The BrainPort converts images into electrical impulses that are felt on the tongue as vibrations or tingling sensations.
Image credit: Wicab Inc
When used with a cane or assistance dog, the BrainPort V100 can enhance people's ability to navigate their environment by literally "tasting the light."
The battery-powered BrainPort looks like a square plastic lollipop - this goes in the mouth and sits on the tongue - connected via a wire to a tiny video camera mounted on a pair of sunglasses that the user wears.
The video camera captures images that are converted to electrical impulses that are sent to electrodes in the lollipop - the impulses are felt on the tongue as vibrations or tingling.
After receiving training and with experience of use, the user learns to interpret the signals through their tongue and determine size, shape and position of objects in front of them and even discern if they are moving.
The Food and Drug Administration (FDA) came to their decision following a review of clinical data on the safety and effectiveness of the device. Effectiveness assessments included object recognition and word identification.Studies showed that 69% of 74 BrainPort V100 users who completed a year's training succeeded in object recognition tests.
Some users reported that the device left a metallic taste in the mouth and gave them a burning or stinging sensation. There were no serious adverse effects, say the FDA.
'It's the brain that sees - not the eyes'
The technology behind the BrainPort was first developed by American neuroscientist Dr. Paul Bach-y-Rita, who died in 2006, having pioneered a new field in brain plasticity. He introduced the concept of "sensory substitution," where signals from one sense are fed into the brain circuits of another, and he developed it as an approach for treating patients with disabilities.
Dr. Bach-y-Rita's idea is that we see the world with our brains and not our eyes - our eyes are merely the sensors. If the sensor is damaged or stops working, then you can use another sensor to get the visual information to the brain.
BrainPort is made by Wicab Inc of Middleton, WI, a company that Dr. Bach-y-Rita founded in 1998.
Robert Beckman, Wicab president and CEO, says one of the advantages of the BrainPort is its simplicity and the fact it does not affect the user's eyes, in case future medical advances - for instance, in stem cell research - offer better alternatives for people who are blind.
Dr. William Maisel, FDA's deputy director for science and chief scientist in the agency's Center for Devices and Radiological Health, says:
"Medical device innovations like this have the potential to help millions of people. It is important we continue advancing device technology to help blind Americans live better, more independent lives."
The National Eye Institute - one of the National Institutes of Health - say the number of Americans who are blind will rise from just over 1.2 million (estimated in 2010) to 2.1 million by 2030 and 4.1 million by 2050.
The device was approved for sale in Europe in 2013.
Medical News Today first learned about the BrainPort in 2010, when a British soldier, who was blinded by a grenade in Iraq in 2007, described how it had transformed his life.