Q&A: Tinnitus Hub Meets Neuromod (Lenire)

[Bob den Hartog]

...people had to sign a huge 23 page disclaimer saying that they wouldn't discuss the program on social media.

Well that's a red flag right there

One thing I'm wondering about Neuromod - would a customer need to be seen by one of their specific audiologists? Is there no way we could get a local audiologist to send on an audiogram?

This. The ideal situation would be, your audiologist makes an up-to-date audiogram, sends it through to Neuromod, they prepare the device and you pick it up / they ship it to ya, with your local audiologist monitoring results. Maybe start with a consultation by phone with Neuromod to see if the treatment would benefit your personal situation, and what are the odds of success.

In the Q&A he said the setting up part was really easy, and they want this to be in the hands of ENT specialists and get it out there to patients. I guess they'd start with their own trained audiologists, with the local ones probably waiting for results before adapting and providing the treatment to their own patients.

 

[Paulmanlike]

Not surprised people had to sign a non-disclosure for Desyncra. Their product is well over priced with very limited evidence it works. I've got to say rewind a few years ago there was as much hype with that as there is with Neuromod now. That's the reason I'm holding back before purchasing. Newbies be warned, the tinnitus market has thrived on small evidence products preying on the prevalent vulnerable.

If you look at the first Neuromod study, even those in placebo groups have some response. That's the nature of tinnitus. How many days do you have where tinnitus is better than other days?

We all need to tread carefully. And report definite improvements. That's our job as sufferers.

It is their job to prove without reasonable doubt who will benefit and the likelihood of it adjusting parameters and what not.

 

[Drone Draper]

Well that's a red flag right there

Yeah! I think, if presented with a huge legal disclaimer, I probably wouldn't go through with it. It'd be one thing if it was part of a study, because you don't want people to leak information, but as a commercial product, that is shady.

In the Q&A he said the setting up part was really easy, and they want this to be in the hands of ENT specialists and get it out there to patients. I guess they'd start with their own trained audiologists, with the local ones probably waiting for results before adapting and providing the treatment to their own patients.

I'm hoping the time between the audiogram and calibration of the device is short, I'd hate to have to fly out to Dublin twice if I don't want to wait for a UK release.

 

[Jack Straw]

Thanks! So I am guessing his status is stale and he has either come out on the board saying that he is no longer experiencing the silence or you are in contact with him off the board? I hadn't seen an update on it.

He is currently no longer providing updates due to an NDA (we assume) regarding the trials.

 

[Jack Straw]

Well that's a red flag right there

You probably don't know this, but there was a tinnitus drug trial in the past that was completely ruined because people in the trial were discussing the drug / results with each other. This led people to realize if they were in the placebo group or not and thus ruined the entire experiment trial completely. This has now become famous with tinnitus companies and going forward all tinnitus drug trials use NDAs since the tinnitus community is so talkative and tight.

So Neuromod doing an NDA is nothing but standard practice and isn't a red flag.

 

[Paulmanlike]

@Drone Draper,

You seem like a cool dude man, but take it from somebody who has had tinnitus a lot longer than you this....

Do not rush out to buy it on release. Hold on. Sit back. Relax. Wait for the evidence base to build up. Sure they've had 3 trials and when we get access to those papers after peer review we can all dissect, dissolve and understand the information together. We can hold on for real patient testimonials that if it is as good as speculated, it is inevitable a wealth of information on it will grow on the internet. Tinnitus Talk included.

The reason for this is that myself have followed tinnitus research a long time (as long as I've had it). It was exciting when the next big thing came out and I rushed out to buy it, realising now it did not work. I'm not saying that will happen again, but it may. I bought the laser therapies, the supplements. Other people on here most notably @carlover bought ACRN at £4,500. No change. I was almost going down the same route, but by then I had accepted tinnitus and decided to hold on. To this day, ACRN still fails to show an internet buzz. You must wait for the internet buzz. I cannot describe the ultimate disappointment one feels when you spend thousands and it does nothing. You deserve to know in advance that there is a great chance it will work for you.

