FDA www.fda.gov now allows the new device BrainPort V100 manufactured by Wicab Inc, www.wicab.com in Wisconsin to be marketed when used with other assistive devices to help the blind process visual images with their tongues.
The BrainPort V100 is 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 when sent to the intra-oral device that is then 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 the objects are moving or stationary.
Clinical data supporting the safety and effectiveness of the device includes object recognition and word identification, as well as oral health exams to determine risks associated with holding the intra-oral device in the mouth.
Studies showed that 69 percent of the 74 subjects who completed one year of training with the device were successful at the object recognition test. However, some patients reported burning, stinging, or metallic taste associated with the intra-oral device but there were no serious device-related adverse events.
The potential advantage of the device is that it can be used regardless of the cause or duration of the blindness and does not require an intact optic nerve to function. Individuals blinded by congenital and acquired causes may use the device.
According to Robert Beckman Wicab CEO, “Another potential advantage is its simplicity. The non-surgical solution allows users to save their eyes in case future developments in stem cell research offer better alternatives for people who are totally blind.”