The FDA approved a device that enables blind users to interpret the shape, size, location and motion of objects from patterns of electrical stimulation on the surface of their tongue.
The BrainPort V100 consists of a camera mounted on sunglasses, a hand-held controller and a small, square-shaped sensor with 400 stimulation points that sits atop the surface of the user's tongue.
"Medical device innovations like this have the potential to help millions of people," said Dr. William Maisel, chief scientist in the FDA's device arm (CDRH) in a statement. "It is important we continue advancing device technology to help blind Americans live better, more independent lives."
The current indication covers 250,000 Americans, Bloomberg reports. It was approved through the de novo pathway for innovative low- to moderate-risk devices that do not have a "substantially equivalent" predicate device, required for clearance through the more common 510(k) pathway.
A clinical trial showed that 69% of 74 subjects were successful at an object recognition test after one year of training with the device.
"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," CEO of manufacturer Wicab, Robert Beckman, told Bloomberg. "We don't want to create false hopes," he warned, adding that patients "need to learn the technology and practice with it. It's more akin to learning a new language than it is to ordinary perception."
Beckman told Bloomberg told that the device will sell for around $10,000. Funding for its development came from Google and the U.S. Department of Defense.
BrainPort was approved for use in Canada and Europe in 2013.
Other devices for blindness are gaining traction too. In 2013, California's Second Sight Medical ($EYES) gained FDA approval for the a retinal implant to treat adults who have a degenerative eye disease. In April, it implanted a version of its Orion I Visual Cortical Prosthesis to treat blindness in an animal study. The new device is supposed to bypass the retina and optic nerve, enabling it to treat blindness in patients with damage to those parts of the eye.
In addition, France's Pixium Vision is seeking a CE mark of its Iris retina implant device.
- read the FDA's statement
- here's Bloomberg's take