New University of Michigan Tinnitus Discovery — Signal Timing

Thank you for posting. Interesting re the hearing loss threshold being 55 dB at 12.5 kHz. That is completely new news. This is not classified as moderate hearing loss conventinally. Anything sub 55-60 dB at 8 kHz on a normal audiogram is classified as moderate hearing loss.

 

This is my concern. I can't modulate my tinnitus. It has a life of its own. Would this device help me at all? Do I have to wait for Otonomy or Frequency Therapeutics or some other hearing loss treatment to fix my tinnitus?

 

Just because you can’t modulate your tinnitus, it doesn’t mean it won’t work. They believe having somatic tinnitus leads to a strong indication that they can target the DCN with their device to alleviate tinnitus. The reason they are doing this is because they want to pass the trials. It doesn’t mean it won’t work if you can’t modulate your tinnitus. You may however be able to modulate your tinnitus, you are just unaware of how to do it.

 

No one knows anything at this point about any of these even the clinicians developing them cannot answer, so no one on here can answer that question it is all speculation.

We won't know anything at all until the clinical trial results, but even then I think we will only start getting answers if any of these treatments come to market and lots of patients start consuming the treatments on offer.

 

100% agree. The first trial results were positive, but only twenty participants and two totally resolved. Mean gain was solid but not spectacular. It will only be through user trials we will have total solid evidence, but I do think 300 participant trial with sham control will give us a good indication.

As for inability to modulate, I think they surely have tried it on someone who can’t. It would be foolish to think they haven’t. Again, though as its fundamental target is the DCN where somatosensory input intertwines with sound signal dictates that trial participants HAD to be able to modulate their tinnitus in order to prove the science behind it.

 

Eh, I don't think that's too hard to believe. Perhaps on an anecdotal or interpersonal level someone might have tried the device but I don't think they would use that as any kind of meaningful information. Although, it does look to me like they have some reason to believe that it wouldn't be as successful on those who can't modulate their tinnitus as much as those who could. Seems like they're trying to get a product out there as quickly as possible.

 

I sent Susan Shore an email asking her exactly the question being discussed now. Here was our conversation:

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Me:
Hi. I was wondering whether people who can't modulate their tinnitus would benefit from the device. My tinnitus is noise-induced but I can't modulate my tinnitus with head, jaw, or neck movements.

Dr. Shore:
We don't know that yet as we have only had people with somatic tinnitus in the trials. It is possible you can modulate if shown how by a professional.

Me:
First, thank you for the response. Is there at least anecdotal evidence that the device works with non-modulated tinnitus or has the device only been used in clinical trials? Forgive me if I sound ignorant of how this science business works!

Dr. Shore:
So far only in clinical trials so we don’t know yet.

Me:
How long does it take for the device to work? Does it take weeks for any results to show?

Dr. Shore:
It depends on the person. I will not be able to continue to answer individual questions. You can look at the publication attached

Me:
Ok! I know you're a very busy person (thank you for the publication by the way)! Just one more question. Why did you specifically choose those who can modulate their tinnitus for participation in your trial? Why exclude those who cannot?

Dr. Shore:
It was a starting point as it involves somatosensory stimulation, so the first group was those who could modulate. This will be my last individual answer. I have added your name to our mailing list for updates later in the year.

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So the takeaway here appears to be "the amount of therapy or use of the device necessary to achieve results depends on the person; the amount of weeks within the clinical trial do not reflect the amount needed to heal" and "they really don't know whether it works on people who can't modulate their tinnitus; the only reason why they have that as a necessary condition is because the device involves somatosensory stimulation".

Considering that all forms of tinnitus involve hyperactive nerves, there is no reason to believe that the device won't work on any form of tinnitus. Even that which can't be modulated. It just hasn't been tried or tested so they have no idea. Furthermore, considering the subjectivity of success as well as the length of time needed to gain results, it doesn't look like they could've meaningfully tried anyways.

@Padraigh Griffin, you should read this.

For those of you interested in reading the publication, here it is:

 

I agree with you, in that tinnitus involves hyperactivity in the DCN. I think you have reason to be hopeful and positive about her device.

 

I think we should just keep an open mind. Keep the door halfway open. A lot of people here believe that our only options are either to fall into depression or construct their entire lives around the success of a particular device or drug. You always have the option to keep living.

 

Plenty of speculation... but we just have to wait for the trial results and hope they can report some positive news.

 

I understand that everyone is desperate and would do almost anything for relief but I do not condone these emails to the researchers. You are literally wasting Shore’s time, replying to emails to answer questions that have already been posted in her research which is all readily available online. All the questions you asked have already been answered for years, and not just in her papers but even on this very thread. Asking about results of a clinical trial, mid trial, is also ridiculous and no researcher would give “anecdotal” evidence and jeopardize a trial.

I don’t know why this culture of blasting emails to the researchers or CEOs of these companies exists here but it should really stop. This is especially true when the questions being asked are inappropriate or already blatantly obvious. All it does is slow the process.

Sorry if this comes off as harsh, but this is the truth and the sense of entitlement needs to change.

 

I only asked what was asked here and many of those questions are ones that didn't have answers. For instance, I don't think there is any information in regards to how long it takes for the device for work. Now we know it depends on the person. I asked whether they tested people who could not modulate their tinnitus at any point (because this question was asked by another poster here) and she answered that they didn't and that they chose people who could because they seemed like the best group for their device.

