Lenire — Bimodal Stimulation Treatment by Neuromod

[Heinrich_S7]

It's not about being disgusting. It's just that they can't say "oh okay we trust you, here is your 2750 dollars".

Plus even if it doesn't work, it takes people and time. So that would mean people would work for free? Really?
Because it didn't work doesn't mean they didn't work. They don't work for free which is totally normal. And you can't simply trust what patients claim.

I am telling you this policy will never exist. First because tinnitus is subjective. Second because they are not just selling a device, they are selling a prestation. You can't reimburse a prestation because you can't take back time.

The issue is they are holding the data away from people and selling a medical device for nearly 3 grand and saying "no refunds!" as well. If the device doesn't even help you in the slightest, or makes your tinnitus worse, you're basically flushing thousands of dollars down the toilet.

Desyncra was a quick kick in the balls. They got your 5 grand, said "no refunds!" and took off with your money in a quick cash grab.

We've been duped before in the tinnitus community. Your argument is correct but it's the customer who loses in the end, to the exact same subjective ignorance Neuromod have.

You lose thousands, they don't, they get your money regardless. This of course would be different if they published concrete data.

 

[GlennS]

Are you sure you read right what I wrote?

Feel free to clarify. The thread seemed to be veering into "you guys are craaaazeeey for buying into it" and that's the sentiment I'm responding to.

This of course would be different if they published concrete data.

In which case the path to take would be wait-and-see. But there will be those who gamble and that's their prerogative.

 

[Dizzyhead888]

The issue is they are holding the data away from people and selling a medical device for nearly 3 grand and saying "no refunds!" as well. If the device doesn't even help you in the slightest, or makes your tinnitus worse, you're basically flushing thousands of dollars down the toilet.

Desyncra was a quick kick in the balls. They got your 5 grand, said "no refunds!" and took off with your money in a quick cash grab.

We've been duped before in the tinnitus community. Your argument is correct but it's the customer who loses in the end, to the exact same subjective ignorance Neuromod have.

You lose thousands, they don't, they get your money regardless. This of course would be different if they published concrete data.

They have published data before, though not a big sample size. You always have the option to wait for the data to come out before you try the device.

But let's think about it in another way.
The data that will come out at one point. What if the results were to be similar to the current results, or let's say worse. Let's say 50% got a reduction rather than 86%.

Would that stop you from trying the device? I think not.

 

[Rio80]

And also cochlear implants. @Rio80 don't lose hope; you will need to wait 1-2 extra years but serving people with serious hearing impairments is definitely in Neuromod's plans.

As a silver lining, by that time, we will definitely know whether Lenire works and with what characteristics.

Was not aware of that. Good to know. Thanks!

 

[Rio80]

Can you post your audiogram here? (blank out any personal info)

Not home for several days but I remember it was 40-60 dB on the lower frequencies and 60-90 dB on the higher. With left ear performing worse than the right.

 

[linearb]

They have published data before, though not a big sample size. You always have the option to wait for the data to come out before you try the device.

But let's think about it in another way.
The data that will come out at one point. What if the results were to be similar to the current results, or let's say worse. Let's say 50% got a reduction rather than 86%.

Would that stop you from trying the device? I think not.

Yeah but what if 3% of people had a permanent worsening?

My pessimistic random speculation about what's hidden in the data they have not published, is just as reasonable as your rose-tinted view.

The number of people who want to fall on a dagger here to defend the right of a for-profit company to work in secrecy is hilarious to me. Haven't we learned anything from the last 50 years of tinnitus treatment efforts?

I want these techs to work as much as anyone and I tend to be fairly bullish on them because I used the UMich device and wish I owned one, but I have no illusions about the motivations of various actors, or the realities of various timelines. I want Lenire to work and have few side effects; if that's the case, and if they truly have a 500-person cohort that would demonstrate that in a way which would withstand peer review... they why haven't they published that?

I also note that UMich appears to be completely ignoring Lenire, as in, not doing anything to their own timelines in response... which is more or less what I'd expect from a legitimate, science-based research apparatus.

 

[GregCA]

Not home for several days but I remember it was 40-60 dB on the lower frequencies and 60-90 dB on the higher. With left ear performing worse than the right.

Do you also remember if you had an air-bone gap?

