New University of Michigan Tinnitus Discovery — Signal Timing

[Kam75]

Hi folks! I used to read this thread several times a day for years.

A few months ago, we learned of the very encouraging results of Phase II of Dr. Shore's device.

Last I heard, we were waiting for Dr. Shore to submit her device to the FDA, if I remember correctly.

What about today? I looked through the last few pages, and it appears that the device has still not been submitted to the FDA. Do we know why it's taking so long?

I stopped following this thread daily because, over the last eight months or so, I had been doing much better. My sleep was of better quality, and I was starting to live "almost" normally again (taking no risk regarding ears, of course). I even allowed myself the luxury of reducing the Mirtazapine.

But for no reason, for one month now, my sleep is again as bad as it was then, and the tinnitus is very intense again. Even when we believe that we are "cured" of this filth, destiny reminds us, at any time, that we are condemned to suffer ad vitam aeternam...

 

[IYIiKe]

Basically, even when they submit to the FDA we won't know, as the FDA does not comment on open cases, and Auricle has stated they will not say when they submit for numerous reasons. There is reason for optimism. Since it was stated to be an organizational goal to submit Q1 to the FDA, it stands to reason that even if that deadline is missed, it has been captured and is being tracked internally at Auricle and is a focus for them to do so. As a result, while there is no information -- at this stage, I would rather take it as no news is actually good news. The only other news is solidified funding for the effort, which, again -- is all positive news. Plus, with funding comes expectations it will be spent to further the way forward -- more eyes on milestones/deadlines.

Pragmatically, there is no anticipated rollout date but I wouldn't expect availability at your local major city audiology center for another two years. It may be available in niche locations a little bit earlier, but not much.

 

[Bhaveen]

Basically, even when they submit to the FDA we won't know, as the FDA does not comment on open cases, and Auricle has stated they will not say when they submit for numerous reasons. There is reason for optimism. Since it was stated to be an organizational goal to submit Q1 to the FDA, it stands to reason that even if that deadline is missed, it has been captured and is being tracked internally at Auricle and is a focus for them to do so. As a result, while there is no information -- at this stage, I would rather take it as no news is actually good news. The only other news is solidified funding for the effort, which, again -- is all positive news. Plus, with funding comes expectations it will be spent to further the way forward -- more eyes on milestones/deadlines.

Pragmatically, there is no anticipated rollout date but I wouldn't expect availability at your local major city audiology center for another two years. It may be available in niche locations a little bit earlier, but not much.

Two years? That's too long to wait. What makes you say two years?

 

[IYIiKe]

Two years? That's too long to wait. What makes you say two years?

FDA approval takes time. There can be bumps in the process, delays in communication, and many other things that can slow it down.

There's also running a company and building it from scratch. To do that, you need to hire and pay a lot of people. For obvious reasons, you don't do all of that before you even know you have a product you can sell.

Manufacturing, Distribution, Audiology Networking, Marketing, Audiology Provider Training, Insurance Outreach, Support, Refurbishment, and scaling up management for all of the before.

All of it takes time and resources, none of which you scale up to write contracts for with the most anticipated tinnitus treatment in decades until you have a green light from the FDA.

Two years is probably optimistic.

 

[Utdmad89]

FDA approval takes time. There can be bumps in the process, delays in communication, and many other things that can slow it down.

There's also running a company and building it from scratch. To do that, you need to hire and pay a lot of people. For obvious reasons, you don't do all of that before you even know you have a product you can sell.

Manufacturing, Distribution, Audiology Networking, Marketing, Audiology Provider Training, Insurance Outreach, Support, Refurbishment, and scaling up management for all of the before.

All of it takes time and resources, none of which you scale up to write contracts for with the most anticipated tinnitus treatment in decades until you have a green light from the FDA.

Two years is probably optimistic.

They could have gone on more than one front! Just in the USA is BS.

 

[dj_newark]

They could have gone on more than one front! Just in the USA is BS.

Everyone always thinks that jobs they don't do are easy.

 

[Pixelito]

FDA approval takes time. There can be bumps in the process, delays in communication, and many other things that can slow it down.

There's also running a company and building it from scratch. To do that, you need to hire and pay a lot of people. For obvious reasons, you don't do all of that before you even know you have a product you can sell.