I have noticed the newbies will go out and buy it, but the experienced vets will wait and there is good reason for that.

I don't want to be negative and I am hoping as much as the next sufferer it works, but anybody reading this who is planning on purchasing straight away, please bear this in mind. Tinnitus is a very subjective condition, there's going to be people who claim it works, it's lowering, etc. Just this morning I thought mine seems quiet today. Sure, if the evidence follows through, not just their own trials but by long term established members on here I will buy one.

Anyway, those who buy one, please keep us all updated. I'm signed up to several tinnitus groups, there's a lot of hype at the moment with this (as seen in the past with other products), I will certainly be keeping a close eye on it.

 

[Bob den Hartog]

You probably don't know this, but there was a tinnitus drug trial in the past that was completely ruined because people in the trial were discussing the drug / results with each other. This led people to realize if they were in the placebo group or not and thus ruined the entire experiment trial completely. This has now become famous with tinnitus companies and going forward all tinnitus drug trials use NDAs since the tinnitus community is so talkative and tight.

So Neuromod doing an NDA is nothing but standard practice and isn't a red flag.

Oh, I fully understand the need for an NDA while a treatment is in its trial false, and don't doubt the need for it during the Neuromod trials. But this wasn't about the Neuromod. This was about Desyncra, which had regular customers ask not to talk about it on social media.

 

[dayma]

@Drone Draper,

You seem like a cool dude man, but take it from somebody who has had tinnitus a lot longer than you this....

Do not rush out to buy it on release. Hold on. Sit back. Relax. Wait for the evidence base to build up. Sure they've had 3 trials and when we get access to those papers after peer review we can all dissect, dissolve and understand the information together. We can hold on for real patient testimonials that if it is as good as speculated, it is inevitable a wealth of information on it will grow on the internet. Tinnitus Talk included.

The reason for this is that myself have followed tinnitus research a long time (as long as I've had it). It was exciting when the next big thing came out and I rushed out to buy it, realising now it did not work. I'm not saying that will happen again, but it may. I bought the laser therapies, the supplements. Other people on here most notably @carlover bought ACRN at £4,500. No change. I was almost going down the same route, but by then I had accepted tinnitus and decided to hold on. To this day, ACRN still fails to show an internet buzz. You must wait for the internet buzz. I cannot describe the ultimate disappointment one feels when you spend thousands and it does nothing. You deserve to know in advance that there is a great chance it will work for you.

I have noticed the newbies will go out and buy it, but the experienced vets will wait and there is good reason for that.

I don't want to be negative and I am hoping as much as the next sufferer it works, but anybody reading this who is planning on purchasing straight away, please bear this in mind. Tinnitus is a very subjective condition, there's going to be people who claim it works, it's lowering, etc. Just this morning I thought mine seems quiet today. Sure, if the evidence follows through, not just their own trials but by long term established members on here I will buy one.

Anyway, those who buy one, please keep us all updated. I'm signed up to several tinnitus groups, there's a lot of hype at the moment with this (as seen in the past with other products), I will certainly be keeping a close eye on it.

Early adopters will be taking some level of risk. Pretty normal. Just depends if you can afford to deal with the $$ and bumps. Some people can't or will not. I for one will be there shocking my tongue with delight. lol

 

[Drone Draper]

@Paulmanlike

Thank you, I do appreciate and understand your concern. As someone who is a newbie sufferer, I understand that my new reality is a bit of a shock and I may be too hasty to buy the magic beans to get me out of this mess.

In fact, I met with an audiologist just this morning, the one who used to sell the Desyncra system and he said "if you want to give me £5,000 to go on holiday, I think it will do as much as this system". So I appreciate the concern.

That said, I am relatively well off - based on the pricing information we've received, I can afford this system with relative ease - and have no dependents. I know the inherent risk of being an early adopter - this may be end up being a nice frisbee or potentially a very expensive USB drive.

