Lenire — Bimodal Stimulation Treatment by Neuromod

[DaveFromChicago]

I've come to terms with the tinnitus I now have so I'm going to wait and see. I don't find any reason to be very optimistic regarding Dr. Shore's device. I'm afraid it is just going to be yet another expensive habituation device without any real positive effect. I'd love to be wrong though, but I'm not holding my breath.

I feel precisely the same.

In a previous post I mentioned that on 01/05/2018 our Chicago Tribune's Health and Wellness Section had a major article about Dr. Shore.

The report back then was that significant clinical trials had already been undertaken, and the device would be released in the middle distant future.

This was long before all of the excuses that have been made for testing delays due to the COVID-19 shutdown.

Something is very seriously amiss when nearly four years have elapsed and we are still receiving replies that further clinical tests have been scheduled during 2022.

This is taking longer than the testing time required for the release of certain drugs.

Given the above, what are we to make of the latest Press Release on 09/07/2021 that states that "Susan Shore's New "Auricle Device" Is Almost Ready For Commercial Release"?

That was three months ago, and when I read it I assumed that "Almost Ready" could very probably mean after three months (what does "Almost Ready" mean to you?).

I get more cynical about this with each passing year. There is too much contradictoriness in their reports.

If it is in fact ever released, I'll bet that (like Lenire) its total cost exceeds $3,000.00; it had damn well better be better than merely a habituation device.

 

[MadsWithT]

I feel precisely the same.

In a previous post I mentioned that on 01/05/2018 our Chicago Tribune's Health and Wellness Section had a major article about Dr. Shore.

The report back then was that significant clinical trials had already been undertaken, and the device would be released in the middle distant future.

This was long before all of the excuses that have been made for testing delays due to the COVID-19 shutdown.

Something is very seriously amiss when nearly four years have elapsed and we are still receiving replies that further clinical tests have been scheduled during 2022.

This is taking longer than the testing time required for the release of certain drugs.

Given the above, what are we to make of the latest Press Release on 09/07/2021 that states that "Susan Shore's New "Auricle Device" Is Almost Ready For Commercial Release"?

That was three months ago, and when I read it I assumed that "Almost Ready" could very probably mean after three months (what does "Almost Ready" mean to you?).

I get more cynical about this with each passing year. There is too much contradictoriness in their reports.

If it is in fact ever released, I'll bet that (like Lenire) its total cost exceeds $3,000.00; it had damn well better be better than merely a habituation device.

Actually, I take the delays with the Shore device as a good sign. It means that they are yet not satisfied with the device and see the importance of continuing work on it, because they don't want to hurt their patients. Unlike Neuromod who released a treatment solution that in any other medical case than for tinnitus would be liable for court case and massive reparations.

 

[DaveFromChicago]

Actually, I take the delays with the Shore device as a good sign. It means that they are yet not satisfied with the device and see the importance of continuing work on it, because they don't want to hurt their patients. Unlike Neuromod who released a treatment solution that in any other medical case than for tinnitus would be liable for court case and massive reparations.

Your indignation about Neuromod is quite justified, and is similar to mine regarding Desyncra (although I did not sustain a worsening from Desyncra).

The only reservation about Auricle's delays consists of the question:

"Will they ever be finished with testing and actually arrive at the desired conclusion?"

 

[AfroSnowman]

Your indignation about Neuromod is quite justified, and is similar to mine regarding Desyncra (although I did not sustain a worsening from Desyncra).

The only reservation about Auricle's delays consists of the question:

"Will they ever be finished with testing and actually arrive at the desired conclusion?"

In October I wrote the CEO of Auricle and asked the when question.

His answer:

With regard to the commercialization schedule, the conclusion of Dr. Shore's confirmatory study will determine next steps with regulatory bodies, so we will have a better idea of where we stand mid 2022. Given that there are no FDA-cleared devices or drugs for the treatment of tinnitus, regulatory bodies—appropriately—have higher hurdles for safety and efficacy that must be satisfactorily demonstrated before clearance is awarded. As such, we don't make public comments concerning timing since it is premature to do so. But please know that Auricle was formed to gain clearance and commercialize Dr. Shore's device, so we are bringing talent and resources to this critical project. You'll certainly hear from us when we have relevant and public news to report!

Kind regards,
Jon
Jon Pearson
CEO & Co-founder
Auricle, Inc.

 

[DaveFromChicago]

In October I wrote the CEO of Auricle and asked the when question.

His answer:

With regard to the commercialization schedule, the conclusion of Dr. Shore's confirmatory study will determine next steps with regulatory bodies, so we will have a better idea of where we stand mid 2022. Given that there are no FDA-cleared devices or drugs for the treatment of tinnitus, regulatory bodies—appropriately—have higher hurdles for safety and efficacy that must be satisfactorily demonstrated before clearance is awarded. As such, we don't make public comments concerning timing since it is premature to do so. But please know that Auricle was formed to gain clearance and commercialize Dr. Shore's device, so we are bringing talent and resources to this critical project. You'll certainly hear from us when we have relevant and public news to report!

