilities through robotic solutions. The iotaSOFT system is currently available in the United States, with ongoing clinical evaluations in various global markets. For further information about iotaMotion, you can visit iotaMotion's website or follow them on LinkedIn, X, Facebook, and YouTube.