Blue plastic appliance case labelled "Vivos" held by a hand wearing a glove

FDA Approval of the The Vivos DNA Appliance is Not What It Seems

The Vivos DNA Appliance is now FDA Approved for the treatment of mild-moderate obstructive sleep apnea. It is considered a medical device because it is used to treat a medical condition, so it is subject to regulation. Medical device regulators like the U.S. Food and Drug Administration are tasked with protecting consumers by ensuring the safety and effectiveness of medical devices on the market.

Generally, it would be reasonable for a consumer to assume that having FDA approval for a medical device means that the device is safe and effective. Given that my treatment with the Vivos mRNA Appliance failed and left me with tipped teeth, I gave the approval further scrutiny and found that all is not what it seems.

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Cartoon letter 'e' with jet of flame streaking across the sky with stars in the background and title text Empowered Sleep Apnea by Dr David E. McCarty

If You’ve Just Been Diagnosed With Sleep Apnea, Empowered Sleep Apnea Is A Good Place To Start

If you’ve been following my health journey for any length of time, you’ll have noticed that I’ve tried a lot of things to recover my energy and vitality. Being diagnosed with severe obstructive sleep apnea was a major turning point for me, but it was also the start of a new quest to find an effective treatment for the condition that would work for me. There are so many options to consider, and even going with the default recommendation of my sleep specialist to just use CPAP didn’t turn out to be trivial.

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Pretty graph showing my Vivos mRNA Appliance had no effect on my obstructive sleep apnea

The Vivos mRNA Appliance Tipped My Teeth and Didn’t Improve My Obstructive Sleep Apnea

Following on from the mid-treatment CBCT scan showing that my Vivos mRNA appliance was tipping my teeth, I’ve decided to stop using it altogether after a sleep study showed that 20.5 months use has had no effect on my severe obstructive sleep apnea. I had the sleep study in June specifically to see what permanent impact the appliance has had on my airway during sleep. The polysomnograph was conducted untreated with neither Vivos mRNA Appliance nor CPAP in use so I could compare against my previous untreated sleep study.

The results were disappointing, to say the least.

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