Kind regards,
Jon
Jon Pearson
CEO & Co-founder
Auricle, Inc.

Thanks very much for this update.

I'm concerned about that comment "Given that there are no FDA-cleared devices or drugs for the treatment of tinnitus, regulatory bodies—appropriately—have higher hurdles for safety and efficacy that must be satisfactorily demonstrated before clearance is awarded."

Really? I recall that I was persuaded to try Desyncra in December 2016 precisely because it had received FDA approval.

A "higher hurdle for efficacy"? Desyncra was as efficacious as shining a flashlight on your head would have been.

There apparently wasn't a hurdle at all if Desyncra's worthless "treatment"(who are no longer in business) got FDA approval (or, if the FDA was unwittingly bamboozled by their Stats, what does that say about them?).

A "higher hurdle for safety"? In that case, since Lenire caused 20% of it's users to have their tinnitus worsened, it should unconditionally not receive FDA approval.

That abovementioned quote sounds suspiciously like just another alibi; is something that's going on with them being obfuscated or just plain unadmitted?

 

[Tomas80]

In October I wrote the CEO of Auricle and asked the when question.

His answer:

With regard to the commercialization schedule, the conclusion of Dr. Shore's confirmatory study will determine next steps with regulatory bodies, so we will have a better idea of where we stand mid 2022. Given that there are no FDA-cleared devices or drugs for the treatment of tinnitus, regulatory bodies—appropriately—have higher hurdles for safety and efficacy that must be satisfactorily demonstrated before clearance is awarded. As such, we don't make public comments concerning timing since it is premature to do so. But please know that Auricle was formed to gain clearance and commercialize Dr. Shore's device, so we are bringing talent and resources to this critical project. You'll certainly hear from us when we have relevant and public news to report!

Kind regards,
Jon
Jon Pearson
CEO & Co-founder
Auricle, Inc.

Why are they still just talking about the FDA? What about Europe and the EMA?

 

[AfroSnowman]

Why are they still just talking about the FDA? What about Europe and the EMA?

You should reach out to him and ask. I assume with US research, US grants, US university, and US company that they are probably focused initially on US market, but maybe prompting the CEO will put it a bit more on his radar.

 

[EDDTEKK]

Why the lack of reviews on Lenire? Also on YouTube (Max Bauer, German audiologist) there are no recent news.

 

[Harder Calm]

Why are they still just talking about the FDA? What about Europe and the EMA?

I guess they simply do one after the other. It's costly and lot of work and they don't want several applications at the same time. But if they get FDA approval and start to make money in the US, I'm sure they will expand, after all, tinnitus is potentially a big world-wide market...

 

[EDDTEKK]

I heard from several German clinics that Lenire won't help tinnitus sufferers whose tinnitus has lasted longer than 10 to 15 years.

No one from the clinics reported solid success in such cases.

 

[Survivor234]

Thanks very much for this update.

I'm concerned about that comment "Given that there are no FDA-cleared devices or drugs for the treatment of tinnitus, regulatory bodies—appropriately—have higher hurdles for safety and efficacy that must be satisfactorily demonstrated before clearance is awarded."

Really? I recall that I was persuaded to try Desyncra in December 2016 precisely because it had received FDA approval.

A "higher hurdle for efficacy"? Desyncra was as efficacious as shining a flashlight on your head would have been.

There apparently wasn't a hurdle at all if Desyncra's worthless "treatment"(who are no longer in business) got FDA approval (or, if the FDA was unwittingly bamboozled by their Stats, what does that say about them?).

A "higher hurdle for safety"? In that case, since Lenire caused 20% of it's users to have their tinnitus worsened, it should unconditionally not receive FDA approval.

That abovementioned quote sounds suspiciously like just another alibi; is something that's going on with them being obfuscated or just plain unadmitted?

Desyncra didn't receive FDA approval as a form of tinnitus treatment but rather as a tinnitus masker. Lenire hasn't gotten FDA approval at all. It's a European device but I can't seem to be able to find if it got approval from either the EMA, HPRA, or BfArM.

Getting approved as tinnitus treatment rather than just a masker would presumably entail higher standards. Such as being able to demonstrate that you have actually been able to reduce or eliminate tinnitus.

 

[Paul1980]

Desyncra didn't receive FDA approval as a form of tinnitus treatment but rather as a tinnitus masker. Lenire hasn't gotten FDA approval at all. It's a European device but I can't seem to be able to find if it got approval from either the EMA, HPRA, or BfArM.

