The age of brain-computer interfaces is upon us

Synchron makes noticeable progress. In August 2020, the company received an investigational drug exemption from the FDA, making it the first company to conduct clinical trials with a permanently implanted BCI. It took five years and “a tremendous amount of work,” Oxley says, to get to that point. A study in Australia followed four patients who had been implanted with the device for 12 months and suggested that such prolonged use of the device was safe.

The company is now moving on to the safety and feasibility part of its testing – to see if the procedure can be performed on multiple patients without serious side effects. The studies also aim to determine how scalable the implant is – whether it could be implanted in anyone’s brain. Synchron plans to implant the device in 15 patients before the end of 2022.

The next phase will be a pivotal trial in which Synchron must demonstrate that the technology is vastly improving aspects of its users’ lives. The patients themselves are interviewed to find out what they hope to achieve or regain with the implant. Assuming the study goes according to plan, the company will seek FDA approval and will advocate for the device to be made available under Medicare, the government’s health insurance program. Getting through Medicare is an important step in making the device available to as many people as possible, Oxley says. He’s vague about the implant’s price, saying it will cost “on the order of the cost of a car” (although he declined to say what kind of car it was).

But as technology advances into the commercial arena comes a range of ethical, legal and social risks. The key ingredient of the device is neural data, which also happens to be a highly sensitive bounty. Questions naturally arise: how long should this data be stored, what should it be used for outside of the immediate application of the device, who owns the data, and who can do with it as they please?

“If these are private companies with commercial interests in the data, is there any risk in monopolizing them in one hand?” says Jennifer Chandler, a law professor at the University of Ottawa who explores the intersection of brain science, law and ethics examined. The question arises, what happens when the company runs out of money and goes under – can patients keep the device? And if they want it removed, would the company pay to have it removed? But the various ethical landmines shouldn’t stop the technology from moving forward, says Chandler. “My approach would be: be aware of the nature of risks, pitfalls and challenges and address them early and prepare while also pursuing the benefits of them.”

Increasing competition in the BCI space has positive and negative implications, says Ian Buckhart, who had a BCI implanted a few years after a spinal cord injury left him paralyzed from the chest down. Buckhart helps lead the BCI Pioneers Coalition, a collective of BCI users who share their experiences. The rush into the market has meant things are getting done faster, and big names like Elon Musk have brought attention to the field. On the other hand, “you want to make sure things are done right,” says Buckhart. “You have to have a little bit of good faith in these companies, that they’re doing things for the right reasons.”

A major concern within the disability community is that all the BCI hype will ultimately go nowhere. Another question on Buckhart’s mind is how long the device can safely remain in the body. Synchron’s device is permanently implanted, which Oxley says is critical to making it commercially viable — but it’s also a factor Buckhart believes may put some patients off.

Oxley dreams of a million implants a year, that’s how many stents and pacemakers are implanted each year. That goal is about 15 to 20 years away, he estimates. And he appreciates the discourse about technology, even if it annoys him. “I want the world to understand that this technology will help people,” he says. “There seems to be an issue around the possible negative aspects of this technology or where it might lead, but the reality is that people need this technology, and they need it now.”

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