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From that whole post about reducing the FDA's protectorate remit and opening people like us up to conmen, your whole stance is, "I must protect Trump." Oh, apologies, he said, "inject disinfectant," which is worlds apart from injecting bleach. I'm relieved the medical doctors didn't listen to...

Ah, yes, having a notoriously anti-scientific figure who once suggested injecting bleach as a solution for COVID-19 will undoubtedly speed up approvals for safe treatments, right? YouTube and Google are already overrun with snake oil salesmen touting tinnitus “cures.” Do you really want to open...

I would suggest that there has been no further development because there is no objective measurement for testing treatment efficacy. For example, if there were a blood marker for tinnitus that could be objectively observed to decrease with the start of a treatment, we might see more active...

Because it's a brain condition, tinnitus is one of those things that just takes as long as it takes to resolve. In an alternate universe, we might have accidentally stumbled upon a cure years ago, like a drug designed for something else that, by pure chance, turns out to cure tinnitus. There are...

10 years is a drop in the ocean for researching, designing, and developing a brand-new medical device, especially when done in partnership with a university.

A lot of companies have social media policies, too. At the company I work for, anyone who shares information that hasn’t been officially released is instantly dismissed.

Please remember that a small clinical trial group emphasizes both super responders and super non-responders. Both can skew data in either direction.

In the same way that insulin doesn't work because diabetics need to keep injecting it? Get a grip; it's a treatment, not a cure.

Not quite. CE marking is proving the safety of your device via a notified body by showing you adhere to the Medical Device Regulations. It’s a huge task.

Saddening, but how many conditions have absolutely nothing on the horizon? Not saying the device will meet our hopes for volume reduction, but compared to thousands of other conditions, we're a rung up on the ladder as we have something coming.

You're probably right. We work with many start-ups, but they have permanent staff that need to be put on the next iteration even prior to launch. There is no visibility on Auricle's staffing level, but they probably aren't at that level. I don't particularly share the rampant pessimism here...

I can’t speak for Auricle specifically, but yes, you would. You can’t change ANY manufacturing processes or specifications after you submit. Technically, any changes or improvements post-submission would either be Gen 1.1 or 2.0, depending on how large a jump it is. So, whilst your regulatory...

I’m not quite sure I understand this. Can someone please explain? When the company I work for submits a new product to regulators that we know/expect will get approval, we generally start to hire new engineers and scientists to look after that specific product. This could be to continuously...

Also, don’t forget the sampling bias for one audiologist who will happily profit from selling it to you. Many people who are not on Tinnitus Talk will buy it, realize it doesn’t work for them, and put it in a cupboard forever. Sampling bias works both ways.

Of course, they can. But don’t get fragile and offended when someone asks you to back up your constant stream of ‘opinion’ with data on how you reached that opinion. If you can’t, people are more than entitled to call you out. And yes, nobody is more informed than anybody else when it comes to...

Even though this post is still large, I had a bigger response about how multiple people here are purposely obtuse and ignoring the plethora of information posted about the regulatory process and why it’s taking Auricle so long. But I have deleted it because it’s much simpler to ask this, and...

Of course there does need to be a balance. But there also has to be a balance to unsubstantiated claims like yours where it may be ‘detrimental.’ An established scientist with data to back up her claims? Or a pessimistic internet poster that takes every opportunity to put a dampener on this...

Once it hits the market, do you want a team of scientists and engineers who designed the device to remain in control and continuously revise and improve it? Or would you like a 'distributor' that bought the rights to it that has no interest in how well it works, has no idea how it works, and...

This doesn’t make sense. 99.99% of drugs and therapies on the market have zero doctor involvement. They treat patients, not develop the treatments. The treatments are mostly developed by those ‘sellouts.’ And it’s not just as easy as throwing money at the research until you strike gold. It...

In the last 1.5 years, they published their final study and said they were preparing for FDA submission. We’re not getting updates on the progress, but I’d say that’s pretty major. Not everybody wants to sell to a large company when they develop something. I think the University of Michigan...

Not really. It's a well-executed study. It's difficult for me to provide any objective evidence as the devices I normally deal with, a placebo would mean death. I cannot see them having to do any more studies, but I need to emphasize here, which many people gloss over, that a successful clinical...

It's impossible to tell if they're on track. In my experience with preparing a regulatory submission, and bearing in mind that the company I work for has around 100 full-time regulatory experts, internal timelines always either go overdue or you make it by a matter of hours. And that's from a...

I am not talking about whether it works or not. My comment is purely aimed at people who have zero idea of what it’s like to prepare a regulatory submission deciding that because it’s taking so long, the device is dead. If you’ve never been a part of a medical device regulatory submission, you...

Unfortunately, this thread has gone down an avenue of people with zero experience or idea of what an FDA submission actually involves deciding that this device is dead in the water because we haven’t seen FDA approval from a publication in six months.

I did this when my tinnitus first worsened. I got a new tone at 4.4 kHz, left it alone for nearly year to see if it would go away; it didn’t. I started listening to the same tone with my phone under my pillow as I slept. For a month the 4.4 kHz tone kept reducing until it became masked by my...

Is it a suggestion or a non-debatable fact? Isn’t logging onto a tinnitus website itself reinforcement? So, discussing treatment options isn’t any more reinforcement than coming here in the first place. People can post on a forum without further involvement and ‘volunteering for simple tasks.’...

Many people can’t habituate, but many can. But it’s an entirely subjective condition, and I don’t think hypothesizing about our best potential treatment to date is in any way impairing habituation. People can discuss a treatment without volunteering ‘for simple tasks.’ The two aren’t even...

