New University of Michigan Tinnitus Discovery — Signal Timing

[BTaylor12]

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 You can share the unpublished results with prospective investors, which is perfectly normal.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.

Agree.

They could be sitting on a mountain of cash right now if they took initiative.

That is of course assuming they have faith it will be successful. Maybe they're not much more confident than the Lenire people.

 

[RunningMan]

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.

The Shore device doesn't "eliminate" ringing. For the study participants that met the eligibility requirements and followed the full protocol, it was clinically effective for 65% of the participants. The reduction in tinnitus (not an elimination) was about 5 dB to 6 dB more than the control group (placebo). That's noticeable but not a large amount as you can sample in the audio files posted earlier. It won't work for everyone. So keep your expectations in check and be patient. It could be 2 or 3 years before it's available to most people.

 

[BobbieJay-1954]

Maybe they're not much more confident than the Lenire people.

I doubt that.

As stated many times here before, the trial for Shore's device was double-blinded placebo controlled. Lenire did not feature a placebo group. That is one of the biggest things that sets them apart and why they should be more confident in their product. After all the hard work that's been put into everything surrounding the device, I do not believe it was all for nothing. I know we're all anxious but it's coming... eventually.

 

[BTaylor12]

I doubt that.

As stated many times here before, the trial for Shore's device was double-blinded placebo controlled. Lenire did not feature a placebo group. That is one of the biggest things that sets them apart and why they should be more confident in their product. After all the hard work that's been put into everything surrounding the device, I do not believe it was all for nothing. I know we're all anxious but it's coming... eventually.

I really hope you're right!

A 50% reduction would mean a lot to most of us.

 

[Pixelito]

The Shore device doesn't "eliminate" ringing. For the study participants that met the eligibility requirements and followed the full protocol, it was clinically effective for 65% of the participants. The reduction in tinnitus (not an elimination) was about 5 dB to 6 dB more than the control group (placebo). That's noticeable but not a large amount as you can sample in the audio files posted earlier. It won't work for everyone. So keep your expectations in check and be patient. It could be 2 or 3 years before it's available to most people.

Dr. Shore explained in the QA that a 6 dB reduction in real-world terms is a 50% reduction in volume. I think any of us would consider that a game-changer.

Also, I believe she said there was an average reduction of 10.9 dB in one test group if I read that part correctly.

 

[BadNeighbors]

As already mentioned, the doom and gloom is a bit odd. Science moves slow and I don't think any of us actually understand the process of getting a device to market. The problem with the division of labor in society is that we superficially understand what everyone else does and think their job is easy, but as soon as we get placed into that role there are all sorts of things that need to be done that we never realized.

Dr. Shore's cautious approach is the opposite of someone just trying to cash in on a snake oil that they can sell to desperate people. Lenire, that clinic in Korea, and some sketchy place using "stem cells" are all treatments rushed to market and we can pay for any of these "treatments" tomorrow, but there is a reason none of us are doing so. It seems to me that we'd likely leave with the same problems but with less money in our pockets.

Dr. Shore is an academic, not a business person. As someone who made the transition from academia to business, the two worlds are very far apart. And, I'd imagine she is being guided by U of Michigan who is the assignee on the patent, which I think means they own the patent, not Dr. Shore. U of Michigan probably has a whole process lined out for this and Dr. Shore probably isn't the only U Michigan Professor with something ready to go to market.

Finally, since this device was developed with tax payer money, I'd like to see the university/government get fair returns on their investment. I don't want them to sign the first deal that is put in front of them or accept some low-ball offer. I have no idea how this works, but I'd like to see the government/university get fairly rewarded for their investment in Dr. Shore's long shot research and I'd like to see those rewards spent on other long shots that a corporation would never invest in. If the NIH hadn't invested in her, who knows if we'd have anything to even cautiously hope for.

