iotaMotion Surpasses 1,000 Clinical Procedures Performed with iotaSOFT® --Defining a New Era in Cochlear Implant Surgery

• Fewer than 5% of eligible patients worldwide receive cochlear implants today
• Hearing loss is the largest modifiable risk factor for dementia, linked to approximately 8% of global cases — more than hypertension, obesity, smoking, or depression

ST. PAUL, Minn., Sept. 25, 2025 /PRNewswire/ -- iotaMotion, Inc., the leader in robotic-assisted insertion systems for cochlear implantation, today announced it surpassed 1,000 clinical procedures utilizing the iotaSOFT^® Insertion System. This milestone underscores growing adoption of the first and only FDA market authorized robotic-assisted cochlear implant insertion system in the United States. The system provides surgeons with enhanced precision, consistency and control to one of the most delicate steps in cochlear implant (CI) surgery.

Now in its second full year of commercialization, iotaSOFT has been adopted in more than 30 leading cochlear implant centers nationwide, as well as an active pre-market clinical study site in Zurich, Switzerland.

"Cochlear implantation is one of the most transformative surgeries in medicine, yet for decades this critical step, electrode array insertion, has relied solely on the limits of the human hand," said Mike Lobinsky, CEO of iotaMotion. "With iotaSOFT, we are advancing CI surgery beyond human capability. By standardizing insertion and expanding access to the latest technology, we are not only empowering surgeons but also breaking down patient barriers like fear of surgery, opening the door for millions who could benefit."

Closing the Hearing Loss Treatment Gap

According to the World Health Organization (WHO), more than 430 million people worldwide experience disabling hearing loss, including more than 60 million individuals with severe or greater impairment, the population most likely to benefit from cochlear implants. Yet adoption remains strikingly low, with fewer than 5% of eligible patients worldwide receiving an implant.

Research highlights several factors driving this gap, including fear of losing residual hearing, lack of awareness about candidacy, emotional hesitancy to give up natural hearing and unrealistic expectations of outcomes. Combined with low global implant uptake, these barriers leave millions untreated despite being clinically eligible.

At the same time, hearing loss has been identified as the largest modifiable risk factor for dementia, accounting for about 8% of global cases — more than hypertension, obesity, smoking, or depression, The Lancet reported in 2020.

The iotaSOFT Insertion System directly addresses these barriers and concerns by enabling electrode array advancement with robotic consistency and control beyond the human hand. Studies and surgeon feedback confirm the system reduces insertion force and variability, helping to reduce trauma, preserve delicate cochlear structures, and improve patient confidence.

A 2025 study in The Laryngoscope, titled Robotic-Assisted Electrode Array Insertion Improves Rates of Hearing Preservation, found that 85% of patients in the robotic-assisted insertion group maintained hearing preservation at one year, compared with 71% in the manual insertion group, according to Khan et al.

"The iotaSOFT System was developed with one clear goal: to provide enhanced control and precision during one of the most critical steps of cochlear implant surgery," said Marlan Hansen, MD, chief medical officer of iotaMotion. "Reaching 1,000 clinical procedures is an important inflection point for both our company and the broader CI field as we demonstrate the value of robotic-assisted approaches in preserving delicate structures of the cochlea."

Surgeons Report Improved Precision and Consistency

The iotaSOFT Insertion System has been integrated into both academic and private practice settings with consistently positive results.

• "This technology allows me to perform electrode array insertions with even greater precision and consistency, case after case," said Michael Seidman, MD, an otologic surgeon at AdventHealth Celebration in Florida. "iotaSOFT has become an integral part of my practice and offers real value in limiting inner ear trauma for my patients."
  
  
• "As our cochlear implant program nears its 100th iotaSOFT insertion, I've seen firsthand the benefits of a steady, controlled advancement of the electrode array," added Eric Kraus, MD, an otologic surgeon at Atrium Health Wake Forest Baptist. "The system brings a level of precision that's simply not possible with manual technique alone."

As iotaMotion advances, the company remains committed to partnering with hearing health professionals worldwide to expand access to the benefits of robotic-assisted cochlear implantation.

About iotaMotion

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, the iotaSOFT^® Insertion System, is designed to preserve delicate intracochlear structures through a slow and consistent electrode array insertion. The system is commercially available in the United States and under clinical investigation in other global markets.

For more information, visit www.iotamotion.com or email pr@iotamotion.com. Follow us on LinkedIn, X, Facebook, YouTube.

Sources:

• World Health Organization. World Report on Hearing. Geneva: WHO; 2021.
• Hearing Health Collaborative. Current Estimates of Cochlear Implant Utilization in the United States. AdultHearing.com, 2023.
• Lancet Commission on Dementia Prevention, Intervention and Care. Lancet, 2020.
• Khan AM, et al. Robotic-Assisted Electrode Array Insertion Improves Rates of Hearing Preservation. The Laryngoscope, 2025.
• iotaMotion Bench Research (internal patient interviews and literature review), 2023; additional data on file.

Media Contact:
Holly Windler
619.929.1275
holly.windler@gmail.com

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