New University of Michigan Tinnitus Discovery — Signal Timing

[Bob3382]

For almost a year, I was checking these sites every Monday, looking for a device by Auricle. If you simply click "search," it will list all of the devices recently approved by the FDA under that category, and it updates with new ones every Monday.

These days, I only check about once a month. However, I just checked again, and there is no reduction in the number of devices being approved (although there is still no Auricle device), so I think the recent cuts have not affected how many devices are being approved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

 

[Mathew Gould]

After the recent cuts at the FDA, I think the chances of this device getting approved through the FDA in the next two to three years are pretty much gone. Sorry to be a pessimist, but the FDA process is already slow enough. With even less staff and funding, I cannot even begin to guess a rough timeline now. And that is just considering the current cuts. I expect more rounds throughout Trump's presidency, which could push things back even further. Given the direction he is heading, I do not even know if the FDA will still exist in the next two to three years.

This makes me wonder: Is there any chance Susan Shore's research and device could be picked up and approved in another country instead of the US? It would be such a waste for this potentially groundbreaking treatment to disappear just because Americans overwhelmingly (I mean, he even won the popular vote) decided they wanted a dictator in charge.

I do not really know why I am asking all this. The US is in serious trouble right now. If Project 2025 is fully implemented (it is already 35 percent complete according to the trackers) and Republicans move into their second phase, tinnitus will be the least of people's concerns if they end up living under a fascist regime.

Anyway, I am supposed to be on a sabbatical from Tinnitus Talk this year. It is just hard to stay away from here and from the news in general when the world seems to be going crazy.

Susan Shore has been messing around with this for a quarter of a century. It is unlikely that it will ever be released, and if it is, the first version of the device will probably be far from effective.

 

[Switty]

This might be a strange thought, but has anyone considered trying to put pressure on the Trump administration to fast track this through the FDA? He is no stranger to executive overreach, and I can't help but feel like he is the type who might do it just to boost his cult of personality.

It would be painful to hear him say, "I cured tinnitus!" at every speech from that point forward, but honestly, that seems like a small price to pay for at least having the chance to try a treatment.

If you have an impulsive populist who loves to take personal credit for victories running the country, why not play the hand you're dealt? Then again, I suppose his big business interests could easily create a conflict.

 

[IYIiKe]

This might be a strange thought, but has anyone considered trying to put pressure on the Trump administration to fast track this through the FDA? He is no stranger to executive overreach, and I can't help but feel like he is the type who might do it just to boost his cult of personality.

It would be painful to hear him say, "I cured tinnitus!" at every speech from that point forward, but honestly, that seems like a small price to pay for at least having the chance to try a treatment.

If you have an impulsive populist who loves to take personal credit for victories running the country, why not play the hand you're dealt? Then again, I suppose his big business interests could easily create a conflict.

The FDA is cutting staff and losing reputable researchers left and right. The top vaccine researcher just resigned because the head of the agency literally believes in discredited pseudoscience and is pushing the FDA to adopt it.

The person in charge is an anti-vaxxer and the kind of person who seriously suggests that "sunlight and eating right" are all you need, while the EPA is being dismantled and deregulated at the same time. If you think RFK Jr.'s neurological issues are concerning because of his dysphonia, wait until you see what happens to Americans in the coming decades. Measles had been practically eradicated by the year 2000.

They clearly do not care about people who are not wealthy. The only chance anything would change is if RFK Jr., the former president, or Melania developed tinnitus.

 

[lymebite]

This might be a strange thought, but has anyone considered trying to put pressure on the Trump administration to fast track this through the FDA? He is no stranger to executive overreach, and I can't help but feel like he is the type who might do it just to boost his cult of personality.

It would be painful to hear him say, "I cured tinnitus!" at every speech from that point forward, but honestly, that seems like a small price to pay for at least having the chance to try a treatment.

If you have an impulsive populist who loves to take personal credit for victories running the country, why not play the hand you're dealt? Then again, I suppose his big business interests could easily create a conflict.

I think that is a good idea, but from what I have gathered through discussions in patient support groups, the delay does not seem to be with the FDA. It appears to be with Susan Shore and Auricle. My understanding is that they still have not submitted their application to the FDA. We cannot blame the FDA until Auricle submits something for them to review.

Nobody seems to know why the application has not yet been submitted.

 

[Kam75]

This might be a strange thought, but has anyone considered trying to put pressure on the Trump administration to fast track this through the FDA? He is no stranger to executive overreach, and I can't help but feel like he is the type who might do it just to boost his cult of personality.

It would be painful to hear him say, "I cured tinnitus!" at every speech from that point forward, but honestly, that seems like a small price to pay for at least having the chance to try a treatment.

If you have an impulsive populist who loves to take personal credit for victories running the country, why not play the hand you're dealt? Then again, I suppose his big business interests could easily create a conflict.

Honestly, and sadly, no one seems to care about tinnitus.

There are illnesses that receive much more attention and interest, such as AIDS, cancer, and others. Finding cures for those conditions is seen as highly rewarding. But tinnitus? Most people simply do not care. Many are not even aware that it exists.

