New University of Michigan Tinnitus Discovery — Signal Timing

[Gb3]

At least we know they have the funding.

 

[Bambam0]

The Shore Lab spent decades researching a novel tinnitus therapy, concluded two human studies which revealed promising outcomes, and a private company that is the exclusive licensee of the patents pertaining to the therapy has been formed and funded to pursue clearance and commercialization.

Deep breaths, y'all. Just read that and take long, deep, breaths.

 

[dj_newark]

This is still at its core an assumption though. Realistically no one knows what they are doing, how they're submitting, nor what hiccups or delays in the process on their end or the FDA's might occur.

Your speculation might even be right IF everything goes great. I'm much more a believer in Murphy's law. I'd much rather be pleasantly surprised than hanging on every guesstimated milestone on the way to production and commercial rollout, as if stressing about it it had any impact on the availability of the device.

That's why I said "IF they're submitting as a 510(k)." Yes it's speculation. Welcome to Tinnitus Talk! You must be new here. Almost everything here is speculation. I present nothing I say here as fact, but what I'm saying is generally correct that the FDA tries to decide 510(k) submissions in 90 days, which can be affected by other influences such as staffing levels and information requests from the FDA. It will likely take way longer than 90 days but almost certainly won't take a whole year (once submitted) which is what I was responding to. But anything can happen and no one here has a crystal ball.

As Jon Pearson points out in his email and is something that I was well aware of, FDA approval and commercialization timelines are completely separate issues. You won't be getting the device 'at your local Walgreens' the day the device is approved. It's a waiting game, we all know that.

All that said, it's almost certain they'll submit as a 510(k) because superficially the device is similar to Lenire. And taking the De Novo route would just be delaying things further. But again, anything could happen, and who really knows?

I am not stressing about the device, I am stressing about my tinnitus which I've had since 1990 and has been severe since 1996. So before someone who's had tinnitus since 2023 judges me on that, just think of what a life with this condition for decades has been like.

 

[RunningMan]

I'd be happy if the device is available within two years.

Same here, although I don't want to be traveling long distances to get access to that limited early availability, so the slow trickle out to other states could take another year or more to show up closer to home. I also want to see the early feedback from real users to see if it actually works outside of the controlled studies for a reasonable percentage of the users.

 

[DebInAustralia]

This is their stance, from Jon Pearson, CEO of Auricle:

...

I want to understand why did Auricle announce back in 2021 that they are nearly market ready?

 

[Utdmad89]

I want to understand why did Auricle announce back in 2021 that they are nearly market ready?

Because they are?

 

[Gb3]

I want to understand why did Auricle announce back in 2021 that they are nearly market ready?

Because they needed funding.

 

[dj_newark]

I want to understand why did Auricle announce back in 2021 that they are nearly market ready?

I wrote Dr. Shore asking that question back when she was still replying to me and all that she would say was that "That statement was taken out of context", but she wouldn't elaborate any further, sadly.

 

[BadNeighbors]

I want to understand why did Auricle announce back in 2021 that they are nearly market ready?

Unfortunately, "nearly" can mean anything depending on the context. I'd imagine nearly ready in the medical device context is a couple of years away, even though we all want it to mean a couple of months.

A product I'm working is "nearly ready" to be launched to the public. We promised investors that it will be released next year. Our customers might interpret a year away as a long time, but for us, the deadline is coming up soon and we all need to scramble to make sure we hit the deadline.

 

[elino]

Science: An ALS Drug Fails. Again.

This reminds me so much of the threads on Tinnitus Talk, especially this one. Dr. Shore and Auricle are the least of the problems, yet you're trying to get them to speed up the process and give you answers that they don't owe you. You won't get a real cure by doing this; get that into your heads and try to learn from the ALS and Alzheimer's cases.

Just like with the recent approvals in Alzheimer's the patient advocacy groups took victory laps after Relyvrio was approved, and they were a big part of the pressure that made the FDA reverse its initial correct decision. Congratulations? I hate to be this way, but I continue to believe that unmet medical need is not by itself enough reason to approve a drug. You need what you've always needed: efficacy and safety. Boring, tedious, expensive efficacy and safety. Desire and despair don't figure in much - in a much different universe, one whose physical laws respected and validated human emotions and human suffering, they would. But we don't live in that world. We never have.