Manufacturing, Distribution, Audiology Networking, Marketing, Audiology Provider Training, Insurance Outreach, Support, Refurbishment, and scaling up management for all of the before.

All of it takes time and resources, none of which you scale up to write contracts for with the most anticipated tinnitus treatment in decades until you have a green light from the FDA.

Two years is probably optimistic.

I think we should view 2024 as the FDA submission year. If we get a submission sometime this year, that would be great. If we also get approval this year, that's major progress. I wouldn't expect anything more in 2024. I think that's a fair expectation.

Hopefully, 2025 is the year of manufacturing, marketing, and distribution.

Realistically, if you're banking on any kind of relief anytime soon, you better hope to heal or habituate. There are far better chances of that coming before this thing does.

 

[Joeseph Stope]

Two years? That's too long to wait. What makes you say two years?

It shows you the nature of the business: someone gets a concept/idea, he has to get the contacts to find support and/or funding, after which the safety and efficacy trials begin. $Money€! Followed by the FDA approval, manufacturing, building up the marketing, educating the ENTs etc.

But I take an optimistic view. It's shorter than growing and farming California Redwood trees.

 

[candlelit]

Are we under the impression there will be a press release or something when the device is submitted to the FDA? This isn't a public company, so I'm not sure of the point, and how else would you know?

 

[Pixelito]

Are we under the impression there will be a press release or something when the device is submitted to the FDA? This isn't a public company, so I'm not sure of the point, and how else would you know?

I'm pretty sure there would only be an announcement by the FDA once the device was approved.

 

[gameover]

I'm pretty sure there would only be an announcement by the FDA once the device was approved.

We'll be able to check that ourselves on FDA webpage anyway.

 

[Utdmad89]

Everyone always thinks that jobs they don't do are easy.

I never said it was easy.

 

[IYIiKe]

They could have gone on more than one front! Just in the USA is BS.

The U.S. is a bigger market. The EU has completely different requirements for commercialization/approval, etc. To be honest, it just kind of makes sense to do the U.S. first.

 

[dj_newark]

I never said it was easy.

It was implied when you said:

They could have gone on more than one front! Just in the USA is BS.

 

[Utdmad89]

The U.S. is a bigger market.

3% of the world's population is hardly anything.

It was implied when you said:

They could have gone on more than one front! Just in the USA is BS.

Just because something is more difficult (I never said it was easy, that's your interpretation) doesn't mean it couldn't have been done!

 

[dj_newark]

Just because something is more difficult (I never said it was easy, that's your interpretation) doesn't mean it couldn't have been done!

Dr. Shore addresses this in the Q&A when the Polish Tinnitus Association asked if they could help commercializing the device in Poland:

Auricle thanks the Polish Tinnitus Association for their interest and desire to provide assistance, but at this time the Company is focused on an FDA clearance. Europe is an important market for the Company, but the European Union's updated Medical Device Regulations reveal that the pathway to clearance is neither simple nor fast relative to the United States. For certain, the Company will focus resources on an EU clearance in the future.

Remember that Auricle has a small staff, and each submission is a lot of work!

 

[IYIiKe]

3% of the world's population is hardly anything.

A couple of years old, but since words didn't do it, here's a chart with bubbles and percentages.

Nothing in the world is done for free.

 

[lymebite]

3% of the world's population is hardly anything

The US may be 3 percent of world population but it is 25 percent of world GDP.

Different ways to measure this number, but no matter how you slice it, the US is a large market.

https://www.theglobaleconomy.com/rankings/gdp_share/

 

[Anomalous]

A couple of years old, but since words didn't do it, here's a chart with bubbles and percentages.

I totally get that Auricle would want to focus on getting FDA approval first, but why are you bringing up this chart? The Michigan Tinnitus Device is, well, a device, not a drug. There are 400 million more people living in Europe than in the US, so this chart shows that the US pays the highest prices in the world for prescription drugs, whereas drug prices are highly regulated in Europe.

 

[Bhaveen]

The U.S. is a bigger market. The EU has completely different requirements for commercialization/approval, etc. To be honest, it just kind of makes sense to do the U.S. first.

But shouldn't it be about getting it into people's hands as quickly as possible, regardless of market size? Surely there's enough money in the UK/Europe to make a good business case.

 

[gameover]

I think Auricle is simply a small team with very little money. Per this thread, they got some money recently. We can hope this is bringing the FDA approval forward.

