New University of Michigan Tinnitus Discovery — Signal Timing

If the operating system is of legal age, or frankly, old enough to drive a car... I'd run and not walk to the next job

Unless you know FORTRAN or COBOL in which case you're probably making money I can only dream of

 

I think this was based on their TENT-A1 results:

 

Study completion date on ClinicalTrials.gov is again postponed to May 2022 (while it was January 2022 not long ago).

Does anyone know the reason?

 

I spoke to Dr. Shore 3 days ago.

She estimated the trial will be complete by April 2022, and said the delay is due to COVID-19.

 

Lord! Q2 2022 is shaping up to be a big quarter for this community.

 

When will this device be available to the public, if you had to guess?

 

Really wish I was qualified to answer. BUT, given the investor video we saw that said it was "nearly market ready" and that the trials end in ~6 months, it seems somewhat plausible that we could all have the opportunity to have electrodes on our head/neck by Xmas 2022!

I'm sure someone else more qualified can follow up though...

 

My gut says we are realistically still 2-3 years away. I wish someone like Elon Musk would buy the technology. Then I would say probably 1 year away.

Dr. Shore has been working on this going on 20 years and still doesn’t have a completed trial. I see no reason why things will all of a sudden accelerate. I would love to eat crow and see this device out sooner but I just can’t imagine how that happens.

 

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.

 

Thanks very much for all of your acquired news and informed speculation.

However, four years ago on 01/05/2018 our Chicago Tribune in a Feature Article about Shore's Device mentioned that it would be ready in the not-too-distant future.

Perhaps I misled myself, but I recall that the Investor Webpage gave me the impression (since a photo of the portable device with accessories was included), that release would be within a matter of a few months.

These endless postponements are patently ridiculous. Do they portend serious, ultimately unresolvable difficulties that will finally end up in the termination of this as a bust?

Have there been any Clinical Trial reports about just how effective this is?

What bothers me is that I asked my very well-regarded ENT Doctor when any drug / treatment would be available, and he replied "In about 100 years." Troublingly, there was no mention of this device.

As I said before, in the Film Version of Capote's "In Cold Blood", while in that seedy Mexican Hotel Room Perry is holding an amateurish map of the Gulf and blathering about how his deep sea diving expedition will yield heaps of Gold from sunken Spanish Galleons. In sheer exasperation Dick rips the map from his hands and shouts, "Quit jackin' off - there ain't no buried treasure."

After eight years and an expenditure of approximately $12,500.00 for once highly touted but ultimately useless placebo junk (of all kinds), I now instruct myself to "quit mentally jackin' off - there ain't going to be a call from your Audiologist about some breakthrough drug and/or treatment."

 

One more question - Why was it so much faster and easier for Lenire to be nearly ready for FDA approval when it feels as if the Glaciers formed the Great Lakes is less time than it is taking Auricle to be available?

 

100 years huh, so why do you even bother with this forum?

 

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 pretty evident which one was more rigorously designed with control groups, crossover, etc.

I will be willing to bet Auricle gets FDA approval before Lenire.

 

That’s an easy one. Capitalism!

It’s maddening to think there is an effective treatment that already exists but we won’t see anything for another 2-3 years at the earliest. Just sit around and suffer because of bureaucratic BS. I have the money to burn and am willing to assume all risks.

 

to Gb3:

Valid point. I was certainly not endorsing this ENT Doctor's comment. He had no business blackpilling a patient with such a remark.

I was only quoting this ENT Doctor. I thought his comment was inexcusably insensitive and perhaps not factually correct; he was, however, only in his oblique way characterizing the daunting difficulties related to finding a real treatment.

And believe me, I am going to pointedly avoid seeing this guy again. In fact, why should anyone see him with an attitude like his?

 

How do you have such means whilst suffering from tinnitus might I ask? Just curious.

 

Sorry, I don't come to this thread often.

Is that true?

 

Bonding over the hypenosis* for the miracle treatment du jour is not the only reason to be on a tinnitus support forum.

* Usually delusional.

 

That is only my best assumption. I don’t see why Dr. Shore would already be forming her own company Auricle if her device didn’t work or they were still trying to figure out if it works.

 

I haven’t let tinnitus stop my career. I have a family to take care of so I had no choice but to keep on keeping on.

 

This. It ain't easy but there is no alternative.

 

You mean like what happened with Lenire?

 

I think Lenire does help some people. Maybe 15-20% of people who try it. I think Lenire is more likely to help people that aren’t as severely distressed as most of us on Tinnitus Talk. Maybe that’s why we don’t see very much positive success of it on this site. Lenire is more of a habituation device.

My rough understanding is:

Tinnitus is due to the overexcited neurons in our brain pathways in the DCN. Lenire is based on exciting additional neurons around those same areas so the original excited neurons which we perceive as the tinnitus noise don’t stand out as much/bad and perception is reduced/improved. The tinnitus is still there but isn’t as bothersome/severe. Almost all of the Lenire reviews that were positive were more along the lines of the tinnitus is still there but they don’t notice it as much or it doesn’t bother them as much.

Auricle works the complete opposite by trying to calm those original excited neurons that are creating tinnitus. That’s why the preliminary published data for Auricle showed reductions in actual tinnitus noise level. This seems a much more effective approach that I think will help a much broader range of people. My tinnitus does not bother me nearly as much on quiet vs loud days.

I believe Auricle will be much more effective and help more people based on these differences.

 

The entire neuromodulation approach is based on the same foundational research from Shore, so that's Michigan, Minnesota (where Lim came from) and Neuromod. If Lenire is ineffective it is either because they failed to execute or that neuromodulation in general is fool's gold.

The qualification that Shore gives again and again that her device is only being tested on "somatic" tinnitus (and a tiny sample-size) is the biggest red-flag for me.

 

Lenire and Auricle are both neuromodulation. That is correct. However, their approaches with regards to stimulation and timings are completely different.

 

Most tinnitus is somatic tinnitus I believe. But the fact that this treatment’s potential is based on such a small sample size and that it is one of the leading potential treatments is truly depressing

 

The sample size (number of people in the trial) will have no effect on if this device will work or not.

They are testing the device at one location in a University setting with a limited budget so a small trial size means nothing to me, good or bad. Even with the small trial it is taking an eternity to complete! I couldn’t imagine how long it would take them to complete a trial of several thousand people. I doubt I would still be around by then and I am only 42 years old.

 

The current trial is more in the 100+ person range, right?

 

I believe so.

 

I’ve written the CEO and addressed this already in this thread. Please go back and read.