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FDA approves device allowing blind people to 'see' with their tongues
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The FDA granted marketing clearance for a device that can aid in orienting the blind with an intra-oral device, according to a press release issued by the agency.
The BrainPortV100 (Wicab Inc.) is an assistive battery-powered device that allows blind people to identify aspects of objects using their tongues.
As detailed in the release, the device consists of "a video camera mounted on a pair of glasses and a small, flat intra-oral device containing a series of electrodes that the user holds against their tongue." The video camera captures an image and converts it into electrical signals that ultimately create a vibrating or tingling sensation on the tongue. After training, the signals allow users to identify an object's position, size, shape and location, as well as any movement, according to the release.
“Medical device innovations like this have the potential to help millions of people,” William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the release. “It is important we continue advancing device technology to help blind Americans live better, more independent lives.”
As detailed in the press release, the BrainPortV100 was approved via the de novo premarket review pathway. In various studies of the device, 69% of participants who used it for at least 1 year demonstrated success in an object recognition test.
The release also stated that no serious adverse events related to the device were reported; some participants experience stinging, burning or a metallic taste.
In Primary Care Optometry News' coverage of Optometry's Meeting 2015, a speaker discussed the BrainPortV100 as part of a lecture on wearable technology for low vision patients.
“Patients say it feels like champagne bubbles,” Bryan M. Wolynski, OD, FAAO, said in his presentation. “People can see shapes and sizes while using this. They’ve been doing indoor rock climbing using this device. It takes 10 hours of training to teach your brain to recognize this.”