New University of Michigan Tinnitus Discovery — Signal Timing

[dj_newark]

I found numerous allusions floating around, including your own, but after a systematic and sustained effort to find the alleged quote I was referring to, I'm fairly convinced it doesn't exist in this thread. If it exists, perhaps it's from an interview around December-January. (It is nowhere to be found by searching for the word "interview".)

I have more information now than when I made those allusions you quote above. I now know that FDA approval does not depend on publishing, at the time I wrote those I was not clear on that.

Dr. Shore said:

We understand the desire to know results as soon as possible, but the release of clinical-trial results is constrained. First, as reputable scientists, we will publish the findings in a relevant journal after proper peer review. Second, regulatory agencies (e.g., FDA, NIH) are careful in their reviews of novel therapies, as they should be, so all of us must be patient

Which may mean that they will wait for publication to submit to the FDA, but the meaning is not 100% clear. She could just be saying that they have to do both things, she may not have been saying that one thing has to take place after another. It seems gratuitous to wait for publication before submitting to the FDA, if it's not necessary to do so. Again, the only one who knows the truth is Dr. Shore.

 

[BadNeighbors]

While we had a really good post about the manufacturing of the device by @Jonno02, I wonder what the investment side of things look like. What do medical device investors want from Dr. Shore and what does the University of Michigan expect of her?

Is Dr. Shore's choice to wait for publication only related to an academic/personal integrity standard or does it also help gain the attention of private investors? Does University of Michigan require publication as part of the standard operating procedures when a Professor discovers something that leads to the development of a new device or product? Dr. Shore has mentioned how this affects veterans, would this be something the DoD or the VHA wanted before giving her further funding to produce the device? Would the publication of the study lead to her company being bought out by Pfizer or some other big company?

And, how much funding does she need to get everything going? 1 million? 10 million? What kind of capital does she need to get the production set up, get the distribution squared away, get the marketing done, develop training materials for audiologists, and so on? Assuming all the manufacturing was outsourced, how many employees does it take to get a company like this off the ground?

What a crazy moment for her. The product will sell itself, but how to make this into a business is a big problem to tackle.

 

[Joeseph Stope]

While we had a really good post about the manufacturing of the device by @Jonno02, I wonder what the investment side of things look like. What do medical device investors want from Dr. Shore and what does the University of Michigan expect of her?

Is Dr. Shore's choice to wait for publication only related to an academic/personal integrity standard or does it also help gain the attention of private investors? Does University of Michigan require publication as part of the standard operating procedures when a Professor discovers something that leads to the development of a new device or product? Dr. Shore has mentioned how this affects veterans, would this be something the DoD or the VHA wanted before giving her further funding to produce the device? Would the publication of the study lead to her company being bought out by Pfizer or some other big company?

And, how much funding does she need to get everything going? 1 million? 10 million? What kind of capital does she need to get the production set up, get the distribution squared away, get the marketing done, develop training materials for audiologists, and so on? Assuming all the manufacturing was outsourced, how many employees does it take to get a company like this off the ground?

What a crazy moment for her. The product will sell itself, but how to make this into a business is a big problem to tackle.

Well, the clinical trials have already been completed, I don't altogether see the problem. Once it gets FDA approval, it's up to the local audiologist -- who, I assume, has been given the basic training of how to operate it, give advice to the patient on its use etc., troubleshoot problems and so forth and off we go.

The biggest, most telling and revealing sample is the real world of tinnitus sufferers. That's us.

 

[Joshyboy]

While we had a really good post about the manufacturing of the device by @Jonno02, I wonder what the investment side of things look like. What do medical device investors want from Dr. Shore and what does the University of Michigan expect of her?

Is Dr. Shore's choice to wait for publication only related to an academic/personal integrity standard or does it also help gain the attention of private investors? Does University of Michigan require publication as part of the standard operating procedures when a Professor discovers something that leads to the development of a new device or product? Dr. Shore has mentioned how this affects veterans, would this be something the DoD or the VHA wanted before giving her further funding to produce the device? Would the publication of the study lead to her company being bought out by Pfizer or some other big company?

And, how much funding does she need to get everything going? 1 million? 10 million? What kind of capital does she need to get the production set up, get the distribution squared away, get the marketing done, develop training materials for audiologists, and so on? Assuming all the manufacturing was outsourced, how many employees does it take to get a company like this off the ground?

What a crazy moment for her. The product will sell itself, but how to make this into a business is a big problem to tackle.

I agree. I think they are aware that the team they have is not set up to get this to mass market and they are waiting and hyping it to get some big pharma company like Pfizer to swoop in and take it forward. Then Pfizer has to think about what makes them more money, a device that helps people or drugs that people have to take for life.

