New University of Michigan Tinnitus Discovery — Signal Timing

[dj_newark]

Not doubting at all, because I'm eagerly awaiting Dr. Shore's device as opposed to trying Lenire.

However, what would you say the major differences are (besides the double blind study)? Is there a different mechanism of action in the stimulation (i.e. cheek and neck vs. tongue) that makes a difference?

There is something about the placement of the electrodes on the different devices that targets different parts of the brain.

The MAJOR difference is that Lenire is meant to be a habituation device. It's not even trying to reduce the level of sound one experiences. I'm not sure how successful it is in that, but from my impression it just DOESN'T FUCKING WORK!

Lenire stimulates the areas of the brain AROUND the cochlear nucleus in an attempt to get you to notice your tinnitus less. It's not even attempting to reduce tinnitus volume as it's trying to excite the brain, compared with Dr. Shore's approach which is to calm hyperexcitability of the cochlear nucleus.

Something about the way that the method that Dr. Shore is using with the electrodes targets the cochlear nucleus and quells the hyperexcitability of the fusiform cells in that region of the brain stem.

You see? You can't just say "Oh they're both using bimodal stimulation for tinnitus so they're the same!" They're not. They both have different effects on the brain and they are targeting different regions of the brain. To say they are the same or even similar is a very superficial view.

 

[UKBloke]

You see? You can't just say "Oh they're both using bimodal stimulation for tinnitus so they're the same!" They're not.

Yep, the two systems are completely different, and Hubert Lim has been quite clear about this. Raising the general level of neuronal excitability to that of the tinnitus (as his device does) is the functional opposite of Dr. Shore's approach of trying to lower the specific tinnitus neuronal excitability to a quiescent state.

Comparing Lenire to Dr. Shore's device is like comparing apples to oranges.

 

[Joshyboy]

Not surprised since Lenire doesn't f*cking work lol.

Lenire is surely helping 3 of my friends currently. I'm considering it myself due to the possibility of Dr. Shore's device being delayed for many more years.

My friends have reported going from their tinnitus bothering them 90% of the time to 30-40% of the time. One barely notices his tinnitus anymore and 3 months ago he was in a very poor mental state.

Also wondering if this Auricle device will ever come to market. Plus, if you invented something meaningful while being employed by the University of Michigan, with their tools, doesn't that invention belong to the university?

This is taking an insane amount of time to enter the market and it's not adding up. Yes, I've read all the posts by the subject matter FDA experts here but still...

 

[ajc]

Plus, if you invented something meaningful while being employed by the University of Michigan, with their tools, doesn't that invention belong to the university?

This already tells me you are just moaning without actually having read or researched the matter at all. University of Michigan has made a licensing agreement regarding the device. Read up before moaning.

Auricle Inc., the exclusive licensee of the patents related to the bi-sensory stimulation, was launched with the help of Innovation Partnerships, the central hub of research commercialization activity at the University of Michigan. Auricle will work towards gaining regulatory clearance and then commercializing Shore's novel bi-sensory tinnitus treatment.

Shore and co-first author David Martel, Ph.D., are co-inventors on the University of Michigan patent and co-founders of Auricle. The University of Michigan has a financial interest in Auricle Inc.

Taken from:

Study shows promising treatment for tinnitus

P.S. Your friends are experiencing the placebo effect with Lenire.

 

[El BUZZ]

Lenire is surely helping 3 of my friends currently. I'm considering it myself due to the possibility of Dr. Shore's device being delayed for many more years.

My friends have reported going from their tinnitus bothering them 90% of the time to 30-40% of the time. One barely notices his tinnitus anymore and 3 months ago he was in a very poor mental state.

Also wondering if this Auricle device will ever come to market. Plus, if you invented something meaningful while being employed by the University of Michigan, with their tools, doesn't that invention belong to the university?

This is taking an insane amount of time to enter the market and it's not adding up. Yes, I've read all the posts by the subject matter FDA experts here but still...

This is the kind of post adding just smoke to the thread plus it seems to me it would belong more to the Lenire discussion. It's obvious you only have not gone through this thread to elaborate a decent and solid opinion but also you are talking as if Auricle device were decades from being released.

