Robotics company iotaMotion has received a paediatric indication expansion for its robotic-assisted iotaSOFT cochlear implant insertion system from the US Food and Drug Administration (FDA).
Broadening the Minnesota-based company’s initial FDA clearance for iotaSOFT in 2020, the system can now be used for cochlear implant insertion procedures in patients four years of age and older.
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Claimed to be the first FDA-approved robotic cochlear implant system, iotaMotion’s system is designed to preserve delicate intracochlear structures through ‘slow and consistent’ electrode array insertion. Electrode arrays in cochlear implants are the structures that electrically stimulate the auditory nerve, bypassing damaged hair cells and sending sound signals to the brain in patients with hearing loss.
In 2023, the company raised $12m from a Series A financing round to speed up the commercial expansion of iotaSOFT.
Mike Lobinsky, CEO of iotaMotion, commented: “Receiving FDA clearance for expanded paediatric use marks a significant milestone for iotaMotion and for families navigating cochlear implant decisions.
“By standardising 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.”
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By GlobalDataAccording to the World Health Organization (WHO), fewer than 5% of eligible cochlear implant candidates receive an implant, despite there being an estimated 430 million people worldwide experiencing disabling hearing loss. Furthermore, in paediatric patients, early access to sound is viewed as a critical aspect in speech, language and educational development, with hearing preservation and surgical variability among the key factors that can delay intervention.
Recent research has found that the use of robots for cochlear implant insertion improved patient outcomes. A study, published in The Laryngoscope journal, found that 85% of patients in the robotic-assisted cochlear implant insertion group maintained hearing preservation at one year, compared with 71% in the manual insertion group.
Marlan Hansen, iotaMotion’s chief medical officer, said: “With the expanded paediatric indication for iotaSOFT, supported by growing clinical evidence, families can have greater confidence that controlled, standardised insertion is designed to protect the cochlear and preserve its structure and function.”
According to GlobalData analysis, the global surgical robotics market is growing at a CAGR of 6.2% and projected to reach a valuation of $16.2bn in 2034, up from $8.89bn in 2024.
