New University of Michigan Tinnitus Discovery — Signal Timing

[Dkellz]

Thanks for everyone's seriously in-depth and well-delivered input into this conversation; it made the narrative easy to follow and understand and I'm looking forward to Dr. Shore's responses to the questions.

I'm Irish and live approx 2 hours drive from the front door of the Neuromod (Lenire) offices; when I first got tinnitus; one of my friends who has used Lenire with success in his opinion, which really pushed me to go and use it. However, from reading the analysis on this website and by reading into the clinical trials I was able to make my own decision to not pursue Lenire, even though I have reactive and bothersome tinnitus & would try anything really to better it.

My point is; the Lenire FDA process was given approval and roll-out - I have absolutely no background in analyzing clinical trials or data, and I was able to distinguish (in my opinion) Lenire is not a solid treatment for tinnitus patients. Surely, given the detail of Dr. Shore's research and the fundamental success in a controlled and placebo-based trial, the FDA process for this would be much easier than the Lenire device. If Lenire was deemed suitable to roll out to aid the tinnitus world, then surely Dr. Shore's should be given some sort of red carpet treatment and a lot of helping hands on the way from the powers that be.

I hope we can see the launch this year as I plan to travel to Michigan from Ireland as soon as it's released. I'd rather make the long journey across the Atlantic than the 2-hour drive to the Lenire office & I'm hoping the powers that be can hold the same sentiment when giving the launch clearance.

 

[Ryan Scott]

My questions for Dr. Shore would be:

How long will manufacturing devices take to meet initial supply and demand?

How long will it take to get audiologists trained for using such a device and will the training be via conferences or web based?

 

[BadNeighbors]

I, and others I am sure, really appreciate the input form those who have any type of experience in the FDA submission process and share that with us. So thank you to those who have provided information and valid points.

I think what is so maddening and just wrong is the fact that society as a whole, or I should really say "the powers that be," have this ultimate control of what is of most importance to get to market and use, like @Nick47 said with the vaccines. Obviously the world needed a response to a pandemic, but because little old tinnitus isn't even a known condition to so many who don't suffer, yet it is the NUMBER ONE disability of the USA military followed by bilateral hearing loss at number 2. Yet NO ONE in "the powers that be" is in any rush or making it a priority to fund and push through a treatment or cure for those who literally risked their lives for this country, and a community that is full of individuals that would be normal functioning, working human beings if it weren't for this shit.

Therefore, more the reason to ask for the possibility of compassionate use avenues. And not just with this, pharmaceuticals as well.

I'd love to see more investment into the FDA so the process could be sped up for all drug and treatment approvals. There are probably so many things that we know nothing about that are making other people's lives completely miserable as well.

However, there are issues with compassionate use and just letting anyone get access to a drug/treatment prior to the approval. I hate the waiting game and I wish things moved faster, but I agree with companies having to jump through hoops to roll things out to the public. I just hope someone at the FDA is working quickly so we can have access to this and experience a bit of peace.

I think this is a great article on why letting anyone have access to something is too risky:

Hashtag Prescription: The Hidden Cost of Crowd-Sourcing a Cure

 

[Stuart-T]

There is a world of difference between a PROFIT driven company and a credit worthy researcher genuinely trying to help people by developing technology that works.

Lenire have to be given credit for the way they have made their device commercially successful.

I don't know who is backing Dr. Shore's device but clearly some business expertise will be needed to get things moving - and the only way that is going to happen is by motivating the right people with the strong possibility of large financial gains.

P.S. Someone claimed the Lenire is a habituation device - that is not what Neuromod claim. They claim it actually reduces tinnitus levels in up to 80% of people.

 

[dj_newark]

There is a world of difference between a PROFIT driven company and a credit worthy researcher genuinely trying to help people by developing technology that works.

Lenire have to be given credit for the way they have made their device commercially successful.

I don't know who is backing Dr. Shore's device but clearly some business expertise will be needed to get things moving - and the only way that is going to happen is by motivating the right people with the strong possibility of large financial gains.

P.S. Someone claimed the Lenire is a habituation device - that is not what Neuromod claim. They claim it actually reduces tinnitus levels in up to 80% of people.

