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On February 6, the FDA announced that it had approved the launch of an innovative prescription medical device developed by Signal Medical Technologies to reduce snoring and mild obstructive sleep apnea.
is different from the device used when the patient sleeps, this is the first medical device used when the patient is awake, and it is designed to improve tongue muscle function and help prevent the tongue from collapsing back while sleeping, thus blocking the air passage.
obstructive sleep apnea is a common sleep apnea with potentially serious long-term effects.
the upper gas channel is repeatedly blocked during sleep, and the airflow decreases or stops completely.
untreated OSA can lead to serious complications such as heart attacks, glare, diabetes, cancer, and cognitive and behavioral disorders.
the eXciteOSA device, developed by Signifier, is a removable tongue muscle stimulation device that contains four electrodes, two above the tongue and two under the tongue.
in the mouth it releases a series of electrical impulses that stimulate the muscles.
a 20-minute session a day while awake for six weeks, followed by weekly use thereafter.
FDA assessed the safety and effectiveness of eXciteOSA devices in 115 patients, including 48 who snored and had mild sleep apnea.
, 87 out of 115 patients snored more than 40 dB less than 20 percent.
of the 48 patients with snoring and mild OSA, the average apnea-Hypopnea Index (AHI) in 41 patients decreased by 48 percent, from 10.21 to 5.27.
" obstructive sleep apnea not only affects sleep quality, if left untreated, but also has other serious health effects.
today's approval offers a new option for thousands of people with snoring or mild sleep apnea.
," said Dr. Malvina Eydelman, Director of the Office of Ophthalmology, Anesthesiology, Respiratory, Otolaryngology and Dental Devices at the FDA's Center for Medical Devices and Radiology.
: This article is intended to introduce medical and health research, not treatment options recommended.
if you need guidance on treatment options, visit a regular hospital.
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