The device, which is designed to aid visually impaired people, is made up of a small video camera attached to a pair of glasses and an intra-oral mouth piece containing an array of electrodes.
The image captured by the device is converted in to electrical signals that are then sent to the intra-oral mouth piece and are perceived as vibrations or a tingling sensation on the user’s tongue.
After about 20 hours of supervised training, users are able to independently interpret sensations such as the shape, size and location of an object as well as determine whether the objects are moving or stationary. The training sessions cover proper interpretation of sensory information and operation of the device controls.
“People are able to learn to interpret these patterns of bubbles or stimulation on their tongue to know what object is in front of them,” said Wicab CEO, Robert Beckman. According to Beckman, users need to learn how to use the technology and practice with it. “It’s more akin to learning a new language than it is to ordinary perception,” Beckman noted.
According to Wicab, the battery-powered BrainPort V100 is intended to compliment rather than replace other assistive technologies such as guide dogs and walking sticks. The system can run for approximately three hours on a single charge.
The FDA reviewed data for the BrainPort V100 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.
The FDA says clinical data supporting the safety and effectiveness of the device included several assessments, such as object recognition and oral health exams to assess risks associated with holding the intra-oral device in the mouth. Studies conducted on 74 subjects who completed one year of training with the device showed that nearly 70% of the subjects were able to successfully identify objects in recognition tests. While some patients reported a stinging or metallic taste associated with the intra-oral device no serious side effects were reported.
BrainPort was approved in Europe in 2013 and has been marketed in the UK, Germany, Sweden and Italy. The product is expected to retail for about $10,000.