 

[Paulmanlike]

Oh, I fully understand the need for an NDA while a treatment is in its trial false, and don't doubt the need for it during the Neuromod trials. But this wasn't about the Neuromod. This was about Desyncra, which had regular customers ask not to talk about it on social media.

Because they know it's an overpriced crock of shit that is a spin of the fortune wheel if it works. They'll go bankrupt otherwise but that isn't our problem, our problem is that we want proper treatments for a cost of over £4,500. Unfortunately people will still buy it because you know, as humans we want solutions to shitty things.

 

[Bob den Hartog]

Exactly. And that's why I called that "don't talk about on social media" thing a red flag. If you're confident about your product, you want people to talk about it, even if that means there'll be those that will say it doesn't work. If you believe in your product, you'll know the good will outweigh the bad.

 

[Drone Draper]

Because they know it's an overpriced crock of shit that is a spin of the fortune wheel if it works. They'll go bankrupt otherwise but that isn't our problem, our problem is that we want proper treatments for a cost of over £4,500. Unfortunately people will still buy it because you know, as humans we want solutions to shitty things.

I remember listening to Christopher Hitchens speak at Google and he said (on religion):

"It comes from a time when we had no good answers, but because we are pattern-seeking animals (a good thing about us), and because we will prefer even a conspiracy theory or a junk theory to no theory at all (a bad thing about us)."

I'm not here to open a debate on religion or our origin - I think there are other places for that, but I do think the statement is true when it comes to human behaviour.

BTW, if it turns out Neuromod doesn't do anything for me, I'll have that sumbitch recalibrated and sent to someone else on the board for free.

Here's the studies Desyncra did:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5390560/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5681957/

 

[GlennS]

Oh, I fully understand the need for an NDA while a treatment is in its trial false, and don't doubt the need for it during the Neuromod trials. But this wasn't about the Neuromod. This was about Desyncra, which had regular customers ask not to talk about it on social media.

That's kind of a sticking point for me. Neuromod is charging people to undergo what is for all intents and purposes a clinical trial, something that is usually the other way around (paying test subjects). (I see many ads in the Boston area for test subjects, usually for depression drugs, go figure. That's how it's done. It's something people who are low on cash do.) So in my book, test subjects for Neuromod are customers, just customers paying for experimental (aka beta-test) products.

I don't like this policy one bit. Depending on your proclivities you can say Neuromod are being greedy or it's just a function of a lack of grant/funding in this sector, but patients should not be expected to roll the dice this way. Think of how many billions of dollars Musk pisses away through mismanaging Tesla vs. how little money it would take to subsidize the testing phase of Neuromod and every other copycat treatment. The initial bootstrap money should come from other sources, not patients. It's kind of like a Kickstarter campaign without framing it as such, and so it feels unfair.

 

[spedgas]

Early adopters will be taking some level of risk. Pretty normal. Just depends if you can afford to deal with the $$ and bumps. Some people can't or will not. I for one will be there shocking my tongue with delight. lol

If I wasn't in the US I would be right there with you. That being said I'm going to use it's non immediate availability as a proving ground. As soon as success stories start coming in my resolve to wait will be difficult. This is still a first generation product.

I'm hoping as they start digging into data from the second trial that it gets refined even more.

 

[dayma]

If I wasn't in the US I would be right there with you. That being said I'm going to use it's non immediate availability as a proving ground. As soon as success stories start coming in my resolve to wait will be difficult. This is still a first generation product.

I'm hoping as they start digging into data from the second trial that it gets refined even more.

FWIW I am in the States. I plan to relay my experiences with the group.

 

[Drone Draper]

Neuromod is charging people to undergo what is for all intents and purposes a clinical trial, something that is usually the other way around (paying test subjects)

That is BS. I didn't know that.

 

[GregCA]

Neuromod is charging people to undergo what is for all intents and purposes a clinical trial, something that is usually the other way around (paying test subjects).

I'm not following you. Can you please elaborate?

 

[Manny]

That's kind of a sticking point for me. Neuromod is charging people to undergo what is for all intents and purposes a clinical trial

Can you clarify what you mean by that? They will be charging for a device that seems to have limited or relatively poor evidence of efficacy, is all.

