The FDA submission [1] says it they have provided reasonable assurances of the effectiveness of the device.

Your link lists all kinds of information about the effectiveness like:

> 80% of participants reported a reduction in tinnitus symptoms

That doesn't sound like snake oil to me...

I'd love to hear from somebody who has tried it. If they say it helped at all, I'd write a $5000 check today.

[1]: https://www.accessdata.fda.gov/cdrh_docs/pdf21/DEN210033.pdf

Yea but you can massage data in a way that it makes something look better than it otherwise would. For example, if you asked people right after a treatment if their tinnitus was a lot better, moderately better, a little better, or no change, then you have framed things in a way that many people might say "a little better" even if it's no change. Or you can disqualify all people for whom there was no change or for whom it became worse as "not suitable for treatment." There are lots of games that can and do get played with these sorts of numbers.