 

[DeanD]

Lenire is surely helping 3 of my friends currently. I'm considering it myself due to the possibility of Dr. Shore's device being delayed for many more years.

My friends have reported going from their tinnitus bothering them 90% of the time to 30-40% of the time. One barely notices his tinnitus anymore and 3 months ago he was in a very poor mental state.

Also wondering if this Auricle device will ever come to market. Plus, if you invented something meaningful while being employed by the University of Michigan, with their tools, doesn't that invention belong to the university?

This is taking an insane amount of time to enter the market and it's not adding up. Yes, I've read all the posts by the subject matter FDA experts here but still...

Did the volume of tinnitus decrease for any of your three friends?

 

[andrewdaniels]

There is something about the placement of the electrodes on the different devices that targets different parts of the brain.

The MAJOR difference is that Lenire is meant to be a habituation device. It's not even trying to reduce the level of sound one experiences. I'm not sure how successful it is in that, but from my impression it just DOESN'T FUCKING WORK!

Lenire stimulates the areas of the brain AROUND the cochlear nucleus in an attempt to get you to notice your tinnitus less. It's not even attempting to reduce tinnitus volume as it's trying to excite the brain, compared with Dr. Shore's approach which is to calm hyperexcitability of the cochlear nucleus.

Something about the way that the method that Dr. Shore is using with the electrodes targets the cochlear nucleus and quells the hyperexcitability of the fusiform cells in that region of the brain stem.

You see? You can't just say "Oh they're both using bimodal stimulation for tinnitus so they're the same!" They're not. They both have different effects on the brain and they are targeting different regions of the brain. To say they are the same or even similar is a very superficial view.

Thank you for this detailed explanation. Totally makes sense. I hope one day, 3 years from now, with devices like this and pharmaceuticals we will not even have to think of tinnitus (or at least it will be much milder )

My tinnitus is not from hearing loss, so I'm hopeful this will still work on me. Any thoughts from the folks who do not have noise related hearing loss? I question if my tinnitus is even somatic.

 

[kingsfan]

My tinnitus is not from hearing loss, so I'm hopeful this will still work on me. Any thoughts from the folks who do not have noise related hearing loss? I question if my tinnitus is even somatic.

I believe Dr. Shore answered this in the Q&A.

Do you believe that all forms of subjective tinnitus (excluding those caused by mechanical issues) are generated in the dorsal cochlear nucleus (DCN)?

All signals must be processed by the cochlear nucleus (including the dorsal cochlear nucleus) before ascending to the rest of the auditory system. Thus, the tinnitus signal that fusiform cells produce is passed along to the rest of the brain. So yes, the tinnitus signal originates in the cochlear nucleus. More central centers may modify the signal that they receive from the cochlear nucleus, including descending pathways.

 

[andrewdaniels]

I believe Dr. Shore answered this in the Q&A.

Thank you! Gives me hope. I am not sure what the mechanical issues are, but I assume those could be rectified already, if people have them?

 

[AnthonyMcDonald]

Lenire is surely helping 3 of my friends currently. I'm considering it myself due to the possibility of Dr. Shore's device being delayed for many more years.

My friends have reported going from their tinnitus bothering them 90% of the time to 30-40% of the time. One barely notices his tinnitus anymore and 3 months ago he was in a very poor mental state.

Also wondering if this Auricle device will ever come to market. Plus, if you invented something meaningful while being employed by the University of Michigan, with their tools, doesn't that invention belong to the university?

This is taking an insane amount of time to enter the market and it's not adding up. Yes, I've read all the posts by the subject matter FDA experts here but still...

My friends doing yoga on the roof, eating carnivore diets, taking Ginkgo biloba & drinking herbal tea every night, meditating, and pouring honey into their ears have reported going from their tinnitus bothering them 90% of the time to 30-40% of the time.

 

[AmePerdue]

I personally don't mind them taking their sweet time. My worst fear is not waiting 3-5 more years for the device. It's trying it and being disappointed and falling into hopelessness and despair again. Despite being on the brink of suicide 2 years ago when my tinnitus started and I discovered Tinnitus Talk, I knew I had to come to terms with learning to live with it for at least a few years no matter what.

