The U.S. Food and Drug Administration has cleared for marketing an assistive device for the blind that translates digital information from a video camera mounted on a pair of glasses into gentle electrical stimulation patterns on the surface of the tongue, helping users to learn to interpret visual images of objects in their environment.
A non-surgical assistive device designed to augment rather than replace other assistive technologies such as a cane or guide dog, the BrainPort V100developed by Wisconsin-based Wicabis battery-powered and includes a small, flat intra-oral device containing 400 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 users tongue.
The sensation is described by users as pictures that are painted on the tongue with tiny bubbles from which the location, position, size, and shape of objects can be determined, and whether they are moving or stationary. White pixels from the camera are felt on the tongue as strong stimulation, black pixels as no stimulation, and gray levels as medium levels of stimulation.
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, FDA reported. As part of the de novo premarket review process, the FDA reviewed the data for the BrainPort V100 through a regulatory pathway for low- to moderate-risk medical devices that are not substantially equivalent to an already legally-marketed device.
According to the regulatory agency, clinical data supporting the safety and effectiveness of the device 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. However, the FDA disclosed that some patients reported burning, stinging or metallic taste associated with the intra-oral device, but that there were no serious device-related adverse events.
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