New University of Michigan Tinnitus Discovery — Signal Timing

Excuse me, I want to keep the temperature down here, but if @linearb was cured, as I seem to remember reading, why would he want to go and get cured again?

I apologize if I have got my wires crossed, i.e. got confused.

 

@linearb felt good effects from the Susan Shore Device, while he was using it. Those good effects didn't last after the trial.

 

Because all of the armchair researchers here do not think it will work and come out, it is safe to say that there is no hope of anything ever coming out in our lifetime.

Got it.

I knew Mr. Doom and Gloom would chime in. It doesn't work! We get it.

 

Also to note, @linearb was a participant in the very first trial where he was only using the device for 4 weeks, instead of the 6 weeks, which showed a more lasting effect.

I mean, you can look up @linearb and read his posts yourself. If I remember correctly, he said that he did receive benefits from the machine while using it, but it went away after his 4 weeks were over. He was also sure to point out that he was in the first original trial, in which there were only 20 participants, and that they only tested for 4 weeks which didn’t show any lasting effects after the trial was over. It was the second, larger trial that had 99 participants using the device over 6 weeks that showed lasting effects.

 

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 knows, maybe alongside the Auricle device I could have really attacked my tinnitus. But I’m scared I’ll do more damage to myself in the years to come until I can try the Auricle device, and I feel that Auricle doesn’t understand this predicament; the device is lying in someone’s drawer - nothing is happening.

It’s a shame we are here. This a serious health condition.

 

It doesn’t work. I got it—no need to keep going on.

 

Out of curiosity, how long was the time frame for FDA submission and approval for Lenire? I was just wondering if it's worth comparing the length of time for submission and approval between Lenire and Auricle. This might be hard to do, as we don't know if/when Auricle is going to submit.

Regarding @linearb's experience in the first clinical trial, I was wondering if they ever gave details on the relief they had? Could they tell if their reduction was real/significant, or could it have been interpreted as just a placebo?

 

Perhaps it's because I have mild rather than severe tinnitus symptoms today, but I'm positively framing this. Auricle is serious about the FDA submission. The Susan Shore et al. studies show promise, albeit with questions folks have raised about the placebo treatment/washout period affecting the actual treatment efficacy. (Maybe that will open some new research avenues.) We have no control over the timeline. I get the desperation of folks at their wits' end suffering. I've been there at various points.

I hope this is one of a couple of treatments that may come down the pike. Perhaps we can look forward to synergistic effects. For the moment, I'll stick with getting enough sleep, calm beach time, a good diet, and a bunch of other stuff I do.

When the release does come (and of course, we have only the vaguest of notions as to when), at least we have a community of people here, some of us who live in the U.S., who may be able to help each other out with accommodations, driving to audiologists, clinics with the device, etc.

 

Different submission requirements entirely. Apples, Oranges.

 

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.

 

The answer to every question you asked is in this thread. Use the search and select "Posted by Member." Years ago, @linearb documented his experience on this thread. There is also a discussion on Lenire's timeline.

 

I've been guilty of being pessimistic myself, but I hope you're correct and that it's just a matter of time.

I'm based in the UK, so unfortunately, I can't offer any accommodation or other support when it reaches the US market. However, I would be more than happy to contribute to any fundraising efforts to assist those who can't afford the device but desperately need it—provided, of course, that there are some positive field reports.

 

That's very kind of you.

At this stage, a fundraiser will be more needed for Tinnitus Quest. It's going to be a serious effort to raise anything significant.

 

You’re misunderstanding my post, but it DOES work. Please, I implore you to read his experience with it. As I already mentioned, he was enrolled in the first trial of 4 weeks, which showed benefits while using the device. The benefits went away after his 4 weeks.

Susan Shore then did another longer study with 99 participants for 6 weeks and was surprised themselves when the results lasted beyond the washout period. That’s after 6 weeks, but not after 4 weeks. Again, @linearb was only enrolled in the 4-week study.

I could conceivably see the machine being used on an ongoing basis of once or twice a week to keep the benefits ongoing after the initial 6 weeks. If that is the case, I would gladly set aside an hour or two a week to use this device if it means my tinnitus is lower and my THI is lower.

Just have a little bit of hope, my friend.

 

Yes, the science behind the device is solid. The marketing and rollout are problematic. Those are two different things; they don't correlate.

 

Dr. Shore mentioned in her recent webinar that the trend of decreasing volume continued even at the 6-week mark. She suggested that this could imply further reductions if usage extends beyond 6 weeks. My thinking is that, like with many treatments—from antidepressants to acupuncture to everyday painkillers—some take longer to show results. I’m hoping that those who showed less of a decrease in volume after 6 weeks might experience further improvement, ultimately leading to better overall results. For some, it might even be a case where nothing happens at first, and then suddenly, at around 8 weeks, things change. I’ve seen reports from Lenire users where they experienced no progress for weeks, and then, all of a sudden, there was a significant improvement.