 

[gameover]

Dr. Shore and Auricle are the least of the problems, yet you're trying to get them to speed up the process and give you answers that they don't owe you.

Strongly disagree. Last I checked most of her research has been funded by taxpayers. We paid for it. I think a little bit of transparency would be the least we deserve, in my opinion.

 

[BadNeighbors]

Science: An ALS Drug Fails. Again.

This reminds me so much of the threads on Tinnitus Talk, especially this one. Dr. Shore and Auricle are the least of the problems, yet you're trying to get them to speed up the process and give you answers that they don't owe you. You won't get a real cure by doing this; get that into your heads and try to learn from the ALS and Alzheimer's cases.

I'm not sure I see the relationship between this ALS drug and our hopes for Auricle to move quickly.

The ALS drug had bad data and the FDA responded by saying, "your data is bad, it doesn't support your conclusions, and we won't be approving this garbage." This ALS drug sounds like Lenire, not Auricle.

I certainly want the FDA to question the data and dig into Dr. Shore's evidence, but I also want Auricle to present its honest case as soon as possible. I do not see how the situation around this ALS drug and the situation around Dr. Shore's device are comparable.

 

[IYIiKe]

Strongly disagree. Last I checked most of her research has been funded by taxpayers. We paid for it. I think a little bit of transparency would be the least we deserve, in my opinion.

This is such an entitled take I don't even know where to begin, and yet, per usual, gets likes/upvotes.

Who is "we," that purportedly paid for the research, and what documents are you in possession of that entitle you to any sort of patent/ownership of IP from the research of the Shore Lab?

 

[gameover]

This is such an entitled take I don't even know where to begin, and yet, per usual, gets likes/upvotes.

Who is "we," that purportedly paid for the research, and what documents are you in possession of that entitle you to any sort of patent/ownership of IP from the research of the Shore Lab?

I wasn't going to respond as you will probably not get it. It is about ethics, empathy and a moral obligation. Yes, US university research is funded by US taxpayers. I've paid shit ton of taxes over the years being in the higher middle class tax bracket (proportionally my tax burden is higher than the lower class and the oligarchy). I am too well to pay little, and I make not enough to "optimize" my taxes. So, you know, I feel a little bit hmm, deserving of transparency, not necessarily entitled. Not every thing in life is about being entitled. There is ethics, largely forgotten concept nowadays. I am not saying Dr. Shore is an unethical, greedy capitalist; certainly not.

But Auricle could do better. There is nothing legally stopping them telling us about the progress. It is not like their work is secret, and interested parties (like competition, Neuromod) for sure know more what's going on with them. These people know each other and certainly talk. It is not a super stealth startup or government project working on next generation of weapons. In the end, the only people kept in the dark are us, sufferers.

 

[Utdmad89]

I wasn't going to respond as you will probably not get it. It is about ethics, empathy and a moral obligation. Yes, US university research is funded by US taxpayers. I've paid shit ton of taxes over the years being in the higher middle class tax bracket (proportionally my tax burden is higher than the lower class and the oligarchy). I am too well to pay little, and I make not enough to "optimize" my taxes. So, you know, I feel a little bit hmm, deserving of transparency, not necessarily entitled. Not every thing in life is about being entitled. There is ethics, largely forgotten concept nowadays. I am not saying Dr. Shore is an unethical, greedy capitalist; certainly not.

But Auricle could do better. There is nothing legally stopping them telling us about the progress. It is not like their work is secret, and interested parties (like competition, Neuromod) for sure know more what's going on with them. These people know each other and certainly talk. It is not a super stealth startup or government project working on next generation of weapons. In the end, the only people kept in the dark are us, sufferers.

Lol, Jon Pearson literally explained why Auricle haven't given any information. And, honestly, you've proven their point with your speculation and digging into their source code without knowing where they are at with any of their processes.

 

[gameover]

Lol, Jon Pearson literally explained why Auricle haven't given any information. And, honestly, you've proven their point with your speculation and digging into their source code without knowing where they are at with any of their processes.

