FDA clears SnoreLessNow mandibular advancement device

[Image courtesy of SnoreLessNow]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.

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 i…

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