New University of Michigan Tinnitus Discovery — Signal Timing

[Pixelito]

Is it time to worry now?

Yes.

This year really flew by, didn't it? I'm sure the next few will too.

 

[BadNeighbors]

I still believe that since the University of Michigan owns the patent for this device, their Innovation Partnership might be leading efforts to bring it to market.

However, I worry that, like many university departments, the University of Michigan's Innovation Partnership is severely underfunded and understaffed. This is a press release the Innovation Partnership released last year about the device.

The funding situation for university inventions looks dismal. For example, their "up to $250,000 for mid-stage funding" program is a drop in the bucket. To put that into perspective, my company spent a minimum of $25 million per year, and likely closer to $200 million, developing an all-digital application over two years. A device like this should have at least a few million dollars behind it. A small startup of 12 people could easily burn through $250,000 in just a few weeks.

I also think organizations like Spotify, Capitol Records, or others in the music industry could easily pitch in funding. They would stand to gain goodwill with musicians and fans who suffer from tinnitus. The minimal funding offered by the university would only make sense if it functions like the Bipartisan Infrastructure Law, offering support to somewhat risky but potentially profitable technologies to encourage private investment. It cannot be the primary investment itself; it must serve as a seal of approval to signal to real investors that this project is worth supporting. I wonder how much we would need as angel investors to influence the University of Michigan and get this moving.

Another thought: Does Tim Walz know about this device? Regardless of politics, he is a well-known figure, a veteran suffering from tinnitus, and the governor of a state renowned for its medical innovation. See this and this for context. While governors do not hand out grants, Walz's network could help connect Dr. Shore's device with medical investors, companies, and individuals who could accelerate its development. Why are we not lobbying him? We should all be camping outside his office to get a few minutes of his time and make him aware of this device.

The lack of awareness is a real issue. If the last three audiologists I visited, including one who is a professor, were unaware of Dr. Shore's device, I doubt Walz knows about it either.

 

[Tryn2BHopeful]

My daughter was born the year this thread started. I pray we see this come out before she goes to college...

 

[withintention]

I still believe that since the University of Michigan owns the patent for this device, their Innovation Partnership might be leading efforts to bring it to market.

However, I worry that, like many university departments, the University of Michigan's Innovation Partnership is severely underfunded and understaffed. This is a press release the Innovation Partnership released last year about the device.

The funding situation for university inventions looks dismal. For example, their "up to $250,000 for mid-stage funding" program is a drop in the bucket. To put that into perspective, my company spent a minimum of $25 million per year, and likely closer to $200 million, developing an all-digital application over two years. A device like this should have at least a few million dollars behind it. A small startup of 12 people could easily burn through $250,000 in just a few weeks.

I also think organizations like Spotify, Capitol Records, or others in the music industry could easily pitch in funding. They would stand to gain goodwill with musicians and fans who suffer from tinnitus. The minimal funding offered by the university would only make sense if it functions like the Bipartisan Infrastructure Law, offering support to somewhat risky but potentially profitable technologies to encourage private investment. It cannot be the primary investment itself; it must serve as a seal of approval to signal to real investors that this project is worth supporting. I wonder how much we would need as angel investors to influence the University of Michigan and get this moving.

Another thought: Does Tim Walz know about this device? Regardless of politics, he is a well-known figure, a veteran suffering from tinnitus, and the governor of a state renowned for its medical innovation. See this and this for context. While governors do not hand out grants, Walz's network could help connect Dr. Shore's device with medical investors, companies, and individuals who could accelerate its development. Why are we not lobbying him? We should all be camping outside his office to get a few minutes of his time and make him aware of this device.

The lack of awareness is a real issue. If the last three audiologists I visited, including one who is a professor, were unaware of Dr. Shore's device, I doubt Walz knows about it either.

@BadNeighbors, it is likely that Innovation Partnership is no longer the sole investor at this point. It seems Auricle was trying to attract additional investment back in 2021, based on this video:



Who knows how successful they were, but it is quite possible that they now have more investors onboard besides Innovation Partnership.

That said, they do seem to be taking their time and only have a couple of employees. This is probably because they do not have enough funding to move faster. However, they would have burned through $250,000 very quickly. There must be more funding in the mix to keep them going.

 

[ccpjc]

My daughter was born the year this thread started. I pray we see this come out before she goes to college...

I pray we see any type of treatment that actually works.

 

[dd314]

I've been out of the loop on this for a while. What do we think now? 2030? 2050?

 

[Joey72]

I've been out of the loop on this for a while. What do we think now? 2030? 2050?

