FDA Approves First Bionic Eye for the Blind

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CLEVELAND –The U.S. Food and Drug Administration has approved the first bionic eye.

The device, Argus II, is an artificial retina that works with a pair of glasses, said Dr. Thomas Steinemann of MetroHealth Medical Center.

Steinemann was on the board that approved the device for use.

The glasses essentially capture an image that’s transmitted to the retina implant, enabling a person to see. The technology will likely cost more than $100,000.

“This is a major seat change because we now have hope, and we now can offer people something. Something is better than nothing, and nothing by that, I mean, they have such limited vision, profound loss of vision, that most of these patients can only see shadows,” Steinemann said.

The device has been tested over the past 10 years in three clinical trials.

However, Steinemann said it is only able to restore some vision to people with a rare genetic disorder, retinitis pigmentosa, an inherited disease that affects nearly 100,000 people nationwide.

In those trials, Steinemann said people were able to see things like crosswalks, images of people and large letters and numbers.

He expects, as the technology improves, it will vastly improve the quality of life of patients.

“We’re just at the beginning. It’s an exciting technology, it’s an expensive technology,” he said. “From an investigator’s standpoint, from somebody who’s followed this through the Food and Drug Administration, it’s an exciting technology. It’s a lot of hope, not only for patients with retinitis pigmentosa, but in the future, perhaps for other patients with blinding eye disease.”