Hinge Health Launches Migraine Program Built Around FDA-Cleared Enso Device
The app-controlled nerve stimulator was cleared on April 16 for over-the-counter acute and preventive treatment of migraine, based on bench testing and comparison with Cefaly.
The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.
Key points
- Hinge Health introduced a Migraine Care Program combining its Enso nerve stimulation wearable, AI-powered trigger tracking and exercise therapy, with rollout planned for May 2026.
- FDA records show Enso for Migraine (K254216) was cleared on April 16 for adults diagnosed with migraine by a physician, for acute and preventive treatment, over the counter.
- No clinical study was run for the clearance; the 510(k) summary relies on bench and human factors testing and published literature on the predicate, Cefaly Connected - OTC.
Hinge Health on April 29 introduced a Migraine Care Program built around its Enso wearable nerve stimulator, which the U.S. Food and Drug Administration cleared for migraine earlier this month, according to the company's press release.
The San Francisco company said it is drawing on its experience in musculoskeletal care, nerve stimulation and exercise therapy. The program pairs Enso with AI-powered insights to help members identify migraine triggers, and with exercise therapy and lifestyle guidance led by care teams, the company said. Hinge Health said more than 125 clients covering more than two million people have adopted the program, which will roll out in May 2026.
"The FDA recently cleared our proprietary Enso device for the treatment of migraine, enabling us to deliver a first-of-its-kind care solution that combines groundbreaking technology with a full care team," said Jeffrey Krauss, Hinge Health's chief medical officer.
What the FDA cleared
The FDA's 510(k) database lists Enso for Migraine (K254216) as substantially equivalent, with a decision date of April 16, 2026, after the submission was received on December 29, 2025. It is classified as a transcutaneous electrical nerve stimulator for migraine, product code PCC, under regulation 882.5891.
According to the indications for use in the agency's clearance documents, the device is indicated for patients 18 and older for acute treatment of migraine with or without aura and for preventive treatment of migraine, and is for patients diagnosed with migraine by a physician. The 510(k) summary describes it as an over-the-counter device.
The summary describes Enso for Migraine as a wearable, app-controlled system that stimulates nerves in the head through transcutaneous electrical nerve stimulation (TENS). The Enso unit attaches by magnets to a gel pad on the skin and is controlled through the Hinge Health mobile app, which runs treatment sessions and sets treatment settings.
How clearance was supported
Hinge Health named Cefaly Connected - OTC (K234029) as the predicate device. The summary lists differences including a smaller, lighter stimulator, reliance mainly on the app rather than an on-device button, a larger gel pad with lower maximum current density, and an asymmetrical biphasic waveform. The company said none of these raise new questions of safety or effectiveness.
"Clinical performance testing was not conducted for the subject device," the summary states. Instead, the company relied on bench testing of waveform, current density and gel pad performance, a human factors study to support over-the-counter use, and published clinical literature on the predicate device.
The release did not disclose pricing for the migraine program.
Sources
- Hinge Health launches comprehensive Migraine Care Program, Hinge Health, April 29, 2026
- 510(k) Premarket Notification K254216: Enso for Migraine, FDA, April 16, 2026
- K254216 clearance letter, indications for use and 510(k) summary, FDA, April 16, 2026