iotaMotion Achieves FDA Approval for Pediatric Cochlear Implant System Expansions

iotaMotion Announces FDA Clearance for Pediatric Use of Robotic Cochlear Implant System

ST. PAUL, Minn. – iotaMotion, Inc., has made a significant stride in medical technology by receiving FDA clearance to expand the pediatric application of its groundbreaking iotaSOFT® robotic-assisted cochlear implant insertion system. The new approval allows the usage of the iotaSOFT® system for children aged four years and older, markedly broadening the possible demographic of patients who can benefit from this sophisticated technology. Previously, the system was cleared only for individuals 12 years and older.

The iotaSOFT® system stands out as the first and only FDA authorized robotic-assisted insertion tool specially designed for cochlear implants. It employs robotics to deliver a slow, consistent, and controlled insertion of the electrode array, which is crucial for maximizing patient outcomes and preserving the delicate structures within the cochlea during the surgical process. This precision reduces variability during surgery, thereby potentially increasing parents' confidence when considering cochlear implants for their children.

Mike Lobinsky, CEO of iotaMotion, expressed his excitement over this enhancement, calling it a pivotal moment for the company and families making cochlear implant decisions. He emphasized that robotic assistance must maintain high surgical standards and provide better outcomes, especially for young patients, who stand to benefit greatly from the early introduction of sound.

To underline the importance of this technology, a recent clinical cohort study published in The Laryngoscope highlighted that robotic-assisted procedures achieved a 85% success rate in maintaining hearing preservation one year post-surgery, compared to only 71% for manual procedures. Dr. Marlan Hansen, co-founder and chief medical officer of iotaMotion, echoed similar thoughts, indicating that robotic assistance in cochlear implantation brings metrics of accuracy and reliability that were previously unattainable.

As a landmark achievement, Cincinnati Children’s Hospital, recognized for its pediatric medical advancements, has become the inaugural pediatric center to integrate the iotaSOFT® system into its cochlear implant program. Dr. Daniel Choo, chief clinical growth officer at Cincinnati Children’s, remarked on the balance between innovation and care, indicating this advanced surgical technique represents a significant step forward in their services.

Globally, it is estimated that over 430 million people experience disabling hearing loss; however, less than 5% of eligible candidates currently receive cochlear implants throughout the world. The need for timely access to sound—especially in children for their speech and language development—cannot be overstated. Early interventions are essential for maximizing educational outcomes, yet concerns about hearing preservation and variability in surgical methods often lead to delays in necessary treatments.

The iotaSOFT® technology addresses these concerns head-on, ensuring that delicate cochlear structures remain intact during procedures. This is particularly significant for children who may later require emerging therapies, including gene-based and regenerative hearing technologies, which require careful and minimally invasive implantation techniques.

In summary, the approval of the iotaSOFT® system for younger patients represents a leap forward in pediatric audiology, offering additional avenues for improving hearing among children and enhancing their overall access to developmental benefits through early intervention. iotaMotion is committed to redefining the cochlear implantation landscape, as it continues to explore innovative paths that could change countless lives.

For more details on their technology and future innovations, you can visit iotaMotion’s official website.