InSleep Health has received 510(K) clearance for its Cloud9 Anti-Snoring System. The indication for use is to reduce or eliminate simple snoring in adults. Cloud9 is a prescription device for home use. This devices uses continuous low positive airway pressure and is specifically labeled to treat simple snoring. The system includes a sports-styled, novel air circuit and innovative small nasal interface, which serves as the mask.
Michael Gusky, founder and CEO of inSleep Health is proud of his invention and of his team’s execution. “This has been my passion and focus for seven years,” says Gusky in a release. “We expect physicians and heathcare professionals to be elated knowing they can finally treat their patients who snore. We learned from doctors the frequency of someone complaining that their wife, husband, or significant other is exhausted from being awakened by their partner’s snoring. Very few possess the temperament at 3 AM to lie awake listening to that sound steal their own sleep. Love is probably the last sentiment that’s on their mind.”
Alan R. Schwartz, MD, of Johns Hopkins University, says, “Our trial demonstrates marked reductions if not complete elimination of snoring by low-levels of continuous airway pressure in habitual snorers without sleep apnea. This technology promises untold improvements in sleep quality and reductions in stress for snorers and their bed partners.” Schwartz is professor of Medicine at Johns Hopkins University, and Director of the Johns Hopkins Sleep Disorders Center, the Sleep Medicine Fellowship Training program, and the Johns Hopkins Center for Interdisciplinary Sleep Research and Education.
The Cloud9 Anti-Snoring System will be commercially available in 2016.