FDA approves Flow's headset as the first at-home brain stimulation treatment for depression
The FL-100 tDCS headset can be prescribed for moderate to severe major depression, alone or alongside medication, with US launch expected in 2026.
The FDA has approved Flow Neuroscience’s FL-100 headset, making it the first at-home brain stimulation device approved for depression in the United States. Doctors will be able to prescribe it for adults with moderate to severe major depressive disorder, either on its own or alongside medication. Flow expects the device to be available in the US in the second quarter of 2026.
How it works
The FL-100 uses transcranial direct current stimulation (tDCS): a weak, steady electrical current delivered through two pads on the forehead to the prefrontal cortex, a region often underactive in depression. Patients use it at home in short sessions, guided by an app, with clinicians monitoring remotely.
The evidence
Approval rested mainly on a randomized, sham-controlled trial published in Nature Medicine. 58% of people using the active device reached remission at 10 weeks, with remission and response rates two to three times higher than sham. Side effects were mostly mild: skin irritation, headache and stinging under the pads. The label notes that reusing pads can cause skin burns. The device is not indicated for treatment-resistant depression.
Flow’s headset has been sold in Europe, the UK and elsewhere for several years. The company reports data from more than 55,000 users.
Why it matters
Until now, US brain stimulation for depression meant clinic-based treatments such as TMS or implanted devices. A prescription device used at home could greatly widen access to non-drug treatment. It is also a milestone for consumer-style neurotech hardware meeting medical approval standards.
Learn more: tDCS · TMS · Flow Neuroscience in the Directory