SnooZeal's OTC, smartphone-controlled sleep apnea device earns CE mark

Over-the-counter daytime antisnoring and sleep apnea device. Image: SnooZeal

SnooZeal’s antisnoring and sleep apnea device scored a CE mark this month, making it the first commercially available over-the-counter device that targets the underlying cause of snoring.

Sleep apnea has a number of causes, but they are all rooted in the relaxation of the tongue and throat muscles during sleep, the NIH says. This relaxation causes the airways to narrow, which doesn’t usually affect breathing. But in people with sleep apnea, it can cause the airway to become fully or partially blocked.

The SnooZeal device addresses the excessive relaxation and loss of tongue muscle tone during sleep, the company said in the statement. The device is worn for 20 to 25 minutes twice a day over six weeks. It delivers electric pulses to the back of the tongue to increase muscle tone with the goal of reversing the over-relaxation of the tongue during sleep. The patient uses a smartphone app to control the treatment.

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The daytime treatment differentiates SnooZeal from currently available treatments that are used at night. These include dental devices and continuous positive airway pressure, where a patient wears a mask that helps keep his or her airways open during sleep.

Other novel treatments for sleep apnea include Nyxoah’s neurostimulation implant. The company is developing an implant and disposable patch that stimulate the nerves of the tongue to make it move slightly, preventing airway obstruction. And NighBalance is developing a device that is worn around the upper body and continuously measures a user’s sleep behavior. If the user rolls onto his or her back, the device vibrates gently, prompting the user to change position without waking.

With the CE mark in the bag, SnooZeal will now turn its sights to launching the device in major EU economies, including the U.K., Ireland, Germany, Spain and France, among others, said Akhil Tripathi, SnooZeal cofounder. It will work with medical device distributors, sleep physicians, ENT consultants and big box retailers to commercialize the device. Initially, SnooZeal will conduct a pre-launch with one or two distributors, Tripathi said. The company will then seek feedback to prepare for a full launch. Tripathi anticipates FDA approval for the device in the second quarter of next year.

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