The new eXciteOSA is used for 20 minutes once a day while awake, for 6 weeks and once a week thereafter.
On February 5, the US Food and Drug Administration (FDA) on its websitewww.fda.gov), authorized the placing on the market of a new prescription – only device designed to reduce snoring and mild obstructive sleep apnea. Unlike devices worn while patients sleep, this is the first device to be worn awake and designed to improve the function of the muscles of the tongue, which over time can help prevent the tongue from collapsing backwards and to obstructs the airways during sleep. “Obstructive sleep apnea not only affects the quality of sleep, but can have other serious health consequences if left untreated. Today’s permit provides a new opportunity for thousands of people experiencing these conditions, “said Dr. Malvina Eidelman, director of the Office of Ophthalmology, Anesthesia, Respiratory, ENT and Dental Devices at the FDA’s Center for Devices and Radiology.
Obstructive sleep apnea (OSA) is a common sleep-disordered breathing disorder with potentially serious long-term effects. This can occur when the upper airways become blocked repeatedly during sleep, reducing or stopping airflow altogether. Untreated OSA can lead to serious complications such as heart attack, glaucoma, diabetes, cancer, and cognitive and behavioral disorders. OSA is classified by the number of apneas (pauses in breathing) plus the number of hypopneas (periods of shallow breathing) that occur on average every hour. This number, called the Apnea-Hypopnea Index (AHI), measures the severity of OSA. Mild OSA is defined as AHI (sleep apnea-hypopnea syndrome) with a score of more than five but less than 15.
The eXciteOSA device (https://exciteosa.com) works by providing electrical muscle stimulation through a mouthpiece that is placed around the tongue. The mouthpiece has four electrodes, two located on the tongue and two located under the tongue. This artifact provides action for electrical muscle stimulation in sessions that consist of a series of electrical impulses with intermediate rest periods. It is used for 20 minutes once a day while awake, for 6 weeks and once a week thereafter.
The FDA has evaluated the safety and efficacy of the device in 115 snoring patients, including 48 patients with snoring and mild sleep apnea. All patients used the device for 20 minutes, once daily for 6 weeks, then discontinued use for 2 weeks before being re-evaluated. Overall, the percentage of time spent snoring at levels above 40 dB was reduced by more than 20% in 87 of 115 patients. In a subset of 48 patients with snoring and mild OSA, mean AHI was reduced by 48%, from 10.21 to 5.27, in 41 of 48 patients. The most common side effects observed are excessive salivation, discomfort in the tongue or teeth, numbness of the tongue, sensitivity to dental fillings, metallic taste, vomiting and jaw clenching.
Patients must undergo a complete dental examination before using the device. The eXciteOSA device is contraindicated for patients with pacemakers or implanted pacemakers (electrodes), patients with temporary or permanent implants, dental appliances, intraoral dentures / restorations / restorations / metal appliances or dental jewelry in the mouth; pregnant women or patients suffering from ulcers in or around the mouth. The device is not intended for patients who have or are suspected of having OSA with an AHI of 15 or more.
The FDA has reviewed the device through the De Novo pre-market review route, a regulatory route for low to moderate risk devices of the new type. Along with this authorization, the FDA establishes special controls for devices of this type, including labeling and performance testing requirements. This means that subsequent devices of the same type with the same intended use may go through the FDA 510 (k) prior notification process, during which the devices may be authorized for marketing, demonstrating substantial equivalence of a predicate device. When observed, special controls, together with general controls, provide a reasonable guarantee of safety and effectiveness for devices of this type.
Digital health is no stranger to sleep apnea. Most of these products focus on sleep monitoring through wearables, sleeping pads and night devices, although some others seek to avoid obstacles by encouraging users to change their position when necessary.
The FDA has granted a marketing authorization for eXciteOSA to Signifier Medical Technologies, LLC, in the United States.