Allow people to speculate, discuss, and talk about it. What harm does it cause you? It might be a coping mechanism or a form of therapy for them. Yes, we get the same questions popping up time and time again, but you can just keep scrolling rather than let it anger you. Back-and-forth...

It’d be awfully quiet if there were no speculation, and instead, we only posted factual study news.

Man’s a research-study-finding-machine.

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...

Perhaps it’s best you find yourself another online community that aligns with your view. Tinnitus Talk is a support forum, not a place for you to subjectively legitimise your own suffering and discard others. What an ignorant person you are.

When it comes to the headphones question, there are a few important things to remember about the advice given on Tinnitus Talk: 1. Most of the cases here are severe. People with severe tinnitus tend to err on the side of caution regarding hearing after developing tinnitus. 2. Many people on...

For non-implantable devices and pharmaceuticals, the FDA scrutinizes patient safety instead of device efficacy. Basically, all they’re interested in is whether Auricle generated the appropriate data to demonstrate that it doesn’t make tinnitus worse in a high proportion of users or has other...

I would be surprised at that, to be honest. It is one thing saying it, but money talks. And the copycat devices will start to pop up soon.

This is a good take.

Depends on severity. If a major change, it may need re-submission. If it’s generally bug fixes and improvements that don’t affect the functionality of the device, there’s a route of a 30-day submission process to get smaller changes through. This route exists so that companies don’t delay...

Nobody knows anything about Auricle. We don’t know if they’re contract manufacturing or doing it in-house. We don’t know what supply agreements they already have. We don’t know what funding they have. Everything here is speculation.

I have to say, this means absolutely nothing to me. Gives me zero reason to doubt the device. I’m an analytical chemist. Not a programmer. But there are times that I need to build a model within software that would give an actual software engineer a stroke. I don’t pretend to be a software...

Fantastic, absolutely love to hear a success story. Would be good to know what you took/dosage so we may have the opportunity to see other success stories come from your victory.

33% success rate for a gen 1 device is still huge. I don’t think anybody here is expecting this to be a golden bullet. But if it works for 33% of people, not only does it show tinnitus is treatable, but there’s a somewhat simple pathway that maybe needs further development to get that 33% up...

Treatment 1 in Study 2 and Group 1 and 2 in Study 1 all agree. It looks like Treatment 2 in Study 2 are the outlier here with how little effect the active treatment seemed to have. That’s what still gives me hope.

I suppose it’s all sort of inconsequential now anyway. We’re at the stage now that it’s a ‘it works or doesn’t’ as we’re waiting for regulatory submission. Phase 2 does indeed have some unanswered questions and the publication really should have gone into detail about why the issues happened...

For medical devices, the regulator is there to ensure patient safety. Auricle do have (supposed) clinical proof the device works and has no major side effects. I’m not a Regulatory Affairs expert, but I’d be surprised if any additional work was requested.

It kinda does though. They chose 12 weeks for any other type of treatment as they would have no way of knowing the return to baseline time for treatments other than their own. 3 months seems like a reasonable time for tinnitus to return to normal levels for a patient based on their own first...

You've obviously completely made your mind up, no matter what answers people try to give you. Not really sure what you're getting out of staying on here to be honest.

I posted a huge reply to that post but I decided to delete it. Glad I did as this says it better.

I checked the patent and found: The method of claim 4, further comprising applying the somatosensory stimulation signal to the subject by applying stimulation to a trigeminal nerve of the subject via facial stimulation or a cervical spinal nerve of the subject to stimulate the somatosensory system.

Unless specific data points are released, I don’t think we’ll ever really know the specifics to that level. I’m trying to look at this device from a high level, there’s plenty of great low level analysis already on this thread. I do believe that tinnitus comes around from maladaptive...

Bluetooth suffers from audio latency up to 20x that of wired headphones. This can increase further depending on range and external factors such as interference from other devices. Not great when your device requires precise timing.

Sorry to hear that. About the nerve thing, I wonder if this is why they paired it with Gabapentin?

Lenire’s head of R&D: WRITE THAT DOWN!!!

Good point. @gameover, don't stress about this too much either way. People that develop medical treatments like Dr. Shore don't really get involved much at all in the submission side of things. She's an expert in tinnitus/her pathway for a treatment. She's not a Regulatory Affairs (RA) expert...

Ah ok, thanks for the clarifications. I’m not sure why they would have done that for software like this, but I have to laugh as it hits close to home. We use custom written software made by third party vendors for some of our lab instruments at work. A lot of the machines still run Windows XP...

Why do you think it’s a bit of a mess? The setup steps in the slides looks quite thorough and it’s obviously designed to be run with specific hardware to generate calibrated tones. I actually think it looks quite decent.

Because Lenire ‘trials’ were a total sham.

Doesn’t make you weak my man. You’re dealing with something there is no escape from, no shutting out and no turning off. I’m not saying it’ll solve everything, but just keep the Michigan device in mind. There’s a serious chance we’ll be seeing real world treatment in 2024. As much as people...

I think it’s because she’s a scientist at heart and this is essentially her life’s work. She’s in charge and has taken her time to get things as good as they possibly can be. Other ventures are likely a ‘invest and we’ll deliver something in ‘X’ years’ so they just launch whatever nonsense...

Absolutely. My most recent ENT at a private hospital in the UK told me ‘there’s no glory for us ENTs in tinnitus as there’s no cure.’ But I also feel like @ErikaS is 1000x more proactive than me so she’s found a decent ENT through hard work.