Getting approved as tinnitus treatment rather than just a masker would presumably entail higher standards. Such as being able to demonstrate that you have actually been able to reduce or eliminate tinnitus.

It has a CE Mark. See: https://www.lenire.com/faqs/

Do those agencies you mention provide anything else?

 

[Survivor234]

It has a CE Mark. See: https://www.lenire.com/faqs/

What is a CE Mark?

As for the agencies I mentioned, I couldn't find anything resembling what I found for the FDA.

 

[Paul1980]

What is a CE Mark?

According to https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices:

Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process.

Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.

You can read the rest. I have a feeling this issue has been discussed in this thread but I did a search and could not find anything. As to how this product achieved its CE mark, maybe the company can provide more info if you really want it.

 

[Krolo]

So it kinda seems that the rebrand of Neuromod and offering psychotherapy and hearing aids shows that it doesn't work even closely as advertised.

 

[ajc]

So it kinda seems that the rebrand of Neuromod and offering psychotherapy and hearing aids shows that it doesn't work even closely as advertised.

What are you mumbling about? What rebrand? Neuromod and Lenire websites seem to be the same as before, no changes.

 

[Johan001]

According to https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices:

You can read the rest. I have a feeling this issue has been discussed in this thread but I did a search and could not find anything. As to how this product achieved its CE mark, maybe the company can provide more info if you really want it.

CE Mark is relatively easy to get. I worked in getting those for industrial machinery (non medical) and it's extremely easy. You basically just need to prove that you have warning stickers all over your device and it's safe to operate. I wouldn't be surprised if it's the same for medical devices. Most of the cheap stuff on Alibaba got CE marks. It doesn't mean it works, just that it won't electrocute you if you switch it on

 

[EDDTEKK]

Neuromod offers now psychotherapy and hearing aid care.

As @Krolo said, this seems to show, that Lenire doesn't work as promoted.

Just received a notification from their mailing list.

 

[Gee82]

It looks like Neuromod realized that their product is a failure and so they turned into one of those tinnitus clinics that sell you whatever to keep the cash flowing in. I wouldn't be surprised if they started offering Jastreboff stuff. How disappointing.

 

[EDDTEKK]

This is their new website: https://www.otologie.com/

 

[Paul1980]

This is their new website: https://www.otologie.com/

Neuromod Limited is the company that makes the product. The CEO is the same as it always has been. See: https://www.lenire.com/about/

Neuromod Medical is the one who changed their name and they are an audiologist. There may be a relationship between the two, but to say this is a result of the product's performance I believe is a misstatement.

What I have noticed though is that on the Lenire site it says their product "eases tinnitus symptoms." That is a relatively new thing. No claims of curing or radical improvements.

As far as CE mark, perhaps it is only regarding the safety, but maybe someone will look into that instead of conjecture.

 

[Bambam0]

Can't believe they still haven't released their TENT-A2 study. I had some faith it would be a more successful program than the TENT-A1 as Dr. Lim was involved. Patiently waiting...

 

[Watasha]

The only thing that helped my tinnitus, and I make clear this was only while taking it - was Trobalt (Retigabine).

What were your experiences with Trobalt?

 

[Juan Carlos]

What were your experiences with Trobalt?

You can check my posts from 2015, for example this:

https://www.tinnitustalk.com/posts/146598/

 

[Gb3]

Is this the TENT-A2 study?

Real-world clinical experience with bimodal neuromodulation for the treatment of tinnitus - A case series

 

[Suaimhneach]

A "higher hurdle for safety"? In that case, since Lenire caused 20% of it's users to have their tinnitus worsened, it should unconditionally not receive FDA approval.

Hey Dave, where did you see 20% of people worsened? First I'm seeing of that and I'm tempted to try it!

 

[AfroSnowman]

Is this the TENT-A2 study?

Real-world clinical experience with bimodal neuromodulation for the treatment of tinnitus - A case series

Nope, looks to me like a new 20 person, no control study. Shockingly if you tell people that they are getting a treatment for tinnitus, people's THI (or attitude about tinnitus) modestly improves.

 

[IntotheBlue03]

So if a stupid American wants to try this, there's literally no way unless we relocate to one of the EU countries it's offered in?

@AfroSnowman, looking at you as I know you have experience here. As silly as my inquiry is.

 

[AfroSnowman]

So if a stupid American wants to try this, there's literally no way unless we relocate to one of the EU countries it's offered in?

@AfroSnowman, looking at you as I know you have experience here. As silly as my inquiry is.

You can fly over and buy one. Take a nice couple day trip to Ireland. No need to relocate.

 

[IntotheBlue03]

You can fly over and buy one. Take a nice couple day trip to Ireland. No need to relocate.

Thanks. I've always wanted to see Ireland anyway