New University of Michigan Tinnitus Discovery — Signal Timing

[MrRing]

Is this technology being researched by other companies, or is it only being investigated by the University of Michigan?

Given the scale of tinnitus, I was wondering if similar projects are being explored elsewhere in the world.

Have any foreign companies conducted research to support or challenge the science behind this type of device?

 

[Joshua Macleod]

FYI: auricle.com is a different Auricle.

Well that wasn't going to be very helpful then, was it?

Thanks!

 

[Pixelito]

With the recent funding cuts and firings at the FDA—which was already underfunded and understaffed—it's unclear how far this will be set back.

The firings seem to have primarily affected employees in the agency's centers for food, medical devices, and tobacco products.

 

[BadNeighbors]

With the recent funding cuts and firings at the FDA—which was already underfunded and understaffed—it's unclear how far this will be set back.

The firings seem to have primarily affected employees in the agency's centers for food, medical devices, and tobacco products.

The news does not look good for us.

I do not understand how this device can make it through the FDA when there is no one there to review it. Of all the departments to cut, why this one? Is this revenge against an agency vetting Neuralink's claims and safety?

We all know the FDA needs improvements, but I worry that this is blocking us and people suffering from conditions even worse than ours from accessing a device that could improve our lives. I have pinned a lot of hope on this device, and the thought of unnecessary political chaos slowing down my chance of relief breaks my heart.

At the same time, the opposite scenario, where the floodgates open and medical devices become as unregulated as supplements, also terrifies me. In the short term, it would benefit me since I just want access to this device. But in the long run, who knows how many scam artists would take advantage of desperate people suffering from tinnitus or other conditions? And how many of those frauds would attract investors, while researchers like Dr. Shore, who seems to be working with integrity to develop real relief, get overlooked because she does not overpromise? I have pinned my hope on her device precisely because she is not a good salesperson, she does not rush, and she clearly is not doing this just for the money.

My heart is broken. I know not to expect relief from her device, but the hope that it will come out soon and the possibility that it could give me my life back is the main thing that keeps me going. (I know this sounds dramatic, but at this moment, it is how I feel.)

 

[MichaelBull]

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.

 

[Pixelito]

The news does not look good for us.

I do not understand how this device can make it through the FDA when there is no one there to review it. Of all the departments to cut, why this one? Is this revenge against an agency vetting Neuralink's claims and safety?

We all know the FDA needs improvements, but I worry that this is blocking us and people suffering from conditions even worse than ours from accessing a device that could improve our lives. I have pinned a lot of hope on this device, and the thought of unnecessary political chaos slowing down my chance of relief breaks my heart.

At the same time, the opposite scenario, where the floodgates open and medical devices become as unregulated as supplements, also terrifies me. In the short term, it would benefit me since I just want access to this device. But in the long run, who knows how many scam artists would take advantage of desperate people suffering from tinnitus or other conditions? And how many of those frauds would attract investors, while researchers like Dr. Shore, who seems to be working with integrity to develop real relief, get overlooked because she does not overpromise? I have pinned my hope on her device precisely because she is not a good salesperson, she does not rush, and she clearly is not doing this just for the money.

My heart is broken. I know not to expect relief from her device, but the hope that it will come out soon and the possibility that it could give me my life back is the main thing that keeps me going. (I know this sounds dramatic, but at this moment, it is how I feel.)

Well, it's not as if nobody is there. The FDA still has staff, though the fired employees were hired by the previous administration to help expedite procedures.

My hope is that the device was submitted to the FDA sometime last year and is far enough along in the process that this won't cause any major delays. The FDA still has an important job to do, and drugs still need to be approved.

If, for some reason, the device hasn't been submitted yet—yikes. Auricle has bigger problems than reckless government policies.

 

[Jonno02]

This is pretty catastrophic.

FDA reviewers are not just clerks; they are scientific and engineering subject matter experts in their respective fields. These are not people who can simply be fired and replaced on a whim. If they leave, they will take their expertise to the private sector, making their skills incredibly difficult to replace. The Trump administration has set the FDA back years with this decision. Instead of streamlining excessive bureaucracy, they have effectively cut off the head of the agency.

This appears to be an act of retaliation, as the FDA was vocal in advising against the use of Ivermectin, which had been promoted as a MAGA-endorsed COVID-19 cure. The agency also, and rightly so, imposed strict limits on Elon Musk's ability to push Neuralink forward without proper clinical research.