 

[GlennS]

I also note that UMich appears to be completely ignoring Leniere, as in, not doing anything to their own timelines in response... which is more or less what I'd expect from a legitimate, science-based research apparatus.

...oooooorrrr what you'd expect from someone who feels no sense of urgency because...tenure.

Pick your poison. Take a risk on something you can try now or wait for Godot.

 

[Heinrich_S7]

They have published data before, though not a big sample size. You always have the option to wait for the data to come out before you try the device.

But let's think about it in another way.
The data that will come out at one point. What if the results were to be similar to the current results, or let's say worse. Let's say 50% got a reduction rather than 86%.

Would that stop you from trying the device? I think not.

Correct, but that was an in-house review, and IIRC they even took that down when it was leaked ASAP.

What matters is if other institutions peer review that data to confirm the results.

The peer review is complete, is it not? They could do us a solid while we wait and show us what other institutions found.

It's a possibility Neuromod doesn't want us to see it because the peer reviewers didn't have favourable conclusions on the results.

The number of people who want to fall on a dagger here to defend the right of a for-profit company to work in secrecy is hilarious to me. Haven't we learned anything from the last 50 years of tinnitus treatment efforts?

Exactly, we have been lied to before by these private companies. I want this device to work just as much as the next guy. But we have had massive cash grabs come at us many times over the decades.

 

[Rio80]

Do you also remember if you had an air-bone gap?

If that's the same thing as bone conduction, part of the test it tested out at 20-40 dB.

 

[Piney]

Gabriel, I don't want to hijack the thread too badly, but I'm obviously looking at it with a different view than yours, that's all. If you sell a product it should be PRODUCTive. If it was 5 0r 10 grand with no results would that be acceptable as well? Where is the line drawn?

I guess the point is patients should get results for their money, just like when I returned my 30 dollar Ring Ease bottle or whatever it was to the pharmacy for a refund. Didn't work, no questions asked. If this device worked, no one would return it for fear of it coming back, it's tailored to them.

Too many doctors and companies get away with robbery. I just hope this one is busy collecting data and making tweaks to their device to make it more effective. I have to believe they are with this forum keeping a close eye.

 

[Mentos]

Yeah but what if 3% of people had a permanent worsening?

My pessimistic random speculation about what's hidden in the data they have not published, is just as reasonable as your rose-tinted view.

The number of people who want to fall on a dagger here to defend the right of a for-profit company to work in secrecy is hilarious to me. Haven't we learned anything from the last 50 years of tinnitus treatment efforts?

I want these techs to work as much as anyone and I tend to be fairly bullish on them because I used the UMich device and wish I owned one, but I have no illusions about the motivations of various actors, or the realities of various timelines. I want Leniere to work and have few side effects; if that's the case, and if they truly have a 500-person cohort that would demonstrate that in a way which would withstand peer review... they why haven't they published that?

I also note that UMich appears to be completely ignoring Leniere, as in, not doing anything to their own timelines in response... which is more or less what I'd expect from a legitimate, science-based research apparatus.

I would ask a couple of questions:

Why in the testimonies movies they published there are no real success stories like complete cure of tinnitus?

Why do they claim only 66% success rate and not 80-90%?

Why do they reject many patients with hearing loss? They could earn money from them.

Why don't they accept as many people as possible in 2019 maximizing their profit?

All of this makes them a legit company in my view.

 

[Chinmoku]

Neuromod could have released a pre-print version of the paper with the results. This is a standard in physics and mathematics (arXiv). Or they could have presented the paper at a conference and published a short version in the conference proceedings/online, while waiting for the full paper review. This is done often in engineering.

Perhaps they don't want to put out IP early but now that the device is out it wouldn't be hard for a competitor to acquire one and try to reverse-engineer the method.

Why not publish a pre-print version of the peer review paper? Even if it is rejected, it can be amended and submitted to another journal.

If they are confident they could really come out with it.

 

[Agrajag364]

...oooooorrrr what you'd expect from someone who feels no sense of urgency because...tenure.

View attachment 31807

Pick your poison. Take a risk on something you can try now or wait for Godot.

So when are you trying Lenire GlennS?

 

[foam]

DIY bimodal stimulation: with a 9v battery on/off the tongue and music on the headphones. Has anyone tried it?

It's probably not as silly as it sounds. Far as I can tell that's exactly what this device it.

