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Category: Additional Information

How does ZQuiet work? Why should I purchase ZQuiet® vs. other anti-snoring options?

ZQuiet® uses the same technology that many anti-snoring devices employ, but is much easier to use: It moves the lower jaw forward which opens the airway and reduces the vibration that causes snoring. Unlike some anti-snoring devices, ZQuiet® lets you breathe completely naturally, through your mouth and nose. Opening and closing your mouth while sleeping is a natural process and ZQuiet’s® “Living Hinge” provides jaw mobility no matter what sleep position you are in. Many customers appreciate the fact that they can even talk or take a drink without having to remove the mouthpiece.

What is the difference between FDA clearance and FDA approval?

ZQuiet® is FDA cleared to treat snoring. All oral anti-snoring devices are considered Class II medical devices regulated by the FDA and must meet their requirements. Technically, if a similar device with the same indicated use exists, the FDA does not “approve” a new device in the same category; they “clear” them for sale under the 510(k) Clearance process. In order to receive FDA Clearance, a product must be proven effective and must also undergo very strict consumer safety testing. There are many anti-snoring devices sold online that are not cleared by the FDA, and there is no way to ensure that those products are effective or safe for consumers, or legal for sale.

What is ZQuiet® made of?

ZQuiet® is made of a soft thermoplastic compound that has undergone stringent consumer testing including toxicology, sensitivity and biocompatibility assessments. It does not contain silicone, latex, or Bisphenol A (BPA). The material is made in the USA, and is specially formulated for medical applications that require FDA compliance.

Where is ZQuiet® made?

We proudly manufacture ZQuiet® and all of the components in the U.S.A.

What’s the difference between Central Sleep Apnea and Obstructive Sleep Apnea?

Central sleep apnea is a neurological condition. Both obstructive sleep apnea and central sleep apnea are medical conditions that can only be diagnosed by a licensed medical practitioner after proper testing.