By the way, some recent tinnitus masking devices, Tinnitogram and Tinearity, took 9 and 7 months from submission to clearance, respectively (links below). This does not tell us how long will Auricle take, but suffice to say things do not tend to go through the FDA very fast.

• FDA: Tinnitogram
• FDA: Tinearity

 

[Muggumbo]

But shouldn't it be about getting it into people's hands as quickly as possible, regardless of market size? Surely there's enough money in the UK/Europe to make a good business case.

I imagine it's an issue with Auricle's size, resources, and ability to support a market across the ocean without a product at the moment. Starting a regulatory process in Europe may cost money and resources that they don't currently have. They may want to get their foot in the US market where they reside to get some revenue going before expanding into foreign markets. Hell, people in this thread are already doubting the company's ability to get their device out in the US anytime soon.

 

[IYIiKe]

I totally get that Auricle would want to focus on getting FDA approval first, but why are you bringing up this chart? The Michigan Tinnitus Device is, well, a device, not a drug. There are 400 million more people living in Europe than in the US, so this chart shows that the US pays the highest prices in the world for prescription drugs, whereas drug prices are highly regulated in Europe.

There are billions more living in China and India, but yet you are wondering why not in Europe first.

The answer is the same.

 

[Jonno02]

Even large companies don't tend to multi-submit.

The amount of resources you'd need would be astronomical. Not only to prepare the submissions, but if you get questions back at the same time from two regulators, your scientist and engineering teams will be overwhelmed and miss the return deadlines.

You do one, get it through and the documentation you've made should be 95%+ ready for any other regulator, as they all have their own preferences.

 

[Watasha]

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.

I hate to break it to you, but I can decide when and where I want to engage in or continue any conversation with anyone (unless, of course, the moderators decide to pull it). It became quite obvious to me that you either never understood or deliberately chose not to recognize the only point I was trying to make and that I was, therefore, wasting my time. Furthermore, I am under no obligation to read your replies.

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.

This may be what got you on the defensive but it was ultimately largely irrelevant to my point.

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.

I couldn't agree more. My opinion is the best thing we can all do is focus on improving ourselves physically, mentally, emotionally, spiritually, and financially so that we can help fund further research and help those who can't help themselves as opposed to endless bickering and speculation. This device has been in the works for a decade+, and what have all these words and endless speculation got us? The world keeps turning. We can either use our efforts productively or unproductively.

 

[IYIiKe]

I hate to break it to you, but I can decide when and where I want to engage in or continue any conversation with anyone (unless, of course, the moderators decide to pull it). It became quite obvious to me that you either never understood or deliberately chose not to recognize the only point I was trying to make and that I was, therefore, wasting my time. Furthermore, I am under no obligation to read your replies.

This may be what got you on the defensive but it was ultimately largely irrelevant to my point.

I couldn't agree more. My opinion is the best thing we can all do is focus on improving ourselves physically, mentally, emotionally, spiritually, and financially so that we can help fund further research and help those who can't help themselves as opposed to endless bickering and speculation. This device has been in the works for a decade+, and what have all these words and endless speculation got us? The world keeps turning. We can either use our efforts productively or unproductively.

Suggesting one is owed any information on product that may or may not have received some form of government grant because one pays taxes is what I take issue with. By doing so, you tacitly supported many opinions that the device is a failure, doomed to fail, et al. because this information has not and will not be provided (which Auricle has frankly sagely identified as to why with people contacting their employees on social media and hanging on every word in this thread.)

This opinion ultimately is emotional and not built on a legal/rational/basic understanding of how grants work.

When given an opportunity to explain your comment in the context of a nuanced, multi-post, and page and on-topic discussion, you declined and stated you couldn't be bothered to read a few more sentences. You're correct that you are free to take random potshots and conflate discussion with bickering if it does not align with your personal outlook, but that does not make it right or productive.

 

[Bhaveen]

I will say that I, for one, feel educated by some of the posts regarding timelines and it's made me consider points that I hadn't thought of before.

The positive comments may make the difference for some people getting out of bed and keep going until the device is market ready.

