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FDA grants 510(k) clearance for device used to treat snoring
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The FDA has granted inSleep Health 510(k) clearance for the company’s Cloud9 Anti-Snoring System, according to a company press release.
The clearance indicates the use of the device to reduce or eliminate simple snoring in adults.
A prescription device used at home, Cloud9 is designed to exert airflow at low pressure.
The system includes a sports-styled, air circuit and small nasal interface that acts as the mask, according to the release.
“Our trial demonstrates marked reductions if not complete elimination of snoring by low-levels of continuous airway pressure in habitual snorers without sleep apnea,” Alan R. Schwartz, MD, director of Johns Hopkins Sleep Disorders Center, said in the release. “This technology promises … improvements in sleep quality and reductions in stress for snorers and their bed partners.”