A trial of 174 people found the device led to greater drops in depression<\/p>\n<\/h3>\n
By I. Edwards HealthDay Reporter<\/b>
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FRIDAY, Dec. 12, 2025 (HealthDay News) \u2014 An at-home device that sends a gentle electrical current to the brain to help treat depression<\/a> has been cleared by the U.S. Food and Drug Administration (FDA).<\/p>\n Experts say the move could expand access to care for many people.<\/p>\n The prescription headset, made by Sweden-based Flow Neuroscience<\/a>, delivers low-level electrical stimulation to a part of the brain involved in mood and stress control. Similar treatments are already used in clinics, but Flow\u2019s device is among the first cleared for home use under the FDA.<\/p>\n \u201cWe\u2019re really about the democratization of access,\u201d said Flow CEO Erin Lee<\/a>, noting that many people cannot reach or afford in-office procedures like transcranial magnetic stimulation. \u201cWe can put it in any home in the United States.\u201d<\/p>\n The device can be used alone or along with antidepressant medications. Flow expects the headset to be available in the U.S. by mid-2026 for about $500.<\/p>\n The company says it\u2019s already talking with insurers and hopes coverage could begin by the end of next year.<\/p>\n Flow\u2019s approach uses transcranial direct current stimulation, a method scientists have studied for years with mixed results. Some trials have shown clear benefits, while others found little difference compared with a placebo.<\/p>\n A key clinical trial with 174 participants, recently published in the journal Nature Medicine<\/a><\/em>, helped win FDA approval.<\/p>\n Adults used the headset for 30 minutes at a time over 10 weeks. The study found that patients using the device had greater relief from depression symptoms than those using a sham version.<\/p>\n By one measure, about 58% of people receiving the stimulation reached remission. Reported side effects included mild skin redness and itching, but the study found no serious safety concerns.<\/p>\n Dr. Daniel Blumberger<\/a> \u2014 a senior scientist at Canada\u2019s largest mental-health teaching hospital, the Center for Addiction and Mental Health \u2014 reacted to the FDA approval in an interview with The Washington Post<\/em>. He noted that Flow’s data is stronger than that previously seen with some other home stimulation devices.<\/p>\n \u201cThis opens up a new era of treatment for depression,\u201d Blumberger said.<\/em><\/p>\n The FDA, meanwhile, pointed out that the research has limitations. For example, experts don\u2019t always agree on how much improvement on depression rating scales counts as a meaningful change.<\/p>\n But the agency said the device showed enough benefit, even if it was “modest,” to outweigh possible risks.<\/p>\n Flow\u2019s headset is cleared for adults 18 and older who do not have treatment-resistant depression. The rechargeable device is expected to last about three years and pairs with a smartphone app for treatment sessions.<\/p>\n Flow said it has already sold 55,000 devices in Europe, where it has been available since 2019, and has recently launched in Australia.<\/p>\n More information<\/strong><\/p>\n The Mayo Clinic has more on depression<\/a>.<\/p>\n