 

[Watasha]

Suggesting one is owed any information on product that may or may not have received some form of government grant because one pays taxes is what I take issue with. By doing so, you tacitly supported many opinions that the device is a failure, doomed to fail, et al. because this information has not and will not be provided (which Auricle has frankly sagely identified as to why with people contacting their employees on social media and hanging on every word in this thread.)

This opinion ultimately is emotional and not built on a legal/rational/basic understanding of how grants work.

When given an opportunity to explain your comment in the context of a nuanced, multi-post, and page and on-topic discussion, you declined and stated you couldn't be bothered to read a few more sentences. You're correct that you are free to take random potshots and conflate discussion with bickering if it does not align with your personal outlook, but that does not make it right or productive.

You're just not getting my very specific point. I am not saying that Dr. Shore or anyone who receives public grant money must disclose xyz. I am saying, very specifically, that your argument made that a taxpayer who contributes only a drop in the bucket in the grand scheme of taxes is not to be respected (for lack of a better word) because they contribute "so little."

Your words: "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."

My belief is this creates an atmosphere of thought that belittles the taxpayer and creates an environment of thinking that places those who receive government funds over those who contribute. I am not in any way speaking directly about Susan Shore, or anyone else who receives grant money, nor even opining on who's owed what and where specifically. Only that the fact that a taxpayer contributes just a drop in the bucket so to speak (as you said), should not place anyone else above them. It is a symbiotic relationship where both parties should be considerate of each other. Now, you're likely going to take that to mean I am in favor of what others on this board are saying regarding what Susan Shore owes the public; I am not. Only that we need to be cautious in acting like one side is more important than other. Just a high-level, philosophical thought. Nothing else.

 

[IYIiKe]

You're just not getting my very specific point. I am not saying that Dr. Shore or anyone who receives public grant money must disclose xyz. I am saying, very specifically, that your argument made that a taxpayer who contributes only a drop in the bucket in the grand scheme of taxes is not to be respected (for lack of a better word) because they contribute "so little."

Your words: "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."

My belief is this creates an atmosphere of thought that belittles the taxpayer and creates an environment of thinking that places those who receive government funds over those who contribute. I am not in any way speaking directly about Susan Shore, or anyone else who receives grant money, nor even opining on who's owed what and where specifically. Only that the fact that a taxpayer contributes just a drop in the bucket so to speak (as you said), should not place anyone else above them. It is a symbiotic relationship where both parties should be considerate of each other. Now, you're likely going to take that to mean I am in favor of what others on this board are saying regarding what Susan Shore owes the public; I am not. Only that we need to be cautious in acting like one side is more important than other. Just a high-level, philosophical thought. Nothing else.

Where I come from, many people claim "their taxes" are "being wasted." Fully-grown adults will froth at the mouth, acting as if they single-handedly prop up all manners of publicly funded entities/institutions on a thin margin of their own annual salary and believe their individual opinion on any given subject should be implemented quite vociferously. Shoot, if research funding were democratized, tinnitus would probably still believe it was caused by a bewitched ear. Having some knowledge of public grants, in the very next sentence in the post you quoted I go on to explain why government grants don't mean jack in terms of output ownership.

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.

Regardless, since you seem to notionally agree that Auricle does not owe the public anything -- a discussion of what a taxpayer is entitled to has nothing to do with this thread, so there really isn't a point to continuing the off-topic discussion about whether Joe Blow's ~18-25% of their annual salary entitles them to any number of things.

 

[gameover]

Where I come from, many people claim "their taxes" are "being wasted." Fully-grown adults will froth at the mouth, acting as if they single-handedly prop up all manners of publicly funded entities/institutions on a thin margin of their own annual salary and believe their individual opinion on any given subject should be implemented quite vociferously. Shoot, if research funding were democratized, tinnitus would probably still believe it was caused by a bewitched ear. Having some knowledge of public grants, in the very next sentence in the post you quoted I go on to explain why government grants don't mean jack in terms of output ownership.

Regardless, since you seem to notionally agree that Auricle does not owe the public anything -- a discussion of what a taxpayer is entitled to has nothing to do with this thread, so there really isn't a point to continuing the off-topic discussion about whether Joe Blow's ~18-25% of their annual salary entitles them to any number of things.

I think this point has been belabored. But it seems you just have to have the last word. We are entitled to our own opinions about the transparency or lack of it.

In the end, yes, we'll find out in due time when/if the device is approved. Hopefully such a date is not too far in the future.