New University of Michigan Tinnitus Discovery — Signal Timing

That is why I wouldn’t rule out a EU release before a US one.

A CE would be faster to achieve than FDA approval and the treatment isn’t ‘novel’ in the EU as Lenire is established.

Hopefully Auricle CEO has a licensee ready to go in the EU.

 

I remember when a university here in Canada was testing the device and 2 patients had their tinnitus cured. It was amazing to read about.

Experimental treatment could help reduce constant ringing of tinnitus

 

That's amazing. Were those people part of the 20 people of the first study in 2017? Or was that some independent study?

 

The rules for FDA approval for medical devices are not the same for medicinal use and devices. For medicinal use it takes years, even over a decade to bring a device to market. For devices the rules are very different and a device can be approved in as little as 6 months! I wouldn't bank on an EU release before a US release given that it's being developed in the US and FDA approval device was already set in motion years ago. It can't be finalized of course until the device is released!

 

Will Dr. Shore's device go through a Phase 3 (if Phase 2 was successful) before they sell it, or will they sell it whilst getting FDA approval?

 

They can't sell it before it gets FDA approval. But there will be no Phase III before it's sold.

 

I know, but EU CE is even more relaxed and shorter timeframes than FDA rules for Grade 2 devices.

Depends a lot on who is interested in licensing the technology.

 

Ok. That's true. It does depend a lot on who licenses the technology. I still think it's going to be a US first product though, and that's not just wishful thinking. They are pursuing the equivalent organizations to the FDA in a lot of countries, I think they'll want to roll it out to as much of the world as quickly as they can. I know they have patents for the device in a number of countries around the world.

 

No. Only two phases for medical devices. They will have to get FDA approval. The process is under the DeNovo pathway. Details of that are here:

https://www.fda.gov/medical-devices...cation-request#FDA_Review_and_Review_Timeline

How far they are through the process is something we don’t know.

 

They say that Dr. Shore's device may help people with somatic tinnitus, I worry that this is going to leave a lot of us out of the picture.

Is there any research on her device for those of us who have tinnitus caused by loud noises?

 

That question has already been asked a dozen times. I'm curious about this myself. I have a Zoom meeting with Prof. Dirk De Ridder in October, I will ask him his opinion about it. Although the only one who really knows the answer to this is probably Dr. Shore. But the way I see it, it's all in the brain so I don't see why it shouldn't help everyone.

 

It would be good to have an updated opening post with all the information currently available because many of these questions come by every few pages. Please take your time to read through the last 10-15 pages. But since you are new and I don't want to scare you away:

- Most of Dr. Shore's research is exclusively around noise induced tinnitus, including this device. It was tested on noise exposed guinea pigs.

- This specific device is not tested on people without somatic tinnitus. But we don't know if the guinea pigs that this was tested on had somatic tinnitus either. Guinea pigs don't talk Still worked for them. I wouldn't worry about this.

- A different bimodal device tested on a Belgian university showed that their device worked the same of somatic or non-somatic tinnitus.

- It would (my theory, not scientifically studied) make sense if it might work slightly better on people with somatic tinnitus - these people might be more senstive to the electroshock stimuli applied since they can already modulate on their own without help.

Regarding the earlier discussion on Phase 2/3. Phase 3 is not required by law but I really wouldn't be surprised if a third study would follow. Perhaps in parallel to the launch.

 

One additional point, I don't believe that the source of the tinnitus (as long as there wasn't a tumor, etc) was one of the qualifying or disqualifying criteria for taking part in this study. I don't believe anything in her papers suggests that her tech is more geared towards noising induced damage as opposed to ototoxic, or anything else. The targeting of somatic tinnitus sufferers was based upon the assumption that those who can already impact their tinnitus by physically pulling of nerves on the face and neck would be promising candidates for the stimulation of those same nerves. The selection of somatic tinnitus sufferers in the study does not exclude that it may be equally impactful on non-somatic tinnitus. It just wasn't tested.

 

Thanks, this is helpful. Do you know if the device could be helpful for low frequency / humming tinnitus or is this more targeted towards the traditional higher pitched ringing tinnitus?

 

Will Susan Shore’s device assist with reactive tinnitus? Or somatosensory pulsatile tinnitus?

 

Noise induced tinnitus IS somatic tinnitus in a lot of cases. All you need to do is see if your tinnitus changes when you clench your jaw, press on your face or make movements with your head. If that's the case then you have somatic tinnitus, whether it was noise induced or not!

However, somatic tinnitus is the only kind of tinnitus that will be helped by the Michigan device AT FIRST. She says they will work on addressing other kinds of tinnitus once the device is out on the market.

 

Dr. De Ridder told me that if you don't respond to Lenire, you might also not respond to Dr. Shore's device since it's the same concept.

Do you guys agree on that? I had hopes but this statement is destroying it...

 

Err, 20 years research from a university will trump some jumped up entrepreneur. I think it will be a decimate improvement on Lenire, no doubts.

Let's say Dr. Shore's trial will show 50% get meaningful improvements, I reckon that will translate to 25-30% getting success on Tinnitus Talk. Before you say I'm negative etc., there is no treatment now, so that's 25-30% more than we've ever had. BIG success and step forward!

I've read threads on Tinnitus Talk from 2013 onwards that look foolish now, as predictions were made that were simply fantasist wishful thinking.