 

[spedgas]

FWIW I am in the States. I plan to relay my experiences with the group.

Excellent, I'm very excited to hear from you about this.

 

[TimmyC]

That's kind of a sticking point for me. Neuromod is charging people to undergo what is for all intents and purposes a clinical trial, something that is usually the other way around (paying test subjects). (I see many ads in the Boston area for test subjects, usually for depression drugs, go figure. That's how it's done. It's something people who are low on cash do.) So in my book, test subjects for Neuromod are customers, just customers paying for experimental (aka beta-test) products.

I don't like this policy one bit. Depending on your proclivities you can say Neuromod are being greedy or it's just a function of a lack of grant/funding in this sector, but patients should not be expected to roll the dice this way. Think of how many billions of dollars Musk pisses away through mismanaging Tesla vs. how little money it would take to subsidize the testing phase of Neuromod and every other copycat treatment. The initial bootstrap money should come from other sources, not patients. It's kind of like a Kickstarter campaign without framing it as such, and so it feels unfair.

You need a source before you say stuff like that on a forum like this. Nowhere have I found (and I have read everything about this device) evidence of them having made clinical trial patients pay for it. The only people who paid are the 100 who bought the first commercial product 4 years ago.

I know why everyone is doubting but no trial in the history of tinnitus has had this many test subjects. Even if it doesn't work, that kind of attention should be appreciated.

 

[ee9892]

That's kind of a sticking point for me. Neuromod is charging people to undergo what is for all intents and purposes a clinical trial

Source? You can't just say that without citing your evidence.

 

[GlennS]

Source? You can't just say that without citing your evidence.

This is a long-long thread. I distinctly remember someone saying it cost ~$5,000 and you were promised half back if it doesn't work. I tried searching for it and can't find it, but that part about the half-refund promise is not my imagination, assuming it's Neuromod and not one of the other two trials going on. It's hard to keep track of the differences between the three. But the $5K figure has been bandied about here for a long time with people weighing whether it's worth it or not. That figure is coming from somewhere regardless of whether they've charged anyone for it yet or not.

Maybe someone can coax Clare B back to clarify whether she had to pay anything.

Oh, and despite the Q&A video this thread is chock full of speculation. Some of it has hard evidence and some doesn't. Hopefully things will become more transparent soon but most of what takes place here day in and day out is some form of speculation.

 

[Drone Draper]

Can you clarify what you mean by that? They will be charging for a device that seems to have limited or relatively poor evidence of efficacy, is all.

I think that's what he means - this is still very unproven and they're charging for it.

I think in this instance, the advice that Paulmanlike gave applies. If you want to be an early adopter, be aware that it may not work and there's not enough data to guarantee anything.

 

[Markku]

I distinctly remember someone saying it cost ~$5,000 and you were promised half back if it doesn't work. I tried searching for it and can't find it, but that part about the half-refund promise is not my imagination, assuming it's Neuromod and not one of the other two trials going on. It's hard to keep track of the differences between the three. But the $5K figure has been bandied about here for a long time with people weighing whether it's worth it or not.

That is not true at all. Neuromod has never charged $5K for this device (I wonder if you confused this with Neuromonics, the audio-only treatment that some people were quoted $5K for, but which has nothing to do with Neuromod?).

This could of course change in the future, as this time around the price might be steeper (minding all the costs involved with running clinical trials, etc.)

When it was briefly in the market, the pricing was as follows:

Back in 2014, I asked them just that question, and they said this:

"It will retail at €2500 which includes €2200 for the device and €300 for the consultation with the audiologist who configures the device to each patients hearing profile. As our sales increase and the costs of manufacture decrease however we do hope to bring that price down slightly over the coming years."​

The device was pulled from the market a short while after though, and the promised peer-reviewed publication never came to be. This time around it's hopefully a different story.

And the Neuromod clinical trials have definitely not cost anything for the participants. I can confirm that.

 

[Agrajag364]

@Drone Draper,

You seem like a cool dude man, but take it from somebody who has had tinnitus a lot longer than you this....

