{"id":44957,"date":"2026-01-14T20:03:00","date_gmt":"2026-01-14T13:03:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=44957"},"modified":"2026-01-14T20:03:00","modified_gmt":"2026-01-14T13:03:00","slug":"iotamotion-receives-fda-clearance-for-expanded-pediatric-use-of-iotasoft-robotic-assisted-cochlear-implant-insertion-system","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=44957","title":{"rendered":"iotaMotion Receives FDA Clearance for Expanded Pediatric Use of iotaSOFT\u00ae Robotic-Assisted Cochlear Implant Insertion System"},"content":{"rendered":"

ST. PAUL, Minn.<\/span>, Jan. 14, 2026<\/span> \/PRNewswire\/ — iotaMotion, Inc<\/a>.,\u00a0creator\u00a0of\u00a0iotaSOFT\u00ae<\/sup>, the first and only FDA cleared robotic-assisted cochlear implant insertion system, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded pediatric use of its\u00a0iotaSOFT\u00ae<\/sup> Insertion System. 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.\u00a0<\/p>\n

\"The<\/a>
The iotaSOFT\u00ae Robotic-Assisted Cochlear Implant Insertion System advances surgery beyond the limits of the human hand with slow, consistent, and controlled electrode insertion to preserve delicate intracochlear structures. Shown with the drive unit guiding the array, iotaSOFT is FDA cleared for patients 4 years and older, expanding access as fewer than 5% of 60M eligible patients worldwide receive implants.<\/span><\/div>\n

“Receiving\u00a0FDA clearance for expanded pediatric use marks a significant milestone for\u00a0iotaMotion 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,\u00a0iotaSOFT helps reduce variability which could provide parents greater confidence as they consider cochlear implantation for their children.”\u00a0<\/p>\n

The iotaSOFT Insertion System\u00a0enables\u00a0precise\u00a0and controlled electrode array insertion during one of the most delicate steps of cochlear implant surgery. By standardizing this critical step, iotaSOFT is\u00a0designed to help preserve delicate cochlear structures, a consideration that is often central to decision-making.\u00a0<\/p>\n

As part of\u00a0this\u00a0milestone,\u00a0Cincinnati Children’s Hospital<\/strong>, a nationally ranked pediatric medical center,\u00a0and\u00a0U.S. News & World Report<\/em> Honor Roll member for 2025\u20132026, has become the first dedicated pediatric center to adopt the iotaSOFT\u00a0Insertion\u00a0System. Cincinnati Children’s joins over 35 leading cochlear implant centers across the United States, including nearly half of U.S. neurotology fellowship training programs,\u00a0that have adopted this\u00a0innovative\u00a0technology.\u00a0<\/p>\n

“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\u2013head and neck surgery. “Robotic-assisted cochlear implantation represents a meaningful advancement in our cochlear implant program.”\u00a0<\/span> \u00a0<\/p>\n

Globally, fewer than 5% of eligible cochlear implant candidates receive an implant, despite more than 430 million people worldwide experiencing disabling hearing loss, according to the World Health Organization. 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.\u00a0<\/p>\n

A 2025\u00a0clinical\u00a0cohort\u00a0study\u00a0published\u00a0in\u00a0The Laryngoscope<\/em>\u00a0(Khan et al.)\u00a0found that\u00a085%\u00a0of\u00a0patients in the robotic-assisted insertion\u00a0group\u00a0maintained\u00a0hearing preservation at one year,\u00a0compared\u00a0with\u00a071%\u00a0in the manual insertion group, according to its authors.\u00a0<\/p>\n

“Robotic assistance in cochlear implantation is about precision\u00a0and consistency,” said\u00a0Marlan Hansen, MD, co-founder and chief medical officer of iotaMotion. “With the expanded pediatric indication for\u00a0iotaSOFT, 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\u00a0atraumatic, cochlear implant array placement early in life.”<\/p>\n

About iotaMotion
<\/strong>iotaMotion, Inc. is a medical technology company based in St. Paul, Minnesota, dedicated to advancing cochlear implant surgery beyond human capability through robotic-assisted solutions. Its flagship technology,\u00a0the\u00a0iotaSOFT\u00ae<\/sup>\u00a0Insertion System, is designed to preserve delicate intracochlear\u00a0structures through slow and consistent electrode array insertion. The system is commercially available in the United States and under clinical investigation in other global markets.\u00a0<\/p>\n

For more information, visit\u00a0http:\/\/www.iotamotion.com\/<\/a> and follow us on\u00a0LinkedIn<\/a>,\u00a0X<\/a>,\u00a0Facebook<\/a>,\u00a0YouTube<\/a>.<\/p>\n

Sources:
<\/strong>Claussen\u00a0AD, et al.\u00a0Comparative Analysis of Robotics-Assisted and Manual Insertions of Cochlear Implant Electrode Arrays<\/span><\/em>.<\/em>\u00a0Otol<\/em>\u00a0Neurotol,<\/em>\u00a02022.\u00a0<\/p>\n

Khan AM, et al.\u00a0Robotic-Assisted Electrode Array Insertion Improves Rates of Hearing Preservation<\/em><\/a>.<\/em>\u00a0The Laryngoscope,<\/em>\u00a02025.\u00a0<\/p>\n

Data on file<\/p>\n

Media Contact:
<\/strong>Sara\u00a0Ashburn-Reed
Sashburn-reed@iotamotion.com<\/a>\u00a0<\/p>\n

\"A<\/a>
A close-up view of the iotaSOFT\u00ae Robotic-Assisted Cochlear Implant Insertion System. The system is FDA cleared for patients four years of age and older.<\/span><\/div>\n

