Breakthrough Status

Vertigo Headband Gains Breakthrough Device Designation

June 29, 2021

Otolith Labs has received a Breakthrough Device designation from the FDA for its noninvasive Vestibular System Masking (nVSM) headband for treatment of vertigo.

The device, which applies localized mechanical stimulation to the inner ear, is in ongoing clinical trials. In one study, 87.5 percent of the 40 participants reported a reduction in their vertigo within five minutes of turning on the device.

The headband is primarily intended for treatment of chronic vertigo in patients who have limited treatment options.

Billionaire Mark Cuban is an investor in Otolith Labs, which is based in Washington, D.C.

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