FDA clears devices to reduce snoring in patients without sleep apnea

Cloud9 Anti-Snoring System--Courtesy of InSleep Health

InSleep Health just received FDA clearance for its Cloud9 Anti-Snoring System, which deploys continuous low positive airway pressure to help snorers (and their annoyed partners). The prescription-only device consists of an air-flow unit and headgear worn around the head that delivers low-pressure air into the nose. The two components are connected via a hose.

Cloud9 is one of the few attempts to treat snoring in patients without sleep apnea.

Targeting the device solely at so-called simple snorers enables inSleep to offer advantages over continuous positive airway pressure devices that reduce snoring but also treat sleep apnea--a breathing problem that's associated with snoring, as well as other problems like daytime sleepiness and insomnia.

InSleep says CPAP devices are poorly tolerated by simple snorers, and that the portable Cloud9 airflow unit is smaller than that used by those devices, while the Cloud9 headgear is more comfortable and can be worn in any sleep position.

Unusually for devices going through the FDA's 510(k) process for low- to moderate-risk devices with a similar predecessor on the market, the Cloud9 underwent a clinical trial.

"Our trial demonstrates marked reductions if not complete elimination of snoring by low-levels of continuous airway pressure in habitual snorers without sleep apnea," said Dr. Alan Schwartz, director of the Johns Hopkins Sleep Disorders Center, in a statement. "This technology promises untold improvements in sleep quality and reductions in stress for snorers and their bed partners."

The device, aimed at the 35 million American simple snorers, will be inSleep's first following commercialization in 2016.

Michael Gusky, Cloud9 inventor and founder of inSleep, stressed benefits of the devices to simple snorers' couples, saying in a statement, "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?"

- read the release

Editor's Note: A previous version of the article said the device delivers oxygen into the nose, instead of low-pressure air.

Suggested Articles

J&J’s Ethicon unit received an FDA clearance for its Vistaseal applicators that spray a biologic sealant from Grifols to help stem surgical bleeding.

Bio-Techne’s urine test has received a breakthrough device designation from the FDA for ruling out unnecessary tissue biopsies.

Qiagen launched a one-stop shop compiling publicly available genomic data, scientific literature and phenotypic information on potential superbugs.