The US Food and Drug Administration (FDA) has allowed marketing of the BrainPort V100, a battery-powered device that includes 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.
Software converts the image captured by the video camera into electrical signals that are then sent to the intra-oral device and perceived as vibrations or tingling on the user's tongue.
"Medical device innovations like this have the potential to help millions of people," said William Maisel, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health.
Clinical data supporting the safety and effectiveness of the BrainPort V100 included several assessments, such as object recognition and word identification, as well as oral health exams to determine risks associated with holding the intra-oral device in the mouth.
Some patients reported burning, stinging or metallic taste associated with the intra-oral device. There were no serious device-related adverse events.
The device has been developed by Wicab, Inc, in Middleton, Wisconsin, and is expected to cost about USD 10,000 when it becomes commercially available.