The Second Sight Orion is a cortical vision prosthesis that bypasses the eye and optic nerve entirely, stimulating the visual cortex directly to evoke the perception of light flashes (phosphenes) in profoundly blind individuals. A pair of glasses-mounted cameras captures video; a wearable processor converts the image into electrode stimulation patterns transmitted wirelessly to an implanted array on V1 (primary visual cortex). The Orion targets individuals blinded by conditions such as glaucoma, diabetic retinopathy, and optic nerve damage who cannot benefit from retinal prostheses. Second Sight previously marketed the Argus II retinal implant before pivoting to cortical stimulation.
An IDE permits a device to be used in a clinical study to collect safety and effectiveness data required for a PMA or 510(k) submission. IDE devices are not approved for commercial sale.
FDA Device Regulatory Guidance ↗