FDA grants 510(k) clearance to snoring-reducing device
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The FDA has granted 510(k) clearance to Mouth Guard+, a mandibular advancement device designed to reduce snoring, according to a press release from SnoreLessNow.
“This clearance will give clinicians an opportunity to recommend an alternative snoring solution to patients who are noncompliant or uncomfortable with CPAP use,” Chris Garvey, BS, chief operating officer and co-founder of SnoreLessNow, told Healio.
According to Garvey, the Mouth Guard+ dental appliance allows an individual to get maximum airflow while sleeping by gently nudging their jaw forward.
One key feature of the device is the patented tension band, which gives the individual wearing the mouth guard full jaw mobility, Garvey told Healio.
The material used to make Mouth Guard+ is another notable characteristic of the device.
“The Mouth Guard+ is made of high quality Swiss biomedical fibers that create and sustain a perfect fit to the user’s mouth,” Garvey said. “It is one of the few that can be molded and then remolded again for fit customization.”
According to the release, individuals do not need a prescription for Mouth Guard+, and this device is already being sold in Europe.
“SnoreLessNow hopes to provide the highest quality snoring solution alternatives to all of the United States and Canada,” Garvey told Healio. “In 2024, we expect to have our products available on Amazon and in large retailers alike.”