[ad_1]
The United States Food and Drug Administration (FDA) has cleared a new prescription device designed to reduce snoring and mild obstructive sleep apnea by improving tongue muscle function. It is approved for adults 18 years of age or older.
Authorization granted to Signifier Medical Technologies, LLC for the eXciteOSA device makes it the first of its kind to be used while awake.
It is a removable muscle stimulation of the tongue that produces neuromuscular stimulation in patients. Sitting around the tongue, the eXciteOSA mouthpiece uses four electrodes – 2 of which are located above the tongue and 2 below the tongue.
The device is intended to be used for 20 minutes once a day for 6 weeks, followed by once a week.
The authorization was based on data assessing the safety and efficacy of the device in 115 patients with snoring. Of the total, 48 also suffered from mild sleep apnea.
All patients used the device as intended and stopped it the following week 6. As a result, in 85 patients the time spent snoring at levels above 40 dB was reduced by more than 20%.
Among the snoring plus sleep apnea subpopulation, the mean apnea-hypopnea index (AHI) was reduced by 48%, from 10.21 to 5.27 in 41 patients.
“Obstructive sleep apnea not only has an impact on the quality of sleep, but can also have other serious health effects if left untreated,” said Malvina Eydelman, MD, director of the office of ophthalmic, anesthetic, respiratory, ENT, and dental devices at the FDA’s Center for Devices and Radiological Health in a statement. “Today’s clearance offers a new option for the thousands of people who suffer from snoring or mild sleep apnea.”
The most frequently reported adverse events were excessive salivation, discomfort in the tongue or teeth, tingling in the tongue, tingling of the teeth, sensitivity to tooth filling, a metallic taste, yawning and a tight jaw.
The device is contraindicated for patients with pacemakers or implanted stimulation leads; patients with temporary or permanent implants, braces, prostheses / restorations / intraoral metal applications or dental jewelry in the mouth; patients who are or intend to become pregnant; or patients with ulcers in or around the mouth.
It is also recommended that patients undergo a complete dental examination before using the device.
Source link
