The U.S. Food and Drug Administration on Friday approved a new device that could help prevent sleep apnea and snoring, and should not be taken at night.
Snoring people and their partners currently have very few options on the market to alleviate their suffering. And much of what’s available includes awkward mouth guards or noisy C-Pap machines.
The authorized eXciteOSA device on Friday is the first of its kind authorized to treat sleep apnea and snoring by improving the muscular function of the tongue by electrical stimulation to the tongue through a mouthpiece that is worn for 20 minutes. per day. It helps to re-train the tongue to prevent it from collapsing backwards and blocking the flow of air during sleep.
Obstructive sleep apnea is common and occurs when the upper airway is repeatedly blocked during sleep, reducing or completely blocking airflow. If left untreated, OSA can lead to serious complications such as glaucoma, heart attack, diabetes, cancer, and cognitive and behavioral disorders.
“Obstructive sleep apnea not only affects sleep quality, but can have other serious health impacts if left untreated. Today’s clearance offers a new option for thousands of people who experience snoring or apnea mild sleep, ”said Malvina Eydelman, MD, director of the Office of Ophthalmic, Anesthetic, Respiratory, ENT, and Dental Equipment at the FDA’s Center for Radiological Devices and Health.
The eXciteOSA nozzle has four electrodes, two located on the tongue and two located below the tongue. It provides electrical muscle stimulation in sessions consisting of a series of electrical pulses with rest periods in between. It is used for 20 minutes once a day while awake, for a period of 6 weeks and once a week thereafter.
The agency said the device reduced loud snoring by 20% in 87 of the 115 patients it evaluated. Of these patients, who all snored, 48 also had mild sleep apnea.
The most common side effects observed were excessive salivation, discomfort in the tongue or teeth, tingling of the tongue, sensitivity to tooth filling, metallic taste, gagging, and sealed jaw.
The FDA granted marketing authorization to Signifier Medical Technologies.