The FDA has given De Novo approval for the first device treatment for sleep apnea (OSA). It can be used while a patient is conscious.
The therapeutic tongue muscle stimulation device, dubbed eXciteOSA, is designed to treat mild sleep apnea. Also, snoring in people aged 18 and up. Patients can use the device for 20 minutes once a day for six weeks. Then later, only once every week is good.
Patients place a silicone mouthpiece with 4 electrodes around their tongue to use it. This is according to the product’s producer, Signifier Medical Technologies. The device’s stimulations serve to strengthen the muscles of the tongue. It helps to avoid blockages during the night.
A portable control unit supports the eXciteOSA mouthpiece. It powers the mouthpiece and a smartphone app that patients can use to track the success of their therapy. It can also create treatment reminders, and communicate data with their doctor.
According to the FDA’s notice, OSA can cause a variety of long-term health effects. This includes heart attacks, glaucoma, diabetes, cancer, and cognitive and behavioral health difficulties.
According to a 2013 study published in the American Journal of Epidemiology, 26% of U.S. people aged 30 to 70 have sleep apnea treatment. On the other hand, a more recent Lancet Respiratory Medicine study calculated the global burden of mild to severe OSA among adults aged 30 to 69 to be 936 million.
Continuous positive airway pressure, or CPAP, is a common treatment for snoring and OSA. But, patients who must use it daily may find it inconvenient or even uncomfortable. The FDA has approved stimulation therapy devices for some time. However, these devices often require an implant and are meant for severe instances of OSA.
Sleep apnea is no stranger to digital health. The majority of these products, such as wearables, sleep mats, and bedside devices, have focused on sleep monitoring. Also, some have attempted to prevent blockages by urging users to change positions as necessary.
The eXcite OSA Device is a new neuromuscular stimulation device that strengthens the intrinsic tongue muscles and can be used at home. It also encourages the conversion of type IIB muscle fibers to type I and IIa fibers. This results in minor OSA and snoring relief. No equipment or therapies are necessary during sleep. This is because the muscle fibers are retrained during day sessions (20 minutes per day).