FDA Gives Market Clearance for Muscle Stimulator to Reduce Snoring and Mild Obstructive Sleep Apnea 

 The Food and Drug Administration (FDA) authorized a prescription-only device (eXciteOSA; Signifier Medical Technologies, Silver Spring, MD) to reduce snoring and mild obstructive sleep apnea. The device is used when the individuals is awake to improve tongue muscle function.

FDA approval was based on a study (NCT___) of safety and effectiveness of the eXciteOSA device in 115 patients with snoring, including 48 patients with snoring and mild sleep apnea. Participants used the device for 6 weeks, 20 minutes daily. Participants were assessed 2 weeks after discontinuing use. Of the 115 participants, 75% reduced time snoring louder than 40 dB by 20%. In a subset of participants with obstructive sleep apnea (OSA) and snoring, 85% had an average reduction in Apnea Hypopnea Index (AHI) score of almost half (10.21 to 5.27 points). 

"OSA 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 device works by delivering electric muscle stimulation through a mouthpiece that sits around the tongue. The dental device has 4 electrodes, 2 located above the tongue, and 2 located below the tongue. The device provides electric muscle stimulation action in sessions that consist of a series of electrical pulses with rest periods in between. It is used for 20 minutes once a day during a wakeful state, for a period of 6 weeks, and once a week thereafter.

Individuals with pacemakers or implanted pacing leads, temporary or permanent implants, dental braces, intraoral metal appliances or dental jewelry, and those who are pregnant or may be pregnant; or patients suffering from ulcerations in or around the mouth should not use the device. Observed common adverse events included dental filling sensitivity, excessive salivation, gagging, metallic taste, tight jaw, tongue discomfort or tingling, and tooth discomfort.