New University of Michigan Tinnitus Discovery — Signal Timing

UMich has a program called Innovation Partnerships, which helps researchers take their products to market. Auricle is a part of that program.

I can't find a link now, but I know that one of the delays in bringing the product to market was working out the investment agreement with UMich in the resulting company, Auricle. I think this got finalized sometime last year?

Also, where did you learn that Auricle is looking for investors? At this point, I understood that they had closed all their investment rounds.

 

I would imagine the three board members (Pearson, Martell, Shore) also hold some major equity in the company and are balancing taking outside investors with maintaining their own equity. With the University of Michigan's backing and their own research funded by a university instead of business investors, it seems like they are in a unique position to succeed.

 

You're probably right.

We work with many start-ups, but they have permanent staff that need to be put on the next iteration even prior to launch. There is no visibility on Auricle's staffing level, but they probably aren't at that level.

I don't particularly share the rampant pessimism here, though. It seems like a simple device. There is very little to the actual hardware. Many years of development have been spent discovering the pathway and getting the timing right. The hardware, at a somewhat high level right enough, is pretty basic. The parts for it are basically available off the shelf and are controlled by built-in firmware.

But just because it's basic doesn't mean it's a case of "build 10,000 of the things in preparation for launch." That's called manufacturing at risk. The risk is that you might need to bin the lot. The FDA might come back and say, "You haven't put a specification tolerance on this part", and Auricle then discovers the parts they've used don't quite meet the actually needed specification, and they need to swap out X part for Y part. Large companies can write off losses like that, and as previously said, Auricle doesn't have the cash to do that. So even after approval, we may see a slow rollout initially, and as the funds build up, manufacturing gets quicker.

The timelines here are even more frustrating because the device is so basic. But I can't agree with the posts saying the device won't see the light of day.

 

It’s a big ask, but can the Tinnitus Talk Founders reach out to Auricle again, or would it be fruitless? It just feels like there is no progress; each day, people suffer when they might not have to.

 

If I could pay a deposit upfront for the device, I would be happy to do so. And certainly, so would many other tinnitus sufferers. They would have a guaranteed source of funding...

 

I'd give it all up if my tinnitus was healed.

This statement by @Markku is saddening. The timelines that people mention here are normally one year after FDA approval, which has not happened yet. So, we're talking 2-3 years.

 

Saddening, but how many conditions have absolutely nothing on the horizon? Not saying the device will meet our hopes for volume reduction, but compared to thousands of other conditions, we're a rung up on the ladder as we have something coming.

 

Thank you so much for following up, and I look forward to hearing the summary! And I know it’s awful to have more questions asked when you write something intended to stop the questions. Still, the most optimistic estimations I’ve seen tend to be that the FDA approval will be by the end of this year, and at least some patients will get it by mid-2025. Are we now saying that’s too optimistic?

 

What I will say is that Auricle will have no outside influence whatsoever. There is nothing the tinnitus community can do to speed it up. It is also very unlikely to be effective for 50% of us, as the clinical trials have shown.

Let it run its course. Instead, donating to and focusing on other treatments currently in or soon to enter human clinical trials will be a better use of everyone's time.

Outside of the USA, Auricle is years away.

Let's keep this thread on-topic.​

 

This is obviously very disheartening. I've seen people say 2026 is the average guess date. If that isn’t based on realism, then what are we looking at here? 2027/2028/2029.

It's crazy in comparison to Lenire, which I promised myself I would not try, but maybe it’s wise to rethink that for now. Hopefully, Auricle can launch soon.

 

Yes. That's why I mentioned before that I'm pushing my prediction off another full year for availability. 2025 was too optimistic. 2026 may be, as well. Better late than never.

 

I want to give a huge thanks to @Markku and @Hazel and anyone else who may be assisting the both of you from the conversation with the Auricle CEO to the newly launched Tinnitus Quest. The nonprofit and volunteer work you two have done and continue to do speaks for the idea, "We cannot change what we have no control over, but what we can control or make a difference with, we will do our best to do so."

So, thank you again for being our voices at the forefront. I don't know when, but I do know this will all pay off someday, and we will have both of you to thank indefinitely for your advocacy.

 

I propose Auricle Contiki Tours for those of us outside of the US.

(This is only half a joke; when the device launches, some nonprofit project like that might be a good idea. Get certain audiologists who are close to hotels on board, etc. I imagine it will cost a bomb, but I doubt American health insurance would cover it anyway, so it wouldn't be any different for tourists.)

 

I agree.

 

Perhaps we'll have better luck with Cilcare or the TU Delft device, although I'm not holding my breath.

 

I'm guessing there's no news on the Auricle update?

 

Right again! How do you manage it?

 

It would be nice to hear some news about the device.

 

I assume they would post it here if there were any news, so that sounds like a good guess.

 

We continue to wait...

 

Why would you think it has changed since @Markku last said they were awaiting Auricle's edit(s) before posting?

 

It's crazy to see sarcastic responses to someone eager to get an update on a device that might help their fight against tinnitus.

 

I honestly don't think they'll hear back from Jon Pearson. Given the flippant response we got from the one communication we had with him, it seems he just doesn't care.

 

I was just thinking out loud, but I’m grateful for all the responses it received.

I guess I’m just blessed with the gift of pointing out the bleeding obvious.

 

People in this thread have gone to lengths to essentially stalk anyone associated with the project on LinkedIn/Facebook. Any information Auricle provides will likely be viewed negatively by the audience here as there are substantially unrealistic expectations. @Markku mentioned there are some unrealistic expectations on rollout based on their discussions, and immediately, the pitchforks came out instead of considering that expectations here are too high.

If you were Auricle, would you want to engage? I don't think they don't care; there isn't anything to gain in the time/effort. @Markku said Auricle might have something to say by the end of the week amid Tinnitus Hub's own launch (Tinnitus Quest) of a substantial effort/endeavor, but that was just an estimate.

It's great to see fervor about a new change in tinnitus treatment, but nothing anyone here does/says will influence the timeline.

Separately, I think there needs to be a realistic discussion about expectations. Tinnitus Talk visitors (typically severe tinnitus sufferers whom I speak of) will not be the target market for the device. There are far more severe sufferers here than in the general population. Since the decrease of the device is measured in THI reduction, it's likely that even if the device proves beneficial, many severe sufferers hanging on to every post/word will not necessarily see world-changing improvement, and their tinnitus will still be substantial.

 

Well, thank you for the doom and gloom for severe tinnitus sufferers. The improvements were measured in TFI, but also loudness reductions were measured. So, I remain hopeful. We will have to wait and see if it can help a severe case.

Still, I think that Auricle's policy of almost no communication is not reasonable, seeing as the likelihood of suicide among that population is high. Especially given that other medical companies do make a public record of their FDA submissions. And if you don't think Pearson's one response we got was flippant, read it again. I honestly don't think that a slightly more open communication strategy would hurt the business.

 

I agree. Simple information regarding the expected FDA submission date would be helpful. We would not expect them to speculate on when the FDA approval would take place. They could also set expectations on how long it might take to start seeing the device at the audiologist after the approval. It is really all we ask about.

 

Color me surprised.