That being said, I too wish this was going faster, but I also have no clue what it takes to go from a prototype to devices actually being in medical offices helping patients. I did look up the history of the MRI machine and the guy who invented the MRI put in for the patent in 1972 (a year after he published a paper about it), the first MRI image was made in 1977, the first cancer patient scan was in 1978, 1978 FONAR (MRI manufacturer) was incorporated, the first MRI machine was available two years later in 1980, and the company went public in 1981. It took a while for this machine to get out there and this was for aliments that attract a lot more attention than ours.

 

[DeanD]

As already mentioned, the doom and gloom is a bit odd. Science moves slow and I don't think any of us actually understand the process of getting a device to market. The problem with the division of labor in society is that we superficially understand what everyone else does and think their job is easy, but as soon as we get placed into that role there are all sorts of things that need to be done that we never realized.

Dr. Shore's cautious approach is the opposite of someone just trying to cash in on a snake oil that they can sell to desperate people. Lenire, that clinic in Korea, and some sketchy place using "stem cells" are all treatments rushed to market and we can pay for any of these "treatments" tomorrow, but there is a reason none of us are doing so. It seems to me that we'd likely leave with the same problems but with less money in our pockets.

Dr. Shore is an academic, not a business person. As someone who made the transition from academia to business, the two worlds are very far apart. And, I'd imagine she is being guided by U of Michigan who is the assignee on the patent, which I think means they own the patent, not Dr. Shore. U of Michigan probably has a whole process lined out for this and Dr. Shore probably isn't the only U Michigan Professor with something ready to go to market.

Finally, since this device was developed with tax payer money, I'd like to see the university/government get fair returns on their investment. I don't want them to sign the first deal that is put in front of them or accept some low-ball offer. I have no idea how this works, but I'd like to see the government/university get fairly rewarded for their investment in Dr. Shore's long shot research and I'd like to see those rewards spent on other long shots that a corporation would never invest in. If the NIH hadn't invested in her, who knows if we'd have anything to even cautiously hope for.

That being said, I too wish this was going faster, but I also have no clue what it takes to go from a prototype to devices actually being in medical offices helping patients. I did look up the history of the MRI machine and the guy who invented the MRI put in for the patent in 1972 (a year after he published a paper about it), the first MRI image was made in 1977, the first cancer patient scan was in 1978, 1978 FONAR (MRI manufacturer) was incorporated, the first MRI machine was available two years later in 1980, and the company went public in 1981. It took a while for this machine to get out there and this was for aliments that attract a lot more attention than ours.

I think you've answered yourself why people are frustrated by the situation. It's for all those things you have mentioned.

Just because something is quick to market doesn't mean it isn't any good.

Also, this isn't the 1970s anymore. The transition time from development, to patent, to manufacture and distribution, to awareness, marketing, hype, drive and PR, can move at lightening speed by comparison - if the company behind it so desires.

 

[Tomas80]

As already mentioned, the doom and gloom is a bit odd. Science moves slow and I don't think any of us actually understand the process of getting a device to market. The problem with the division of labor in society is that we superficially understand what everyone else does and think their job is easy, but as soon as we get placed into that role there are all sorts of things that need to be done that we never realized.

Dr. Shore's cautious approach is the opposite of someone just trying to cash in on a snake oil that they can sell to desperate people. Lenire, that clinic in Korea, and some sketchy place using "stem cells" are all treatments rushed to market and we can pay for any of these "treatments" tomorrow, but there is a reason none of us are doing so. It seems to me that we'd likely leave with the same problems but with less money in our pockets.

Dr. Shore is an academic, not a business person. As someone who made the transition from academia to business, the two worlds are very far apart. And, I'd imagine she is being guided by U of Michigan who is the assignee on the patent, which I think means they own the patent, not Dr. Shore. U of Michigan probably has a whole process lined out for this and Dr. Shore probably isn't the only U Michigan Professor with something ready to go to market.

