Ann: FDA Clearance for O2Vent Optima Oral Device, page-17

It’s not hard to get a device approved through FDA. The hard bit it getting it approved along with claims that it does such and such. So the FDA approval is no big deal (it is of course necessary before they can market) - the big thing is what claims about the product the FDA has approved. If it’s just another device for sleep apnoea then it no big deal as there are already many approved devices.

I haven’t looked yet at whether OVH have made specific claims about the efficacy of the device and whether these claims have been supported by the FDA - but the announcement just looks like the device has been cleared as a device