FDA authorizes new device intended to reduce snoring and treat sleep apnea

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The device only needs to be worn for 20 minutes during the day to be effective

In what could be a game-changer for those who struggle with snoring and sleep apnea, the Food and Drug Administration (FDA) has approved eXciteOSA, a new device designed to treat both those conditions. 

Up to this point, many consumers have depended on CPAP machines to treat snoring and sleep apnea; these devices are usually worn while sleeping and create positive air pressure to assist breathing. However, eXciteOSA is the first device intended for use during the day, and it reportedly only needs to be worn for 20 minutes.

“Obstructive sleep apnea (OSA) not only impacts sleep quality, but can have other serious health impacts if untreated. Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” said Malvina Eydelman, MD., director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health.

Retraining the tongue

The FDA says the device is innovative because it’s the first of its kind that’s cleared to treat sleep apnea and snoring by improving tongue muscle function. The product works by delivering electrical stimulation to the tongue through a mouthpiece worn for 20 minutes a day over a period of six weeks. The agency’s assessment states that the device “helps retrain the tongue to prevent it from collapsing backwards and blocking airflow during sleep.”

Before you pop open the champagne, the device has some limitations. The company behind eXciteOSA says its device is useful for “mild” sleep apnea and snoring. After testing the device with 115 patients, the FDA said it found eXciteOSA reduced loud snoring by more than 20 percent in 87 of those patients.

The FDA says that patients should get a comprehensive dental examination before they use the device. It determined that the device should not be used by patients with temporary or permanent implants, dental braces, intraoral metal prosthesis/restorations/appliances, or dental jewelry in the mouth.

Other warnings go out to patients who are or may become pregnant, patients suffering from ulcerations in or around the mouth, and those with a sleep apnea index of 15 or higher.

Do you know one snore from another?

The manufacturer said consumers considering purchasing its device need to consider if a person’s snoring problem is a true disorder rather than something brought on by other factors.

“If snoring is having a negative effect on your life and sleep quality, it is helpful to know about the various different types of snoring. This way, you can get a general idea if you are a sporadic snorer or a potential OSA patient and need to see a doctor.”

Telling the difference between “primary snoring” and OSA-related snoring is pretty straightforward. Here are the four considerations consumers should take into account that are not OSA-related:

  • The anatomy of a person’s mouth and nose: “A low, thick, soft palate can narrow your airway and facilitate snoring,” the manufacturer notes.

  • Alcohol consumption: eXciteOSA will not likely remedy a snoring situation brought on by drinking alcoholic beverages, which tend to relax the muscles of the airway.

  • Sleeping position: Sleeping on your back allows gravity to narrow your airway and can cause snoring.

  • Being overweight: Fat deposits in the back of the throat may narrow the airways and also cause snoring. Being overweight is simply something eXciteOSA can’t address.

More information about eXciteOSA and CPAP-related machines

The manufacturer has yet to announce availability or prices for eXciteOSA, but interested consumers can sign up to be notified when it is available to purchase. The company will also offer a 14-day money-back guarantee.

As you can tell, there are a lot of directions people can go to try to reduce “regular” snoring or OSA-related snoring. For example, buying an adjustable bed might help eliminate snoring. ConsumerAffairs has done some of that homework for you by preparing a guide on CPAP machines, including reviews, costs, and FAQs. You can find that guide here.

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