Looking glum.

 

[withintention]

I'll focus on the positive side! They hired a new mechanical engineer last year, and Dr. Shore gave a public talk about the research that led to the development of the device. Although they are unwilling to share details about their planned FDA submission—which is disappointing—I still see these as positive signals.

 

[ccpjc]

Looking glum.

I'm going to assume this is due to the less-than-ideal results of Lenire.

 

[BadNeighbors]

@BadNeighbors, it is likely that Innovation Partnership is no longer the sole investor at this point. It seems Auricle was trying to attract additional investment back in 2021, based on this video:

Who knows how successful they were, but it is quite possible that they now have more investors onboard besides Innovation Partnership.

That said, they do seem to be taking their time and only have a couple of employees. This is probably because they do not have enough funding to move faster. However, they would have burned through $250,000 very quickly. There must be more funding in the mix to keep them going.

I wonder if we can still get in on the ground floor, either as individuals or as a group.

It would be an interesting silver lining to all our suffering if we could reap the rewards of investing in this device early on. Could we form an LLC or another type of legal entity, buy shares within that entity, and then have it invest collectively in Auricle? I imagine we'd need to invest as a group since few of us likely have large sums of cash readily available to invest individually.

On another note, while clicking around, I saw that Michigan recently passed a bill to invest in new companies. Auricle supported this bill, and hopefully, for our sake, they'll be able to access those funds. The more support we can provide to new companies aiming to improve lives, the better. Way to go, Michigan!

 

[dd314]

I'm going to assume this is due to the less-than-ideal results of Lenire.

Lenire and Auricle operate in different ways. Lenire works by increasing hyperactivity in the dorsal cochlear nucleus (DCN) to distract the brain from tinnitus. In contrast, Auricle reduces hyperactivity, aiming to address the underlying issue directly.

 

[withintention]

In the US, investing in a pre-IPO company typically requires being an Accredited Investor, which involves meeting certain income or net worth criteria.

A straightforward approach might be to determine how many of us are interested in investing and calculate the total amount we could contribute. With that figure in hand, we could approach the CEO to gauge their interest. If the CEO is open to the idea, the next step would be to form an LLC to finalize the deal.

However, it's worth noting that the company might not be seeking additional funding at this stage, as bringing in more investors could dilute the equity of the existing shareholders.

 

[Joey72]

I'm going to assume this is due to the less-than-ideal results of Lenire.

That's what I'm thinking. Even though the devices are different, the FDA may be more cautious about approving the Shore device after witnessing the failure of Lenire.

 

[captain macarena]

Lenire may not be the overwhelming success we all hoped for, but it is still a treatment option—though a very expensive one. Some people might not be satisfied with how the research study was designed, such as the absence of a placebo group, or with how the results were reported (e.g., "91.5% of patients experienced a meaningful reduction in tinnitus after 12 weeks of treatment with Lenire").

However, it is an FDA-approved treatment option, and there are individuals who have benefited from it.

 

[Jonno02]

That's what I'm thinking. Even though the devices are different, the FDA may be more cautious about approving the Shore device after witnessing the failure of Lenire.

The FDA does not care about commercial success.

Their primary concern is determining whether the device poses an unacceptable risk of negative impacts to the end user.

 

[UKBloke]

Obviously speculation, but based upon the available facts and balance of probability, this is the situation as I personally see it:

Regarding trial criteria, the UMich team set the bar of clinically significant effect as low as possible. This is detailed in one of the post-trial Q&As Susan Shore gave Tinnitus Hub. Although in itself, the point is perhaps not too significant, I don't think it can be overlooked.

We know that the gold standard for clinical trials is to be double-blind, placebo-controlled, and crossover after a period of washout. Again, for reasons Susan Shore detailed in the Q&A, post-washout data in the last trial cannot be considered. So here we are.

When Susan Shore discussed the invalidated crossover, i.e. a 50% loss of the trial data, it appeared to me at the time that she was spinning the situation quite positively. On my side, however, I was very disappointed, and although I'd stop short of labeling the trial a failure, I think avoidable errors were made. I should just say that I don't wish to discuss my perspective on that particular point because it will only generate an argument that I think is counter-productive at this moment in time.

Taking the above into consideration, perhaps the most pressing question from a research and regulator point of view is, what the heck do we do now?

Based on the last trial data, I think it's pretty clear the FDA cannot certify the device to the highest standard for efficacy and safety in humans. On that point, I don't know if the USA is similar to Europe in as much as it would be possible to certify the current device to a lower "CE" type of standard? If that were the case I would suggest the options going forward are relatively clear.

