New University of Michigan Tinnitus Discovery — Signal Timing

[withintention]

The University of Michigan invested $14M+ into the research and gave all the findings to Auricle? Auricle is looking for investors. What will the university gain? Whose money was behind the clinical trials? I don't understand how this works.

If they don't want to talk about FDA approval, OK, but why can't they say what the relationship between the University of Michigan and Auricle is, and what the mission and goals are?

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.

 

[marqualler]

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.

 

[Jonno02]

You are looking from the perspective of a large corporation flush with money. I think these rules do not quite apply to a small-time show like Auricle. Of course, there is a remote possibility they submitted and are working on improvements, but I am doubtful about it. Their pace and track record do not suggest that.

Or cheaper to manufacture, most likely.

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.

 

[Bhaveen]

Yeah, it's a decent amount of money with little practical impact so far—a sad state of affairs.

I wish Auricle considered selling the device in a country without regulatory obstacles while they work on approval/clearance in the US. That would be a real goodwill gesture for suffering people. Panama would be inconvenient, but I bet people would gladly do it if the alternative were waiting however many years. I guess it would create an appearance of working around the system. But that is silly. FDA has no jurisdiction abroad.

So sad. People needed help years ago.

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.

 

[Markku]

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.

One step ahead of you: we had a very informative 1-hour call with the CEO last week. It was of course all confidential, but at the end, we offered to draft an update for the community. We did that, and it's now being reviewed & edited by Auricle. Hopefully, it's ready for publishing later this week.

You shouldn't expect answers to all your burning questions. It's within their rights to do as little or as much PR as they want to.

What I hope you will get is an understanding why the whole process is much more complex than many people here truly realize. The timelines presented here are much too hopeful and not based in realism. It's not just about the regulatory affairs, it's also about everything else that will ensue after that.

 

[Tomas80]

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...

 

[Bob3382]

At least you have been able to do these things. My family lives hand to mouth, I can't work, and I have a small child. I wonder why some are so-called blessed and others are completely ignored.

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

One step ahead of you: we had a very informative 1-hour call with the CEO last week. It was of course all confidential, but at the end, we offered to draft an update for the community. We did that, and it's now being reviewed & edited by Auricle. Hopefully, it's ready for publishing later this week.

You shouldn't expect answers to all your burning questions. It's within their rights to do as little or as much PR as they want to.

What I hope you will get is an understanding why the whole process is much more complex than many people here truly realize. The timelines presented here are much too hopeful and not based in realism. It's not just about the regulatory affairs, it's also about everything else that will ensue after that.

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.

 

[Jonno02]

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.

 

[Bhaveen]

One step ahead of you: we had a very informative 1-hour call with the CEO last week. It was of course all confidential, but at the end, we offered to draft an update for the community. We did that, and it's now being reviewed & edited by Auricle. Hopefully, it's ready for publishing later this week.

You shouldn't expect answers to all your burning questions. It's within their rights to do as little or as much PR as they want to.

What I hope you will get is an understanding why the whole process is much more complex than many people here truly realize. The timelines presented here are much too hopeful and not based in realism. It's not just about the regulatory affairs, it's also about everything else that will ensue after that.

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?

 

[Nick47]

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.​

 

[Dkellz]

One step ahead of you: we had a very informative 1-hour call with the CEO last week. It was of course all confidential, but at the end, we offered to draft an update for the community. We did that, and it's now being reviewed & edited by Auricle. Hopefully, it's ready for publishing later this week.

You shouldn't expect answers to all your burning questions. It's within their rights to do as little or as much PR as they want to.

What I hope you will get is an understanding why the whole process is much more complex than many people here truly realize. The timelines presented here are much too hopeful and not based in realism. It's not just about the regulatory affairs, it's also about everything else that will ensue after that.

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.

 

[RunningMan]

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?

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.

 

[ErikaS]

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.

 

[WilRic]

Outside of the USA, Auricle is years away.

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.)

 

[JimmyStrong]

Outside of the USA, Auricle is years away.

I agree.

 

[Fields]

Outside of the USA, Auricle is years away

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

 

[Bhaveen]

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

 

[Joeseph Stope]

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

Right again! How do you manage it?

 

[Tim Dziwisch]

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

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

 

[RebelScum]

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

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

 

[Alberte]

We continue to wait...

 

[IYIiKe]

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

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

 

[Dkellz]

Right again! How do you manage it?

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

 

[dj_newark]

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

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.

 

[Bhaveen]

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

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

Right again! How do you manage it?

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

 

[IYIiKe]

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.

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.

 

[dj_newark]

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.

 

[gameover]

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.

 

[Markku]

Bad news:

Auricle has decided not to release any statement at this time. We're disappointed, obviously, as we were expecting to be able to give you some more insight. But they want to stick to their strategy of focusing on their mission rather than engaging with the public. Essentially, their thinking is that no matter how carefully you phrase things, there will always be misinterpretations and people will always want to know more, so it doesn't serve anyone well in the end. It's also not common practice for healthcare companies to make public statements about investigational devices.

We are of course free to speak about the challenges of bringing a medical device to market in general, about which we did learn more through the call with Jon. At this time, however, we will make no further attempts to mediate between the public and Auricle. We would also strongly recommend anyone who wants to know more to refrain from contacting Auricle or anyone associated with it, as it will serve no purpose. Just let them do their work and rest assured that they are doing their best to get the device to market.

 

[Joey72]

Color me surprised.