FDA Clears Home Brain-Stimulation Device to Help Treat Depression

FRIDAY, Dec. 12, 2025 (HealthDay News) — An at-home device that sends a gentle electrical current to the brain to help treat depression has been cleared by the U.S. Food and Drug Administration (FDA).

Experts say the move could expand access to care for many folks.

The prescription headset, made by Sweden-based Flow Neuroscience, 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’s device is among the first cleared for home use under the FDA.

“We’re really about the democratization of access,” said Flow CEO Erin Lee, noting that many people cannot reach or afford in-office procedures like transcranial magnetic stimulation. “We can put it in any home in the United States.”

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.

The company says it’s already talking with insurers and hopes coverage could begin by the end of next year.

Flow’s 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.

A key clinical trial with 174 participants, recently published in the journal Nature Medicine, helped win FDA approval.

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.

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.

Dr. Daniel Blumberger — a senior scientist at Canada’s largest mental-health teaching hospital, the Center for Addiction and Mental Health — reacted to the FDA approval in an interview with The Washington Post. He noted that Flow's data is stronger than that previously seen with some other home stimulation devices.

“This opens up a new era of treatment for depression,” Blumberger said.

The FDA, meanwhile, pointed out that the research has limitations. For example, experts don’t always agree on how much improvement on depression rating scales counts as a meaningful change.

But the agency said the device showed enough benefit, even if it was "modest," to outweigh possible risks.

Flow’s 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.

Flow said it has already sold 55,000 devices in Europe, where it has been available since 2019, and has recently launched in Australia.

More information

The Mayo Clinic has more on depression.

SOURCE: The Washington Post, Dec. 11, 2025

What This Means For You

If you deal with depression and have trouble accessing treatments in an office setting, this home device may soon offer another option to discuss with your doctor.