Finally, since this device was developed with tax payer money, I'd like to see the university/government get fair returns on their investment. I don't want them to sign the first deal that is put in front of them or accept some low-ball offer. I have no idea how this works, but I'd like to see the government/university get fairly rewarded for their investment in Dr. Shore's long shot research and I'd like to see those rewards spent on other long shots that a corporation would never invest in. If the NIH hadn't invested in her, who knows if we'd have anything to even cautiously hope for.

That being said, I too wish this was going faster, but I also have no clue what it takes to go from a prototype to devices actually being in medical offices helping patients. I did look up the history of the MRI machine and the guy who invented the MRI put in for the patent in 1972 (a year after he published a paper about it), the first MRI image was made in 1977, the first cancer patient scan was in 1978, 1978 FONAR (MRI manufacturer) was incorporated, the first MRI machine was available two years later in 1980, and the company went public in 1981. It took a while for this machine to get out there and this was for aliments that attract a lot more attention than ours.

We cannot look for similarities between probably the most complicated medical device (MRI) and Auricle. For me, personally, nothing can explain why Auricle's commercialization can take so long.

 

[Fightthearmy]

As already mentioned, the doom and gloom is a bit odd. Science moves slow and I don't think any of us actually understand the process of getting a device to market

Even fewer of us understand the meaning of the word 'market-ready'. Is it newspeak?

 

[RunningMan]

Dr. Shore explained in the QA that a 6 dB reduction in real-world terms is a 50% reduction in volume. I think any of us would consider that a game-changer.

I tested it with sample tones with and without -6 dB adjustment, and it's definitely lower and better when compared back to back. Mine varies by far more than 6 dB just from day to day. But, I was concerned about the wording "eliminated" and "condition is going to be gone" due to the Shore device, which looked to be setting higher expectations than the study itself showed. Also, the per protocol group was 40% points higher for the percentage of participants that had clinically significant changes in their tinnitus scores (65%) vs. the relevant control group (25%). Hopefully, we'll see better rates of significant improvement among members here.

 

[TashaJane]

As already mentioned, the doom and gloom is a bit odd. Science moves slow and I don't think any of us actually understand the process of getting a device to market. The problem with the division of labor in society is that we superficially understand what everyone else does and think their job is easy, but as soon as we get placed into that role there are all sorts of things that need to be done that we never realized.

Dr. Shore's cautious approach is the opposite of someone just trying to cash in on a snake oil that they can sell to desperate people. Lenire, that clinic in Korea, and some sketchy place using "stem cells" are all treatments rushed to market and we can pay for any of these "treatments" tomorrow, but there is a reason none of us are doing so. It seems to me that we'd likely leave with the same problems but with less money in our pockets.

Dr. Shore is an academic, not a business person. As someone who made the transition from academia to business, the two worlds are very far apart. And, I'd imagine she is being guided by U of Michigan who is the assignee on the patent, which I think means they own the patent, not Dr. Shore. U of Michigan probably has a whole process lined out for this and Dr. Shore probably isn't the only U Michigan Professor with something ready to go to market.

Finally, since this device was developed with tax payer money, I'd like to see the university/government get fair returns on their investment. I don't want them to sign the first deal that is put in front of them or accept some low-ball offer. I have no idea how this works, but I'd like to see the government/university get fairly rewarded for their investment in Dr. Shore's long shot research and I'd like to see those rewards spent on other long shots that a corporation would never invest in. If the NIH hadn't invested in her, who knows if we'd have anything to even cautiously hope for.

That being said, I too wish this was going faster, but I also have no clue what it takes to go from a prototype to devices actually being in medical offices helping patients. I did look up the history of the MRI machine and the guy who invented the MRI put in for the patent in 1972 (a year after he published a paper about it), the first MRI image was made in 1977, the first cancer patient scan was in 1978, 1978 FONAR (MRI manufacturer) was incorporated, the first MRI machine was available two years later in 1980, and the company went public in 1981. It took a while for this machine to get out there and this was for aliments that attract a lot more attention than ours.

SO WELL PUT! So well put.