So in the grand scheme of things 3 more years of suffering look like nothing compared to a prospective lifetime of bothersome tinnitus.

After suddenly getting this life-changing disease and dreadfully learning there's no treatment, actually getting an effective treatment within a decade of my tinnitus onset would already seem like a miracle to me. Just imagine, actually getting history's first ever tinnitus treatment barely a few years into it... I'd even feel like taking part of history in some way.

After 2 years of coming across nothing but tinnitus quackery, especially IRL, I'm very thankful of them actually working to help us with actual science-based treatment, light years ahead of anything else. Medical breakthroughs are hard and take time. I'm glad they're trying. Imagine being blinded by Glaucoma and getting your vision back 10 years later with optic nerve regeneration technology. That's how miraculous it would sound.

 

[El BUZZ]

My friends doing yoga on the roof, eating carnivore diets, taking Ginkgo biloba & drinking herbal tea every night, meditating, and pouring honey into their ears have reported going from their tinnitus bothering them 90% of the time to 30-40% of the time.

LOL.

I wouldn't be surprised if our mate @Joshyboy had invested in Neuromod stock and is now desperately trying to raise the sales by any means.

That or he has relatives working at Neuromod...

This thread is rich in objective and well documented posts. Let's show some respect for people who, besides suffering from this nasty condition, takes a very valuable time to guide the rest of us with science-backed, sober, interesting interventions, please.

 

[silenceismusic]

My friends doing yoga on the roof, eating carnivore diets, taking Ginkgo biloba & drinking herbal tea every night, meditating, and pouring honey into their ears have reported going from their tinnitus bothering them 90% of the time to 30-40% of the time.

To be honest, excluding the honey in the ear, those are not bad advice. Will work for some people.

 

[Fightthearmy]

I personally don't mind them taking their sweet time. My worst fear is not waiting 3-5 more years for the device. It's trying it and being disappointed and falling into hopelessness and despair again. Despite being on the brink of suicide 2 years ago when my tinnitus started and I discovered Tinnitus Talk, I knew I had to come to terms with learning to live with it for at least a few years no matter what.

So in the grand scheme of things 3 more years of suffering look like nothing compared to a prospective lifetime of bothersome tinnitus.

After suddenly getting this life-changing disease and dreadfully learning there's no treatment, actually getting an effective treatment within a decade of my tinnitus onset would already seem like a miracle to me. Just imagine, actually getting history's first ever tinnitus treatment barely a few years into it... I'd even feel like taking part of history in some way.

After 2 years of coming across nothing but tinnitus quackery, especially IRL, I'm very thankful of them actually working to help us with actual science-based treatment, light years ahead of anything else. Medical breakthroughs are hard and take time. I'm glad they're trying. Imagine being blinded by Glaucoma and getting your vision back 10 years later with optic nerve regeneration technology. That's how miraculous it would sound.

Not this codswallop again, for the 53249nth time... Take almost any ailment, at any time from the past two decades, and you seem to be always 3-5 years away, tops, from a breakthrough treatment. Younger people can easily afford to lose 3-5 years and still be reasonably hot stuff, but once you're putting off your dreams past a certain age, many of those doors will have closed on you.

 

[AnthonyMcDonald]

To be honest, excluding the honey in the ear, those are not bad advice. Will work for some people.

Maybe to decrease stress and for mental/physical health, but definitely not for decreasing objective tinnitus volume

 

[AmePerdue]

Not this codswallop again, for the 53249nth time... Take almost any ailment, at any time from the past two decades, and you seem to be always 3-5 years away, tops, from a breakthrough treatment. Younger people can easily afford to lose 3-5 years and still be reasonably hot stuff, but once you're putting off your dreams past a certain age, many of those doors will have closed on you.

I'm not implying that the more we wait, the more Auricle will be a silver bullet. It may very well turn out to be a disappointment and it will certainly not work on everyone. But it's been the only truly promising tinnitus-specific treatment in the pipeline since my onset and the only one giving me any glimmer of hope. I'm just glad they exist and that Dr. Shore and her team are trying a scientifically sound approach aimed at actually suppressing tinnitus loudness and none of that "teach the brain to forget it" quackery. They're the only ones explicitly acknowledging a serious need for actual tinnitus treatment. I wish it would get FDA approval as soon as possible but I don't blame them for not communicating on it if there is any chance it could put the application in jeopardy. The only thing I want is for the device to actually get to market, be it tomorrow or 5 years from now.

