The FDA announced today that it authorized the marketing of a device for reducing snoring and mild obstructive sleep apnea.
The prescription-only device is used while awake to improve tongue muscle function, which can help prevent the tongue from collapsing backward and obstructing the airway during sleep. It is the first device of this kind used while awake, according to a news release.
Signifier Medical Technologies‘ ExciteOSA device delivers electrical muscle stimulation through a mouthpiece sitting around the tongue. The mouthpiece consists of four electrodes, two above and below the tongue, each. The device’s sessions consist of a series of electrical pulses with rest periods in between, as it is used for 20 minutes once per day during a wakeful state over a six-week period. Then, it is used once per week thereafter.
The FDA observed the ExciteOSA device in 115 patients with snoring, including 48 with snoring and mild sleep apnea. All patients used the device for 20 minutes once per day for six weeks before discontinuing use for two weeks before being reassessed.
Overall, the percent of time spent snoring at levels louder than 40dB was reduced by more than 20% in 87 out of 115 patients, while levels of the Apnea-Hypopnea Index (AHI) in those with sleep apnea were reduced by 48% in 41 out of 48 patients. The most common adverse events observed were excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging and tight jaw.
“Obstructive sleep apnea not only impacts sleep quality, but can have other serious health impacts if untreated. Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” FDA director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Dr. Malvina Eydelman said in the release.