An electronic device worn during the daytime and proven to reduce snoring and sleep apnea at night has been approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
The device, which is the first of its kind to hit the market, is named "eXciteOSA" and was developed by the British medical technology company Signifier Medical Technologies Ltd (SMT).
FDA said its investigation shows eXciteOSA reduced loud snoring by 20% in 87 out of the 115 patients it assessed. Of these patients, who all snored, 48 also had mild sleep apnea.
The device doesn't have to be worn at night. SMT says eXciteOSA can be used at any time during the day, but recommends it be used before a user goes to sleep at night.
It calls eXciteOSA the world's first daytime therapy proven to strengthen weak tongue muscles known to be the cause of sleep apnea and snoring..
The company said the eXciteOSA device delivers small electric currents through a mouthpiece to a user's tongue. The electrical charges stimulate the tongue muscle and improve its tone.
The mouthpiece is used for 20 minutes once a day while the user is awake, for a period of 6 weeks, and once a week thereafter.
"The improved tone of the tongue muscle will help in keeping the breathing passage open during your sleep and reduce the vibration of the throat region," said SMT.
The device is the first of its kind cleared to treat sleep apnea and snoring by improving tongue muscle function by delivering electrical stimulation to the tongue.
The eXciteOSA mouthpiece has four electrodes: two located above the tongue and two located under the tongue. It provides electrical muscle stimulation in sessions that consist of a series of electrical pulses with rest periods in between.
The mouthpiece is connected to a control unit through a USB connector and port. It's placed onto the mouth above and below the tongue.
"Obstructive sleep apnea not only impacts sleep quality, but can have other serious health impacts if untreated," said Dr. Malvina Eydelman, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices at the FDA.
"Today's authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea."
The most common side effects observed with the device's use are excessive salivation, tongue or tooth discomfort, tongue-tingling, dental filling sensitivity, metallic taste, gagging, and tight jaw.