Frankly, I found Pearson's email condescending towards sufferers (the "Hooray! I just asked my brother's aunt's nephew's wife" bit). It is understandable people are anxious and can write various nonsense. It still does not change my opinion that more transparency would be better here. You may, of course, disagree.

Of course I speculated after reviewing the changes to the code by Dr. Martel, and qualified it as such. Really, does it prove his point? Or maybe it actually proves my point, that transparency from Auricle would be better and would dispel many speculations?

It's not the end of Q1 yet, so no issues here.

By the way, the mention of Q1 was removed from the UMich webpage. Below is the archived version, and when you go to the current webpage, it is no longer mentioned:

https://web.archive.org/web/2023120...ates-licensing-with-bell-ringing-celebration/

 

[IYIiKe]

I wasn't going to respond as you will probably not get it. It is about ethics, empathy and a moral obligation. Yes, US university research is funded by US taxpayers. I've paid shit ton of taxes over the years being in the higher middle class tax bracket (proportionally my tax burden is higher than the lower class and the oligarchy). I am too well to pay little, and I make not enough to "optimize" my taxes. So, you know, I feel a little bit hmm, deserving of transparency, not necessarily entitled. Not every thing in life is about being entitled. There is ethics, largely forgotten concept nowadays. I am not saying Dr. Shore is an unethical, greedy capitalist; certainly not.

But Auricle could do better. There is nothing legally stopping them telling us about the progress. It is not like their work is secret, and interested parties (like competition, Neuromod) for sure know more what's going on with them. These people know each other and certainly talk. It is not a super stealth startup or government project working on next generation of weapons. In the end, the only people kept in the dark are us, sufferers.

So I don't want to belabor because I know your whole interest and place of heart is to obtain the device as soon as possible in hopes it helps you and others -- but the tax thing just isn't true. The amount of lifetime taxes most people contribute isn't paving the roads, paying for schools, salaries, et al. -- we are very much microscopic pieces of the puzzle. In reality, individually, we don't really do much of anything.

Government grants don't come with strings. They are intended to increased knowledge in a field of research. By all accounts, Dr. Shore has delivered and has published many articles over the years that if not increasing knowledge of tinnitus and treating it, is helping break ground on some wrong paths to fixing it (which is still helpful). Private grants may or may not come with strings. In terms of commercializing these outputs, they are typically owned in part or full by the institution (UMich). There is no taxpayer owed update on what the university does. The output is typically the published research.

There very much is competition (Dirk De Ridder's device is only the beginning), but there are also restrictions. Dr. Shore et al. are partners with UMich who get their take and undoubtedly have had lengthy negotiations on the future and their cut. None of this process is owed to the public.

Again, you state there are no legal restrictions on updates or what have you but you simply don't know that. There very well could be internal MoU/agreements between UMich and Auricle.

Auricle gains nothing by publicly stating internal deadlines or milestones except undue pressure like the kind you're generating (from a good place), and I haven't found a program manager yet who willingly signs up to public oversight and deadlines unnecessarily. I can't think of a worse idea than coming to potential users of your product who are desperate and frankly very negative at times and overpromise/under deliver. You could see such a negative response that funding is pulled over such rumors.

The truth is sufferers aren't going anywhere, and the process takes time. We'll get it when we get it, and unfortunately, unless someone here is Musk-level loaded, not much influence is going to come from worrying about it, it certainly doesn't make future outreach likely.

 

[RunningMan]

By the way, the mention of Q1 was removed from the UMich webpage. Below is the archived version, and when you go to the current webpage, it is no longer mentioned:

https://web.archive.org/web/2023120...ates-licensing-with-bell-ringing-celebration/

That doesn't look like a good sign for this being submitted to the FDA in Q1.

 

[Fields]

According to In2Being, they were also responsible for designing the software for the Auricle device – as stated on their website.

Mechanical, electrical, and software design: Our team designed a next-generation tinnitus treatment device, producing detailed mechanical and electrical plans and a software operating system.

Not sure whether this refers to whatever's on GitHub or a separate piece of software.