 

[Pixelito]

I tested it with sample tones with and without -6 dB adjustment, and it's definitely lower and better when compared back to back. Mine varies by far more than 6 dB just from day to day. But, I was concerned about the wording "eliminated" and "condition is going to be gone" due to the Shore device, which looked to be setting higher expectations than the study itself showed. Also, the per protocol group was 40% points higher for the percentage of participants that had clinically significant changes in their tinnitus scores (65%) vs. the relevant control group (25%). Hopefully, we'll see better rates of significant improvement among members here.

Understood. Keep in mind that I was also trying to provide optimism in my reply for a member who has frequently expressed suicidal thoughts.

 

[Jonno02]

Understood. Keep in mind that I was also trying to provide optimism in my reply for a member who has frequently expressed suicidal thoughts.

To be fair, at least two people have had their tinnitus eliminated by the device in the first study, IIRC.

 

[Cmspgran]

And she said several people wanted to desperately buy the device to keep for very large sums of money too.

I honestly think, from everything I've read, it'll be someone in-between. Even somewhere in-between is light years further on from CBT, sound therapy and WNGs.

 

[Jim Vasilakis]

I will repeat it once more for the people downplaying the reduction from the device.

If you are lucky and you are among the 70% that this device helps, then there is a VERY GOOD chance that the more you use it, the more it reduces tinnitus.

Don't get too stuck on the whole "only 6 dB reduction". I highly doubt that after 6 months of non-stop use the reduction will only be 6 dB. Again IF you are affected by the device and there is a change.

 

[dd314]

70% that this device helps

Or less. Or 100%. We don't know and neither does Dr. Shore.

 

[F-u-T]

If you are lucky and you are among the 70% that this device helps, then there is a VERY GOOD chance that the more you use it, the more it reduces tinnitus.

Unfortunately after 20 years of research, no one knows the answer to this question. We probably won't know anytime soon either.

 

[Pixelito]

To be fair, at least two people have had their tinnitus eliminated by the device in the first study, IIRC.

And those test groups only had a limited exposure to the device. There is every reason to believe, and Dr. Shore has confirmed, that with extended use the success rates and reduction in volumes could increase.

Unless you simply choose not to believe the results, there is every reason to believe this will be life-changing for many of us. My expectations will remain through the roof until the day this device is in my hands and I can find out for myself.

 

[GlennS]

It's always an experience to go cold-turkey on Tinnitus Talk for 6+ months and then pop back in this thread. I do think when it comes to Susan Shore, the best approach is not to follow her progress so closely that you go through the emotional see-saw of ETAs slipping and slipping into the future. We kind of know by now this is going to take longer than we want.

 

[Joeseph Stope]

Unfortunately after 20 years of research, no one knows the answer to this question. We probably won't know anytime soon either.

A lot can happen in 20 years. Like your tinnitus problem might decline in importance -- and relevance -- if it's overshadowed by other health problems.

Still, I'm hopeful.

 

[BobbieJay-1954]

My expectations will remain through the roof until the day this device is in my hands and I can find out for myself.

I feel the same way. I have a very strong feeling that this device will work for me since a part of my tinnitus seems to have something to do with my jaw. The ability to modulate my tinnitus is one of many reasons I've been very optimistic. Even if I felt like it wouldn't help me personally, I would still advocate its potential for those it may help instead.

 

[Josh59]

In a month's time, it will be a year since the Palm Springs Hearing Seminar with the presentation of Dr. Shore's interesting results and device.

Time flies...

It's incredible that no health professionals, health organisations, media, associations, patients or forum members have any information about an approximate release date for this device. It makes you wonder whether the device will ever be released...

 

[Gb3]

In a month's time, it will be a year since the Palm Springs Hearing Seminar with the presentation of Dr. Shore's interesting results and device.

Time flies...

It's incredible that no health professionals, health organisations, media, associations, patients or forum members have any information about an approximate release date for this device. It makes you wonder whether the device will ever be released...

