The FDA has cleared its first robotic surgery system designed for placing cochlear implants in people facing hearing loss—in an entire package the size of a thumb.
While the term robotic surgery typically conjures images of an operating table lined with multiple, autonomous arms, iotaMotion’s minimalist system focuses 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.
The Iowa-based company’s open-platform iotaSoft system is designed to work with a range of different implants and fit easily into a surgeon’s typical workflow. By attaching to the bones of the patient’s skull, the single-use device helps guide the insertion of electrodes with consistent speed and force.
"Historically, cochlear implant electrode arrays have been placed solely by hand with forceps and other manual instrumentation,” iotaMotion’s medical director, Marlan Hansen, M.D., said in a statement.
By slowing down the procedure and giving the surgeon added control, iotaMotion aims to limit the amount of damage caused to the delicate cochlea by the surgery itself, to help maintain the patient’s remaining hearing.
According to the company, studies have shown that when inserting the implants manually, the amount of force used can spike as the electrode is pushed through the final millimeters across the sensitive areas of the ear. iotaMotion estimates that between 15% and 50% of all people who receive a cochlear implant have reported additional losses of their natural hearing.
"There are clear opportunities to improve outcomes, optimize preservation of existing function, and support consistent results for surgeons and patients in the U.S. and around the world," said Hansen, who also serves as chair of the department of otolaryngology at the University of Iowa.
IotaMotion said it plans to begin rolling out its device to healthcare professionals in the coming months, through a controlled commercialization schedule following the FDA’s de novo clearance.
Earlier this year, in another example of a miniaturized machine providing a robotic solution to a specific surgical problem, the FDA cleared Interventional Systems’ Micromate, a boxlike device that allows physicians to perform percutaneous operations without exposing themselves to radiation.
The palm-sized Micromate attaches to the operating table and is controlled by a joystick to line up a biopsy needle or ablation probe from entirely outside the operation room while being guided by real-time fluoroscopy or CT scans.