I'm starting to feel hopeful again!

 

Very true. I believe the recent lack of communication from Auricle has unnecessarily soured my perspective. This might be due to my recent transition from a mild to severe case of tinnitus. However, after re-reading the positive results of the Phase 2 trial and reading posts from @linearb about their experience with the device, I’m feeling a bit more hopeful.

Based on my research, it appears that Lenire was submitted to the FDA on August 18, 2021, and wasn't approved until March 6, 2023, according to this FDA document. So, if that's any indication, it took roughly 18 months from FDA submission to approval.

Considering that Susan Shore's/Auricle's device only completed its Phase 2 results, which were released on June 2, 2023, and the FDA submission is expected sometime in 2024 (if it hasn’t been submitted yet), we’re likely looking at FDA approval for Auricle's device around 2026, at the earliest.

One encouraging point is that Lenire became available in the U.S. just a month after FDA approval in April 2023. This suggests that Lenire/Neuromod used the 18 months effectively, preparing everything to hit the ground running as soon as approval was granted. I hope Auricle can do the same. However, the lack of updates from Auricle is naturally a bit concerning.

I also hope Auricle reconsiders their U.S.-focused strategy. Lenire was launched in the UK and Europe within a year after FDA approval, so I don't see why Auricle couldn’t aim for something similar.

The main reason I’m posting this comment is that, while this device could be positive and potentially groundbreaking, we’re likely looking at 2027/2028 at the earliest before it’s rolled out, gathers reliable real-world data, and becomes available for us to use.

In the meantime, I’m planning to step away from here, and I recommend others do the same. My severe tinnitus is awful, but I’m certain it will be at least a little more manageable if I spend less time reading and thinking about it. As difficult as it is to avoid focusing on it, I’m going to immerse myself in life as much as possible (while taking precautions in loud environments).

There’s really no point in checking in frequently until Auricle achieves FDA approval. Plus, they don’t seem inclined to release further information themselves. We might as well wait until 2026 and check back then. That’s just my perspective—if checking in daily or weekly brings you comfort, that’s understandable. But I think for many people, stepping away from tinnitus websites and getting busy with life might do more good.

To everyone here with mild, moderate, or severe tinnitus, I wish you all the best now and in the future. Hopefully, we’ll be experiencing more peaceful moments in the next 5–10 years. Take care!

 

It's the other way around. Lenire was available in parts of Europe around 2019-2020, so years before America.

Yes, frequently checking here is fruitless.

 

On the other hand, we don't know for sure that it wasn't submitted to the FDA a while ago, possibly even last year.

But I agree that preparing for the worst-case scenario is not a bad idea.

 

After listening to the aforementioned recent interview of Neuromod's Dr. Hubert Lim, I wouldn’t be surprised if the FDA asked Auricle for an additional clinical trial.

 

Why do you say that?

 

In Dr. Shore's clinical trial(s), the patient population was kind of small compared to Lenire.

Dr. Hubert Lim also said that you really can’t have a true placebo with a device like Lenire because people can tell if they are not getting the electric stimulation. This might be the same with Auricle.

 

Yes, a third of us! (That is, a third of us will be experiencing more peaceful moments in the next 5-10 years.) And this only applies to a relatively privileged group. Are you well-paid? Do you have a degree? Do you live in North America? Is your car new? Although I don't check any of these boxes, I should probably still consider myself 'privileged'—being from the West, holding two noisy jobs despite having tinnitus (both low-wage, of course), and currently not having any significant medical expenses.

It might be decades before something like Auricle is covered by health insurance.

 

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

 

If Lenire could be approved with just two clinical trials, Auricle could also be approved. It's non-invasive, meaning the clinical trial requirements are less stringent.

 

Dr. Shore mentioned communicating with the FDA throughout the clinical trial process, so one would hope she followed the FDA's guidelines. In some articles, she has been quoted as saying her focus is now on commercialization, so ideally, another clinical trial won’t be necessary.

However, based on previous posts, it seems they’ve hired someone to design a take-home version of the device. I find this surprising and a bit confusing because I assumed that version would have been used during the clinical trials to satisfy FDA requirements. I also understand that clinical trial participants did take home the device they were using.

Any thoughts on this?

 

I think Dr. Shore's placebo was related to the timing.

 

The clinical trial device looked like this:



Of course they want to design a better-looking and easier to use device for the general market availability?

 

You are not getting this confused with the Bionics Institute technology, are you? They are looking at several more portable prototypes. I've heard nothing of new prototypes for Auricle.

 

If I remember correctly, the active arm received electrical impulses so faintly that the participant soon habituated to them and did not feel them. In essence, they were blinded to whether or not they had active or placebo treatment. That's how Dr. Shore explained her blinding.