the fda approved a prescription tongue muscle stimulation device that claims to reduce mild sleep apnea and snoring in patients with obstructive sleep apnea. compared with prior devices used at nighttime for the treatment of osa, such as continuous positive airway pressure therapy, exciteosa would be the first device to improve tongue muscle function while awake, which over time can prevent the tongue from collapsing backward and obstructing the airway during sleep. the approval comes after the fda assessed the safety and effectiveness of the device in 115 patients with snoring, including 48 patients with comorbid snoring and mild sleep apnea.
moreover, among patients with comorbid snoring and mild sleep apnea, average levels of the apnea hypopnea index (ahi) fell by 48%, from 10.21 to 5.27, in 41 of the 48 patients. today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” said 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, in a statement. through a silicone mouthpiece with 4 electrodes distributed above and below the tongue, the device delivers electrical muscle stimulation in sessions that consist of a series of electrical pulses, with rest periods in between. the device is also contraindicated for patients with pacemakers or implanted pacing leads, who are pregnant, who have ulcerations in or around the mouth, and who have various dental and orthodontic hardware, such as dental braces.
inspire sleep apnea innovation is the only fda approved obstructive sleep apnea treatment that works inside your body. no mask. no hose. just sleep. sleep surgery specialist broadens treatment alternatives upper airway stimulation therapy oral appliance therapy multidisciplinary pap- the new treatment – known as inspire upper airway stimulation (uas) therapy – offers the first implantable device for treating obstructive sleep apnea. the, .
a continuous positive airway pressure (cpap) machine is the most common and most reliable method for treating it. the cpap machine pushes a people with obstructive sleep apnea who haven’t found relief may benefit from a cpap alternative called inspire. it’s a pacemaker-like the new treatment – known as inspire upper airway stimulation (uas) therapy – offers the first implantable device for treating obstructive sleep apnea. the, .
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