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There was no placebo control group in this study, so this is worthless data. Plus, @Mentos, who took part in one of the trials was strongly encouraged to state that the treatment helped him, despite the fact that it did not. I have one more friend who used this method, and she was not happy either.

This is serious stuff. Questions like "Dr. Shore, when will the FDA approval be finished", or "Dr. Shore, when will the commercialization be completed" are pointless, as there are dozens of variables that are not under the control of Auricle. However, we deserve clear information if they have...

Again, all we do here is speculating. When it comes to the parameters and the way the device works, that is a good exercise, as we have a lot of official data. When it comes to the business side, we have almost zero insights. Let's wait for the interview with Dr. Shore. I'm only saying this...

I feel the same. I did what I could to habituate. I've been doing TRT for a year and a half now. All I can say TRT helped a little bit and I learned how to minimize the impact of tinnitus on my life. But TRT does not cure, and I find Jastreboff almost a sadist, as he thinks achieving silence...

I understand you and your point of view is logical. However, now we are building our expectations on assumptions, not facts. To be honest, the date when the device is approved is not that important for me. I feel safe, as the data are promising. And that is the most important part.

I cannot pinpoint the source, but I remember precisely: Dr. Shore submitted the request for FDA approval at the same time she submitted the publication for peer review.

It is worth mentioning that the trial lasted only 4 weeks. There is a suspicion longer use will result in permanent recovery.

Yes, you are.

Yes. This is very, very good news! I hope Dr. Shore will remain in good health. If this is the case, the future is bright. I'm so grateful to @Markku for this clarification.

You are the best. I had an anxiety attack after seeing the news of Dr. Shore retiring, but this made my day.

That would be brilliant, but unfortunately that is only speculation. I hope @Hazel and @Markku will be able to ask Dr. Shore for clarification about her plans. Right now, the news of her retiring might be causing anxiety for thousands of people. I would be very grateful if someone clears this up.

I'm sad that Dr. Shore did not release additional information for the tinnitus community, to clarify her plans. Now all we can do is speculate.

Sorry. I did not mean that you are spreading negativity. I would like to direct that at people who will find this information disturbing and panic as a result.

Yes. It means that she will receive money from the retirement system, but will continue to work. This is a common situation in the scientific field. I couldn't imagine her leaving for good when the device is not FDA approved. It is the fruit of her life. I guess she will stop working and...

It was in bad taste indeed. Dr. Shore is our only hope, she is dedicated to us and we owe her our highest respect. Good on you for your apologizing for your mistake.

Yeah... I guess it will be set up along with some interview and you will be free to go. I'm just wondering if any tweaks in the software will be needed (due to the tinnitus parameters changing), and if we will be able to solve that remotely. If that is the case, I'm all good. I've never been to...

I love your optimism. I'm also one of the funny fellas here. However, it slowly starts to scare me, that there is totally no business infrastructure on Auricle's side. FDA is one animal. They need to have contracts with OEM factories and sales structures. How can they be working on that, if they...

I left some space on my forehead for this. I've spoken with a shit ton of Doctors and Professors of Audiology. If they are not researchers themselves, they do not care about any research at all. They start to pay attention to a treatment only after it is registered as an official procedure. I'm...

Valid point stated by a knowledgeable member. That brings hope.

A totally valid point. I did not find any information saying a published study is necessary for FDA approval. If the device becomes available before the study publication, I'm taking my shot. I'd rather have my brain fried like beacon, than live with this mother***ker longer than necessary.

Yes, Dr. Shore said exactly that. She want to depress neurons in the DCN (I'm assuming this means slowing them down). I have the same reaction to marijuana and huge doses of alcohol as well.

We don’t want a 3rd trial! Let us have the device available ASAP. Then we will test it on ourselves.

As usual, I totally agree with @AnthonyMcDonald. Numerous devices for electrical stimulation of the ear have been already tested. The oldest one I'm aware of was set up in 1972. If that path was the right one, we would all have been cured a long time ago. However, I think this field should not...

Totally false. Medical University of Łódź, Poland, where @Mentos was treated, started testing this shit in early 1970s. Basically it is a very old method.

