A battery-powered device that allows blind patients to "see" with their tongues has been cleared by the FDA.
A battery-powered device that allows blind patients to “see” with their tongues has been cleared by the FDA.
The BrainPort V100 includes a video camera mounted on a pair of glasses and a small, flat device with electrodes that is held against the user’s tongue. The image captured by the camera is converted into electrical signals that are sent to the intra-oral device, perceived as tingling on the tongue.
Through training and repeated use, a blind individual can learn to interpret these vibrations to determine the location, size, and shape of objects, as well as whether they are moving or stationary.
“Medical device innovations like this have the potential to help millions of people,” stated William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “It is important we continue advancing device technology to help blind Americans live better, more independent lives.”
The FDA based its approval for the BrainPort V100 on several assessments, including clinical studies that showed 69% of 74 subjects who completed 1 year of device training were successful at object recognition. Some subjects reported burning, stinging, or metallic taste associated with the intra-oral device, but there were no serious related adverse events.
The National Eye Institute reported that more than 1.2 million individuals in the United States were blind in 2010, and this number is expected to rise to 2.1 million by 2030 and 4.1 million by 2050.