The U.S. Food and Drug Administration on Friday approved a new device that can help prevent sleep apnea and snoring – and it does not need to be worn at night.
People who snore – and their partners – currently have very few options to alleviate their suffering. And many of the available items include awkward mouth guards or noisy C-Pap machines.
The eXciteOSA device authorized Friday is the first of its kind to treat sleep apnea and snoring by improving tongue muscle function by delivering electrical stimulation to the tongue through a mouthpiece worn 20 minutes a day. It helps to retrain the tongue to prevent it from collapsing backwards and blocking airflow during sleep.
Obstructive sleep apnea occurs and occurs when the upper airway is repeatedly blocked during sleep, reducing or completely blocking airflow. Untreated, OSA can lead to serious complications such as glaucoma, heart attack, diabetes, cancer and cognitive and behavioral disorders.
“Obstructive sleep apnea not only affects sleep quality, but can also have other serious health consequences if left untreated. Today’s consent offers a new option for thousands of individuals experiencing snoring or mild sleep apnea,” said Malvina Eydelman. , Managing Director, Director of the Office of Ophthalmic, Anesthetic, Respiratory, ENT and Dental Devices at the FDA’s Center for Devices and Radiological Health.
The eXciteOSA nozzle has four electrodes, two above the tongue and two below the tongue. It provides electrical muscle stimulation during sessions consisting of a series of electrical pulses with rest periods in between. It is used for 20 minutes a day while you are awake, for a period of 6 weeks and then once a week.
The agency said the device reduced loud snoring by 20% in 87 of the 115 patients it evaluated. Of the patients who all snored, 48 also had mild sleep apnea.
The most common side effects noticed were excessive salivation, discomfort in the tongue or teeth, tingling in the tongue, sensitivity to the dental filling, metallic taste, struggling and stiff jaw.
The FDA granted the marketing authorization to Signifier Medical Technologies.