The U.S. Food and Drug Administration has approved its first at-home, non-drug therapy for depression: a wearable brain stimulation headset developed by Flow Neuroscience.
The device, called FL-100, is cleared for use as both a standalone treatment and in combination with medication for adults with moderate to severe major depressive disorder. The prescription headset uses transcranial direct current stimulation to deliver a gentle electrical current to the brain’s prefrontal cortex, the region responsible for regulating mood and stress responses. Flow Neuroscience notes this area is often underactive in people with depression, which affects more than 20 million adults in the United States.
About one-third of these patients do not respond to antidepressants, and many discontinue medication due to side effects.
“Flow’s FDA approval is a watershed moment for the treatment of depression: the first step in moving from pharmaceutical treatments to tech-based therapies with minimal side effects,” said Flow CEO Erin Lee.
In a randomized, sham-controlled trial of 174 participants, published last year in Nature Medicine, the headset showed significant improvements on clinician-led depression scales and self-reported questionnaires after 10 weeks of at-home therapy. Participants wore the device for 30 minutes per session, beginning five times per week for the first three weeks, then three times per week for the remainder of the study. Sessions included remote supervision via video conferencing.
Researchers found the therapy effective in patients taking antidepressants for treatment-resistant depression, undergoing psychotherapy, or not taking any medication.
“Among our real-world users, 77% see improvements in as little as three weeks,” said Flow’s Chief Medical Officer Kultar Garcha, M.D. “Such treatment, previously confined to clinics, can now be delivered at home, offering a scalable way to expand access to effective depression care.”
Flow Neuroscience, based in Sweden, first launched the headset in the U.K. in 2019, priced around $500 and paired with a behavioral therapy app providing videos and guidance on sleep, nutrition, fitness, and meditation. The device has been used by more than 55,000 people across the EU, the U.K.’s National Health Service, Switzerland, and Hong Kong. It previously received a breakthrough designation from the FDA and regulatory approval in Australia.
“For more than six years, we’ve been building an evidence base globally through clinical trials, peer-reviewed research, and real-world case reports. The approval of FL-100 in the U.S. will now offer millions of patients an accessible and effective non-drug treatment option,” said Flow co-founder and Chief Scientific Officer Daniel Månsson.
Flow plans to make the headset commercially available in the U.S. in the second quarter of next year and is exploring its use for traumatic brain injury, addiction, and sleep disorders.
“We are committed to ensuring that Flow becomes part of a standard treatment pathway for depression care,” Lee added. “Our focus is on helping as many patients as possible achieve remission from depression.”
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