Recent content by Jim Vasilakis

If Lenire could be approved with just two clinical trials, Auricle could also be approved. It's non-invasive, meaning the clinical trial requirements are less stringent.

Yes, the science behind the device is solid. The marketing and rollout are problematic. Those are two different things; they don't correlate.

I'm not talking about a loud bar; I'm talking 70-80 dB, which is fine.

From my understanding, it works similarly to residual inhibition. For residual inhibition to work, you don't have to match your tinnitus sound exactly. You can go to a bar and listen to music, and your tinnitus can disappear for a while.

Saying that Dr. Shore's device doesn't work, when not only have there been two clinical trials with great results but other studies using bimodal electrical stimulation have also yielded good results, is bad faith. It might not work for everyone, but it does work. Reductions above 11 dB aren't...

We don't know if the participants in the second trial returned to baseline, but they kept improving without using the device, which didn't happen in the first trial. All in all, the common pattern is that the device improvement is NOT a placebo. In both studies, there were reductions in the...

It was more fine-tuned since the results remained after the six-week period, whereas in the first clinical trial, tinnitus returned to baseline after four weeks. The results of the second clinical trial were permanent.

Placebo doesn't reduce tinnitus volume by 10 dB, especially since most people's tinnitus loudness is below 20 dB. That kind of decrease is more than just a psychological effect. Also, a placebo doesn't last for months; it can last for some days, but it returns to baseline. That's why placebo is...

There is no evidence that you habituate to the device. There is evidence that increasing the treatment duration causes more benefits, as shown in Study 2. That's a fact.

The placebo effect doesn't cut your tinnitus by 75% and 11 dB for almost two months. I'm not a tinnitus expert, but that I know. A decrease like that is physiological, not psychological. I don't think there has been a tinnitus sufferer who had the placebo effect for more than some days.

A placebo effect can't cut your tinnitus in half for months. That's not how it works.

So, I see we have circled back to the skepticism era. I understand it; tinnitus can make everyone pessimistic and bitter. I just want to remind you most bimodal stimulation studies with electrical signals have reduced the tinnitus volume and annoyance in most participants. So, it's not just Dr...

Why would EU approval be years away? The FDA is stricter than the EU usually.

Anyone who thinks that a device created by an esteemed Michigan Professor who has been in the field for 30 years is a scam needs to get off these forums. And this is coming from an inherently cynical person who became even more so after tinnitus. You are not thinking straight. It might not be...

It's clear to me that the device will help the majority of patients with somatic tinnitus which again is the majority of tinnitus patients overall. I'm not throwing headlines like 90% of tinnitus patients will have 70% reduction but it seems to me the majority will have SOME reduction.