Statements like yours are ridiculous. Dr. Shore has stated that Auricle are in the process of working with the FDA to get approval. She has retired and has stated that she is focusing on getting this device ready for commercialization. Yes, we don't have a release date, but to say it won't ever be released is just paranoia.

 

[EDDTEKK]

I think Tinnitus Talk members are a bit disappointed at the lack of communication by Auricle. I fully understand that. I also want the device available sooner rather than later. Unfortunately, Auricle doesn't keep us informed regarding the device's status.

In terms of marketing, they could learn from Neuromod. I hope Susan Shore will live to see how the treatment works in the market.

Please also remember that the trials Dr. Shore did were not independently done. We don't know yet, besides their own published results, how well the device will really work.

 

[Tomas80]

I think Tinnitus Talk members are a bit disappointed at the lack of communication by Auricle. I fully understand that. I also want the device available sooner rather than later. Unfortunately, Auricle doesn't keep us informed regarding the device's status.

In terms of marketing, they could learn from Neuromod. I hope Susan Shore will live to see how the treatment works in the market.

Please also remember that the trials Dr. Shore did were not independently done. We don't know yet, besides their own published results, how well the device will really work.

The approaching competition, for example NUEYNE-T100, may lead Auricle to change its strategy and come to other continents earlier. Let's hope.

 

[slc]

This video on FDA timelines might be of interest.

 

[dj_newark]

Statements like yours are ridiculous. Dr. Shore has stated that Auricle are in the process of working with the FDA to get approval. She has retired and has stated that she is focusing on getting this device ready for commercialization. Yes, we don't have a release date, but to say it won't ever be released is just paranoia.

I've heard that it can take anywhere from 6 months to 2 years to prepare a submission to the FDA for a Class 2 medical device! So it appears that those saying that she has not submitted to the FDA are probably correct! But that's because the bulk of the post scientific work is preparing the FDA submission. The approval process, by contrast, goes quickly in a matter of months.

Again, we don't have enough information and I am not an FDA expert. But this seems a likely explanation as to why this is taking so long!

 

[Onguacchiat]

One thing I am not sure yet of (and maybe no one is?) is if Dr. Shore's device is targeted to somatic tinnitus only, or not.

The pre-clinical trials have been conducted on animals with somatic tinnitus; not sure about the clinical trials, though.

Does this mean that the device will work only for somatic tinnitus sufferers or not? Being my tinnitus is noise induced and not changing with any jaw/head/neck movement at all, this would be disheartening.

But I think I also read somewhere that experimenting on somatic tinnitus cases was just easier, probably because it is the easiest way to identify tinnitus in a non-human entity? I cannot find the source though.

 

[EDDTEKK]

How can you know a lab animal has somatic tinnitus?

 

[Kleiner]

One thing I am not sure yet of (and maybe no one is?) is if Dr. Shore's device is targeted to somatic tinnitus only, or not.

The pre-clinical trials have been conducted on animals with somatic tinnitus; not sure about the clinical trials, though.

Does this mean that the device will work only for somatic tinnitus sufferers or not? Being my tinnitus is noise induced and not changing with any jaw/head/neck movement at all, this would be disheartening.

But I think I also read somewhere that experimenting on somatic tinnitus cases was just easier, probably because it is the easiest way to identify tinnitus in a non-human entity? I cannot find the source though.

I asked to Dr. Shore 4 months ago if my case (noise trauma, 50% somatic and 50% non-somatic tinnitus) could benefit from this technology. She said as long as I have somatic tinnitus, the non-somatic part could benefit from it.

I read her patents/papers and I wasn't able to find the point that made her say it.

After all, it's possible that basically most tinnitus has a common place of generation but for one reason or another the somatic capacity varies, from total to almost zero.

I say that because, for example, my non-somatic tinnitus is, I think, somatic under very specific conditions (TENS stimulation with certain wave forms etc.)

The somatic/non-somatic barrier is not so clear in my opinion, many presumed non-somatic cases could be somatic to some extent, and get relief from this device.