inSleep Health receives FDA clearance for Cloud9 Anti-Snoring System

inSleep® Health announced today that it has received 510(K) clearance for the company's 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 is the first clinically proven device, using continuous low positive airway pressure, specifically labeled to treat simple snoring.

The Cloud9® System provides comfortable airflow at extremely low airway pressure. The system includes a sports-styled, novel air circuit and innovative small nasal interface, which serves as the mask. Cloud9 users and their bed partners will enjoy quiet restful sleep, free from the disruptive sound of snoring.

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. He adds, "We expect physicians and heath care 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," says Gusky.

There are over 35 million consumers in the U.S. who can be classified as simple snorers, and as many bed partners who experience nightly interrupted sleep due to the disturbing noise. Experts say the importance of a good night's sleep to restore a harmonious bedroom relationship should not be under estimated.

Added Alan R. Schwartz, MD of Johns Hopkins University, "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." (Dr. Alan R. 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.)

Gusky concluded, "Cloud9 is totally designed and engineered from the perspective of both the snorer and the bed partner's needs. It's fabulously comfortable and an easily adoptable solution. In a coupled relationship, it's important to demonstrate empathy for the partner's sleep needs. Personally, I found it unimaginable that as many as 25% of couples would sleep apart, because of snoring. What's the point of being a couple?"

Source:

inSleep Health

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