With 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.
“Medical device innovations like this have the potential to help millions of people,”said William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health.
Clinical data supporting the safety and effectiveness of the BrainPort V100 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.
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.
Some patients reported burning, stinging or metallic taste associated with the intra-oral device. There were no serious device-related adverse events.
The device has been developed by Wicab, Inc, in Middleton, Wisconsin, and is expected to cost about $10,000 (roughly Rs. 6,35,400) when it becomes commercially available.