The Food and Drug Administration (FDA) has approved for marketing the BrainPort V100 (Wicab, Inc.) device to help orient blind people by helping them process visual images with their tongues, when used with other assistive devices (eg, cane, guide dog).

The BrainPort V100 is a new battery-powered device that consists of a video camera mounted on a pair of glasses with a small, flat intra-oral electrodes-containing device that the user holds against their tongue. The captured images are converted by a software into electrical signals that are sent to the intra-oral device. The user then perceives them as vibrations or tingling on their tongue.

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The user can be trained to interpret the signals to determine the location, position, size, and shape of objects, and to determine whether they are in motion or still.

Safety and efficacy of the BrainPort V100 was based on several assessments, including object recognition, word identification, and oral health exams to determine risks associated with intra-oral use. Data from the studies showed 69% of the 74 participants who completed one year of training with the device were successful at the object recognition test. There were no serious device-related adverse events.

The BrainPort V100 device was reviewed by the FDA  through the de novo premarket review pathway.

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