U.S. Approves First Device to Treat Depression with Brain Stimulation at Home

US approves first device to treat depression with at-home brain stimulation

By Claire Cameron edited by Tanya Lewis

For the first time, this week the U.S. Food and Drug Administration approved a brain stimulation device designed to treat depression at home. The approval of the first device of its kind for the treatment of depression at home expands treatment options for depression beyond medication.

Made by Flow Neuroscience, the device is worn like a headset that delivers electrical current to a part of the brain called the dorsolateral prefrontal cortex, known to be involved in mood disorders and depression. The technique, known as transcranial direct current stimulation (tDCS), has its skeptics. A 2023 essay published in the Lancet found that tDCS was no better than a placebo for treating depression, while other research, including trials funded by Flow Neuroscience, showed some benefit.

Key to FDA approval was a Phase 2 trial conducted in 2024 in 174 people. Participants who wore the headset for 30-minute sessions over 10 weeks reported experiencing significant relief from their depression symptoms compared to controls who did not use the headset. In a document summarizing the data supporting its decision, the FDA said the helmet’s benefits, “although modest, are sufficient to outweigh its likely risk.” The agency highlighted headaches and skin irritation among possible risks of the device.

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“The FDA’s approval of Flow is a watershed moment for the treatment of depression: the first step toward moving from pharmaceutical treatments to technological therapies with minimal side effects,” said Erin Lee, CEO of Flow Neuroscience, in a recent statement.

FDA approval will make the headset available by prescription to treat moderate to severe major depressive disorder in adults. The company is negotiating with health insurers about possible coverage for the device, which will likely cost between $500 and $800, according to Reuters.

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