Even medical students rarely discuss tinnitus during their university studies, largely because there is still no scientific consensus on its underlying mechanism.

On top of that, Trump has other priorities to promote himself, such as ending the war in Ukraine or attempting to take over Greenland.

 

[ZFire]

Getting corporate interests out of our government-funded research IS a good thing.

Cutting childhood cancer research, was it?

 

[Nick47]

My understanding is that they still have not submitted their application to the FDA. We cannot blame the FDA until Auricle submits something for them to review.

Nobody seems to know why the application has not yet been submitted.

This is the most sensible comment I have read on this thread in a long time.

The trial ended three years ago.

Think about that, or focus on other avenues until there is an update.

 

[withintention]

You only get one chance to launch a new product.

I have been at five startups, and we always wished we could take more time to get things right before launching. However, investors often pushed for an early release. The long-term cost to the business of losing a couple of years of revenue is minimal compared to the cost of recalling a product or receiving bad press. Unfortunately, many venture capitalists become panicky and push companies to make short-term decisions that end up harming the business in the long run.

Auricle hired someone last year to work on ambient sound rejection and electromagnetic interference. These were clearly two areas where they saw room for improvement. If they have smart, patient investors, as it seems they do, and they are choosing to make improvements before the product is released, I think that is a very good sign for the company's future.

 

[Joergen]

This is the most sensible comment I have read on this thread in a long time.

How is it sensible to assume something based on speculation within a patient group? There is a flip side to false hope, you know.

 

[BadNeighbors]

Let's see how things play out over the next month. It seems those who will be fired will likely get their notice in the next two weeks.

The FDA needed reform, but whether this is the reform it needed is another question.

What I would like to see is for the groups that act as our lobbying agencies to lay out a plan to gain the attention of high-level politicians from both parties. This is a veterans issue, which means both sides will want to claim a win or act in a bipartisan way.

I would like a lobbyist to come to our forum and explain what is going on, what steps they are taking to raise awareness of our condition, and how they plan to use this moment to influence the FDA's rulemaking in our favor. I know there are people who claim to represent us, and I would love to have an AMA with them.

On the Democratic side, we know Tim Walz has tinnitus. He is a potential presidential candidate in the next race. How can we get his attention? How can we let him know there is real promise in this device? What other key Democrats have tinnitus? What well-known Democratic celebrities or donors are affected? And once we have their attention, what should our next steps be?

On the Republican side, Trump signed an executive order to reduce regulation at the FDA, though the agency remains in a state of uncertainty. How do we ensure that our lobbyists are guiding those changes in a direction that benefits us? Pete Hegseth, a veteran himself, likely understands how valuable tinnitus relief would be for troops and vets. What Trump-supporting celebrities have tinnitus? How can we influence RFK Jr.?

I will deal with everything else in my life at another time. For now, I want the lobbyists to participate in an AMA and help us understand what progress they are making with both parties, and how they are advocating for our interests during this period of transition.

Whether I personally view the changes at the FDA as positive or negative does not matter. What matters is that this device is fully vetted and moved through the process quickly, and that other future devices or medications are also reviewed and advanced without delay.

We are all on the same team. We are all suffering together. I have my own strongly held political beliefs, but at this moment, I do not care if Barry Goldwater or Eugene Debs comes back from the grave to secure research funding for our condition and help get this device approved. I am not going to reject support from anyone who is willing to help. I do not care if Dukakis or Reagan want to tell me they cured tinnitus, as long as I can hear them say it instead of hearing this constant hssssssssssssss every second of every day.

 

[annV]

I know there are people who claim to represent us, and I would love to have an AMA with them.

Who are these? I don't think anyone is doing political lobbying for tinnitus. It's extremely expensive and difficult. There is no money going around to engage in lobbying.

 

[Fra]

Auricle hired someone last year to work on ambient sound rejection and electromagnetic interference. These were clearly two areas where they saw room for improvement. If they have smart, patient investors, as it seems they do, and they are choosing to make improvements before the product is released, I think that is a very good sign for the company's future.

May I ask how did you get this information?

 

[Joeseph Stope]

Let's see how things play out over the next month. It seems those who will be fired will likely get their notice in the next two weeks.

The FDA needed reform, but whether this is the reform it needed is another question.

What I would like to see is for the groups that act as our lobbying agencies to lay out a plan to gain the attention of high-level politicians from both parties. This is a veterans issue, which means both sides will want to claim a win or act in a bipartisan way.

I would like a lobbyist to come to our forum and explain what is going on, what steps they are taking to raise awareness of our condition, and how they plan to use this moment to influence the FDA's rulemaking in our favor. I know there are people who claim to represent us, and I would love to have an AMA with them.

On the Democratic side, we know Tim Walz has tinnitus. He is a potential presidential candidate in the next race. How can we get his attention? How can we let him know there is real promise in this device? What other key Democrats have tinnitus? What well-known Democratic celebrities or donors are affected? And once we have their attention, what should our next steps be?