 

[Watasha]

So I don't want to belabor because I know your whole interest and place of heart is to obtain the device as soon as possible in hopes it helps you and others -- but the tax thing just isn't true. The amount of lifetime taxes most people contribute isn't paving the roads, paying for schools, salaries, et al. -- we are very much microscopic pieces of the puzzle. In reality, individually, we don't really do much of anything.

Government grants don't come with strings. They are intended to increased knowledge in a field of research. By all accounts, Dr. Shore has delivered and has published many articles over the years that if not increasing knowledge of tinnitus and treating it, is helping break ground on some wrong paths to fixing it (which is still helpful). Private grants may or may not come with strings. In terms of commercializing these outputs, they are typically owned in part or full by the institution (UMich). There is no taxpayer owed update on what the university does. The output is typically the published research.

I think we need to be cautious tossing around the idea of "severing the bond" between taxpayer and publicly funded projects. Publicly funded projects and programs do work for the people, and those receiving taxpayer funds have an obligation to do so ethically, with good stewardship, and with the public interest in mind. They must never forget this: even when it means they don't answer to the people directly and on a whim, they still work for us for the public good.

 

[UHPTS]

Not sure whether this refers to whatever's on GitHub or a separate piece of software.

What is on GitHub is just an incredibly crappy software to assess one's tinnitus. It has nothing to do with the device you use for the actual treatment.

 

[gameover]

What is on GitHub is just an incredibly crappy software to assess one's tinnitus. It has nothing to do with the device you use for the actual treatment.

It was used in the trials to establish your tinnitus parameters, which were used to program the device. So "nothing" is not entirely accurate. Whether they use this, or if they developed something new, we do not know.

 

[IYIiKe]

I think we need to be cautious tossing around the idea of "severing the bond" between taxpayer and publicly funded projects. Publicly funded projects and programs do work for the people, and those receiving taxpayer funds have an obligation to do so ethically, with good stewardship, and with the public interest in mind. They must never forget this: even when it means they don't answer to the people directly and on a whim, they still work for us for the public good.

But they don't work for the public though. They work for whatever institution employs them. Their positions might be funded by grants, but there are specific outputs that are obtained in exchange.

There is also no indication that anyone here is actually referencing a single thing that is "publicly funded," and simply alluding to "taxes," as an explanation. This ignores all context of how academia, grants, and research works. The research has been provided and can be readily accessed online. I am not in possession of any grants (and I doubt anyone here is either) that the lab itself may have indulged in its research process, but typically publication is all that is owed.

"Ethically, good stewardship, public interest" are all very nice words, but they really don't mean anything in the context of what is being suggested—that there is some sort of obligation in excess of whatever grant agreements were made with UMich. That simply does not exist—and if it did with strings like giving up all IP generated during research, it's likely large subsets of research wouldn't ever occur.

The idea that this extends to the commercialization/patents that are generated is not accurate and paints unreasonable expectations for how these processes work, lending only to disappointment.

 

[Watasha]

But they don't work for the public though. They work for whatever institution employs them. Their positions might be funded by grants, but there are specific outputs that are obtained in exchange.

There is also no indication that anyone here is actually referencing a single thing that is "publicly funded," and simply alluding to "taxes," as an explanation. This ignores all context of how academia, grants, and research works. The research has been provided and can be readily accessed online. I am not in possession of any grants (and I doubt anyone here is either) that the lab itself may have indulged in its research process, but typically publication is all that is owed.

"Ethically, good stewardship, public interest" are all very nice words, but they really don't mean anything in the context of what is being suggested—that there is some sort of obligation in excess of whatever grant agreements were made with UMich. That simply does not exist—and if it did with strings like giving up all IP generated during research, it's likely large subsets of research wouldn't ever occur.

The idea that this extends to the commercialization/patents that are generated is not accurate and paints unreasonable expectations for how these processes work, lending only to disappointment.

