FDA Authorizes Marketing of New Device for Snoring, Mild OSA
The US Food and Drug Administration (FDA) has authorized marketing of the eXciteOSA device—a new device geared toward decreasing snoring and mild obstructive sleep apnea (OSA) among individuals aged 18 years or older.
Many devices for OSA are used while patients sleep. However, the new device is used while patients are awake to help improve muscle function in the tongue and to eventually help prevent the tongue from collapsing as the patient sleeps, which leads to obstruction of the airway.
“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, in a press release.
Excessive salivation, tingling in the tongue, discomfort in the tongue or teeth, sensitivity in dental fillings, metallic taste, jaw tightness, and gagging were the most common adverse events associated with use of the eXciteOSA device.
FDA authorizes marketing of novel device to reduce snoring and mild obstructive sleep apnea in patients 18 years and older. News release. US Food and Drug Administration. February 5, 2021. Accessed February 8, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-novel-device-reduce-snoring-and-mild-obstructive-sleep-apnea-patients-18