As a result, we are likely to see medicines and medical devices reach the market that are not only ineffective but potentially dangerous.

Companies seeking regulatory approval should consider focusing on alternative markets until the situation at the FDA stabilizes.

 

[Joeseph Stope]

This is pretty catastrophic.

FDA reviewers are not just clerks; they are scientific and engineering subject matter experts in their respective fields. These are not people who can simply be fired and replaced on a whim. If they leave, they will take their expertise to the private sector, making their skills incredibly difficult to replace. The Trump administration has set the FDA back years with this decision. Instead of streamlining excessive bureaucracy, they have effectively cut off the head of the agency.

This appears to be an act of retaliation, as the FDA was vocal in advising against the use of Ivermectin, which had been promoted as a MAGA-endorsed COVID-19 cure. The agency also, and rightly so, imposed strict limits on Elon Musk's ability to push Neuralink forward without proper clinical research.

As a result, we are likely to see medicines and medical devices reach the market that are not only ineffective but potentially dangerous.

Companies seeking regulatory approval should consider focusing on alternative markets until the situation at the FDA stabilizes.

Well, the Donald is older now than Joe Biden was when he started.

If CNN is anything to go by, Elon Musk's push to downsize the federal government is leading to all sorts of blunders—like firing the people in charge of nuclear defense, the ones overseeing bird flu control, or those responsible for authorizing new medical devices and products. How is the US supposed to compete in the global market if new innovations are being stifled? There is such a thing as a false saving.

The world is watching to see whether Ukraine will become the next Afghanistan.

But perhaps I shouldn't be interrupting the new president's honeymoon period. His first month in power is hardly over yet.

 

[vilebubbles]

Great! Looks like a sound and electrical stimulus device. They said based on 15 years of research. Let's hope it doesn't take that long to be available.

Lol.

 

[Pixelito]

FDA rehires staff to its medical devices division after mass layoffs

The Trump administration is reinstating some employees in the Food and Drug Administration's medical devices division after dozens were laid off as part of a government-wide cost-cutting initiative led by billionaire Elon Musk and his Department of Government Efficiency, according to two people familiar with the matter.

Around 180 employees from the FDA's Center for Devices and Radiological Health, including physicians and cybersecurity experts, were let go on Feb. 15, two workers said they were told by their supervisors.

"These people are indispensable," one said. "Many of these roles require so much training and specialization and are so important for keeping people alive."

The medical devices division is responsible for approving and monitoring the safety of a range of products, from X-ray machines to surgical implants.

It's unclear how many employees were offered their jobs back, or how many would ultimately return.

FDA rehires staff to its medical devices division after mass layoffs

Around 180 FDA medical device workers were laid off this month by Elon Musk's Department of Government Efficiency.

www.nbcnews.com

 

[Funkmaster]

It has been almost a year since Susan Shore's Michigan Tinnitus Device (Auricle) was supposed to be submitted to the FDA. There has been no news, and it seems the FDA has been severely weakened.

Have we lost hope, or is there still reason to be hopeful?

 

[Joey72]

It has been almost a year since Susan Shore's Michigan Tinnitus Device (Auricle) was supposed to be submitted to the FDA. There has been no news, and it seems the FDA has been severely weakened.

Have we lost hope, or is there still reason to be hopeful?

In 2022, 46% of their budget came from regulated industry user fees, while the remaining portion was funded by the congressional budget.

 

[ploughna]

I would love to be wrong, but I do not think any weakening of the FDA will make much of a difference.

I would love to see Lenire, with their fresh influx of funding, $10 million on top of the previous $33 million, license the technology from the University of Michigan for a next generation version of their device.

Or maybe a two-tier approach. For those with mild tinnitus, the "tongue tickler" for the bargain price of $5000. But for more stubborn cases, the all new "brain zapper" for only $10000.

 

[IYIiKe]

It's really bad. I think we have to seriously consider that the U.S. will no longer be the first country to produce a Susan Shore device.

 

[HighleyTall]

Sound and electrical stimulus devices are not going to cure tinnitus or hyperacusis.

However, for the first time in 20 years, I believe they are close to discovering the exact cause. If they succeed, it will likely take another 5 to 10 years to develop medications or gene therapy.

Unless a miracle happens, I will no longer be here to see it.