Your sarcasm is annoying me, to be honest. We have never had such thorough basic science done during the development of a treatment. I'm talking about Dr. Shore of course. If you have doubts, please keep it to yourself, as folks from Shore Lab might visit this forum. We should support them and...

I totally agree with you @AnthonyMcDonald (as usual to be honest). Your outcomes are aligned with my brainstorming. It is a very logical assumption that tinnitus is generated in DCN: - If tinnitus was generated in cochlea, then all people with hearing loss should have tinnitus. We all know this...

If @Mentos will get even 1% improvement after this, I'm taking the shot as well. A doctor from Kazakhstan finds it legit. So I must consult it with him: In this case, I have high expectations.

Yes, but there is XEN1101, which is basically the same drug, and could be used off-label soon.

It won't flop like Lenire for thousands of reasons that have been widely described here many times.

I have the same assumption. If 4 weeks gave 50% reduction, and 6 weeks gave 75% reduction, it is quite logical, to assume, that after 10 weeks you could achieve silence, or almost silence.

It will be a BIG change. 75% tinnitus volume reduction will be as good as a cure. Who knows, maybe after extended use of the device the reduction will be even greater. I also think, those, who are well habituated, will have the best results. This is only my assumption though. I agree. When my...

Someone from here already asked Dr. Shore about multi-tonal tinnitus. The answer was that the majority of tinnitus sufferers have more than one sound. So basically Dr. Shore does not consider multi-tonal tinnitus as something that would stop the treatment from being effective. As a multi-tonal...

1. Neuromod did not develop a proper model of tinnitus. 2. Neuromod did not spend 15 years on basic science. 3. Neuromod did not perform a double-blinded crossover study. 4. Neuromod do not have magical jacket Dr. Shore has on every interview. You can be skeptical as long as you want. In a...

I totally agree. It does not matter if you lost some hearing because of a metal concert, ototoxic drug, or maybe alien fu...ed you in your ear while you were sleeping. At the end, there is hyperexcitation in DCN as Dr. Shore has said. So everyone, be optimistic. Please be!

They clearly state in their FAQ that temporary worsening may occur. Any magnetic stimulation has such side effect as far as my knowledge goes. However, I understand your concern. Hopefully some people here will test it and check if the worsening is truly temporary.

Great summary. The tinnitus community should make it really clear to researchers that we are against spending money on another psychological analysis. Resources should be directed ONLY to solving the root of the problem. The medical cause. I think I will contact Prof. Dirk De Ridder myself and...

I know Polish healthcare system very well. I'm assuming that patients will have to pay for the device for 10 years. After that, our Ministry of Health will make the decision to cover the costs by national healthcare system.

There is an easy way to import this drug to Poland via our Ministry of Health. I think they import it from Belgium.

Not true. The outcomes of the 1st trial are already published. So it is not only told, but it has already (at least to some degree) been proven it works.

They deserve every single dollar that the device will bring, plus I hope they will live long and happily surronded by hookers and tons of crack.

Totally agree. The latest update by @Hazel made me believe that. It is not bad news. XEN1101 is developed by big company and is advanced in trials. I think it will he easier for them to deal with FDA and commercialization than it is for Thanos. I will have no issues with taking it off-label...

Great response for negative attitude.

Yes - we have hope. Never before has any tinnitus trial been this successful at such an advanced stage, nor has there been any with such rigorous design and deep pre-trial basic science done. I'm personally very confident this will bring us at least some kind of relief.

I'm not that scared of TFI not being reduced significantly. If the study objects were new sufferers (<6 months), their feelings were totally distorted by panic/lack of understanding/hate towards doctors. Even when they felt better, they might have been frustrated that they do not have 100% silence.

@Hazel, @Markku, you are a gift from God. If you will be interviewing Susan, I think the hottest question would be multi-tonal tinnitus. I imagine that in such a case you would have to have separate treatments for every tone/frequency you have. This is the logical conclusion after hearing the...

@Hazel, I'm also joining the request for an update. Maybe it would be possible for you to ask Dr. Thanos for an update. There has been no news for two years. I checked everywhere, plus I tried to contact Dr. Thanos himself.