 

[LGuapo]

Nice to see Dr. Shore's device get more mainstream(ish) attention on a YouTube channel with almost 8 million subscribers:

 

[lolkas]

I agree. I think they are aware that the team they have is not set up to get this to mass market and they are waiting and hyping it to get some big pharma company like Pfizer to swoop in and take it forward. Then Pfizer has to think about what makes them more money, a device that helps people or drugs that people have to take for life.

The device needs to be used constantly, until something can regenerate the hearing damage somehow. I see what you are saying though.

 

[Jim Vasilakis]

The device needs to be used constantly, until something can regenerate the hearing damage somehow. I see what you are saying though.

There is no guarantee that it needs to be used constantly. People in the trials kept improving weeks after they stopped using it and changes remained months after washout.

 

[DeanD]

The device needs to be used constantly, until something can regenerate the hearing damage somehow. I see what you are saying though.

If they could find a way of making recurring income from the device, then big pharma may want to know, but one-time purchases are not in the pharmaceutical industry's interests.

That said, it would be doubtful the device is cheap, the market is not small, and recurring revenue will come from new sufferers who end up with tinnitus through the same channels everyone here has. I'm very surprised there isn't more investment interest - but Auricle are playing this incredibly tight, and very slow compared to today's fast moving industries.

I guess until there is a release and real improvements are shown in the outside world, it may be still too early doors for the big money and players to arrive.

 

[Jonno02]

If they could find a way of making recurring income from the device, then big pharma may want to know, but one-time purchases are not in the pharmaceutical industry's interests.

That said, it would be doubtful the device is cheap, the market is not small, and recurring revenue will come from new sufferers who end up with tinnitus through the same channels everyone here has. I'm very surprised there isn't more investment interest - but Auricle are playing this incredibly tight, and very slow compared to today's fast moving industries.

I guess until there is a release and real improvements are shown in the outside world, it may be still too early doors for the big money and players to arrive.

This isn't pharmaceutical. Medical device doesn't equal pharmaceutical.

There are medical device manufacturers just as large as big pharma that absolutely do operate off of one-time purchases. But every single device has a shelf life. If this device has an expected life of say 10 years - remember it may need to be used every day forever - it will wear out, break etc. So you will have repeat customers even if nobody else ever develops tinnitus. Not to mention revisions, improvements to further versions etc. that will make people upgrade.

 

[Joshyboy]

If they could find a way of making recurring income from the device, then big pharma may want to know, but one-time purchases are not in the pharmaceutical industry's interests.

That said, it would be doubtful the device is cheap, the market is not small, and recurring revenue will come from new sufferers who end up with tinnitus through the same channels everyone here has. I'm very surprised there isn't more investment interest - but Auricle are playing this incredibly tight, and very slow compared to today's fast moving industries.

I guess until there is a release and real improvements are shown in the outside world, it may be still too early doors for the big money and players to arrive.

I'll be surprised if Dr. Shore's device ever sees the light of day. I hope I'm wrong though. I have more hope in the meds coming out at this point.

 

[DeanD]

This isn't pharmaceutical. Medical device doesn't equal pharmaceutical.

I meant medical industry really, rather than core pharma of pills and potions.

Guess we all just want this to move faster than it is. Never seen a company with a potential breakthrough product move so slow without attempt at publicity or media attention.

Looks like it's just back to remaining patient and revisit here in 6 months' time.

 

[Nick47]

Never seen a company with a potential breakthrough product move so slow without attempt at publicity or media attention.

Yes, the lack of media attention on the trial results surprised me.

 

[Bambam0]

Gotta jump in a remind everyone that the study has barely been published for 4 months. The FDA won't look at a pre-submission (yes, multiple meetings occur prior to you being able to submit) meeting until then.

It is highly likely it has not been submitted. This has nothing to do with the company. It has everything to do with the FDA.

Hard as it may be, stay strong. Everything happens very slowly, then (like with Lenire) all at once.

 

[gameover]

Yes, the lack of media attention on the trial results surprised me.

Sad and disappointing. They need to push for media attention, but somebody needs to be on top of it.

I am still annoyed about the naming conflict with https://auricle.com. Don't tell me they are disputing their trademark/naming rights. I honestly liked Michigan Tinnitus Device, pretty clear right away what it is for.

Who knows, maybe https://auricle.com will deliver a hearing restoration solution (although it looks like some small time operation in a very early stage, 8 people listed on LinkedIn), and thus remedy for tinnitus before https://auricle-inc.com bothers to put up a webpage...

