The Food and Drug Administration approved a device Thursday that it says can help blind people orient themselves by processing visual images using their tongues.
The BrainPort V100, produced by Wisconsin-based Wicab Inc., is a battery-powered device that includes a small video camera mounted on a pair of glasses and a small, lollipop-like mouthpiece with 400 electrodes. When the user holds the "lollipop" to his or her tongue, images gathered by the camera are converted into electrical signals that tingle like champagne bubbles or "Pop Rocks" candy.
Over time, users can learn to interpret the signals to determine the size, shape and locations of objects, and to tell if what they are looking at is moving or stationary. The company says the device, which can run several hours on a single charge, is meant to complement rather than replace other forms of assistance, such as using a cane or a guide dog.
"Medical device innovations like this have the potential to help millions of people," William Maisel, chief scientist at FDA's Center for Devices and Radiological Health, said in an announcement about the approval. "It is important we continue advancing device technology to help blind Americans live better, more independent lives.
The technology behind the device has been under development for decades and was first undertaken by the late neuroscientist Paul Bach-y-Rita, a pioneer in the field of neuroplasticity. The device was approved in Europe in 2013 and marketed in Germany, Italy, Sweden and the United Kingdom. Its initial price tag was about $10,000, Wicab chief executive Robert Beckman told a Wisconsin paper at the time.
The FDA said Thursday that studies of the BrainPort V100 showed that nearly 70 percent of the 74 blind people who completed one year of testing with it were able to successfully identify objects in a recognition test. Some patients reported burning, stinging or a metallic taste associated with the mouthpiece, but the agency said it received no reports of serious side effects.
More than 1.2 million Americans were blind as of 2010, according to the National Institutes of Health's National Eye Institute. That number is expected to rise to more than 2 million people by 2030 and 4 million people by 2050.