The FDA (or whatever other governing body) can certify the device "as is" to a less rigorous (although apparently safe for the patient) standard and thus allow Auricle to market. Or, the FDA could demand another clinical trial. What Auricle chooses to do is then ultimately up to them.

I find it hard to accept that Susan Shore, who at times over the years has seemed almost robotic when asserting her dedication to proper science and clinical testing, would want anything less than 100% useable data from a completed trial. To get her way on that would clearly require more money, which is where Jon Pearson comes in.

I've very little to say about Jon Pearson because there's not a great deal of information out there about him as far as I can tell. I do find it rather curious that the CEO of a medical device manufacturing company is pitched as an Entrepreneurial Senior Leader, though. I'm not a fan of this kind of language because there is a world of difference between being entrepreneurial and being an entrepreneur.

Regardless of whose pockets any additional money may come out of (I'd like to make it known that I won't be investing), I'm leaning towards the idea that UMich/Auricle will eventually announce the need for further research to solve the washout problem followed by an additional clinical trial. It's probably not what people want to hear, but I believe this is where we're at.

 

[IYIiKe]

Based on the last trial data, I think it's pretty clear the FDA cannot certify the device to the highest standard for efficacy and safety in humans.

Based on what?

You have no idea if the device has even been submitted, or if any communication between Auricle and the FDA has occurred.

Much like the several last pages, there is a bunch of wild speculation with no basis.

Maybe that guy six months ago was right, and the thread should just be locked for a year.

 

[Nick47]

I'm leaning towards the idea that UMich/Auricle will eventually announce the need for further research to solve the washout problem followed by an additional clinical trial. It's probably not what people want to hear, but I believe this is where we're at.

@UKBloke, something Berthold Langguth said during his Q&A with Tinnitus Quest really caught my attention. While discussing Auricle, he mentioned that we won't truly know its efficacy until a larger trial is conducted (or something along those lines). A Freudian slip, perhaps?

 

[UKBloke]

Based on what?

Based on 50% of the pivotal trial data being unusable.

You have no idea if the device has even been submitted, or if any communication between Auricle and the FDA has occurred.

We don't need to know about that. 50% of the data is unusable. Whatever they have been working towards cannot now be delivered.

Much like the several last pages, there is a bunch of wild speculation with no basis.

Read the first line of my post again. Then consider the facts and weigh these against the balance of probability. Then consider that until this thread is locked the debate is open. But before you do that, consider some previous posts here talking about financing this operation. If you manage to get that far without whipping yourself into a lather, put the financing question into the context of what went down with Frequency Therapeutics.

I've steered clear of this thread for a long time now. But when people start talking about financing, I'm going to step in and make my own personal point of view public. I'd suggest you start taking a couple of hours prior to replying so you can think before speaking.

 

[captain macarena]

Obviously speculation, but based upon the available facts and balance of probability, this is the situation as I personally see it:

Regarding trial criteria, the UMich team set the bar of clinically significant effect as low as possible. This is detailed in one of the post-trial Q&As Susan Shore gave Tinnitus Hub. Although in itself, the point is perhaps not too significant, I don't think it can be overlooked.

We know that the gold standard for clinical trials is to be double-blind, placebo-controlled, and crossover after a period of washout. Again, for reasons Susan Shore detailed in the Q&A, post-washout data in the last trial cannot be considered. So here we are.

When Susan Shore discussed the invalidated crossover, i.e. a 50% loss of the trial data, it appeared to me at the time that she was spinning the situation quite positively. On my side, however, I was very disappointed, and although I'd stop short of labeling the trial a failure, I think avoidable errors were made. I should just say that I don't wish to discuss my perspective on that particular point because it will only generate an argument that I think is counter-productive at this moment in time.

Taking the above into consideration, perhaps the most pressing question from a research and regulator point of view is, what the heck do we do now?

Based on the last trial data, I think it's pretty clear the FDA cannot certify the device to the highest standard for efficacy and safety in humans. On that point, I don't know if the USA is similar to Europe in as much as it would be possible to certify the current device to a lower "CE" type of standard? If that were the case I would suggest the options going forward are relatively clear.

The FDA (or whatever other governing body) can certify the device "as is" to a less rigorous (although apparently safe for the patient) standard and thus allow Auricle to market. Or, the FDA could demand another clinical trial. What Auricle chooses to do is then ultimately up to them.