As for wasting Shore's time, if I was, she would not respond. This happened last time I conversed with her. She told me she was unable to respond and then put me on a mailing list for updates next summer.

I don't know what is entitled about asking questions directly to researchers if they are open to communications. I didn't expect an answer nor did I believe I deserved an answer.

 

@Survivor234, while I understand there are differences of opinion here and some rehashing of information, these question and response posts are very helpful at least for newcomers like myself who are still navigating through the myriad of information within these threads or the publications. So I thank @Survivor234 for reaching out and the further clarification.

As a high frequency sufferer (15-16 kHz) I also reached out to the clinician regarding the pitch matching of their device which, while maybe listed in one of their publications, I wasn’t able to easily locate. He advised that the maximum frequency was in the 12 kHz range but again, since the target of the device is the DCN, still feels the device will be beneficial regardless of exact pitch matching. Attaching screenshots of the responses here.

 

Well, at least until recently it seemed like Shore had plenty of free time given the pace she was moving with this thing.

 

Thanks @IntotheBlue03 for sharing the information. Really helpful.

 

@Survivor234, seriously I could have answered all those questions for you!

Then she asks you to stop and you still ask another question!

 

I'm not sure what the issue is. I didn't know that this information was available. I just saw that some people were asking questions about the device and decided to ask them to her.

 

Ventral cochlear nucleus bushy cells encode hyperacusis in guinea pigs

Since we’re in a mood for answering questions in this thread...

If Susan Shore is saying the VCN is the origin point of hyperacusis in this paper and not the DCN, do you guys feel as if the device will have no effect on hyperacusis?

I’m curious because at one point I believe in emails like the above people had asked her that and she said at the time they didn’t know. Don’t quote me on that though.

Lenire claimed people with hyperacusis were super responders originally and then never said much else about hyperacusis. We all know how their device has turned out though :/

 

The bottom line is that no one can give any meaningful answer to any of these questions.

I am frankly amazed the people contacted had the time to respond at all, but think it is because they are obviously caring about the plight of what people go through and have seen people struggling.

As for these questions and answers though, there are just no facts. It's all theory and guess work at the moment. None of these trials end up working out as expected.

I really want something to work, I really do, I'm sick of this buzzing and pain and want to have a day where I am not worrying about my ears, but at the moment what we got to help us is ourselves, nothing more, and that's just a fact.

I hope Dr. Shore's device works great and is a fantastic treatment for tinnitus patients, but we got to let the woman and the team work and find out if their theory's has merit.

Everyone on here is a scientist and can debate all the ins and outs of the drugs and technologies but at the end of the day it means nothing, it's just giving us something to do while the real scientists who are working to resolve and understand the issue are getting on with the task at hand.

But I fall on the side of giving them a break and wait for the results rather than contacting them individually or if there is going to be a contact maybe that's something that @Hazel and the forum moderators could facilitate i.e. collate questions and have a single contact / response. But then again I guess they do this with the Tinnitus Talk Podcast etc.

Please don't get me wrong, I am not trying to come over negative, but people are seeking facts and there are no facts that exist until the trial results, and even then there's no viable treatment until a product comes to market and you can try it yourself.

 

I agree @ColinUK. Fact of the matter is that scientists aren't superheroes. We can't expect them to know everything pertaining to their device; especially considering that they're doing trials specifically to learn about it and its effectiveness. A lot of these questions are only going to be solved once the device is in our hands. From there, other scientists, clinicians, and consumers will have the opportunity to do whatever they want with the device.

I think the same goes for FX-322, FX-345, OTO-313, OTO-413, etc. While what is being trialed might seem inadequate for many tinnitus sufferers, the fact of the matter is that the primary goal is to A. find a treatment that works for at least a good portion of people and B. get the product out as quickly as possible.

 

I’m curious to know whether they intend to sell the device directly to consumers or if we’ll have to go through audiologist and/or ENT and what kind of time that will build into the rollout.

 

That’s a very good question @prowlinacage, I know that an Auricle contact email is somewhere in this thread, I will see if I can locate and contact them to inquire as I wondered the same.

 

Surely a home device with telehealth support and pitch matching etc, similar to Lenire.

 

Keyword here is 'desperate'.

I'm fairly certain it'll be rolled out via audiologists.

 

The fact Dr. Shore and her team have spent so much time on this device trial (20 years+) worries me a lot. It's non invasive procedure so if the results were good, I guess it would already have been on the market years ago.

 

I think the trial started last year after being delayed a year due to COVID-19. The basic science, developing models, testing in animals, and finally the limited human trails (2017?) took 20 years. The final large scale trial that we are all waiting on is just a year old.

 

This device will be another scam like Lenire is. If the device worked, I am sure they would be much faster to enter the market.

 

That's not how things work. You need to go through multiple phases of testing, trials, etc. in order to get FDA approval. And with a device like this that typically takes multiple weeks to work, you can't just speed things up. For the record though, Susan Shore's device is probably going to be rolled out the quickest. Other treatments like Otonomy's or Frequency Therapeutics' aren't even remotely finished trial wise (although they are close).

 

Since the device requires pitch-matching, it will almost certainly be something audiologists will carry out.

 

What terrible input. Sincerely, no offense but think, research and reflect before you type. Read my post about Lenire earlier in the thread. No placebo control. Or sham device to be correct. This is totally different and as a University funded project will take time.