The U.S. Food and Drug Administration on Friday approved a new device that can help prevent sleep apnea and snoring – and it doesn’t have to be worn at night.
People who snore – and their partners – currently have very few options on the market to relieve their suffering. And much of what is available involves uncomfortable mouthguards or noisy C-Pap machines.
The eXciteOSA device approved Friday is the first of its kind released to treat sleep apnea and snoring by improving tongue muscle function by delivering electrical stimulation to the tongue through a mouthpiece worn for 20 minutes a day. It helps retrain the tongue to keep it from flipping back and blocking airflow during sleep.
Obstructive sleep apnea is common and occurs when the upper airway becomes repeatedly blocked during sleep, reducing or completely blocking air flow. 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 also have other serious health effects if left untreated. The current approval offers a new option for the thousands of people 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 eXciteOSA mouthpiece has four electrodes, two above the tongue and two 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 you are awake for a period of 6 weeks and then once a week thereafter.
The agency said the device reduced loud snoring by 20% in 87 of the 115 patients it assessed. Of those patients, who all snored, 48 also had mild sleep apnea.
The most common side effects were excessive salivation, discomfort of the tongue or teeth, tingling in the tongue, sensitivity to dental fillings, metallic taste, retching and tight jaw.
The FDA has granted marketing authorization to Signifier Medical Technologies.