FDA Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive Sleep Apnea in Patients 18 Years and Older

Today, the U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild obstructive sleep apnea. Unlike devices used while patients sleep, this 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.

“Obstructive sleep apnea not only impacts sleep quality, but can have other serious health impacts if untreated. Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” said Malvina Eydelman, MD., director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health.

Obstructive sleep apnea (OSA) is prevalent sleep-disordered breathing with potentially serious long-term effects. It can occur when the upper airway becomes blocked repeatedly during sleep, reducing or completely stopping airflow. Untreated OSA can lead to serious complications such as heart attack, glaucoma, diabetes, cancer, and cognitive and behavioral disorders. OSA is categorized by the number of apneas (pauses in breathing) plus the number of hypopneas (periods of shallow breathing) that occur, on average, each hour. This number, called the Apnea-Hypopnea Index (AHI) measures the severity of OSA. Mild OSA is defined as an AHI score of more than five but less than 15. The device, the eXciteOSA, is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce snoring and mild sleep apnea for patients who are 18 years or older. See more folks thanks.

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