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Perhaps this would be helpful. There is a big misunderstanding here of how this all works. TL;DR: it's a comprehensive and timely process. The FDA is very rigorous and statements like "but once it's finished, there is no reason to delay the process. There are people who can't go on much longer."...

Not sure where this comes from. The FDA process and the academic process proceed in parallel, but the FDA process determines when information can be disclosed and published. I think this research has preceded remarkably on schedule considering the challenges COVID-19 presented for clinical...

Not at all "BS." It's driven by the FDA approval process as clearly stated in previous posts by the Auricle CEO and other informed forum members. There is every incentive to go as fast as possible.

Because it just amplifies the frustration and provides no value. For example, the post saying FDA approval is not necessary where just a page or two back the CEO clearly said that FDA approval is driving the process. There are people that are trying to offer informed guidance or predictions...

Thanks @DaveFromChicago for posting @Jason Ranovik's informed and helpful post. I would point out, however, that Jason's expertise is publishing non-medical research. Here we are more concerned with the FDA approval process than peer review publishing. Regardless, it seems to be progressing...

Why not do some research into the regulatory process and the risks before assuming they don't exist? Why not assume it's proceeding and hope for the best?

I propose we all assume that competent people are working diligently and as quickly as possible. It's a better assumption than some of the name calling and wild conjecture. I also think an expert on the FDA approval process would be enlightening for the forum, if one could be found. In the...

I think the answer was posted previously...

Everyone needs to chill a bit. The study will be concluding this month and it will be unblinded during the FDA approval process. The pace will be determined by the FDA. I have faith that the company will do their part to go as fast as possible as they certainly have the incentive.

I agree 100% with your strategy. Take reasonable precautions, but get on with your life. See the thread by Robson Healy for a success story. Focusing too much on tinnitus just reinforces it.

It's hard to hear, but be patient DaveFromChicago... Careful scientific research takes time and there have been no postponements other than the recent pandemic delays. Take a closer look at the clinical trial design of Lenire vs Shore's most recently completed and the trial in progress. It's...

The device will need FDA approval after a successful trial conclusion. That will be the main determinant on timing. Early 2023 is possible, but it's hard to predict how long the approval process will take.

I think the danger with headphones and ear buds is that you underestimate the volume, especially with noise canceling. I believe, however, that carefully limiting your volume makes them safe. I know there is a lot of anecdotal evidence otherwise here, but I also know a tinnitus researcher who...