inSleep® Health announced it has received 510(K) clearance from the U.S. Food and Drug Administration 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. It is the first clinically proven device, using low continuous positive airway pressure, specifically labeled to treat simple snoring, according to the company.
The Cloud9® System provides airflow to patients at extremely low airway pressure while they sleep. 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.
“This has been my passion and focus for seven years,” said Michael Gusky, founder and CEO of inSleep Health. “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 a.m. to lie awake listening to that sound steal their own sleep.
There are more than 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 underestimated.
A clinical trial conducted by Dr. Alan R. Schwartz, director of the Johns Hopkins Sleep Disorders Center and the Johns Hopkins Center for Interdisciplinary Sleep Research and Education, demonstrated “marked reductions if not complete elimination of snoring by low-levels of continuous airway pressure in habitual snorers without sleep apnea.” The new technology “promises untold improvements in sleep quality and reductions in stress for snorers and their bed partners,” said Schwartz.
“Cloud9 is totally designed and engineered from the perspective of both the snorer and the bed partner’s needs,” Gusky added. “It’s fabulously comfortable and an easily adoptable solution.
The company’s Cloud9 Anti-Snoring System will be commercially available in 2016. For more information, visit www.insleephealth.com.