 

[JimmyStrong]

That would be so disappointing, not to mention embarrassing for them. They've had since 2019 to "prepare" that documentation and perfect it along the way. I am going to hope that this is not the case for their situation. Our community needs and deserves a true wave of hope and general timeline for treatment/intervention. We shouldn't have to literally beg for it or just be left in the dark continuously. People are literally killing themselves due to this condition. I'm so sick and tired for all of us.

We really are left in the dark.

 

[Jonno02]

We really are left in the dark.

Unfortunately the objective, cold, hard truth is that Susan Shore owes us nothing. She has no requirement to keep us updated, although we're all desperate for some news.

 

[Pixelito]

Auricle, Inc., the privately-held company that is the exclusive licensee of the patents related to The Shore Lab's tinnitus therapy, is engaging with the FDA concerning a regulatory clearance. The Company is not, however, providing guidance or other information concerning the status of its engagement. It is not appropriate for companies in the midst of negotiations with the FDA to forecast or otherwise publicly speculate on the terms and conditions that may lead to a clearance.

Does anyone interpret this quote as a possible sign it has been submitted and offer an explanation as to why they haven't made an announcement pertaining to the submission?

 

[InNeedOfHelp]

I agree. I think they are aware that the team they have is not set up to get this to mass market and they are waiting and hyping it to get some big pharma company like Pfizer to swoop in and take it forward. Then Pfizer has to think about what makes them more money, a device that helps people or drugs that people have to take for life.

Who is hyping what? Where do you see hype from Auricle? We obviously set the bar of expectation way too high.

They clearly fundraised at the wrong location and there is apparently no large company as an investor behind this. It points to private equity that provided some funding for the first few units and that's it.

16 months after completion of a Class 2 device trial, apparently with pre-FDA alignment, and with a equivalent (bimodal stimulation) approved, and still no FDA approval to me shows mismanagement in setting up Auricle. Everything is pointing towards an extremely soft launch, piece by piece, in the US only. I certainly don't hope for channeling through audiologists. It's a neurological disease and this should be treated by a neurologist or in worst case an ENT.

Gotta jump in a remind everyone that the study has barely been published for 4 months. The FDA won't look at a pre-submission (yes, multiple meetings occur prior to you being able to submit) meeting until then.

It is highly likely it has not been submitted. This has nothing to do with the company. It has everything to do with the FDA.

Hard as it may be, stay strong. Everything happens very slowly, then (like with Lenire) all at once.

You don't need a published study for FDA submission. Anyone who waits for that is very incompetent. It has nothing to do with the FDA. It has everything to do with the company.

The secrecy around the FDA submission is plain stupidity too. Announcing a FDA submission does not increase the chance of the FDA claiming that you are promoting an unapproved product as Dr. Shore says. That is probably some instructions she got from her FDA "expert."

I try not to be pessimistic, but at this pace, in Europe, XEN1101 will see the light way before this device. Let a commercial company handle a worldwide market launch and approval, and let her scientific team stay in the lab and do science. Sell your patent and technique, set your pride apart and let a capable healthcare company take this up to market.

This approach of mismanagement affects people that are in urgent need of support.

Come on, even the treatment protocol/doses is not known. What will the instructions be? Use it for 6 weeks as in the trial? And then you stop? Because you did not test longer, we don't know the impact. Will 10 weeks give a better effect? Will the tinnitus eventually rebound and come back? Do we need to use it as maintenance every 2-3 weeks? The set up of the trial was so bad that no treatment protocol ("doses') came out on how to actually use the device. How on earth will the FDA approve a device with no known protocol?

Look at XEN1101 and SPI-1005. They have months and years of open label extensions after their trials to gather data. They are prepared.

 

[AnthonyMcDonald]

I don't really understand the doom & gloom and the speculations on this thread. Susan Shore isn't a massive multi-billion dollar corporation. I'm sure she's doing her best to bring it to market. I see no reason for her to delay the process any further. She's not getting any younger, and I'm sure she sees the massive sales potential of her device and would love to reap the rewards as soon as possible & sip cocktails on a beach in Italy. Being confident in your work is one thing, but starting massive marketing campaigns before your device is even approved is silly.

 

[Josh59]

I don't live in the United States but I'd like to know what the American Tinnitus Association thinks about Dr. Shore's device? I suppose they know about it?

 

[DimLeb]

I don't live in the United States but I'd like to know what the American Tinnitus Association thinks about Dr. Shore's device? I suppose they know about it?

I don't think they would care to learn about it.

They are okay with what they currently showcase - CBT, sound "therapy" and other yoga crap.