If your job depends materially on public funding, then I believe there is a social contract that exists to use those funds wisely. You're getting into the nitty gritty, and I'm simply pushing back on the idea that "we, the little taxpayer" do not mean much because we individually contribute so little of the vast revenues raised by taxes. The specifics of UMich are not as pertinent to what I'm trying to say. And that is pushing back on the general concept that simply because we contribute so little, those who use public funds can do as they please. In my opinion, the post that I was responding to is attempting to severe that bond of accountability simply because we individually contribute so little.

 

[IYIiKe]

If your job depends materially on public funding, then I believe there is a social contract that exists to use those funds wisely. You're getting into the nitty gritty, and I'm simply pushing back on the idea that "we, the little taxpayer" do not mean much because we individually contribute so little of the vast revenues raised by taxes. The specifics of UMich are not as pertinent to what I'm trying to say. And that is pushing back on the general concept that simply because we contribute so little, those who use public funds can do as they please. In my opinion, the post that I was responding to is attempting to severe that bond of accountability simply because we individually contribute so little.

I don't understand where the presumption comes that the funds aren't being used wisely. There is groundbreaking treatment that may soon be available only because of the research work performed. Claiming that funds aren't being used wisely is simply unfounded and frankly I have contemplated not responding because people just don't understand how this works. When people here are saying "publicly funded," I'm presuming they mean via grant. For the sake of argument, I have decided not to ask "are you sure it wasn't funded with tuition, donations, or private/outside funding?" and have decided to discuss grants.

The output for a grant is the research itself (re: publication), which has already occurred. The funds have been used appropriately. Expressing displeasure at the (lack of) speed of commercialization or communication prior to commercialization by UMich/its affiliates is simply unreasonable, because UMich does not owe any public person anything -- information or otherwise.

There is no social contract, there is no legal compelling factor for UMich to do frankly anything with the research they've performed -- or if they do -- at any given speed. The proof of the lack of such a thing is evident in how the current system of grant funding works.

Like it or not, tinnitus is a very niche condition/affliction compared to other afflictions. Given that most people here are outliers of the condition, the vast majority of sufferers are not bothered enough to seek treatment. As a result, treatment and cures for tinnitus is extremely low priority. In fact, so low, that without public grants it would never have likely been researched at all. Dr. Shore may have ended up researching something completely unremarkable without grants pertaining to tinnitus over the past decade. If there were not public grants that came without strings, she may not have been able to find what she has -- because she needs funding in order to sustain a position, undergraduates, care and feeding of the lab, and show she is contributing to UMich's bottom line in order to feed herself.

Well that's not fair! How is the public enhanced you ask? The grant requires the proposed recipient to not only outline a plan of research, but provides milestones that typically end with publication of their research/findings. That's it. There's no "hey because you found something that might work, you owe the public complete transparency into what you'll do for the next forever, we own the IP of anything you create!"

So let's think now about why that is. The reason that is the case is because if there were strings attached, no institution with a brain would waste the requisite manpower, lab space, time, administration, effort, et al. on something like tinnitus. They would likely flock to some other pursuit where either there were no such strings, or there were more potential for gain (like commercialization, patents, prestige, etc.) They would not waste undergraduate and professor resources on something like tinnitus without funding.

In the end the greater good is served. In the case of a breakthrough, like with the Shore Lab, the research provided will result in commercialization of such a device by Dr. Shore or others so long as there is demand. It's just a matter of time. But saying that "funds are being wasted," or "misused," is simply without any basis.

 

[Watasha]

I don't understand where the presumption comes that the funds aren't being used wisely. There is groundbreaking treatment that may soon be available only because of the research work performed. Claiming that funds aren't being used wisely is simply unfounded and frankly I have contemplated not responding because people just don't understand how this works. When people here are saying "publicly funded," I'm presuming they mean via grant. For the sake of argument, I have decided not to ask "are you sure it wasn't funded with tuition, donations, or private/outside funding?" and have decided to discuss grants.

The output for a grant is the research itself (re: publication), which has already occurred. The funds have been used appropriately. Expressing displeasure at the (lack of) speed of commercialization or communication prior to commercialization by UMich/its affiliates is simply unreasonable, because UMich does not owe any public person anything -- information or otherwise.

