- The U.S. Food and Drug Administration approved marketing of a new device that could help patients suffering from obstructive sleep apnea.
- The device is the first device of its kind to be intended for use during the day, most devices are intended for use during sleep.
- FDA assessments found that the device reduced loud snoring by more than 20% in 87 out of 115 patients.
The U.S. Food and Drug Administration approved Friday a new device that could help prevent sleep apnea and snoring — and it doesn't need to be worn 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 Friday 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 through a mouthpiece worn for 20 minutes a day. It helps retrain the tongue to prevent it from collapsing backwards and blocking airflow during sleep.
Obstructive sleep apnea is prevalent and occurs when the upper airway becomes blocked repeatedly 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 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," 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 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. It is used for 20 minutes once a day while you're awake, for a period of 6 weeks, and once a week thereafter.
The agency said the device reduced loud snoring by more than 20% in 87 out of the 115 patients it assessed. Of those patients, who all snored, 48 also had mild sleep apnea.
The most common side effects include pooling of saliva, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging and tight jaw, according to Signifier Medical Technologies, which will market the device. The company noted that the side effects were transient and occurred only during the 20-minute therapy sessions.
Correction: This article was updated to reflect that a device reduces loud snoring by more than 20% of 87 out of 115 patients that the FDA assessed. The percentage was misstated in an earlier version of this article.