In a first, 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 such device for home depression treatment expands therapeutic options for depression beyond drugs.
Made by Flow Neuroscience, the device is worn as a headset that delivers electric current to a part of the brain called the dorsolateral prefrontal cortex, which is known to be implicated in mood disorders and depression. The technique, known as transcranial direct current stimulation (tDCS), has its skeptics. A 2023 trial published in the Lancet found tDCS to be no better than a placebo for treating depression, while other investigations, including trials funded by Flow Neuroscience, have shown some benefit.
The technique is “conceptually promising,” says Robert Reinhart, an associate professor at Boston University, who was not involved in the Flow Neuroscience study. But, he adds, “tDCS has been studied for more than two decades, and the evidence base is mixed.”
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Key to the FDA approval was a 2024 phase 2 trial involving 174 people. Participants who wore the headset for 30-minute sessions over 10 weeks reported experiencing significant relief from their depression symptoms compared with controls who did not use the headset. In a document summarizing the data backing its decision, the FDA said that the headset’s benefit, “while modest, is sufficient to outweigh its probable risk.” The agency pointed to headaches and skin irritation as among the possible risks of the device.
Reinhart points out that the device expands nondrug options, especially for patients who haven’t responded well to depression medication. “It expands the therapeutic landscape in a space that sorely needs more accessible interventions," he says, but he caveats, more work is needed to establish tDCS’s long-term efficacy. “It’s not a panacea, but it’s a meaningful expansion of the tool kit.”
“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 Erin Lee, Flow Neuroscience’s CEO, in a recent statement.
The FDA’s approval will make the headset available by prescription to treat moderate to severe major depressive disorder in adults. The company is negotiating with health insurance providers over possible coverage for the device, which is likely to cost between $500 and $800, according to Reuters.
Editor’s Note (12/12/25): This story was updated to add comments from Robert Reinhart.
