Synchron is making tangible progress. In August 2020, the company was granted an investigational device exemption from the FDA, allowing it to become the first company to conduct clinical trials of a permanently implanted BCI. To reach this point took five years and a “huge amount of work,” says Oxley. A trial 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 engaged in the safety and feasibility part of its testing—finding out if the procedure can be performed on multiple patients without serious side effects. The trials also aim to determine how scalable the implant is—whether it could be implanted into everybody’s brain. Synchron plans to implant the device into 15 patients before the end of 2022.
The next phase will be a pivotal trial, in which Synchron will have to show that the technology significantly improves aspects of its users’ lives. This will involve consulting the patients themselves to find out what they hope to gain or regain with the implant. Providing the trial goes to plan, the company will then apply for FDA approval and make a case for the device to be made available under Medicare, the government-provided health insurance program. Going through Medicare is a key step toward making the device as accessible to as many people as possible, Oxley says. He’s vague about the price of the implant, saying it will cost “in the order of magnitude of the cost of a car” (though he declined to say what kind of car).
But with the technology increasingly entering the commercial space comes a raft of ethical, legal, and social risks. The device’s key ingredient is neural data, which also happens to be a highly sensitive bounty. Questions naturally arise: How long should that data be stored, what should it be used for outside of the device’s immediate application, who owns the data, and who gets to do what they want with it?
“If this is private corporations with commercial interests in the data, is there anything kind of risky if it’s monopolized in one set of hands?” says Jennifer Chandler, a professor of law at the University of Ottawa who studies the intersection of the brain sciences, law, and ethics. There are questions around what happens if the company runs out of money and goes under—do patients get to keep the device? And if they want to get it taken out, would the company pay for removal? But the various ethical landmines shouldn’t prohibit the technology moving ahead, Chandler says. “My take would be: Be aware of the kinds of risks, pitfalls, challenges and address them early on and prepare, while pursuing the benefits of this as well.”
The mounting competitiveness in the BCI space yields positive and negative effects, says Ian Burkhart, who was implanted with a BCI a few years after a spinal cord injury left him paralyzed from the chest down. Burkhart helps lead the BCI Pioneers Coalition, a collective of BCI users who share their experiences. The rush to market has meant things are getting done faster, and big names like Elon Musk have drawn attention to the field. On the flipside, “you want to make sure that things are being done the right way,” says Burkhart. “You have to have a little bit of good faith in these companies that they’re doing things for the right reasons.”
A big worry within the disabled community is that all the BCI hype will ultimately lead nowhere. Another question on Burkhart’s mind is how long the device can last safely in the body. Synchron’s device is permanently implanted, which Oxley says is crucial to making it commercially viable—but it’s also a factor that Burkhart thinks may put some patients off.
Oxley dreams of a million implants a year, which is how many stents and cardiac pacemakers are implanted annually. That goal is about 15 to 20 years away, he figures. And he appreciates the discourse surrounding the technology, even if it does irk him. “What I want the world to understand is that this technology is going to help people,” he says. “There seems to be a theme around the possible negative aspects of this technology or where it might go, but the reality is that people need this technology, and they need it now.”
Updated 8-1-2022 12:30 pm ET: A previous version of this piece misspelled Ian Burkhart’s name.
Image and article originally from www.wired.com. Read the original article here.