Marketing authorization issued for device to reduce snoring, mild obstructive sleep apnea
The FDA has authorized the marketing of eXciteOSA, a prescription device for the reduction of snoring and mild obstructive sleep apnea, according to a press release.
Intended to improve tongue muscle function as the first device to be used while awake, the eXciteOSA (Signifier Medical Technologies) delivers electrical muscle stimulation through a mouthpiece that sits around the tongue, the release said.
In an assessment of safety and effectiveness of the device, in 87 out of 115 patients, the percent of time spent snoring at levels louder than 40 dB was reduced by more than 20%. In a subset analysis of 48 patients with snoring and mild obstructive sleep apnea, the average Apnea-Hypopnea Index score was reduced by 48% in 41 patients.
“Obstructive sleep apnea not only impacts sleep quality, but can have other serious health impacts if untreated,” 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, said in the release. “Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea.”