On Feb. 5, 2021, the FDA authorized marketing of a new prescription device, eXciteOSA (formerly Snoozeal), to reduce snoring and mild obstructive sleep apnea. It is the first device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep.
Manufactured by Signifier Medical Technologies, eXciteOSA is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue to reduce snoring and mild sleep apnea for patients who are 18 years of age or older. The eXciteOSA device is not intended for patients who have or are suspected of having moderate or severe sleep apnea with an apnea-hypopnea index of 15 or higher.
The device works by delivering electrical muscle stimulation through a mouthpiece that sits around the tongue. The eXciteOSA mouthpiece has four electrodes, two located above the tongue and two located below the tongue. The device provides electrical muscle stimulation action in sessions that consist of a series of electrical pulses with rest periods in between. It is used for 20 minutes once a day during a wakeful state, for a period of 6‐weeks, and once a week thereafter.
About Sleep Apnea
Nearly 30 million adults in the U.S. have obstructive sleep apnea, a chronic disease that involves the repeated collapse of the upper airway during sleep. Common warning signs include snoring and excessive daytime sleepiness. A common treatment is CPAP therapy, which uses mild levels of air pressure, provided through a mask, to keep the throat open during sleep. Other treatments include oral appliance therapy, positional therapy, and upper airway stimulation.
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Photo: U.S. Food and Drug Administration.