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.

 

[dj_newark]

P.S. Someone claimed the Lenire is a habituation device - that is not what Neuromod claim. They claim it actually reduces tinnitus levels in up to 80% of people.

Have you ever seen a company claim anything other than a 75% or an 80% success rate or something like that? It's called marketing. So they latch onto a highly suspect measure of success such as TFI/THI to "prove" their worth.

Because tinnitus is so subjective by nature, the only way have any idea what a person is experiencing is to have them fill out a questionnaire. Trouble is that questionnaire is very influenced by how a person is feeling at any given time. They could be having a bad day at school or work or a fight with their partner, and that will influence how they fill out the TFI/THI questionnaire. Even though what's influencing how they feel may have absolutely nothing to do with their tinnitus. It's very affected by an individual's psychological state. I don't consider it a very reliable measure of how someone is doing with tinnitus, but of course people with products to sell you like Dr. Ben Thompson and Neuromod will swear by it!

No, what will really help propel tinnitus research forward is when we have an objective measure for tinnitus. That is what the Bionics Institute in Australia is working on. A friend of mine was in a trial for their objective measure for tinnitus, and she's said it was pretty accurate, as I remember.

If you really want to see a how a product like Lenire is performing in the wild, it's always good to check the user reports. And I'll give you a hint: they're not good! So who are you going to believe? What Neuromod is saying about their product? Or what people using it are saying? Sure it's anecdotal. But I'll believe what users on Tinnitus Talk say before I believe Neuromod's bullshit study that didn't even use a placebo control!

 

[Stuart-T]

Have you ever seen a company claim anything other than a 75% or an 80% success rate or something like that? It's called marketing. So they latch onto a highly suspect measure of success such as TFI/THI to "prove" their worth.

Because tinnitus is so subjective by nature, the only way have any idea what a person is experiencing is to have them fill out a questionnaire. Trouble is that questionnaire is very influenced by how a person is feeling at any given time. They could be having a bad day at school or work or a fight with their partner, and that will influence how they fill out the TFI/THI questionnaire. Even though what's influencing how they feel may have absolutely nothing to do with their tinnitus. It's very affected by an individual's psychological state. I don't consider it a very reliable measure of how someone is doing with tinnitus, but of course people with products to sell you like Dr. Ben Thompson and Neuromod will swear by it!

No, what will really help propel tinnitus research forward is when we have an objective measure for tinnitus. That is what the Bionics Institute in Australia is working on. A friend of mine was in a trial for their objective measure for tinnitus, and she's said it was pretty accurate, as I remember.

If you really want to see a how a product like Lenire is performing in the wild, it's always good to check the user reports. And I'll give you a hint: they're not good! So who are you going to believe? What Neuromod is saying about their product? Or what people using it are saying? Sure it's anecdotal. But I'll believe what users on Tinnitus Talk say before I believe Neuromod's bullshit study that didn't even use a placebo control!

I am not talking about what the devices actually do. I am referring to what is claimed and on Neuromod's website they claim a reduction in the severity of tinnitus. I suppose they might include improved habituation in that.

Yes, agreed, and I have looked at the Lenire reports. Maybe 1/3 claiming some improvement and many or most of those are claiming a reduction in tinnitus volume.

 

[dj_newark]

I am not talking about what the devices actually do. I am referring to what is claimed and on Neuromod's website they claim a reduction in the severity of tinnitus. I suppose they might include improved habituation in that.

Yes, agreed, and I have looked at the Lenire reports. Maybe 1/3 claiming some improvement and many or most of those are claiming a reduction in tinnitus volume.

I am on Neuoromod's website, and they don't claim that. They claim that their mission is to reduce suffering. That doesn't mean they are claiming they reduce tinnitus volume or severity. That's a big difference!

Tinnitus is such a variable condition. Again, if Lenire helps with anything, it helps with the perception of the condition. It does not reduce tinnitus volume. If people are experiencing relief, good for them, but I think it does the most for moderate or mild cases. I'm seeing a lot of reports for whom it either did nothing or that it made their condition worse. I'm not convinced that that it's useful.

