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Obstructive sleep apnea is a common sleep apnea with potentially serious long-term effects.
the upper gas vessel repeatedly clogs during sleep, reducing or stopping airflow 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 muscle.
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 who snored, 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.
'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 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.
: (1) FDA Authorizes Marketing of Novel Device to ReduceSnoring and Mild Obstructive Sleep Apnea in Patients 18 Years and Older.Retrieved February 5, 2021, from