\u00a0<\/p>\n

\"iotaMotion\u2014<\/a>
iotaMotion\u2014 the leader in robotic-assisted insertion systems for cochlear implantation and maker of the iotaSOFT\u00ae Insertion System, the first and only FDA cleared robotic-assisted insertion system, indicated for patients 4 years and older.<\/span><\/div>\n

\u00a0<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

ST. PAUL, Minn.<\/span>, Jan. 14, 2026<\/span> \/PRNewswire\/ — iotaMotion, Inc<\/a>.,\u00a0creator\u00a0of\u00a0iotaSOFT\u00ae<\/sup>, the first and only FDA cleared robotic-assisted cochlear implant insertion system, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded pediatric use of its\u00a0iotaSOFT\u00ae<\/sup> Insertion System. 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.\u00a0<\/p>\n

\"The<\/a>
The iotaSOFT\u00ae Robotic-Assisted Cochlear Implant Insertion System advances surgery beyond the limits of the human hand with slow, consistent, and controlled electrode insertion to preserve delicate intracochlear structures. Shown with the drive unit guiding the array, iotaSOFT is FDA cleared for patients 4 years and older, expanding access as fewer than 5% of 60M eligible patients worldwide receive implants.<\/span><\/div>\n

“Receiving\u00a0FDA clearance for expanded pediatric use marks a significant milestone for\u00a0iotaMotion 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,\u00a0iotaSOFT helps reduce variability which could provide parents greater confidence as they consider cochlear implantation for their children.”\u00a0<\/p>\n

The iotaSOFT Insertion System\u00a0enables\u00a0precise\u00a0and controlled electrode array insertion during one of the most delicate steps of cochlear implant surgery. By standardizing this critical step, iotaSOFT is\u00a0designed to help preserve delicate cochlear structures, a consideration that is often central to decision-making.\u00a0<\/p>\n

As part of\u00a0this\u00a0milestone,\u00a0Cincinnati Children’s Hospital<\/strong>, a nationally ranked pediatric medical center,\u00a0and\u00a0U.S. News & World Report<\/em> Honor Roll member for 2025\u20132026, has become the first dedicated pediatric center to adopt the iotaSOFT\u00a0Insertion\u00a0System. Cincinnati Children’s joins over 35 leading cochlear implant centers across the United States, including nearly half of U.S. neurotology fellowship training programs,\u00a0that have adopted this\u00a0innovative\u00a0technology.\u00a0<\/p>\n

“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\u2013head and neck surgery. “Robotic-assisted cochlear implantation represents a meaningful advancement in our cochlear implant program.”\u00a0<\/span> \u00a0<\/p>\n

Globally, fewer than 5% of eligible cochlear implant candidates receive an implant, despite more than 430 million people worldwide experiencing disabling hearing loss, according to the World Health Organization. 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.\u00a0<\/p>\n

A 2025\u00a0clinical\u00a0cohort\u00a0study\u00a0published\u00a0in\u00a0The Laryngoscope<\/em>\u00a0(Khan et al.)\u00a0found that\u00a085%\u00a0of\u00a0patients in the robotic-assisted insertion\u00a0group\u00a0maintained\u00a0hearing preservation at one year,\u00a0compared\u00a0with\u00a071%\u00a0in the manual insertion group, according to its authors.\u00a0<\/p>\n

“Robotic assistance in cochlear implantation is about precision\u00a0and consistency,” said\u00a0Marlan Hansen, MD, co-founder and chief medical officer of iotaMotion. “With the expanded pediatric indication for\u00a0iotaSOFT, 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\u00a0atraumatic, cochlear implant array placement early in life.”<\/p>\n

About iotaMotion
<\/strong>iotaMotion, Inc. is a medical technology company based in St. Paul, Minnesota, dedicated to advancing cochlear implant surgery beyond human capability through robotic-assisted solutions. Its flagship technology,\u00a0the\u00a0iotaSOFT\u00ae<\/sup>\u00a0Insertion System, is designed to preserve delicate intracochlear\u00a0structures through slow and consistent electrode array insertion. The system is commercially available in the United States and under clinical investigation in other global markets.\u00a0<\/p>\n

For more information, visit\u00a0http:\/\/www.iotamotion.com\/<\/a> and follow us on\u00a0LinkedIn<\/a>,\u00a0X<\/a>,\u00a0Facebook<\/a>,\u00a0YouTube<\/a>.<\/p>\n

Sources:
<\/strong>Claussen\u00a0AD, et al.\u00a0Comparative Analysis of Robotics-Assisted and Manual Insertions of Cochlear Implant Electrode Arrays<\/span><\/em>.<\/em>\u00a0Otol<\/em>\u00a0Neurotol,<\/em>\u00a02022.\u00a0<\/p>\n

Khan AM, et al.\u00a0Robotic-Assisted Electrode Array Insertion Improves Rates of Hearing Preservation<\/em><\/a>.<\/em>\u00a0The Laryngoscope,<\/em>\u00a02025.\u00a0<\/p>\n

Data on file<\/p>\n

Media Contact:
<\/strong>Sara\u00a0Ashburn-Reed
Sashburn-reed@iotamotion.com<\/a>\u00a0<\/p>\n

\"A<\/a>
A close-up view of the iotaSOFT\u00ae Robotic-Assisted Cochlear Implant Insertion System. The system is FDA cleared for patients four years of age and older.<\/span><\/div>\n

\u00a0<\/p>\n

\"iotaMotion\u2014<\/a>
iotaMotion\u2014 the leader in robotic-assisted insertion systems for cochlear implantation and maker of the iotaSOFT\u00ae Insertion System, the first and only FDA cleared robotic-assisted insertion system, indicated for patients 4 years and older.<\/span><\/div>\n

\u00a0<\/p>\n

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