 

[Utdmad89]

No, what will really help propel tinnitus research forward is when we have an objective measure for tinnitus. That is what the Bionics Institute in Australia is working on. A friend of mine was in a trial for their objective measure for tinnitus, and she's said it was pretty accurate, as I remember.

I can't wait for that objective measure to be in use, so many products and charlatans will be exposed!

 

[Stuart-T]

I am on Neuoromod's website, and they don't claim that. They claim that their mission is to reduce suffering. That doesn't mean they are claiming they reduce tinnitus volume or severity. That's a big difference!

Tinnitus is such a variable condition. Again, if Lenire helps with anything, it helps with the perception of the condition. It does not reduce tinnitus volume. If people are experiencing relief, good for them, but I think it does the most for moderate or mild cases. I'm seeing a lot of reports for whom it either did nothing or that it made their condition worse. I'm not convinced that that it's useful.

Copied from the Neuromod website.

They literally claim improvement in tinnitus symptom severity as I said.

 

[dj_newark]

I can't wait for that objective measure to be in use, so many products and charlatans will be exposed!

Precisely! I am looking forward to an objective measure of tinnitus almost as much as I am looking forward to Dr. Shore's treatment! I really hope that the Tinnitus Talk Q&A with her can happen soon. There are so many questions that need to be answered!

 

[2noist]

They literally claim improvement in tinnitus symptom severity as I said.

Yes they do but they refer to improvement in TFI (Tinnitus Functional Index), a subjective questionnaire on how tinnitus symptoms affect your life, that goes from 0 to 100 points and a reduction of 13 points is considered clinically significant and that's just about what Lenire achieved in its trials. Problem with that? Give someone a bowl of ice cream and ask them to report their TFI, you'll find those 13 points reductions very easily, from placebo, too... And that's the reason why there has been no placebo controlled trials for Lenire.

TFI makes it so that they can use the 91-95% improve figures without being jailed. Disgusting, to say the least...

Dr. Shore's trials have shown actual tinnitus loudness reductions, a whole different world!

 

[Nick47]

They literally claim improvement in tinnitus symptom severity as I said.

You're right, they do claim improvements in tinnitus symptom severity. But a symptom of tinnitus could be anxiety, depression or stress. Clever wording and nothing else. Tinnitus loudness was not used as a primary or secondary end point in their trials and therefore cannot be claimed.

 

[Stuart-T]

Yes they do but they refer to improvement in TFI (Tinnitus Functional Index), a subjective questionnaire on how tinnitus symptoms affect your life, that goes from 0 to 100 points and a reduction of 13 points is considered clinically significant and that's just about what Lenire achieved in its trials. Problem with that? Give someone a bowl of ice cream and ask them to report their TFI, you'll find those 13 points reductions very easily, from placebo, too... And that's the reason why there has been no placebo controlled trials for Lenire.

TFI makes it so that they can use the 91-95% improve figures without being jailed. Disgusting, to say the least...

Dr. Shore's trials have shown actual tinnitus loudness reductions, a whole different world!

OK but it sounds like Neuromod are claiming it actually reduces tinnitus levels. How many desperate people don't bother to understand how the trials were conducted?

You're right, they do claim improvements in tinnitus symptom severity. But a symptom of tinnitus could be anxiety, depression or stress. Clever wording and nothing else. Tinnitus loudness was not used as a primary or secondary end point in their trials and therefore cannot be claimed.

Yes and a symptom could also be phantom sounds such as ringing, chirping etc. If you have inner ear inflammation or damaged audio receptors, the symptom can be these sounds. Then there are knock on effects such as stress - which are secondary symptoms.

 

[Gb3]

OK but it sounds like Neuromod are claiming it actually reduces tinnitus levels. How many desperate people don't bother to understand how the trials were conducted?

Neuromod doesn't claim Lenire lowers tinnitus loudness. Leave it alone.

 

[ZFire]

There are so many questions that need to be answered!

There are.

The 99 individuals who participated in Dr. Shore's clinical trial, it would be nice to get in touch with some of these individuals. Maybe have them come on here and share/document their personal experiences with Dr. Shore's device.

