A new, thumb-sized device from iotaMotion called iotaSoft intended to help place cochlear implants into patient’s ears, received De Novo clearance from the Food and Drug Administration (FDA), according to an article in Fierce Biotech.
According to the article, the Iowa-based company’s iotaSoft system is designed to focus “on the single task of planting electrode arrays within the inner ear, yet with more precision than the human hand—and with no heavy hardware required.” In attaching to the bones in the patient’s skull, the single-use device “helps guide the insertion of electrodes with consistent speed and force,” helping limit the potential damage to the cochlea itself, and to prevent additional hearing loss.
“Historically, cochlear implant electrode arrays have been placed solely by hand with forceps and other manual instrumentation. With the advent of robotic-assisted systems like the iotaSoft, we will now have the ability to place the electrode into the delicate, tiny structures of the cochlea with the added precision and stability that robotic assistance provides.” said Marlan Hansen, MD, iotaMotion Medical Director and Department of Otolaryngology Chair at the University of Iowa, in a press release published on the company’s website. “There are clear opportunities to improve outcomes, optimize preservation of existing function, and support consistent results for surgeons and patients in the US and around the world.”
The company estimates, according to the article,“between 15% and 50% of all people who receive a cochlear implant have reported additional losses of their natural hearing,” due to the force utilized when pushing the electrode through the sensitive portions of the ear.
The company will begin rolling out the device to healthcare professionals in the coming months, according to Fierce Biotech, through a “controlled commercialization schedule following the FDA’s De Novo clearance.”
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Source: Fierce Biotech