 

[SafeMusicFan]

If Lenire was able to reach the market, it would be an absolute shame if the "Susan Shore device" did not.

I don't expect it to be a miracle cure, but I do believe it will be reasonably more effective than Lenire for a significant number of people—almost certainly. Any progress in reducing symptoms contributes to the development of better, more effective treatments in the future.

In other words, this cannot be allowed to fade away. If the US administration cannot make it happen, I hope the Michigan team will share their research with other scientists or find alternative ways to ensure their discoveries contribute to a better future. Ethically, this is essential.

I wonder if there are alternative paths forward in case the FDA route turns out to be a dead end. That said, I wouldn't worry too much just yet. Still, I truly hope we get an update before 2026.

 

[Josh-mh]

Remember, everyone—one day at a time! Each day that passes brings us one step closer to the device becoming available!

 

[Anomalous]

It's really bad. I think we have to seriously consider that the U.S. will no longer be the first country to produce a Susan Shore device.

At this point I'm wondering whether they've shelved the project entirely.

 

[Watasha]

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.

Let's not get hysterical. The US is in serious trouble due to its current fiscal situation, including deficit spending and national debt. However, there is no fascist regime, nor will there be one, despite some of the more benign similarities—such as nationalism and a cult of personality—between Trump and actual fascist regimes like Benito Mussolini's, where rampant violence was used to suppress dissent.

"Fascist repression was thus more intense and ideological than previously thought and even shared some important similarities with Nazi and Soviet terror." We are nowhere near Nazi or Soviet terror in this country. I would argue that forced vaccinations, related firings, and de-banking were far more in line with historical authoritarian measures than anything Trump has done.

The left is far more intolerant of opposing views than the right, and studies support that.

Regarding the Susan Shore device, many of the terminated employees at the FDA have been reinstated. They had all of 2024 to work on approval, so let's wait and see what happens. Dr. Shore will provide an update when she can.

At this point I'm wondering whether they've shelved the project entirely.

This is my fear. Something doesn't feel right, but we would hear from Dr. Shore if that were the case.

 

[Fightthearmy]

"Fascist repression was thus more intense and ideological than previously thought and even shared some important similarities with Nazi and Soviet terror." We are nowhere near Nazi or Soviet terror in this country. I would argue that forced vaccinations, related firings, and de-banking were far more in line with historical authoritarian measures than anything Trump has done.

The left is far more intolerant of opposing views than the right, and studies support that.

I don't see how there's a connection to tinnitus...

 

[Joey72]

I don't see how there's a connection to tinnitus...

People are overreacting because the former president was elected again. Some refer to this as "Trump Derangement Syndrome."

 

[tiniturk]

People are overreacting because the former president was elected again. Some refer to this as "Trump Derangement Syndrome."

Are they really overreacting, though? His actions in his first months as a reelected president have been extremely extreme, and the kidnapping of Mahmoud Khalil only confirmed that.

Anyway, DOGE does not offer a positive outlook for tinnitus sufferers.

 

[Scruffiey]

Sound and electrical stimulus devices are not going to cure tinnitus or hyperacusis.

However, for the first time in 20 years, I believe they are close to discovering the exact cause. If they succeed, it will likely take another 5 to 10 years to develop medications or gene therapy.

Unless a miracle happens, I will no longer be here to see it.

I don't think anyone claimed they would, but it would certainly be nice to have any proven tinnitus treatment available—even if it only helps mild sufferers through their first panic-inducing experience or shaves off a few decibels for those with more severe cases, making it a little easier for them to relax.

Also, I can't pretend that the prospect of snake oil treatments like Lenire losing all legitimacy and funding isn't a bit of a perk.

Don't give up hope. It's entirely possible that something off-label isn't far away to at least help you get through. The discovery of the mechanism behind hyperacusis could have significant implications sooner than we think. And while I don't believe it will be a cure or even a direct tinnitus treatment, I'm really curious about the effect SPI-1005 (Ebselen) might have on our various associated symptoms.

 

[Watasha]

I don't see how there's a connection to tinnitus...

You would need to read the post I was responding to in order to understand why fascism was brought up in a tinnitus thread.

I am curious why you took exception to my post but not theirs.

 

[Fightthearmy]

You would need to read the post I was responding to in order to understand why fascism was brought up in a tinnitus thread.

I am curious why you took exception to my post but not theirs.

