Their Bionic Eyes Are Now Obsolete and Unsupported
IEEE Spectrum · Published 2022-02-15 (updated 2022-02-17) · By Eliza Strickland & Mark Harris
Source: https://spectrum.ieee.org/bionic-eye-obsolete
Article text (key passages, lightly condensed)
Patient stories
Barbara Campbell was walking through a New York City subway station during rush hour when her world abruptly went dark. For four years, Campbell had been using a high-tech implant in her left eye that gave her a crude kind of bionic vision, partially compensating for the genetic disease that had rendered her completely blind in her 30s. “I remember exactly where I was: I was switching from the 6 train to the F train,” Campbell tells IEEE Spectrum. “I was about to go down the stairs, and all of a sudden…” It wasn’t her phone battery running out. It was her Argus II retinal implant system powering down. The patches of light and dark that she’d been able to see with the implant’s help vanished. Despite some repair attempts by Second Sight, her system never worked again.
Terry Byland is the only person to have received this kind of implant in both eyes. He got the first-generation Argus I implant, made by Second Sight Medical Products, in his right eye in 2004 and the subsequent Argus II implant in his left 11 years later. He helped the company test the technology, spoke to the press movingly about his experiences, and even met Stevie Wonder. Yet in 2020, Byland had to find out secondhand that the company had abandoned the technology and was on the verge of going bankrupt. While his two-implant system is still working, he doesn’t know how long that will be the case. “As long as nothing goes wrong, I’m fine,” he says. “But if something does go wrong with it, well, I’m screwed. Because there’s no way of getting it fixed.”
Ross Doerr, another Second Sight patient, doesn’t mince words: “It is fantastic technology and a lousy company.” He received an implant in one eye in 2019 and remembers seeing the shining lights of Christmas trees that holiday season. He was thrilled to learn in early 2020 that he was eligible for software upgrades. Yet in the early months of the COVID pandemic, he heard troubling rumors about the company and called his Second Sight vision-rehab specialist, who confirmed the company was “going through some transitions.” Doerr couldn’t get an MRI to check for a brain tumor because MRI providers are instructed to contact Second Sight before performing any scans on Argus patients — and Second Sight wasn’t picking up the phone. He eventually got a CT scan instead, which found nothing. “I still don’t know if I have a brain-stem tumor or not.”
These three patients, and more than 350 other blind people around the world with Second Sight’s implants in their eyes, find themselves in a world in which the technology that transformed their lives is just another obsolete gadget. One technical hiccup, one broken wire, and they lose their artificial vision, possibly forever. A defunct Argus system in the eye could cause medical complications or interfere with procedures such as MRI scans, and it could be painful or expensive to remove.
Technology and company history
Second Sight began with a flash of light. In 1991, Robert Greenberg, an electrical engineer turned medical student, stood in an operating room watching as a retinal surgeon inserted a tiny wire into the eye of a blind patient. When the wire touched the retina and delivered a jolt of current, the man reported a spot of light. Greenberg spent years developing the technology at the Alfred Mann Foundation; he spun off Second Sight with three cofounders in 1998. Clinical trials of Argus I (16-electrode array) and Argus II (60-pixel array) resulted in European regulatory approval in 2011 and U.S. approval in 2013.
The Argus II system consists of the implant (surgically implanted in ~4 hours), special glasses with a small camera that sends video to a video processing unit (VPU) on the user’s belt, which reduces images to 60 black-and-white pixels and beams them wirelessly to an antenna on the eye, which sends signals to the 60-electrode array on the retina. Patients perceive shades of gray that appear and disappear as they move their heads — “a brand-new sense that people must learn how to use.” Greenberg admits: “There’s no doubt that it was very crude.”
Commercial failure
Second Sight was selling the Argus II for around 497,000. A positive outcome was far from certain: Linda Kirk stopped using her device a couple of years after a 2017 implant, finding it “more distracting than enabling.” Aries Arditi, a principal investigator for the Argus II clinical trial at Lighthouse International, says his research study showed “weakness” with the device’s vision quality; Second Sight wouldn’t let him publish or present the results.
