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