FDA approves first home-use headset to treat depression in US

The headset uses transcranial direct current stimulation, where electrical energy is directed into the head from the outside. (Representative Image)

The US Food and Drug Administration approved Flow Neuroscience’s headset that uses electrical currents to treat depression at home, the first device of its kind cleared for sale in the country.

Called FL-100, it weighs less than a pair of over-the-ear headphones and the company said thursday it will be available in the second half of 2026. It’s been sold since 2020 in Europe, and customers can get it from Flow’s website for 459 euros ($537). Patients in the US will need a prescription, and the price will be roughly the same, Flow Chief Executive Officer Erin Lee said. It’s also available in a few other countries.

There’s mounting evidence about the effectiveness of electrical stimulation for depression, but its use in the US has been largely limited to experimental trials or clinics that require in-person treatment. Flow’s approval follows increased interest in brain stimulation in general, made popular by Elon Musk’s brain implant company Neuralink Corp. and others that are developing devices to treat paralysis, vision loss and mental illnesses.

“We really see this as a defining moment in the timeline of mental health treatment,” Lee said in an interview. The device could provide an alternative to psychiatric drugs that have unwanted side effects, she said.

The FDA approval is for major depressive disorder. Flow is planning more trials for bipolar disorder, traumatic brain injury, pain and addiction. It is developing a new version of the device that will also be able to detect brain activity, so stimulation could be customized, Lee said.

The headset uses transcranial direct current stimulation, where electrical energy is directed into the head from the outside. It has two pads that rest on the forehead to deliver the stimulation. Patients wear it a few times a week for 30 minutes each.

Flow gained approval with a study that showed patients who used the device experienced greater reduction in depressive symptoms than those who used a modified version that didn’t provide ongoing electrical stimulation. Both groups showed improvement, though those using the real device improved more, as early as four weeks after treatment began.

The FDA approved the device through its “premarket approval” process, the most stringent pathway for medical devices, Lee said. The agency had floated the idea of clearing it through a less strict procedure, but Flow chose the more challenging path to reassure the public about its safety and effectiveness, she said.

The device can be prescribed by primary care physicians or specialists, and Flow has been talking with telehealth groups whose clinicians could handle it, Lee said. The company is also talking with insurance companies about coverage. The headset is a one-time purchase for US patients, though replacement pads are needed, Lee said. There are no subscription or maintenance fees.

Flow has raised $22 million, and is in the middle of another funding round to support the US commercial launch, which should bring in about $30 million, Lee said. Khosla Ventures is the company’s largest investor, she said.