The sheer quantity of value judgments—not to mention the weasel words (e.g., "studies support that")—made it harder to digest.

 

[IYIiKe]

Anyone who believes RFK Jr. is a positive influence on HHS or that gutting NIH research, including limiting the G&A rate of university grants that support labs of all kinds, bodes well for tinnitus research is not only wrong but severely misinformed. Or maybe they have a brain worm.

I invite them to attend a "measles party" or whatever nonsense is being promoted today.

 

[Watasha]

The sheer quantity of value judgments—not to mention the weasel words (e.g., "studies support that")—made it harder to digest.

What difference would value judgments make in relation to your question about how something is related to tinnitus? I am not the one calling the current admin a dictator or using words like fascist regime. Ask him that question, not me, unless of course you are just being partisan.

I am sorry that studies supporting left wing intolerance upset you, but that is a fact. They are far more likely to end friendships and relationships than those on the right and are also less willing to be friends with or date people who have different political views. That is quite concerning when you think about the echo chamber they create for themselves. Your partisan blinders are clearly on.

Weasel words? Give me a break. That is a really rude thing to say to someone who shares your goal of ending the blight of tinnitus and is simply calling out the hypocrisy of labeling the current administration a fascist dictatorship when the prior one engaged in oppression and censorship.

Our focus should be on the Susan Shore device. If there are cuts at the FDA, we can discuss that without throwing around terms like dictator and fascist. Thankfully, many of those jobs have been reinstated, but we do not even know yet if she has submitted her device to them.

Anyone who believes RFK Jr. is a positive influence on HHS or that gutting NIH research, including limiting the G&A rate of university grants that support labs of all kinds, bodes well for tinnitus research is not only wrong but severely misinformed. Or maybe they have a brain worm.

I invite them to attend a "measles party" or whatever nonsense is being promoted today.

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

 

[Joergen]

The sheer quantity of value judgments—not to mention the weasel words (e.g., "studies support that")—made it harder to digest.

What value judgments are you referring to? Do you even know what that term means?

I can't stand how rude people are in this forum, and that post was particularly disgusting.

For the record, I believe Trump is a fascist, and unfortunately, Americans are in for a lot of pain. However, this discussion belongs in another thread.

Let's all hope the FDA is still functioning well enough to approve the device. I'm more concerned about production, investment, and supply lines being disrupted due to Trump's tariff insanity. Hopefully, the dust will settle soon.

 

[Joey72]

Are they really overreacting, though? His actions in his first months as a reelected president have been extremely extreme, and the kidnapping of Mahmoud Khalil only confirmed that.

Anyway, DOGE does not offer a positive outlook for tinnitus sufferers.

Almost half of the FDA's funding comes from corporate user fees, while the rest is provided by Congress.

I am not here to defend Trump or Musk. The truth is we do not know what is causing the delay.

 

[BadNeighbors]

Look, we are all suffering from tinnitus. There is no reason to come here looking for political arguments.

When I visit this thread, it usually means my tinnitus is acting up and I am looking for updates or a bit of hope. I am not here to read anyone's interpretation of what is happening with the American government. I do not want to hear personal opinions or complaints about policies, and I definitely do not want to deal with someone trying to demean others through culture war discussions. In this space, I do not care which party someone thinks is the most intolerant. I care about my brain no longer producing this constant hiss, so I can quietly read a book and enjoy some peace before I die.

We are all dealing with tinnitus. Maybe we should focus on that shared experience first, rather than on whatever political affiliations we might have. If someone wants to debate the merits of the government or argue about what constitutes fascism, there are plenty of political forums for that. This is absolutely not the space for it. My ears are already driving me crazy. I have no interest in reading that kind of nonsense today.

Of course, we cannot avoid politics entirely, since they are connected to medical research, regulation, funding, and access. However, our focus here should be on how these things specifically relate to this device. That includes potential cuts or changes to the FDA or other institutions that might play a role in its development and rollout, such as the VA.

If someone wants to put a political flag on their car and insult those with different views, they are free to do that. But maybe they could take it to a forum where people gather to discuss their support or criticism of the government more broadly.

Suffering from tinnitus is already difficult enough. Dealing with inflammatory, off-topic posts is not what I came here for today. Let's all try to avoid the broader political arguments. And maybe, just maybe, if someone says something we do not like, we can choose to ignore it instead of turning everything into a debate.