Medical-Grade Products

FDA Approved Sleep Apnea Appliances

FDA Accepted

The Food and Drug Administration (FDA) is charged with protecting consumers against potentially harmful products. This includes regulating medical devices such as sleep apnea appliances. Since 2010, the FDA has granted premarket notification to more than 65 sleep apnea devices. These appliances have been found to be safe and effective. However, they cannot be purchased over-the-counter, so you will need a prescription to get one.

There are numerous models available, all of them FDA-approved for treating obstructive sleep apnea. They should only be used for treating mild to moderate sleep apnea, and they should not be used by patients under age 18. Beware of sleep apnea appliances that you can purchase online, as these are lower-quality, not regulated, and will not be a proper fit. Getting an appliance directly from your doctor is a better, safer choice, and your doctor will ensure that the appliance is comfortable to wear.

Depending on your case, sleep apnea appliances may be a more convenient choice than CPAP therapy. We can evaluate your sleep apnea and give you information about the treatment options that will work best for you. We can customize an appliance to provide the greatest effectiveness and comfort possible. Give our sleep apnea expert a call today to start discussing your options.

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