On 18 July 2019, Second Sight sent patients a letter saying it would be phasing out the retinal implant technology to clear the way for the Orion brain implant. The letter promised continued support, but an ex-engineer told Spectrum: “We didn’t really support the basic Argus after that. We didn’t sell any more, we didn’t make any more, we didn’t have anything to do with it anymore.”
In February 2020, the senior director of implant R&D left, swiftly followed by its CEO. On 30 March, Second Sight laid off the majority of its remaining employees and announced its “intention to wind down operations,” citing COVID-19’s impact on financing. Within weeks, physical assets went up for auction. Second Sight didn’t inform any of its patients of the company’s collapse. “No letter, email, or telephone call,” Doerr wrote on Facebook. “Those of us with this implant are figuratively and literally in the dark.”
Jeroen Perk (Netherlands, Argus II implanted 2013, youngest recipient at 36) was using the system for up to 9 hours a day when his VPU fell from his belt and shattered. He had no vision, no Argus, and no support. He crowd-sourced spare parts from the Argus II community in Europe and got a refurbished system working by February 2021. “It is a pity that the Argus is not going any further,” he says. “But I’m a lucky bastard. I never have any regrets about doing this.”
Safety data
Second Sight conducted an FDA-mandated postapproval study, following 30 patients from 2007 to 2019: 36 serious and 152 nonserious “adverse events” were observed. Spectrum analyzed all 90 MAUDE reports for the Argus II (2014–2020): nearly 80% reported a surgical intervention, including hemorrhages, low eye pressure, and in ~15% of cases, detached retinas. Data from 2017 (published 2020) showed that 83% of 244 postapproval patients had experienced no serious events after two years.
Orion brain implant and aftermath
The Orion brain implant (also 60-electrode) had begun a clinical trial with six patients in 2018, funded by NIH as a $6.4 million project over five years. Benjamin Spencer, one of the six Orion patients, was initially delighted — “Here’s my wife — I’ve never seen [her] other than in my dreams” — but when Second Sight collapsed, “there was a lot of anxiety among some patients that they were going to be left high and dry.” One of the six chose to have the device removed in order to safely have an MRI scan.
After Spectrum contacted Second Sight, the company sent letters to Argus clinicians and users stating “we will do our best to provide virtual support” and that it has a limited supply of VPUs and glasses for replacements. No repairs or replacements are possible, however, if the implant itself fails.
In June 2021, Second Sight raised 5 per share, promising to focus on the Orion trial. Its stock price plunged to ~$1.50. In February 2022, the company announced a proposed merger with Nano Precision Medical (NPM). NPM CEO Adam Mendelsohn told Spectrum he doesn’t yet know what contractual obligations the combined company will have to Argus and Orion patients, but NPM will try to do what’s “right from an ethical perspective.” The past, he said, is “simply not relevant to the new future.”
Broader context
Not all companies will succeed, and Second Sight provides a cautionary tale for bold entrepreneurs interested in brain tech. What happens when cutting-edge implants fail, or simply fade away like yesterday’s flip phones and Betamax? Even worse, what if the companies behind them go bust?
Paris-based Pixium Vision is conducting European and U.S. feasibility trials with its Prima system for AMD — a much more common condition than RP. Daniel Palanker (Stanford), who licensed the technology to Pixium, says the Prima implant is smaller, simpler, and cheaper than the Argus II. “If you provide excellent vision, there will be lots of patients. If you provide crappy vision, there will be very few.”
Some clinicians are trying to salvage what they can. Gislin Dagnelie (Johns Hopkins) has set up a network of clinicians still working with Argus II patients, experimenting with thermal cameras, stereo cameras, and AI-powered object recognition.
Abandoning the Argus II technology — and the people who use it — might have made short-term financial sense for Second Sight, but it’s a decision that could come back to bite the merged company if it does commercialize a brain implant. As Doerr says: “Who’s going to swallow their marketing for the Orion?”
Authors: Eliza Strickland (IEEE Spectrum features editor; AI and biomedical engineering; MS journalism, Columbia) and Mark Harris (investigative science/technology reporter, Seattle).
Article updated: 17 February 2022.