There is no social contract, there is no legal compelling factor for UMich to do frankly anything with the research they've performed -- or if they do -- at any given speed. The proof of the lack of such a thing is evident in how the current system of grant funding works.

Like it or not, tinnitus is a very niche condition/affliction compared to other afflictions. Given that most people here are outliers of the condition, the vast majority of sufferers are not bothered enough to seek treatment. As a result, treatment and cures for tinnitus is extremely low priority. In fact, so low, that without public grants it would never have likely been researched at all. Dr. Shore may have ended up researching something completely unremarkable without grants pertaining to tinnitus over the past decade. If there were not public grants that came without strings, she may not have been able to find what she has -- because she needs funding in order to sustain a position, undergraduates, care and feeding of the lab, and show she is contributing to UMich's bottom line in order to feed herself.

Well that's not fair! How is the public enhanced you ask? The grant requires the proposed recipient to not only outline a plan of research, but provides milestones that typically end with publication of their research/findings. That's it. There's no "hey because you found something that might work, you owe the public complete transparency into what you'll do for the next forever, we own the IP of anything you create!"

So let's think now about why that is. The reason that is the case is because if there were strings attached, no institution with a brain would waste the requisite manpower, lab space, time, administration, effort, et al. on something like tinnitus. They would likely flock to some other pursuit where either there were no such strings, or there were more potential for gain (like commercialization, patents, prestige, etc.) They would not waste undergraduate and professor resources on something like tinnitus without funding.

In the end the greater good is served. In the case of a breakthrough, like with the Shore Lab, the research provided will result in commercialization of such a device by Dr. Shore or others so long as there is demand. It's just a matter of time. But saying that "funds are being wasted," or "misused," is simply without any basis.

Respectfully, I'm not going to read your post as it's far too long. You either want to argue with me or are not understanding me and I don't have the time to go back and forth (go back and read the part of your post that I quoted when responding originally). My only point is pushing back on your point that individual taxpayers pay so little into the large pot, that that is somehow being used to justify that taxpayers don't have some sort of inherent right to transparency, stewardship, etc. and that I think it's a dangerous path to go down to sever the bonds of trust between taxpayers and those who receive said funds.

 

[IYIiKe]

Respectfully, avoid making off-topic/out-of-context comments if you wish to make innocuous replies and have no interest in continuing the discussion thereafter. Especially if you want to say you can't take the time to read a few more sentences than you have written after.

If you look at the posts receiving attention in this thread over the past few pages, they are the ones claiming Dr. Shore has failed, inciting unrealistic expectations, or outright claiming some sort of ownership of the Shore lab/information from a private company.

All of these takes are not only patently wrong and/or misguided but detrimental to the mental health of those who hope to be someday treated by the device.

For those who don't wish to be disappointed further, ignore the doomers/gloomers here and go about your life. Do not set unrealistic expectations for the device and its rollout, and take care of yourself—and ignore the one asking you to grab your pitchforks for no reason at all.

 

[Pixelito]

That doesn't look like a good sign for this being submitted to the FDA in Q1.

The amount of time it's taken to prepare for submission gives the impression that Auricle has serious concerns about this passing FDA approval. That's good. It could also very well be in submission as we speak.

Lol, Jon Pearson literally explained why Auricle haven't given any information. And, honestly, you've proven their point with your speculation and digging into their source code without knowing where they are at with any of their processes.

Until there is something real to tell us, I don't even want any more lip service that leaves us with more questions than answers. I get exactly what Pearson is saying.

 

[Jonno02]

The amount of time it's taken to prepare for submission gives the impression that Auricle has serious concerns about this passing FDA approval. That's good. It could also very well be in submission as we speak.

For non-implantable devices and pharmaceuticals, the FDA scrutinizes patient safety instead of device efficacy. Basically, all they're interested in is whether Auricle generated the appropriate data to demonstrate that it doesn't make tinnitus worse in a high proportion of users or has other serious effects.

The amount of time taken to prepare for submission doesn't suggest they have these concerns. Getting submission ready is a monumental task that requires a very specific way of presenting data and write-ups. And as you said, they may have already submitted.

We just need to sit tight.

 

[Nick47]

We should mothball this thread for 6 months.