The U.S. Food and Drug Administration (FDA) has authorized the marketing of a new prescription-only daytime device that may revolutionize the way we treat sleep apnea and snoring. The device is used while awake to improve tongue muscle function, which can help prevent the tongue from collapsing backwards and obstructing the airway during sleep.
The device is called eXciteOSA and is made by Signifier Medical Technologies.
“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 in a statement 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.
Obstructive sleep apnea (OSA) is a common disorder with potentially serious long-term effects such as heart attack, glaucoma, diabetes, cancer, and cognitive and behavioral disorders. The eXciteOSA device delivers electrical muscle stimulation during the day through a mouthpiece that sits around the tongue.
The FDA assessed the device in 115 patients with snoring, including 48 with snoring and mild sleep apnea. They found that the percent of time spent snoring at levels louder than 40dB was reduced by more than 20% in 87 out of the 115 patients that used the device as prescribed.
They also found a decreased rate of Apnea-Hypopnea Index, the index used to measure the number of apneas (pauses in breathing) plus the number of hypopneas (periods of shallow breathing) that occur each hour. The average AHI was reduced by 48%, from 10.21 to 5.27, in 41 out of 48 patients with OSA.
"We are thrilled that this groundbreaking treatment will soon be available in the U.S., offering an entirely unique, simple, and comfortable solution that has the potential to improve the lives of millions of people,” said in a statement Akhil Tripathi, CEO, and co-founder of Signifier Medical Technologies.