Perhaps Dr. Shore could kindly inquire about their interest in participating on Tinnitus Talk, where their experiences could be valuable to others seeking information and support. Most of us after all are going to be future customers of her device... just saying

This could also tie us in the meantime while we wait for this FDA approval. Just a thought.

 

[Lurius]

Did someone ask Dr. Shore about the price? I think I forgot to ask about the price. The most important question.

 

[Markku]

Did someone ask Dr. Shore about the price? I think I forgot to ask about the price. The most important question.

Many did.

In total there were nearly 900 questions. We curated them and sent them to Dr. Shore.

A lot of the questions were interesting, like... people went over their medical history and asked if drug x might have caused their tinnitus, or if they should sue their doctor for negligence, or if tinnitus can cause erectile dysfunction, etc. If we do a similar Q&A in future, need to stress even more what it is about, now it took many hours to clean up the questions

But many gems as well that we might not have been able to come up with ourselves - thanks to all who participated!

 

[Nick47]

In total there were nearly 900 questions. We curated them and sent them to Dr. Shore.

Good heavens, where's AI when you need it!

 

[Markku]

Good heavens, where's AI when you need it!

Oh we did first try several AI tools! Some of them wouldn't accept the long list of questions, and when it would, it couldn't really understand what is a question Dr. Shore can in theory even answer, what questions are more important than others, and finally grouping similar questions together, creating a cohesive list with sub-topics etc.

It would probably have taken more time to figure out how any AI tool can come up with a similarly neat end result like we ended up with, than just doing it by hand

 

[Gb3]

I knew people were gonna ask irrelevant questions.

 

[Lurius]

I think I stayed mostly on point, although that wasn't exactly difficult.

 

[Alberte]

Thanks for your patience, @Markku! I suppose there were a lot of irrelevant questions...

 

[slc]

View attachment 55459

Copied from the Neuromod website.

They literally claim improvement in tinnitus symptom severity as I said.

Yes, their statement is problematic.

As opposed to the Neuromod site (which is super misleading), the Lenire.com website states, "A recent clinical trial showed that 95% of participants who used Lenire as directed demonstrated an improvement in tinnitus symptom severity (as measured by THI score) when evaluated after 12 weeks of treatment."

The term "tinnitus symptom severity" is not clear UNTIL they state, "as measured by THI score." Of course, THI does not measure decibel level. It is an attempt to measure how bothered the person is by tinnitus. Thus an improvement in emotional outlook, or achievement of "habituation" (a term that I find way too loose and overused), or even placebo effect, belief that something happened because at least a person was treated and someone listened... so many factors might influence the THI score.

Basically Lenire -- at least on lenire.com -- is claiming that THI scores will improve. The chart displayed on their page indicates an improvement from 51.2 to 33.5, so in the "moderate" to "high mild" range. In my view, folks with relatively moderate symptoms have a way better shot at "habituating" and addressing emotional distress.

This study points out limitations in THI (Tinnitus Handicap Inventory):

Improved measurement of tinnitus severity: Study of the dimensionality and reliability of the Tinnitus Handicap Inventory

Some key quotes:

• "So, the precision of measurement is the highest for the subjects with moderate tinnitus severity."
• "Kennedy and colleagues (Kennedy V, Wilson C, Stephens D. Quality of life and tinnitus. Audiol Med 2009;2:29–40) noted that THI, compared to other tinnitus-related questionnaires, contains a disproportionately large number of items related to psychological/emotional aspects of tinnitus. The results of our study also suggest that tinnitus severity as measured by THI captures mainly the emotional aspects of tinnitus."

So my take from this all. THI is more reliable in the moderate range AND the Tinnitus Handicap Inventory (THI) is weighted towards "psychological/emotional aspects of tinnitus." Lenire, while claiming, "an improvement in tinnitus symptom severity," in reality is mostly about psychological improvement for folks with moderate tinnitus. However, at first view, Lenire apparently offers relief that is more than psychological, which of course, is NOT the case – especially if that statement, "as measured by THI score" is either left out or poorly understood by the reader.