Do not rush out to buy it on release. Hold on. Sit back. Relax. Wait for the evidence base to build up. Sure they've had 3 trials and when we get access to those papers after peer review we can all dissect, dissolve and understand the information together. We can hold on for real patient testimonials that if it is as good as speculated, it is inevitable a wealth of information on it will grow on the internet. Tinnitus Talk included.

The reason for this is that myself have followed tinnitus research a long time (as long as I've had it). It was exciting when the next big thing came out and I rushed out to buy it, realising now it did not work. I'm not saying that will happen again, but it may. I bought the laser therapies, the supplements. Other people on here most notably @carlover bought ACRN at £4,500. No change. I was almost going down the same route, but by then I had accepted tinnitus and decided to hold on. To this day, ACRN still fails to show an internet buzz. You must wait for the internet buzz. I cannot describe the ultimate disappointment one feels when you spend thousands and it does nothing. You deserve to know in advance that there is a great chance it will work for you.

I have noticed the newbies will go out and buy it, but the experienced vets will wait and there is good reason for that.

I don't want to be negative and I am hoping as much as the next sufferer it works, but anybody reading this who is planning on purchasing straight away, please bear this in mind. Tinnitus is a very subjective condition, there's going to be people who claim it works, it's lowering, etc. Just this morning I thought mine seems quiet today. Sure, if the evidence follows through, not just their own trials but by long term established members on here I will buy one.

Anyway, those who buy one, please keep us all updated. I'm signed up to several tinnitus groups, there's a lot of hype at the moment with this (as seen in the past with other products), I will certainly be keeping a close eye on it.

I've had tinnitus for just 17 months but I will definitely wait before buying this device.

The necessary skepticism isn't unique to tinnitus; anyone who's had any of the body's many hard to treat, poorly understood conditions ends up very cynical eventually... even about published trial evidence.

 

[Paulmanlike]

I think where the whole charging for the treatment during trials may have come from is the Desyncra device - not the Neuromod device. I think I remember Mark Williams, the chief audiologist, stating there was a conflict of interest in one of their trials because they were paying customers who they got their data from.

But the trial for Neuromod has been funded by Neuromod.

 

[GlennS]

I think where the whole charging for the treatment during trials may have come from is the Desyncra device - not the Neuromod device. I think I remember Mark Williams, the chief audiologist, stating there was a conflict of interest in one of their trials because they were paying customers who they got their data from.

But the trial for Neuromod has been funded by Neuromod.

Thanks for the clarification. That's encouraging.

 

[hsk]

I don't mind answering questions but there's a limit to what I know. I know there were different groups where the device was set up differently but I don't know what group I was in. I do know there was no placebo. We were not supposed to know what group we were in.

I think someone posted a link to this document earlier, it gives more technical information.

The tones you heard during the treatment -- could you describe what it was like? Was it a continuous single tone that occurred at the same time as the tongue stimulation? Or was it random sounds scattered in time?

 

[shasta0863]

What's an estimated time on this? I'm not sure I can make it to the end of the year. I can't lose 3 years of a battle getting to a semi-stable place to have tinnitus so bad and reactive, constantly jabbing me every half second with a non-stable tone and competing with other sounds I hear, that I'm to the point of just wanting to end it. It's not living. My mind is broken. My anger is causing self harm and causing more hyperactivity in my brain.

The new experiment drugs not approved if you're dying thing that got enacted in U.S should apply to those willing to end their lives to escape this. Couldn't just have NORMAL TINNITUS like I struggled with before. A tone, a loudness, the end. No, it turns into this constantly up and down high pitch jab that makes me physically ill to hear with noises causing it to wind up and compete in sound level.

ENTs are going to have to get trained on this I assume... another year? I just can't go on much longer with this deterioration or no relief.

 

[Lilah]

Is there any type of tinnitus where the Neuromod device doesn't treat or is less effective for? Since there are about 100 causes for tinnitus, I'm curious. Hopefully, there is hope for all.