Although Tinnitus Talk stands up better than any social media group I've been in for being realistic.

 

That's the stupidest thing I've ever read about these devices and I've read a lot. Shows once again how clueless even the most "knowledgeable" doctors/researchers/etc are about tinnitus.

The devices' concepts are almost the opposite of each other. Dr. Shore's device targets only the region that is generating the tinnitus sound and tries to calm it down, while Lenire "supposedly" targets all regions and tries to simulate all those to make the tinnitus one "weaker".

Lenire has no solid proof it even works, as nearly all reviews on the internet are mixed. Its studies were flawed and usually without a placebo group. I don't know if Dr. Shore's device really works or not, but so far the evidence is far more positive and solid. Of course, we must wait till these Phase 2 results.

 

No. It's not the same concept. I suspect a lot of what Dr. De Ridder says because he is frequently wrong!

In Lenire they stimulate all the areas of the brain around the DCN to make it more active so the brain notices tinnitus less. Dr. Shore's device makes the fusiform cells of the DCN less active so that your brain doesn't produce the sound.

Lenire is meant as a habituation device because the thinking is that if you make areas of the brain more active, it notices tinnitus less. Whereas the Dr. Shore device actually makes the noise in your head less loud. The two concepts are POLAR opposites, and completely different approaches.

I am not sure about reactive tinnitus. But it will not treat pulsatile tinnitus.

I am also not sure about somatosensory tinnitus, but if by that you mean somatic tinnitus then yes it will! It's designed only for somatic tinnitus now. But it may treat pulsatile, non-somatic and other forms of tinnitus later after the initial release of the device. Dr. Shore said that she will work on addressing other forms of tinnitus after the device is released.

 

Pulsatile tinnitus has to do with veins or arteries. It’s an actual real sound your veins are making because of an impingement or blockage. From what I understand, they can fix pulsatile tinnitus if they can locate the problem area.

 

I am less familiar with pulsatile tinnitus. You are right. So, Dr. Shore's device won't be able to treat that, but there are at least existing avenues for treatment.

What device was this? Could you elaborate or, if you have any more information, could you provide it?

 

Effectiveness of bimodal auditory and electrical stimulation in patients with tinnitus: A feasibility study

 

Though there are a few bimodal stimulation approaches and they tend to get all lumped together, Dr. Shore's device sticks out to me as slightly more rigorous for a few reasons; their animal model is designed to induce tinnitus through 'hidden' hearing loss rather than heavier noise exposure, the somatosensory spike timing plasticity targeting makes a lot of sense, and the trials so far have used a sham/active/washout approach that makes it easy to see accumulative effects. I also personally lend a little more weight to their use of TFI measurement over THI.

Of course none of that means that they've got a reliable effect for certain, but those factors differentiate it enough from previous bimodal approaches that I'm paying very close attention to this despite the responder rate so far being little better than others.

 

there is a subset of somatic tinnitus called somatosensory pulsatile tinnitus whereby the DCN no longer cancels somatosensory sounds hence modulation of sounds through muscle or joint movements. The other theory is that the auditory pathway/brain taps into existing somatic pathways to maintain neural pathways.

So I’m not referring to pure pulsatile tinnitus like most are used to hearing about.

 

There are some YouTube videos where Dr. Susan Shore explains that basically all tinnitus is from some kind of hearing loss, either hidden or otherwise. Basically the fusiform cells are overactive because of the hearing loss, and her device aims calming those cells down from their hyperactive state, thereby lowering tinnitus. Somatic tinnitus in her point of view is caused by some kind of hearing loss, which can be caused by noise.

My tinnitus was caused by noise and I can alter it very prominently with my jaw, etc.

I hope this device works. I can't wait to see the results from Phase 2.

 

Thanks for the helpful responses. I never realized that clenching my jaw would change the noise a bit.

Also, I went back a few pages and I saw the discussion of Dr. Shore's upcoming talk. According to her clinical trial listing, it was set to end on 2022-07-06. I work in the social sciences and finishing a study in July and presenting my tentative conclusions 5 months later wouldn't be hard at all.

Moreover, in the social sciences, we often present tentative findings/conclusions at conferences. I've presented at over 15 academic conferences and the majority of my presentations were on papers that I hadn't finished yet. I don't know the rules/norms of her field, but for the social sciences a paper doesn't need to be in its final form to be presented.

Finally, failures are just as important as successes. I tell my students finding out what doesn't work is important. Our hypothesis being wrong isn't a failure, instead it is the creation of important knowledge. The only failure is when we do poor research and get invalid or unreliable data/or misinterpret our data. I hope Dr. Shore's hypothesis was correct and we see amazing results, but even if her hypothesis wasn't right, I feel that we will at least have good data/analysis that will move us a step closer to relief.

 

As I understand, Dr. Shore's device works for those with no to mild hearing loss at the tinnitus frequencies?

 

Her clinical trial isn’t necessarily the same as commercial use but...

• No greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss at the tinnitus frequencies.

 

Cool. That sounds like I would qualify. I have only mild to moderate mid-range hearing loss, also known as a "cookie bite" hearing loss, and then another moderate drop off in the higher frequencies of around 13,000-14,000 Hz. And presumably that's where the majority of my tinnitus lives.

I can easily modulate and change the sound of my tinnitus by clenching my jaw and other head and neck movements. So it's my great hope that this device will work for me!