Basically, when reading between the lines, Lenire is indicating less emotional/psychological distress for those with moderate tinnitus.

 

[DeanD]

OK but it sounds like Neuromod are claiming it actually reduces tinnitus levels. How many desperate people don't bother to understand how the trials were conducted?

Yes and a symptom could also be phantom sounds such as ringing, chirping etc. If you have inner ear inflammation or damaged audio receptors, the symptom can be these sounds. Then there are knock on effects such as stress - which are secondary symptoms.

Unfortunately this is how great marketing works for underperforming products. It can lead you to believe something without it actually being said.

The wording is purposefully and deceitfully written in this precise way to make you think it lowers volume - and if it was ever questioned, they can clearly show it's never mentioned.

MODERATOR NOTE:

Further Lenire discussion belongs here:

Lenire — Bimodal Stimulation Treatment by Neuromod

 

[dj_newark]

In total there were nearly 900 questions. We curated them and sent them to Dr. Shore.

Thank you, @Markku! Out of the 900 questions, approximately how many were submitted to Dr. Shore? Also for the seminar she'll be speaking at in France this September, will that be covered by Tinnitus Talk the same way that the Palm Springs Hearing Seminars were covered when she spoke there last year?

 

[AnthonyMcDonald]

My Lord, my biggest concern was that this Q&A would be wasted on bullshit nonsense questions. Thanks for filtering them out, @Markku.

 

[Markku]

Thank you, @Markku! Out of the 900 questions, approximately how many were submitted to Dr. Shore? Also for the seminar she'll be speaking at in France this September, will that be covered by Tinnitus Talk the same way that the Palm Springs Hearing Seminars were covered when she spoke there last year?

We ended up with about 60 questions but I don't think Dr. Shore will be able to answer all of those even if she wanted to - I made the suggestion that we regardless list the questions that couldn't be answered so people know what cannot be answered and hopefully that further helps people refrain from emailing her directly (she really can't respond to individual queries anymore).

Should we have missed some crucial question(s), we can always kindly ask her to answer it after the fact and add to the Q&A - so I would maybe consider the Q&A a living thing rather than a one and done kind.

Regarding the 13ème Colloque AFRÉPA event at Centre de Congrès Pierre Baudis, Toulouse, France in September, Dr. Shore won't present anything new there since the publication. The whole event will be in French which we don't speak (her presentation will likely have an interpreter). So all this taken together, we most likely aren't attending that one. That said, for someone whom French isn't foreign and they are nearby, it sounds quite interesting, with a good set of researchers attending. For the hyperacusis folks, Arnaud Norena will present there too.

 

[dd314]

You're right, they do claim improvements in tinnitus symptom severity. But a symptom of tinnitus could be anxiety, depression or stress. Clever wording and nothing else. Tinnitus loudness was not used as a primary or secondary end point in their trials and therefore cannot be claimed.

I'd be willing to bet that volume is the biggest variable when people take the TFI. I've taken it myself, and there are questions like:

- "Do you believe you have a horrible disease?"
- "Does tinnitus interfere with your daily activities?"

I can think of no greater factor in these questions than tinnitus VOLUME. In my mind, TFI is a proxy for volume.

 

[Joeseph Stope]

I'd be willing to bet that volume is the biggest variable when people take the TFI. I've taken it myself, and there are questions like:

- "Do you believe you have a horrible disease?"
- "Does tinnitus interfere with your daily activities?"

I can think of no greater factor in these questions than tinnitus VOLUME. In my mind, TFI is a proxy for volume.

This seems so obvious... like saying rain is wet. But I seem to recall reading somewhere in the tinnitus literature that the volume of tinnitus is not a good measure of distress... that some people with a loud volume tinnitus will say that it's not that bothersome (have they somehow habituated?) and others who have a low volume tinnitus are driven round the bend by it.

The volume of tinnitus that a patient hears (subjectively of course) would be one of the easy things to measure. Simply play the approximated tone in the audiogram at various degrees of volume and ask "Is that louder or softer than your tinnitus?" And you could also find the volume that masks it completely, and come up with some approximation of how loud it is.