On the Republican side, Trump signed an executive order to reduce regulation at the FDA, though the agency remains in a state of uncertainty. How do we ensure that our lobbyists are guiding those changes in a direction that benefits us? Pete Hegseth, a veteran himself, likely understands how valuable tinnitus relief would be for troops and vets. What Trump-supporting celebrities have tinnitus? How can we influence RFK Jr.?

I will deal with everything else in my life at another time. For now, I want the lobbyists to participate in an AMA and help us understand what progress they are making with both parties, and how they are advocating for our interests during this period of transition.

Whether I personally view the changes at the FDA as positive or negative does not matter. What matters is that this device is fully vetted and moved through the process quickly, and that other future devices or medications are also reviewed and advanced without delay.

We are all on the same team. We are all suffering together. I have my own strongly held political beliefs, but at this moment, I do not care if Barry Goldwater or Eugene Debs comes back from the grave to secure research funding for our condition and help get this device approved. I am not going to reject support from anyone who is willing to help. I do not care if Dukakis or Reagan want to tell me they cured tinnitus, as long as I can hear them say it instead of hearing this constant hssssssssssssss every second of every day.

There is some merit in what you say. Back in the 1990s, a story circulated that Ronald Reagan had tinnitus, supposedly from a gunshot. When he was President, he asked some of the top doctors if they could do anything for him. The reply was, "No, Mister President, I'm sorry, we can't do anything."

At that point, Nancy Reagan, his wife, stepped in and said, "Well, go get something." As a result, funds were released and possibly more was invested into basic research.

But perhaps the most notable step forward—though some might disagree—was the paper from Jastreboff. It helped those with mild tinnitus learn to ignore it, and in a way, it encouraged them to give up the good fight. That left the rest of us carrying the world on our shoulders.

C'est la vie. I hope that this time scientists gain a comprehensive understanding of the auditory system and how to repair it. A step forward for all, with no one left behind.

 

[Nick47]

How is it sensible to assume something based on speculation within a patient group? There is a flip side to false hope, you know.

My Impressions:

1. The initial headline results presented at Palm Springs were very promising.
2. When the full paper was published, the first arm (treatment first) continued to look very promising.

However, when I looked further, the second arm (placebo first) showed no effect from the treatment. On top of that, the answer provided by Dr. Shore did not make any sense.

There are also issues with blinding. Were the participants actually blinded or not? Then there is the number of participants who followed the protocol. It was well below 99. This is a Phase 2 trial, which should have been much larger than the 20 participants in Phase 1. I believe 57 participants completed the trial, and one arm, with around 30 patients, showed no benefit from the treatment.

The Phase 1 trial had no such issues.

Taken together, all of this suggests that the treatment is likely somewhat effective for some patients.

To become deeply invested in this and expect a quick and smooth transition to market is to ignore the evidence and avoid asking the important questions raised by the study.

@withintention has done some digging and found a notice for recruitment. This might be related to improving the device, or it could mean nothing at all.

What I am saying is that we should stay open to all possibilities.

 

[Watasha]

Cutting childhood cancer research, was it?

View attachment 60277

Ah, the old appeal to emotions. We are talking about RFK Jr., not Elon. If the United States does not rein in its spending, there will not be money for anything except the interest on the national debt. So let us try to have a more serious conversation instead of petty gotchas.

 

[withintention]

May I ask how did you get this information?

@Bhaveen posted it upthread.

 

[Jonno02]

Ah, the old appeal to emotions. We are talking about RFK Jr., not Elon. If the United States does not rein in its spending, there will not be money for anything except the interest on the national debt. So let us try to have a more serious conversation instead of petty gotchas.

This year, $650 million was cut from the medical research budget, and the reduction did not only affect cancer research (source).

Meanwhile, since his inauguration on January 20, Trump's golfing trips have cost U.S. taxpayers $26 million (source). Extrapolated out, that comes to $132 million a year for one man to play golf—at his own resorts.

Are we seriously using "cost saving" as an excuse when these are the numbers? Come on.

One in two people will be diagnosed with cancer in their lifetime, which is far more than the number who will develop tinnitus. You have repeatedly said that people need to contact political representatives to push for tinnitus funding. But if cancer treatment is being cut and defunded, what kind of chance does tinnitus research have? Almost none.

 

[Joey72]

The FDA is cutting staff and losing reputable researchers left and right. The top vaccine researcher just resigned because the head of the agency literally believes in discredited pseudoscience and is pushing the FDA to adopt it.

The person in charge is an anti-vaxxer and the kind of person who seriously suggests that "sunlight and eating right" are all you need, while the EPA is being dismantled and deregulated at the same time. If you think RFK Jr.'s neurological issues are concerning because of his dysphonia, wait until you see what happens to Americans in the coming decades. Measles had been practically eradicated by the year 2000.

They clearly do not care about people who are not wealthy. The only chance anything would change is if RFK Jr., the former president, or Melania developed tinnitus.

The FDA is not reducing funding for medical devices, according to a news article I read a few days ago.