The US Food and Drug Administration (FDA) has allowed marketing of a new device that when used along with other assistive devices, like a cane or guide dog, can help blind people in orientation, mobility, and object recognition by processing visual images with their tongues.
The BrainPort V100 is a battery-powered system that includes a video camera mounted on a pair of glasses and a small, flat, intraoral device containing a series of electrodes that the user holds against his or her tongue. Software converts the image captured by the video camera into electrical signals that are then sent to the intraoral device and perceived as vibrations or tingling on the user’s tongue. With training and experience, the user learns to interpret the signals to determine the location, position, size, and shape of objects, and to determine if objects are moving or stationary.
More than 1.2 million Americans were blind as of 2010, according to the National Institutes of Health’s National Eye Institute (NEI). The NEI forecasts that this number will rise to 2.1 million by 2030, and to 4.1 million by 2050. The FDA reviewed the data for the BrainPortV100 through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device. 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 intraoral device in the mouth. Studies showed that 69% of the 74 subjects who completed one year of training with the device were successful at the object recognition test. Some patients reported burning, stinging, or metallic taste associated with the intraoral device. There were no serious device-related adverse events.
The BrainPort V100 was developed by Wicab in Middleton, Wis.
(Source: FDA Press Announcements; June 23, 2015)
