FDA approves eXciteOSA, the first daytime device for reducing snoring and helping mild obstructive sleep apnea.
The first daytime, tongue-stimulating device, eXciteOSA, gets FDA approval for marketing. It is the first device of its kind which can be used while the affected individual is awake. It intends to improve tongue muscle function by neuromuscular stimulation. If used appropriately and regularly, it can help prevent the tongue from falling back during sleep, thereby preventing airway obstruction, sleep apnea, and snoring.
The user has to place the silicone mouthpiece around the tongue. It then sends electrical muscle stimulation through the 4 electrodes on the mouthpiece. The electrical pulses are in series with alternating resting periods.
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, said:
“Obstructive sleep apnea not only impacts sleep quality but can have other serious health impacts if untreated. Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea.”
Who can use eXciteOSA?
Patients who are 18 years or older and have mild OSA can benefit from this tongue strengthening device. However, this device is not an alternate for professional help, nor it is intended for patients with moderate to severe sleep apnea.
How often should it be used?
Ideally, the device should be applied to the tongue once a day for 20 minutes during the day, i..e when the user is awake. After using it daily for 6‐weeks, the user can then use it once a week only.
Did the authorities test the device?
For FDA approval, the device was tested on 115 patients who had complaints of snoring. Out of 115, 48 patients were with snoring and mild sleep apnea. All patients used the device as advised. Thereafter, they discontinued the use for 2 weeks before reassessment. Majority of the patients showed improvement.
Are there any side effects of eXciteOSA?
Users may experience tongue discomfort, excessive salivation, tooth discomfort, tingling, dental filling sensitivity, metallic taste, gagging, and tight jaw. However, there are no major complications or adverse effects.