 

[Jonno02]

I don't live in the United States but I'd like to know what the American Tinnitus Association thinks about Dr. Shore's device? I suppose they know about it?

ATA and BTA will probably hate it, because it'll mean less donations for them to do sweet FA with. Instead, people will spend their money on Susan Shore's device.

 

[Joeseph Stope]

ATA and BTA will probably hate it, because it'll mean less donations for them to do sweet FA with. Instead, people will spend their money on Susan Shore's device.

An alternative outcome might be that the Shore device will help some percentage of us, the remainder will be left thumping keyboards... so if you are fortunate to belong to the lucky winners, well don't forget us. Pleeeeeeezzz.

 

[Blix M. Paraglot]

I don't live in the United States but I'd like to know what the American Tinnitus Association thinks about Dr. Shore's device? I suppose they know about it?

They have published one article about her research on their website and awarded her two grants, totaling approximately $100,000, out of over six million dollars donated to research over the past thirty-five years. So, yes, they know about her research and support it.

 

[BobbieJay-1954]

I don't really understand the doom & gloom and the speculations on this thread. Susan Shore isn't a massive multi-billion dollar corporation. I'm sure she's doing her best to bring it to market. I see no reason for her to delay the process any further. She's not getting any younger, and I'm sure she sees the massive sales potential of her device and would love to reap the rewards as soon as possible & sip cocktails on a beach in Italy. Being confident in your work is one thing, but starting massive marketing campaigns before your device is even approved is silly.

 

[Pixelito]

Don't underestimate greed. I have no idea what's going on, but there are multiple parties involved, so I would not be so sure everyone is on the same team. Point is - waiting to gain a bigger share may be an acceptable strategy for one or more party. Pure speculation, we do not know what is going on, but Dr. Shore being so tight-lipped is worrisome. There is nothing that prevents them from saying "we submitted to FDA". If they are not saying it, I suspect (speculate) they have not.

There is also the possibility that they are all in sync and everybody is on the same team indeed (I hope so!). But maybe they have not attracted suitable (in their minds, or at all) investment to make it possible to move things along yet, including making submission to FDA. Especially in the new monetary regime, where money is more expensive. Hard to believe Lenire could attract investment, but they have a ready product (even if fraudulent), while Auricle evidently does not.

All speculation. But without concrete information that things are moving along, we have no reason to believe anything positive.

And the fact that http://auricle-inc.com still has no webpage has me concerned. Sure, web presence and marketing might not be a top priority, but it should be arguably a high one - to let the world know they are serious and they are coming with a killer product. So far - nothing there.

She said in the Q&A that they have no immediate plans for a website. I wouldn't expect a website to go live until they have an actual product to sell.

 

[gameover]

When you think about the whole thing, it is ridiculous. They could have submitted to the FDA even before publishing the paper. It would have been approved by now. They should have lined up investment, again before publishing the paper. You can share the unpublished results with prospective investors, which is perfectly normal. That's how you get ahead. To think if they had done it, the device could be basically available now and lives could be saved.

Capitalism or not, I find it deeply unethical to sit on a lifesaving invention, while people wither away and some die.

Sadly, Dr. Shore is not Jonas Salk.

People, don't forget a patent is running down with every day that passes. I'm sure it was granted a few years ago. That patent loses potential income with each passing day. Delays are not advantageous to any party. In addition, treatments are progressing through clinical trials and some will come to market, further squeezing the earning potential of Auricle.

Finally, the Chinese will be busy making their own devices as they care not for copyright infringements.

The patent expires in 2034. They apparently applied in 2014.

Source:

https://patents.google.com/patent/US9242067B2/en

 

[Pixelito]

There is no guarantee that it needs to be used constantly. People in the trials kept improving weeks after they stopped using it and changes remained months after washout.

What I want to know is what happens when you experience loud environments after the treatment. Eliminating ringing is wonderful. The next question is, can I have my old life back? I'm not talking about going to concerts, but at least be able to dine in crowded restaurants, hang out in a bar, or enter any crowded or noisy room without fumbling for my earplugs.

 

[Jim Vasilakis]

What I want to know is what happens when you experience loud environments after the treatment. Eliminating ringing is wonderful. The next question is, can I have my old life back? I'm not talking about going to concerts, but at least be able to dine in crowded restaurants, hang out in a bar, or enter any crowded or noisy room without fumbling for my earplugs.

It depends on the level of hearing loss you have. The device calms down cells, it doesn't repair hearing loss. I guess a bar is safe but a club or a concert wouldn't be advised even if your tinnitus went away. At least until a hearing regenerative drug comes up.

 

[spedgas]

Worried the timeframe here is going to push me into the arms of Lenire.