iotaSOFT® goes international: a clinical study begins in Zurich

In May 2025, iotaMotion announced the first use of the iotaSOFT® Insertion System outside the United States. The system is being used in a pre-market clinical investigation at University Hospital of Zurich in Switzerland, led by Professor Alexander Huber.

Here’s what that study is about, and why research like this matters to people exploring cochlear implants.

First, what is iotaSOFT?

During cochlear implant surgery, the surgeon places a thin electrode array inside the cochlea, your inner ear’s hearing organ. iotaSOFT is designed to assist the surgeon during cochlear implantation by controlling the speed of electrode array insertion. It delivers a controlled insertion and is designed to reduce electrode array insertion variability and forces.

In the U.S., iotaSOFT is FDA-authorized and commercially available. Outside the U.S., it is under clinical investigation. That’s what the Zurich study is.

What the Zurich study is looking at

The study is titled “Analysis of electrocochleographic signals during speed-controlled cochlear implant electrode array insertion in a non-randomized controlled trial.” That’s a mouthful, so let’s break it down:

• Electrocochleography (ECochG) is a way of recording signals from the inner ear. In this study, those recordings are taken in real time while the electrode array is being inserted.
• Speed-controlled insertion is what iotaSOFT provides: the array advances at a steady, controlled speed.
• The goal, according to the announcement, is to study the relationship between how the array is inserted and how the cochlea responds, as measured by ECochG.

The announcement says this approach may pave the way for future advances in cochlear implant programming and hearing preservation strategies. Those are research questions, not results yet.

In the researchers’ words

Professor Huber said:

“Bringing this new robotic-assisted technology for cochlear implantation to University of Zurich was extremely important to our team. It will enable us to continue to advance cochlear implant care and explore techniques that have never been used clinically prior to this study.”

Mike Lobinsky, President and CEO of iotaMotion, said:

“This represents a major milestone for iotaMotion as we expand outside of the United States with our technology.”

Why research matters to you

If you’re considering a cochlear implant, you may wonder how new technology is studied. Clinical investigations like this one help surgeons and researchers learn more about how insertion technique relates to how the inner ear responds. There is a growing amount of clinical evidence supporting the benefits of robotic-assisted cochlear implantation, and studies like Zurich’s add to it.

You can browse published research on our Resources page. Surgeons can find more on our surgeons page.

What this means if you live in the U.S.

Nothing changes about access in the U.S.: iotaSOFT is already available at cochlear implant centers here. The announcement noted it had been used in more than 750 U.S. cases at that time (that number has since passed 1,000; see our milestone post).

What’s next

The announcement said wider availability of iotaSOFT outside the U.S. was planned for 2026.

Read the full press release, or visit our patient page to learn more.

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.