iotaMotion Gains FDA Approval for Pediatric Use of iotaSOFT® Cochlear Implant System

In a groundbreaking development, iotaMotion, Inc. has announced that it has received FDA 510(k) clearance to extend the use of its iotaSOFT® Robotic-Assisted Cochlear Implant Insertion System to pediatric patients. This innovative system, which is the first of its kind to gain FDA approval for robotic-assisted cochlear implant insertion, allows for enhanced precision during surgery, thus facilitating better outcomes for young patients.

Currently, the iotaSOFT® system is authorized for use in children aged four and above, which significantly expands access to robotic-assisted cochlear implantation for school-aged children. By improving the accuracy of electrode insertion, the iotaSOFT® system aims to better preserve the delicate structures within the cochlea, an essential aspect of the surgical process.

Mike Lobinsky, the CEO of iotaMotion, remarked on the implications of this approval: "Receiving FDA clearance to extend pediatric use marks an important milestone for iotaMotion and for families making decisions about cochlear implants. By standardizing one of the most delicate steps in cochlear implant surgery, iotaSOFT helps reduce variability, potentially giving parents greater confidence when considering cochlear implantation for their children."

One significant feature of the iotaSOFT® system is its ability to facilitate controlled and gradual insertion of the electrode guide during a critical phase of the cochlear implant procedure. This careful approach aids in preserving the fragile cochlear structures, thereby enhancing the likelihood of successful auditory outcomes for young patients. As part of this milestone announcement, Cincinnati Children's Hospital, a nationally recognized pediatric medical center, has become the first pediatric center to adopt the iotaSOFT® system.

Dr. Daniel Choo, a prominent figure in the hospital's otolaryngology department, emphasized the importance of integrating innovative technologies to provide the highest quality of care, stating: "Robotic-assisted cochlear implantation represents a significant advancement in our cochlear implant program."

Despite an alarming global statistic indicating that less than 5% of eligible patients receive cochlear implants—while more than 430 million people worldwide suffer from debilitating hearing loss, according to the World Health Organization—this advancement is pivotal for improving access to life-changing treatments. Early access to sound is particularly crucial for pediatric patients, as it directly influences speech development, language acquisition, and education.

Concerns about preserving residual hearing and surgical variability have often delayed necessary interventions. However, clinical studies such as the cohort study published in The Laryngoscope in 2025 reveal promising results: 85% of patients utilizing the robotic-assisted insertion maintained their hearing preservation one year post-surgery, compared to only 71% of those undergoing manual insertion.

Dr. Marlan Hansen, co-founder and medical director of iotaMotion, elaborated on the advantages of robotic assistance, stating, "The precision and consistency provided by robotic assistance in cochlear implantation can be life-changing. With the expansion of pediatric indications, backed by growing clinical evidence, families can be more confident that controlled, standardized insertion is designed to protect the cochlea while preserving its structure and function. This is especially critical for children who stand to benefit from emerging therapeutic advances, including genetic and regenerative hearing technologies, which are likely to rely on non-traumatic placement of cochlear implant guides in early life stages."

In summary, iotaMotion's achievement in gaining FDA approval to expand the iotaSOFT® system for pediatric use highlights its commitment to advancing cochlear implant surgery through robotic technology. With significant implications for improving hearing restoration in children, this development places iotaMotion at the forefront of innovations in medical technology.

For more information about iotaMotion and its pioneering systems, visit iotaMotion's website or follow them on LinkedIn, X, Facebook, and YouTube.