As for "losing years", the sad truth is we have to keep living as best as we can assuming our tinnitus will not improve for the foreseeable future anyway. I'm personally not going to live the next couple years desperately refreshing this thread daily as if my life depended on this device. My current life is about 50% suicidal thoughts and 50% normal, so for the moment I'm going to cherish the latter 50%. The idea that Auricle is coming sometime in the future alone at least helps me cope.

I remember reading the Lenire thread 2 years ago and coming across the "Just release it already! What are they waiting for?" posts, only for the enthusiasm and impatience quickly giving way to the lackluster reviews and disappointments. I guess that's where my perspective on some of the responses here come from. I wouldn't want Auricle to feel pressured to rush anything.

I wish the world was made differently and things could move quicker. But I don't blame Dr. Shore for that. If anything I resent the Kv7 channel opener companies for not trialing their drugs specifically for tinnitus.

 

[SarahMLFlemmer]

Why did we change our minds from hoping it Dr. Shore's device would come out in Spring 2024 to now 2025-2026? What changed?

 

[Nick47]

Why did we change our minds from hoping it Dr. Shore's device would come out in Spring 2024 to now 2025-2026? What changed?

Reading between the lines, it seems they 'may' not have submitted for approval. Hearsay at this stage. I think many are also concerned at the prospect that the resources are not there to commercialise this on a large scale.

 

[Ryan Scott]

Why did we change our minds from hoping it Dr. Shore's device would come out in Spring 2024 to now 2025-2026? What changed?

A lot of people changed their opinions once the Dr. Shore Q&A was released. Timeline guesses are pure speculation at this point. Maybe I can make a path forward diagram and someone can correct me for errors to be edited.

FDA approval > manufacturing to demand > training practitioners > administration.

 

[BTaylor12]

Why did we change our minds from hoping it Dr. Shore's device would come out in Spring 2024 to now 2025-2026? What changed?

There's nothing in the near future, that's why.

If they had now announced FDA had approved the device, then 2024 is the earliest it could be available.

There's really been no news regarding the device coming to market. It's going to be a while yet.

Here's to hoping for FDA approval announcement this year, which appears to be the best case scenario at this point, but I'm not holding my breath.

 

[SarahMLFlemmer]

There's nothing in the near future, that's why.

If they had now announced FDA had approved the device, then 2024 is the earliest it could be available.

There's really been no news regarding the device coming to market. It's going to be a while yet.

Here's to hoping for FDA approval announcement this year, which appears to be the best case scenario at this point, but I'm not holding my breath.

Bro.

 

[kingsfan]

You think if we use this device every day for the rest of our lives, our tinnitus will never get worse, and we can stop wearing earplugs and avoiding loud sound? Not saying I'd go straight to a loud club or anything, but man would I love to hop on a rollercoaster again.

 

[Utdmad89]

You think if we use this device every day for the rest of our lives, our tinnitus will never get worse, and we can stop wearing earplugs and avoiding loud sound? Not saying I'd go straight to a loud club or anything, but man would I love to hop on a rollercoaster again.

I'd like to know this too! I just want to watch United at Old Trafford again (and take my son when old enough).

 

[BobbieJay-1954]

You think if we use this device every day for the rest of our lives, our tinnitus will never get worse, and we can stop wearing earplugs and avoiding loud sound? Not saying I'd go straight to a loud club or anything, but man would I love to hop on a rollercoaster again.

I'd definitely say that we should still exercise caution even when using the device. I'm certainly going to feel a lot better about hearing crashes and bangs throughout my house or maybe at a restaurant if there's an accident but I'm still going to wear hearing protection if I'm somewhere kinda loud. I think it depends on a person's tinnitus level and how they react to sounds too.

