The FDA has cleared for marketing the BrainPort V100, an investigational medical device that people who are blind may use with a white cane or guide dog to perceive the location, position, size, and shape of objects, and to determine whether objects are moving or stationary. The BrainPort V100 was reviewed by the FDA 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 battery-operated non-surgical device, manufactured by Wicab, Inc., of Middleton, Wisconsin, includes a video camera mounted on a pair of sunglasses that is connected to a small, flat lollipop-like device containing 400 electrodes that the user holds against the tongue. Software converts the image captured by the video camera into electrical signals that are sent to the lollipop device and felt as vibrations on the user’s tongue.
According to Wicab, the video camera works in a variety of lighting conditions and has an adjustable field of view. 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. Users of the device report the sensation as pictures that are painted on the tongue. A small hand-held unit about the size of a cell phone provides user controls and contains a rechargeable battery. With a minimum of 10 hours of supervised one-on-one 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.
According to the FDA, the safety and effectiveness assessment of the BrainPort V100 included object recognition and word identification, as well as oral health exams to determine risks associated with holding the intra-oral device in the mouth. Clinical studies showed that 51 of the 74 subjects who completed one year of training were successful at the object recognition test. Some subjects reported burning, stinging or metallic taste associated with the intra-oral device. There were, however, no serious device-related adverse events reported.
Robert Beckman, CEO of Wicab, recently told Mobile World Live that he “is looking to mobile and wireless technologies to improve the company’s first-generation BrainPort V100 device.” Right now the device is not connected to the internet, explained Beckman. “[Through the use of wireless connections] we can eliminate the handheld controller and all the controls will be on the frame of the glasses, and we will wirelessly connect the device to mobile technology which will greatly expand the capabilities of the device.”