I find it hard to accept that Susan Shore, who at times over the years has seemed almost robotic when asserting her dedication to proper science and clinical testing, would want anything less than 100% useable data from a completed trial. To get her way on that would clearly require more money, which is where Jon Pearson comes in.

I've very little to say about Jon Pearson because there's not a great deal of information out there about him as far as I can tell. I do find it rather curious that the CEO of a medical device manufacturing company is pitched as an Entrepreneurial Senior Leader, though. I'm not a fan of this kind of language because there is a world of difference between being entrepreneurial and being an entrepreneur.

Regardless of whose pockets any additional money may come out of (I'd like to make it known that I won't be investing), I'm leaning towards the idea that UMich/Auricle will eventually announce the need for further research to solve the washout problem followed by an additional clinical trial. It's probably not what people want to hear, but I believe this is where we're at.

@UKBloke, you may very well be correct in your assessment, and it sounds like you have a solid understanding of research and clinical trials. However, this thread began in 2013, so I hope you're wrong and the FDA approves the Shore device in 2025.

I haven't used Lenire (I couldn't afford it), but I personally know an audiologist who has seen patients experience improvements from using it. Lenire's FDA approval does set a precedent, and while it's different from the Shore device, it is similar in that both are bimodal stimulation devices. The key difference seems to be that the Shore device targets the area where tinnitus is thought to originate (the dorsal cochlear nucleus), whereas Lenire is designed to refocus the brain away from the sound.

If the Shore device can help some people with tinnitus and is proven safe, I hope the FDA approves it, providing another treatment option for those who suffer.

 

[Jonno02]

Based on the last trial data, I think it's pretty clear the FDA cannot certify the device to the highest standard for efficacy and safety in humans. On that point, I don't know if the USA is similar to Europe in as much as it would be possible to certify the current device to a lower "CE" type of standard? If that were the case I would suggest the options going forward are relatively clear.

There is nothing in the data released from Dr. Shore's publications to suggest that the treatment or device is unsafe. Efficacy and safety are entirely separate considerations. The FDA would question the safety of the device only if, for example, a certain percentage of the population experienced something like seizures during the treatment window. The clinical significance criteria appear to follow industry standards and are based on statistical analysis formulas, not something cherry-picked by Dr. Shore's team in this instance.

There is no less rigorous regulatory pathway in the EU compared to the United States. In Europe, you must comply with the Medical Device Regulations (MDR) and submit through an accredited sponsor organization. Both the FDA submission process and the EU regulatory process are massive undertakings.

 

[IYIiKe]

Based on 50% of the pivotal trial data being unusable.

We don't need to know about that. 50% of the data is unusable. Whatever they have been working towards cannot now be delivered.

Read the first line of my post again. Then consider the facts and weigh these against the balance of probability. Then consider that until this thread is locked the debate is open. But before you do that, consider some previous posts here talking about financing this operation. If you manage to get that far without whipping yourself into a lather, put the financing question into the context of what went down with Frequency Therapeutics.

I've steered clear of this thread for a long time now. But when people start talking about financing, I'm going to step in and make my own personal point of view public. I'd suggest you start taking a couple of hours prior to replying so you can think before speaking.

9-10 paragraphs of baseless speculation. You have no idea what is required/what the FDA will or will not do.

Great. I can't wait for next week's iteration of the same.

 

[UKBloke]

@UKBloke, something Berthold Langguth said during his Q&A with Tinnitus Quest really caught my attention. While discussing Auricle, he mentioned that we won't truly know its efficacy until a larger trial is conducted (or something along those lines). A Freudian slip, perhaps?

Did anybody press him on that comment? I can't remember...

it sounds like you have a solid understanding of research and clinical trials. However, this thread began in 2013, so I hope you're wrong and the FDA approves the Shore device in 2025.

I've just done what I felt I had to and acquaint myself with these processes since Neuromod really started to look like a serious contender six or seven years ago (or however long it was).

Regarding the age of this thread, you're quite right. But it's always worth remembering that Susan Shore based her work on 15 years of prior research, so cumulatively, we're currently looking at around 27 years of knowledge-building in her specific area.

I haven't used Lenire (I couldn't afford it), but I personally know an audiologist who has seen patients experience improvements from using it.

It would be interesting if your audiologist friend was willing to share some details of what they're observing in that regard. Questions like, what does the average time since tinnitus onset appear to be for those patients using Lenire? And, is the audiologist using any kind of tinnitus loudness measure, like MML for example, prior to and after treatment?

Great. I can't wait for next week's iteration of the same.

Have you considered not visiting this website at all and instead signing on for updates direct from Auricle?