The US Food and Drug Administration approved a new device on Friday that could help prevent sleep apnea and snoring – and should not be worn at night.
Snoring people – and their partners – currently have very few options on the market to alleviate their suffering. And much of what is available involves awkward mouthpieces or noisy C-Pap devices.
The eXciteOSA device approved on Friday is the first of its kind authorized to treat sleep apnea and snoring by improving the function of the tongue muscles by delivering electrical stimulation of the tongue through a mouthpiece worn for 20 minutes a day. It helps to requalify the tongue to prevent falling back and blocking the flow of air during sleep.
Obstructive sleep apnea is predominant and occurs when the upper respiratory tract is repeatedly blocked during sleep, reducing or completely blocking airflow. 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 the quality of sleep, but can also have other serious health effects if left untreated. Today’s clearance offers a new option for thousands of people suffering from snoring or mild sleep apnea,” he said. Malvina Eydelman, MD, director of the FDA’s Office of Ophthalmic, Anesthetic, Respiratory, ENT, and Dental Devices for Radiological Health and Devices.
The eXciteOSA mouthpiece has four electrodes, two above the tongue and two below the tongue. Provides electrical muscle stimulation in sessions that consist of a series of electrical impulses with rest periods between them. It is used for 20 minutes once a day while you are awake, for a period of 6 weeks and once a week thereafter.
The agency said the device reduced heavy snoring by 20% in 87 of the 115 patients it evaluated. Of those patients, all snoring, 48 also had mild sleep apnea.
The most common side effects observed were excessive salivation, discomfort of the tongue or teeth, tingling of the tongue, sensitivity of the tooth filling, metallic taste, gagging and tight jaw.
The FDA has granted marketing authorization to Signifier Medical Technologies.