The Food and Drug Administration on Friday approved a new device that can help prevent sleep apnea and snoring – and does not need to be used at night.
People who snore – and their partners – currently have very few options on the market to alleviate their suffering. And much of what is available involves uncomfortable mouth guards or noisy C-Pap machines.
The eXciteOSA device authorized on Friday is the first of its kind released to treat sleep apnea and snoring, improving the muscular function of the tongue by providing electrical stimulation to the tongue through a mouthpiece worn for 20 minutes a day. It helps to retrain the tongue to prevent it from falling back and blocking the airflow during sleep.
Obstructive sleep apnea is prevalent and occurs when the upper airways are blocked repeatedly during sleep, reducing or completely blocking the air flow. If left untreated, OSAS can lead to serious complications, such as glaucoma, heart attack, diabetes, cancer and cognitive and behavioral disorders.
“Obstructive sleep apnea does not only affect sleep quality, but can have other serious health impacts if left untreated. Today’s authorization offers a new option for the thousands of individuals who have snoring or mild sleep apnea” , said Malvina Eydelman, MD., Director of the Office of Ophthalmic, Anesthetic, Respiratory, Otorhinolaryngological and Dental Devices at the FDA’s Center for Devices and Radiological Health.
The eXciteOSA mouthpiece has four electrodes, two located above the tongue and two located below the tongue. It provides electrical muscle stimulation in sessions that consist 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 once a week thereafter.
The agency said the device reduced loud snoring by 20% in 87 of the 115 patients evaluated. Of these snoring patients, 48 also had mild sleep apnea.
The most common side effects observed were excessive salivation, discomfort in the tongue or tooth, tingling in the tongue, sensitivity of dental filling, metallic taste, choking and a tight jaw.
The FDA has granted marketing authorization to Signifier Medical Technologies.