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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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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CBCT scan showing skeletal expansion and teeth tipping

Fourteen Month Vivos mRNA Appliance Update: Mid-treatment CBCT Scan Shows Expansion and Teeth Tipping

This update has been delayed for a few reasons: My mum died in September 2021 and that’s been taking up a lot of my time and emotional energy. I had a mid-treatment CBCT scan and was concerned about the results, so I wanted to talk this over with my provider before posting about it. I also had nasal surgery to improve my daytime breathing and have been recovering from that.

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