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But after the clinical trial, hasn’t the software and hardware of the device remained unchanged? It’s been ready to launch since then. If you think they’ve handled this within a reasonable timeline, you’re kidding yourself.

The clinical trials began a decade ago. It's fair to say that the process has not been fully optimized overall.

It’s difficult reading that because of the fact that maybe 2+ months could have extremely promising effects. Yet Auricle isn’t experienced enough to launch it. I’ve had some success with my tinnitus recently via dry fasting and other things. However, the effects aren’t exactly permanent. Who...

I agree here. It's really hard to not make Lenire comparisons when looking at FDA submission and the post rollout - which in retrospect the Neuromod team has seemingly done efficiently, regardless of what we think the capabilities of the device are exactly. That is what makes this all worrying...

It's crazy to see sarcastic responses to someone eager to get an update on a device that might help their fight against tinnitus.

This is obviously very disheartening. I've seen people say 2026 is the average guess date. If that isn’t based on realism, then what are we looking at here? 2027/2028/2029. It's crazy in comparison to Lenire, which I promised myself I would not try, but maybe it’s wise to rethink that for now...

Because the chart shows multiple measurements for each participant over time, allowing researchers to track changes and trends accurately. However, it doesn't specify which dots are related or indicate the stages at which improvements occurred, making it difficult to discern which measurements...

I live in Ireland but plan to fly to America to pay over the odds to any audiologist who will treat me. I will happily pay double the price for the device.

I don’t believe for a second that Dr. Shore hasn’t known the answer to this. She must have a few of these devices, and I’m sure friends and family would have benefitted from using the device behind closed doors. Surely, she knows someone with intrusive tinnitus. For all we know, treatment for...

I took it for three days. Tinnitus started on the second two-pill dose, but stupidly, I didn’t know it was ototoxic and kept going for another two days until I googled it. My tinnitus fluctuates a lot. It’s not as bad as when it started, but it’s still about 65 dB.

My tinnitus started after taking Clarithromycin, and I still have it 15 months later. It’s changed tones and volumes 20 times. It’s surreal. One tone is very annoying, and I can hear it over everything.

I think Lenire and Dr. Shore's device have very different actual mechanisms and outputs. A friend of mine got great results with Lenire, though; he swore by it. However, I haven’t tried it because the clinical trials were a shambles, and I’m scared that if I do and the Shore device happens to...

I understand your sentiments here & I also support rationality; however, there are 212 pages here of repetition. I do not in any way discourage anyone here from speaking their mind - or pushing for answers. In nearly all 212 pages here, you will find a question of hope, a frustration, a push -...

The bottom line here is that without the device being launched, we only have second-hand data. Frustrations are rising here because the device is taking so long - it's simple. There are people reading this who may have substantially good results from the device when it's available—the pity...

I have no idea why anyone’s concerned about who funds the device as it currently lies on a shelf gathering dust. I wouldn’t care if it was funded by The Wolf of Wall Street as long as it was in the market and helping people.

This all sounds great, but it’s troubling that the device that helped completely ‘resolve’ an ENT’s tinnitus is sitting on a shelf somewhere, gathering dust. As stated before, the trials began a decade ago; the device still uses the same software and hardware as it did back then (correct me if...

This is an excellent insight into the regulatory process for sure. Your statement effectively outlines the inherent challenges in the regulatory submission process, particularly for companies with limited resources. However, why can't we compare this to Neuromod's Lenire? It's clear that despite...

You're adding 'the device is dead' to people pointing out that the submission is labored and seems held back / slow. Those things are in no way exclusive of each other - it feels like you've added the 'device is dead' part to be dramatic. I haven't seen anyone here say that the device is dead...

Exactly where we are now, it seems.

At the risk of sounding constantly negative, Hubert Lim/University of Minnesota collaborating with Dr. Susan Shore could be a disaster. It would likely delay the launch of Dr. Shore's device by years (on top of the years we are waiting now). Hopefully, collaboration can happen after we have a...

There are absolutely zero surprises here.

Interesting. Is that the same COVID-19 pandemic where Lenire managed to get to market and be rolled out?

Wasn’t that nearly a decade ago? The clinical trial was limited in numbers. We’ll get much more valuable data after the rollout. They are wasting an incredible amount of valuable time.

I'm not talking about her communication directly; after the clinical trial data release, I assumed she would have had to fulfill some PR. I’m not impressed by her answers to Tinnitus Talk's questions. They all looked like they were answered by a PR bot. All in all, it’s been a shambles so far.

It’s not speculation. What I see voiced in this thread are facts. Clinical trial results Lack of visibility about launch plan Lack of communication in general Inability to submit to FDA These are facts.

Is no one else concerned about their inability to launch this device? POV: You're Susan Shore, and you have the first device in history to treat tinnitus. Your inbox is full of people begging for help for years. Every time you walk down the street, someone asks for an update. Desperate people...

A very strange reply to someone clearly in need of words of help as opposed to what you said. Get a grip of yourself. Why would someone who is better come back to Tinnitus Talk to remind themselves of the bad times. We’re all owed nothing here. CBD may have worsened your tinnitus but...

I agree with the positivity but also I think it's a good idea for us to keep pragmatic in our approach to the Michigan device. I think it's a lot safer mentally for everyone to be cautious and to follow the data to make a call on whether it will work or not. A blanket approach of predicting it...

There’s something seriously comforting to me that someone reading this thread daily, with bothersome tinnitus, is going to get relief from this device. It won’t be us all, but there’s someone out there who is at the end of the road this device will save. There’s something amazing about that...

Hi all, I got tinnitus from a mixture of things in April 2023, I was taking an antibiotic called Clarithromycin on the day it kicked off, but a week before I used ototoxic ear drops, I was super stressed and I'd been around loud music all my life. I have no hearing loss on the hearing tests I...

While I don't mean to sound pessimistic, my concern centers on the stories I've read about Dr. Shore being inundated with requests for access to her equipment after the trial. It seems that countless individuals afflicted with tinnitus have reached out to her over the years, pleading for relief...

Hi, how was your MRI in ballykelly? Mine got postponed because of another health issue, im in on monday, nervous about the loudness!

Thanks for everyone's seriously in-depth and well-delivered input into this conversation; it made the narrative easy to follow and understand and I'm looking forward to Dr. Shore's responses to the questions. I'm Irish and live approx 2 hours drive from the front door of the Neuromod (Lenire)...

Hi @Hardwell, Thanks for your reply; I was taking Clarithromycin because a few weeks prior I had some sort of blockage in my ear, this took my hearing down dramatically and then it all came back. I had met my doctor on the street randomly and I still had some issues, mainly slight off balance...

I am hoping to get some advice on my tinnitus experience. It's been a complicated journey for me, and I'm not sure what steps I should take next. Here's my story: About four weeks ago, I woke up with unilateral high-pitched tinnitus in my right ear after taking Clarithromycin the previous...

I've been pondering a question that I think deserves our attention. Are there individuals who are better at managing tinnitus than others? I have encountered people in my own life from my home city who are living with tinnitus and seem to be managing well, even though they do have difficult...