SnoreLessNow announced today that the FDA granted 510(k) clearance for its over-the-counter dental device.
Known as SomniFit-S in Europe, the Anti-Snore Mouth Guard+ reduces snoring by positioning the jaw gently forward. It allows for increased airflow and eliminates airway obstruction by tissues inside the mouth, requiring no masks, hoses or electronics.
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Swiss manufacturer Oscimed SA makes the device and SnoreLessNow made it available for purchase through a partnership with the company. Commercial availability begins in March 2024.
Maryland-based SnoreLessNow says the device uses a patented adjustment band to help the jaw move freely. It enables talking and drinking while using the device. The same band goes across the front teeth, distributing tension evenly for comfort and effectiveness.
Oscimed designed the material from biomedical polymers, using up to 40% less materials than other mandibular advancement devices in the U.S. It also offers flexibility and discretion in wearing, the company says. The device requires molding only through placement in hot water for a customizable fit. Users can also remodel more than once if they fail to garner the perfect fit at first.
According to SnoreLessNow, more than 500,000 units of the device have already been sold in Europe. It requires no prescription.
