The US Food and Drug Administration granted 510(k) clearance to SnoreLessNow’s Mouth Guard+, an over-the-counter mandibular advancement device for snoring.
Known as the SomnoFit-S in Europe, the anti-Snore Mouth Guard+ is a small dental appliance that reduces snoring by positioning the jaw gently forward, allowing an opening for increased airflow and eliminating airway obstruction by tissues inside the mouth.
The anti-snore Mouth Guard+ uses a patented adjustment band that helps the jaw to move freely, allowing talking and drinking with the device on. The same band spans across the front teeth distributing tension more evenly to achieve maximum comfort and effectiveness.
Produced in Switzerland, the material is made of Swiss biomedical polymers and uses up to 40% less materials than other mandibular advancement devices on the US market, making it more flexible and discreet to wear, according to a release from the company.
It uses a simple molding method of being placed in hot water to create a customizable fit for the user. It can even be remolded more than once if the perfect fit is not achieved the first time.
No prescription is required for purchase. The Maryland-based company’s anti-snore Mouth Guard+ will be available for purchase on SnoreLessNow’s website in March 2024 through a partnership with Swiss manufacturer Oscimed SA.
Photo caption: Mouth Guard+
Photo credit: SnoreLessNow
