iotaSOFT® is now FDA-cleared for children ages 4 and up

In January 2026, iotaMotion announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance (K252339) to expand use of the iotaSOFT® Insertion System to cochlear implant patients ages 4 and older. That opens robotic-assisted cochlear implantation to school-aged children.

If you’re a parent weighing a cochlear implant for your child, here’s what this news means and what to ask next.

What changed

iotaSOFT is intended for use in ages 4 and up. It is designed to assist the surgeon during cochlear implantation by controlling the speed of electrode array insertion, the step where the surgeon places the implant’s thin electrode array inside the cochlea.

The clearance doesn’t change who qualifies for a cochlear implant. That decision is still made by your child’s cochlear implant team. It changes which patients the surgeon may use iotaSOFT with during the procedure.

Why controlled insertion matters

The cochlea is small and delicate. iotaSOFT delivers a controlled insertion into the cochlea and is designed to reduce electrode array insertion variability and forces. It’s designed to help preserve the delicate structures within the cochlea.

The surgeon stays in control throughout. iotaSOFT enhances the surgeon’s ability to control the electrode array insertion. It does not perform the surgery on its own.

For parents, that can bring peace of mind during an important decision.

A dedicated children’s hospital joins

As part of the announcement, Cincinnati Children’s Hospital became the first dedicated pediatric center to adopt the iotaSOFT Insertion System. Daniel Choo, MD, chief clinical growth officer and professor of otolaryngology–head and neck surgery at Cincinnati Children’s, said:

“Robotic-assisted cochlear implantation represents a meaningful advancement in our cochlear implant program.”

The announcement also says more than 35 cochlear implant centers across the U.S. had adopted iotaSOFT at that time. Our Find a clinic page lists current centers.

Which implants does it work with?

iotaSOFT is open platform technology compatible with all three cochlear implant manufacturers. Ask your child’s team which implant they recommend, and see our pages on MED-EL and Advanced Bionics compatibility.

Questions parents can ask the cochlear implant team

• Is my child a candidate for a cochlear implant?
• Does your center offer robotic-assisted insertion with iotaSOFT?
• How do you decide whether iotaSOFT is right for my child?
• What does surgery day look like, and how should we prepare?
• What happens after surgery, including activation and follow-up visits?

Every child is different. Your child’s surgeon and audiologist are the right people to answer these for your family.

Learn more

• Read the full press release
• Learn how iotaSOFT works
• Read What is robotic-assisted cochlear implant insertion?
• Visit our patient page

Ready to take the next step? Find a clinic.

hearing, advanced.®

Individual results and outcomes can vary. Talk to your doctor to see if the iotaSOFT Insertion System is the right choice for you. Safety information: iotamotion.com/resources.

Indication: The iotaSOFT® Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion. The iotaSOFT® Insertion System is intended for use in cochlear implant patients ages 4 years and older during cochlear implant procedures using either a round window or cochleostomy approach.