New University of Michigan Tinnitus Discovery — Signal Timing

No doubt you guys have just received the email from Susan Shore. There's not really much in there we don't already know but promising stuff that her lab is communicating directly with subscribers:

 

Great to see it moving forward - I hope Auricle are capable of building what's needed to bring it to market in a timely fashion. FDA approval and building the device have reasonably deterministic timelines, it's getting the funding and building out the organization, infrastructure, relationships, commercial agreements, training programs, software tools for programming, etc that'll take all the time. As mentioned before, a partnership or licensing agreement with Neuromod (Lenire), who have all this but not the underlying technology, would be by far the quickest and most effective way to bring this to market but how likely is that?

It may have changed but last time I looked, Auricle was a one-person organization, so I'm very interested to see how and when the funding and people are going to come from to make it all happen (currently they only have $350K of debt financing).

Keeping an eye on this is a good way to assess progress.

 

One thing that troubles me, and maybe it shouldn't, is that there is no website for Auricle.

 

One thing I can say about Dr. Shore is she has integrity. Reading emails from some of you where she has personally responded to you says an enormous amount about this woman. Yes, she has been professional and had to keep information within to protect the scientific integrity, and has done so as a professional scientist.

There are not many who have kept in touch with the tinnitus community. Some have appeared on podcasts to grab money off us (Frequency Therapeutics, Otonomy and Prof. Thanos Tzounopoulos) and others infiltrated for the same purpose (Hough Ear Institute) but none have had regular or personal contact over such a long period of time.

Others like Dr. De Ridder do come on the Tinnitus Talk Podcast to update and share information without pitching for money.

I'm really pleased for Dr. Shore, her work has born fruit!

 

Neuromod, the company who claims over 90% success rate for Lenire based on studies that are not placebo-controlled? I would rather wait an extra year than let those scammers take any advantage from Dr. Shore's work!

 

I'm not concerned per se, but your observation kind of supports my point - it looks like a one-person organization with a registered company name and that's about it. There's a lot of work (and cost) to develop the current prototypes into a mass producible product, develop the supply chain, and do everything I mentioned above regarding distribution, agreements, training, support, etc. I do this (in a different field) for a living, so have a good sense of what it takes. My best guess, and that's all it is so I hope people don't jump down my throat at this , is that once funding is in place, 2 years would be a realistic timeline (maybe 18 months if pushed hard by a well-funded and experienced team working in parallel on all elements of bringing it to market).

 

There is one sentence that is particularly interesting in her email, she says "We are dedicated to bringing this novel therapy to the millions of global sufferers of this terrible affliction".

It's already positive just to read that she hopes to help "millions" of people

 

Can someone explain in a little more detail how Dr. Shore's device works? (I've also tested Lenire without success and would like to identify key differences so that I can believe in Dr. Shore's device.)

So which sounds are played? What frequencies, durations, pauses (i.e. timing?) What kind of electric currents? Nerve stimulation, muscle stimulation, massage function?

How long does the treatment last overall, and how long/how many times is it applied per day?

 

Great to hear - thanks!

 

Must be tough, knowing insider things, and knowing the severity of people's situation, yet still not able to share anything. If you're positive, I guess I will copy your positivity

 

Thank you for this.

It's painful to know that within EU Dr. Shore's device could be brought to market without any regulatory approval, just a simple CE Mark. Yet there seems to only be focus on a difficult, long and painstaking FDA process. If the 'investor' (I'm still hoping for big pharma) wants return on investment, start scaling up in other markets in parallel to US/FDA. Just like Lenire did. Start-ups or R&D companies can simply not supply global markets. That's why big pharmaceuticals acquire the rights/licenses of certain medical interventions. Same as XEN1101. Xenon Pharmaceuticals will not be the company to bring this to market, it will be licensed for sure.

I work in pharmaceutical manufacturing. The investment of building a capacity to produce active pharmaceutical ingredients is tremendous, especially on the scale of millions of tablets. That's why we and others use third party manufacturing for certain substances.

What is worrying that the FDA did not approve Lenire after 2 years of initiating the process. FDA does not require placebo control and the study results of Lenire are quite significant (not talking about real life).

 

I don't really know much about FDA, but maybe (and hopefully) it will not take as much time to authorise the marketing of Susan Shore's device, as it is an American device?

 

I actually got a little teary eyed about this email. The reason is that she specifically calls it a "terrible affliction".

My GP completely dismisses tinnitus as a joke at best. My ENT pats me on the shoulder and says that "everything will be ok, because that's how life works". My audiologists refuse to criticize Jastreboff and thinks TRT is amazing. They also repeat the "you'll get used to it" -line in a wooden and perfunctory way, they almost sounds like a Brezhnev-era apparatchik giving the party line. I have never met anyone who was willing to call tinnitus for what it is - a disaster to humanity, endless torment for some, just flat out one of the most horrible things that can happen to you (or not, it depends).