 

[kingsfan]

I'd definitely say that we should still exercise caution even when using the device. I'm certainly going to feel a lot better about hearing crashes and bangs throughout my house or maybe at a restaurant if there's an accident but I'm still going to wear hearing protection if I'm somewhere kinda loud. I think it depends on a person's tinnitus level and how they react to sounds too.

Yea, I meant to include "every day situations". It would be nice to not have to wear hearing protection in the car and to the store, etc. But I'll probably always wear protection in busy restaurants and other louder environments. I'll also probably never go to a bar, club, or live show ever again, regardless, just to protect my hearing.

 

[Forever hopeful]

What Neuromod are claiming is that Lenire reduces TFI/THI. That's what they consider "tinnitus levels", however that is not measuring volume. What TFI/THI measures is your REACTION to tinnitus.

That is why it is a habituation device. Because it only manages your reaction to your tinnitus, and does not reduce volume. I don't think they are making the claim that Lenire reduces volume. If they are making that claim, it is bullshit.

So far, only Dr. Shore's device is proven to reduce the volume that tinnitus sufferers experience.

But tinnitus volume is somewhat subjective. Right? I can have very low level tinnitus and it can be extremely bothersome and intrusive and therefore, I think it's very high in volume.

Somebody could have tinnitus that they estimate to be 60 dB high and it doesn't bother them.

I guess my question is, if it isn't objective tinnitus, the majority of which it is not, then how did they effectively measure the tinnitus volume?

 

[Lucifer]

You think if we use this device every day for the rest of our lives, our tinnitus will never get worse, and we can stop wearing earplugs and avoiding loud sound? Not saying I'd go straight to a loud club or anything, but man would I love to hop on a rollercoaster again.

Maybe we need a combination of Dr. Shore's device and BHV-7000/XEN1101 potassium channel opener drugs to get rid of tinnitus and hyperacusis/noxacusis permanently.

Obviously I would definitely protect my ears around loud noise but on the occasion where I experience unexpected loud noise, I hope Dr. Shore's device and these drugs would help.

 

[RunningMan]

But tinnitus volume is somewhat subjective. Right? I can have very low level tinnitus and it can be extremely bothersome and intrusive and therefore, I think it's very high in volume.

Somebody could have tinnitus that they estimate to be 60 dB high and it doesn't bother them.

I guess my question is, if it isn't objective tinnitus, the majority of which it is not, then how did they effectively measure the tinnitus volume?

They used TinnTester. There's a question about this in the Q&A where Dr. Shore responded about it.

Could you clarify what exactly is "TinnTester" and has it been third party validated? And what method of testing is it utilizing to verify perceived tinnitus noise levels? There seems to be 2 different methodologies of tinnitus volume level testing (e.g., a more basic method using real world sound levels measured like any other sound and a more tinnitus specific one that appears to be a measure of the actual raw volume of the tinnitus itself that uses your hearing loss as a basis).

TinnTester is a software suite designed by Larry Roberts to measure psychophysical attributes of tinnitus including loudness and likeness at several frequencies. The TinnTester reports loudness measurements in dB SPL which can also be expressed as sensation level (SL) by comparing to the audiogram. There have been a number of studies showing test-retest reliability.

 

[dj_newark]

But tinnitus volume is somewhat subjective. Right? I can have very low level tinnitus and it can be extremely bothersome and intrusive and therefore, I think it's very high in volume.

Somebody could have tinnitus that they estimate to be 60 dB high and it doesn't bother them.

I guess my question is, if it isn't objective tinnitus, the majority of which it is not, then how did they effectively measure the tinnitus volume?

Through masking levels. Yes, most tinnitus is subjective, but to determine volume they use MML - or Minimum Masking Level. They play a masking sound like a white noise through headphones and gradually increase the level until it covers the sound of your tinnitus. However, for some, like myself, tinnitus can be unmaskable. That's how they go about it in these medical trials and an audiologist who knows about tinnitus can also do this for you.

 

[BTaylor12]

Bro.

June of 2013 was the first post on this thread about the device.

Thinking we'll be wearing this thing next year? I've got a bridge to sell you.

Need to be realistic and look at all options, and not hang our hat on just one.

Don't get me wrong, if it comes out tomorrow I'm signing up to try it. But it's been a decade. A decade.