Hinge Health Receives FDA 510(k) Clearance for Enso for Migraine TENS Device
Summary
Hinge Health received FDA 510(k) clearance for its Enso for Migraine device, an over-the-counter transcutaneous electrical nerve stimulator for the acute and preventative treatment of migraine in adults 18 and older. The wearable, app-controlled system delivers TENS therapy via a forehead-mounted device with reusable hydrogel pads. The clearance was granted through substantial equivalence to the Cefaly Connected predicate device.
Why it matters
This FDA clearance expands the addressable market for Hinge Health into the large and underserved migraine population, where more than 20 million U.S. adults experience migraine episodes. As an OTC device, Enso for Migraine can be accessed without prescription, potentially improving adherence and reducing barriers to effective non-pharmacological migraine treatment.
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