To see such a serious scientist and researcher use these words the same way I would, makes me feel incredibly proud of not giving in to the hacks who's been trying to make me feel like I'm the crazy one. I refuse to let anyone hijack my narrative and mold it into some PG-13 version of the truth.

I might jump on the tattoo train myself.

 

You should give yourself a pat on the back. Running the gauntlet at the point of clinical care can be a real minefield.

 

Make no doubt about it, severe tinnitus is hard. Doctors don’t question me about it and write scripts for any drugs I ask for (I’m back to none - nothing helps). They know I’ve worked disasters, war zones, high risk and high profile international work, they know I spit nails and don’t complain, but for me this is as hard as anything I’ve lived through.

Don’t let them gaslight you about this. Dr. Shore is right, tinnitus is a terrible affliction. I’m glad she calls it as such.

 

I have grave concerns that the FDA has not yet approved Lenire after 2 years them initiating the FDA approval process. FDA approval for devices are supposed to take about 6 months according to my research.

Will Dr. Shore's device be any different? I know she was a lot more rigorous in her scientific process, including a placebo, where Lenire did not. They took great pains to document their study in the hopes of publishing. I am wondering if the 'basic science' approach that Dr. Shore and her team took will make a difference. I don't want to wait another 2 years or more for her device to be approved.

 

I'd like to think it's because Lenire is:

FDA probably has intelligent enough brains to see through Lenire's horseshit studies with no placebo control.

Dr. Shore comes from an acclaimed institution and her research is much more robust.

 

Anyone who can help with the above?

 

A couple years old but a good explanation for people like me who aren’t brain scientists:

https://www.sciencefriday.com/segments/a-temporary-relief-for-tinnitus-sufferers/#segment-transcript

 

@George Brunner, this is a good explanation:

Susan Shore on Bimodal Stimulation for...

 

Not temporary anymore lol.

 

I have learned a lot from Dr. Shore's research leading to this treatment. The key thing is understanding that in most cases somatic tinnitus is the result of NIHL.

I see so many running in a panic to see a dentist or chiropractor because they can modulate their tinnitus with their jaw or neck.

Of course these practitioners are happy to take your money.

Given the findings of this trial, I was thinking yesterday about trials ongoing for tDCS, biobanks and various other scattered theories that don't build off this basic scientific finding of the DCN being the generator of tinnitus. Even Dr. De Ridder is going off on alternative tangents at times.

Surely these findings will drastically change the way we research and develop treatments?

 

Out of curiosity, if tinnitus as a result of an acoustic trauma is supposedly derived from NIHL, wouldn't that mean all noise trauma related tinnitus 'should be' somatic?

Or does this depend on what the noise has damaged in the ear?

I'm new to this and trying to join the dots.

 

I was watching a lecture from Dr. Shore earlier today from 2010. As I understood it, reduced input from the auditory nerve from cochlear damage leads to an increase in Glutamate. At the same time in some (but not all) the other nerves that go to the dorsal cochlear nucleus (not just the auditory nerve), like the trigeminal nerve (face), vestibular nerve, dorsal column (neck) also show an increase in Glutamate activity. This heightened excitatory action is manifested in the DCN without the presence of external sound and is perceived in the auditory cortex as sound.

The lecture:

Susan E. Shore - Saturday Morning Physics -...

 

Thanks for sharing - interesting.

My 2-month-old tinnitus is 100% noise related, but I have yet to find any somatic elements to it. I guess for me no extra Glutamate is coming from the other nerves to the DCN, and must 100% be from the auditory nerve.

Must be hidden NIHL in my case as my before and after noise trauma audiogram tests show the same hearing loss I've had for years.

 

I agree with this but I would just add that I would pay for even a small amount of a cure too. No way I'd not pay for it just because it's only 20% effective.

 

Can anyone make sense of this from Dr. Shore?

• In vitro (test tube) experiments have demonstrated that fusiform cells after high frequency stimulation (100 Hz, 1 sec) show an increase in synaptic strength (called 'potentiation'), while after low frequency stimulation (1 Hz, 5 min) they show a decrease in strength (called 'depression').

In relation to an audiogram, aren't both 1 Hz and 100 Hz low frequencies?

 

I don't think this has to do with sound. Maybe it's electrical current? Like 100 Hz means 100 pulses/sec? In any case, 1 Hz is so low of a frequency that barely any creature can hear it. But 100 Hz compared to 1 Hz is a "higher" frequency indeed. I might be totally wrong though.