In an increasingly lucrative market, dozens of companies and startups are selling futuristic-looking headgear that promise to connect to your brain to relieve stress, enhance memory, improve sleep or increase focus. But, but, but: Experts suggest these products make mostly unsubstantiated claims and in some cases can harm unwary buyers. "There's a bit of pulling the wool over people's eyes, trying to talk up these products in a way that isn't sincere and transparent," says Karola Kreitmair, a medical ethics expert at the University of Wisconsin. What's happening: There are two broad categories of wearable brain devices — those that record the user’s brain activity and others that stimulate the brain with electrical currents. These technologies are mainstays in research labs and hospitals — but now they're on Amazon and Kickstarter, too. None of the three — a small subset of the growing market — offers research showing that their specific devices do what they claim. None responded to requests for comment. The big picture: Many companies are imbuing products with an air of medical legitimacy without pointing to serious research. A common pattern: Companies say their products are based ontechnology that has been shown to be beneficial in some way — but provide no research on their products. Customers who buy an ineffective device could be in for more than a disappointing waste of money. The government has done little to police companies selling these devices straight to consumers. "This is a case where industry has run away with something because people are willing to pay money for it — but regulation and validation completely lags behind," Kreitmair, the University of Wisconsin professor, tells Axios. An FDA spokesperson said the agency doesn't discuss potential investigations, but that the agency has in the past increased scrutiny of certain devices "when necessary to protect patients.
The nascent but potentially lucrative wearable brain device sector needs greater regulation, as growing numbers of companies are selling devices without scientific that proof they both work and are not harmful, according to ethics experts. A study published in the journal Neuron found only eight out of 41 neurotechnology products aimed at the public—including children—included relevant peer-reviewed research, while 33 provided supporting research. Experts have called for researchers, industry experts and regulators to increase monitoring of such direct-to-consumer goods.