US approves first device to treat depression at home. Here’s how it works

In the US, an estimated 20 million adults suffer from depression. They now have a reason to cheer. Soon, many of them will be able to treat themselves at home with the help of a new headset. The first-of-its-kind device got a nod from the US Food and Drug Administration (FDA) and is ready to be launched in the second quarter of 2026.

Made by Flow Neuroscience, a company that specialises in mental health innovation, FL-100 looks like a regular headset. It aims to offer an alternative to typical antidepressants that can cause side effects with long-term use, the company said on Thursday (December 12). 

Here is how the device for depression works.   

What we know about the headset   

FL-100 is a headset and a brain stimulation device that is designed to treat depression at home. It has two pads that rest on the forehead to deliver the stimulation. This prescription device uses transcranial direct current stimulation, where electrical energy is directed into the head from the outside. It is a technique that has been studied for years, but its effectiveness is debated.   

The device is a non-drug, at-home therapy considered as a stand-alone treatment for patients with moderate to severe depression, according to Medical Economics. Some medical experts have hailed it as a milestone for expanding mental health treatment beyond drugs.   

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Erin Lee, the CEO of Flow Neuroscience, said, “Flow’s FDA approval is a watershed moment for the treatment of depression.” 

Daniel Månsson, co-founder and chief scientific officer, noted that approval of FL-100 in the US will offer millions of patients an accessible and effective non-drug treatment option.

How does the device work?   

The headset delivers a gentle electrical current to a part of the brain called the dorsolateral prefrontal cortex, which regulates mood and stress. With two pads on the forehead, it counteracts moderate to severe depressive disorders in adults aged 18 and older.

While electric stimulation is widely used to treat depression, what makes this product different is that it aims to deliver a relatively low dose of the current at home instead of in a clinic, according to a report in The Washington Post.

Patients typically follow a 12-week course, starting with five sessions per week for three weeks, then tapering to two or three sessions weekly for the remaining nine weeks. Each session lasts 30 minutes, reports Reuters.

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Has the device given results in clinical trials?

The approval of the FDA was based on a clinical trial with 174 participants. 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, according to a report in Scientific American. 

The result of that experiment, published in Nature Medicine in 2024, showed a reduction in depression scores, and patients experienced immense relief. About 58 per cent of patients who received the stimulation were in remission, according to the Washington Post. 

The side effects of the experiment were temporary and mild, including skin irritation and headache; however, there were no serious reactions. Flow said that skin burns have occurred when the device’s pads were reused or dried out. 

The FDA asserted that the headset’s benefit, “while modest, is sufficient to outweigh its probable risk.” It also pointed to the skin itching and headaches as among the possible risks or side effects of the device. During the evaluation, it cited some limitations, such as a lack of consensus. 

The FDA has previously cleared other devices that treat depression with electrical stimulation, but in 2019 finalised a new rule that sets a higher bar, as per the report. CEO Lee said. “Flow’s was the first electrical stimulation device to win clearance through this process.”

The device has been available for sale in other parts of the world. It has been used by over 55,000 people in Europe, the UK, Switzerland and Hong Kong, Flow said. 

How much will this device cost in the US? 

Lee told Reuters that “The price is still being finalised; however, the headset is expected to cost between $500 and $800.” The company is negotiating with insurance payers and expects to announce coverage partnerships in early 2026, she added.   

Lee added that there are no subscription or maintenance fees. It’s a one-time purchase for US patients and will be available in the country by the middle of 2026. 

How common is depression in the US? 

According to the Centres for Disease Control and Prevention, depression rates in the US have surged 60  per cent over the past decade, affecting more than 20 million adults.   

A report by the National Health Interview Survey (NHIS) says that more than one in 10 US adults took prescription medication for depression in 2023. Women (15.3 per cent) are more than twice as likely to take medication for depression as men (7.4 per cent). 

With inputs from agencies