Brain-Zapping Wearable Device Hits Market without FDA Clearance

Thync, a startup with roots in Boston and Silicon Valley, has managed to bring a device that delivers electricity to the brain to the U.S. market after the FDA exempted it from needing regulatory approval.

The transcranial direct current stimulation device from Thync (Los Gatos, CA) is said to alter a user’s mood—to make them feel either calmer or more alert—within minutes. The company is now launching a Google ad campaign promoting it as an alternative to caffeine.

In fact, the latter point is one of its initial strategies—a wearable to provide an alternative to mood-altering beverages ranging from coffee to Red Bull to alcohol.

While the technology’s promise to electrically alter user’s mood has raised eyebrows of skeptics, Thync has raised considerable funding from investors like Khosla Ventures. Last year, the company announced that it had raised $13 million in funding and was still awaiting from FDA on whether the device would be regulated as a medical device or a consumer product.

The triangular-shaped device, which is on sale for $299, is affixed to the head above the right eyebrow and the neck using an adhesive patch. An accompanying app, known as Thync vibes, allows a user to select the type of stimulation they want and fine-tune the amount of electricity being delivered to the brain. The head-mounted portion of the device communicates to smartphones using Bluetooth.

A review of the technology last year reports that the technology, when cranked to its maximum setting, makes a user feel like “ants are on the inside of your skin and dancing a wild myrmecoid folk dance.” After wearing it in the energy mode for 20 minutes, Quartz reviewer Jeff Yang concluded: “The difference, I must admit, is palpable: Everything seems more finely etched, crisper.”

The app comes preloaded with mental routines dubbed “vibes” that range in duration from 5–15 minutes.

The company was founded in 2011 by researchers with backgrounds in fields ranging from neuroscience to consumer electronics hailing from prestigious universities such as MIT, Harvard, and Stanford.

The company’s so-called “chief of vibes,” Sumon Pal met its chief scientifice officer, William “Jamie” Tyler while the two were post doc researchers at Harvard.

Its CE is Isy Goldwasser, who was previously the CEO of Symyx Technologies (Santa Clara, CA) and an entrepreneur-in-residence at Khosla Ventures.

While the current product only delivers el