FDA Approves Device That Helps Blind People “See” With Their Tongue

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The FDA has approved a new medical device developed by Middleton, WI-based  startup Wicab, Inc. that helps blind people navigate their surroundings by delivering a series of coordinated pulses to the tongue. Marketed as an oral electronic vision aid, Wicab won De Novo FDA approval for it due to the fact that it is a non-invasive, low-risk device, and that no substantially equivalent devices are currently available on the market.

Wicab’s device, called the BrainPort V100, includes a headset with an embedded video camera that captures visual data that is pixilated and then delivered to the surface of the patient’s tongue as a series of vibrations delivered by a grid of electrodes held in the mouth. The device translates real-time video into greyscale patterns, where darker portions of the image vibrate at full strength, hues of gray vibrate at increasingly softer levels, and white areas do not vibrate at all. Users describe the experience as having streaming images drawn on the tongue with small vibrating bubbles. With training, users are able to interpret the vibrations “to determine the location, position, size, and shape of objects, and to determine if objects are moving or stationary,” according to the FDA’s press release.

While its device is both promising and innovative, Wicab’s future was in question for a period during its early days. Launching as a device designed to help patients with balance issues, with an accelerometer instead of a video headset, Wicab raised $10 million in VC funds to finalize development and move its product through a round of clinical trials. Unfortunately, the trials showed no measurable improvement in balance when compared to a control group and Wicab nearly went out of business.

After laying off a large portion of its fledgling staff, Wicab found its second chance in the DoD, which thought the device might have potential in helping soldiers blinded in combat. The DoD awarded Wicab a $3.2 million grant to adapt its technology into its current form. Wicab’s next stroke of luck came in the form of a grant from Google, which gave the company $2.5 million without taking equity to help it pay for a 75-person clinical trial.

With the results of that trial, Wicab applied for FDA approval to bring its product to market, and now has an approved device. The company does not see its product as a stand-alone visual aid, but instead sees it taking a supplementary role alongside service animals and white canes.


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