FDA approves device to help the blind 'see' via their tongues

The Food and Drug Administration has allowed marketing of a new device that when used along with other assistive devices, like a cane or guide dog, can help orient people who are blind by helping them process visual images with their tongues.

The BrainPort V100 is a battery-powered device that includes a video camera mounted on a pair of glasses and a small, flat intra-oral device containing a series of electrodes that the user holds against their tongue. Software converts the image captured by the video camera in to electrical signals that are then sent to the intra-oral device and perceived as vibrations or tingling on the user’s tongue.

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.

How does it work?

Whenever we learn a new dance move or how to solve a math problem, the brain develops new neural pathways to reflect this skill and make it easier to repeat. This physical change in the brain’s composition is known as brain plasticity, and it's what allows a person to use the BrainPort effectively. When a person loses a sense, either from birth or injury, their brain develops new neural pathways to compensate for the disability, which is where the BrainPort's functions fit in.

Although it’s the eyes that take in the visual stimulus from our environment, it’s essentially the brain that converts this stimulus into vision. The BrainPort simply re-teaches the brain to see by training it to receive a visual stimulus from the tongue rather than the eyes.

According to the National Institutes of Health’s National Eye Institute (NEI), in 2010 more than 1.2 million people in the United States were blind. NEI projects that number of Americans who are blind will rise to 2.1 million by 2030 and 4.1 million by 2050.

The FDA reviewed the data for the BrainPortV100 through the de novo premarket review pathway (opens in a pdf), a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally-marketed device.

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.

BrainPort is manufactured by Wicab, Inc., in Middleton, Wisc., USA.

However, the device is likely to be expensive; Wicab told Popular Science that it will cost $10,000 per unit, the same as its price when first reported back in 2009.

But while this price appears significant, when compared to the current price estimates of some of the other visual recovery devices that cost more than $100,000 and are only meant for certain blinding diseases alone, BrainPort V100 sounds a much better deal, specially since it can be used by anyone, irrespective of the disease that has caused the blindness.

Sources: 1 2 3

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