Sleep Apnea – FDA Approval

Angie Szumlinski Featured, Studies

The U.S. Food and Drug Administration authorized marketing 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 backward and obstructing the airway during sleep.

“Obstructive sleep apnea not only impacts sleep quality but can have other serious health impacts if untreated. This 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.

The FDA assessed the safety and effectiveness of the eXciteOSA device in 115 patients with snoring, including 48 patients with snoring and mild sleep apnea. All patients used the device for 20 minutes, once a day for 6 weeks, then discontinued use for 2 weeks before they were reassessed. Overall, the percent of time spent snoring was reduced. The most common adverse events observed were excessive salivation, metallic taste, gagging, and tight jaw.

If you or someone you care about has a diagnosis of sleep apnea or “snores”, this might be something to check out! Remember, sleep is vitally important to our overall health and if something as simple as wearing a device for 20 minutes a day can improve our sleep (or those we sleep with!) it might be worth checking out! Stay the course, stay well, mask up, get vaccinated, and stay tuned!