 

[Annpann]

I am travelling to the Hermitage Clinic on 11th October and am looking at the Airport Hopper.

Has anyone used this bus service? If I travel to the N4 footbridge, is it a long walk from there?

I am sure someone posted before but I cannot find the post. I would be grateful for any advice as I intend to book tickets in advance.

 

[linearb]

I would ask a couple of questions:
All of this makes them a legit company in my view.

I never said they weren't "legitimate". For what it's worth, my gut read is that they believe in their tech and are trying to help people.

That said, if they have truly conducted a longitudinal, 500-sample study which has withstood peer review and supports their marketing language with no reservations... then where's the peer reviewed paper in a real journal? This isn't a specific dig at Leniere, it's a dig at anyone who puts profit and product ahead of proof and prudence.

When they were a smaller company backed mostly by a couple angels with tinnitus, they had access to a runway that they no longer have, because they have taken normalized VC dollars and now they have to ride that forward towards profitability. Again, this doesn't mean they're disingenuous, lying, or even necessarily that their data won't, ultimately, support their claims... but I'll believe it when I see it. Personally I have little problem throwing $5K at something that might not work, and the only things keeping me from booking a trip to Ireland are:
* time
* I got improvement with no initial worsening from the UMich device, as did everyone who got any improvement from the device. So, reports of initial worsening, even if temporary, concern me, and also make me think there may be some differences between these two technologies which we're not going to understand for a while.

...oooooorrrr what you'd expect from someone who feels no sense of urgency because...tenure.

*shrug* she's got tinnitus herself and in my handful of interactions with her she's been incredibly empathetic and expressed a strong desire to get a product on the market as soon as possible specifically because of what a huge unmet need it is for a bear of a chronic condition. If that's all an act, she's good at it, and that's probably all I've got to say on this until we have moar datas.

Let's not forget that this is partially out of Shore's own hands; at this point, wheels are turning, ink has been signed with a medical device manufacturer, etc. The pace of institution-backed science-based research tends to be slow, but with a lot of gravity behind it that causes it to tend to just stumble forward regardless of a a changing landscape around it.

 

[EDDTEKK]

6 weeks passed and nobody has anything positive to report... I think our euphoria has been dampened. It looks like it's not that quick "cure" everybody was hoping for

So sad.

 

[eagerUser]

6 weeks passed and nobody has anything positive to report... I think our euphoria has been dampened. It looks like it's not that quick "cure" everybody was hoping for

So sad.

There are people here having their tinnitus quieter than pre-Lenire. Head to the User Experiences.

 

[acute]

6 weeks passed and nobody has anything positive to report... I think our euphoria has been dampened. It looks like it's not that quick "cure" everybody was hoping for

So sad.

Nobody said this was a cure... And of course not a quick one...

Anyway, I am also somewhat disappointed, although it is still early.

 

[GregCA]

If that's the same thing as bone conduction, part of the test it tested out at 20-40 dB.

It's not, it's the difference between bone conduction and air conduction. Try to post your audiogram when you get home: it'll be a lot easier to interpret (I hope).

 

[Krolo]

Anyone in Dublin tomorrow or on the 10th? Would love to grab a beer while I am in town!

 

[Skinjob]

I have stayed (mostly) silent on this thread because people who have had successful reduction or elimination of their tinnitus using bimodal stimulation (including @kelpiemsp) noticed no change until at least two months in. You are all suffering from premature expectations and impatience. I am distrustful of any early positive reports from my experience with my own remarkable placebo effect when I used Neuromonics 12 years ago. My tinnitus almost completely disappeared for a time and I was overjoyed. Then it came back. The placebo effect is a real thing. So is the nocebo effect.

This is slow going and everyone is going way too fast. It took months in @kelpiemsp's and @Clare B's cases. It's too early to be expecting anything at all.

 

[Allan1967]

Can someone remind me on - people with hyperacusis were on the clinical trials and some people who have purchased Lenire have hyperacusis?

 

[Autumnly]

people with hyperacusis were on the clinical trials

Yes, people with hyperacusis participated in Neuromod's trials as well. Hyperacusis was defined as: "We defined hyperacusis as sound sensitivity to loudness discomfort levels (LDL) of 60 decibels sound level (dB SL) or less." - Ross O'Neill. (Question 4: "Is the treatment more effective on tinnitus, hyperacusis, or both?")

People with hyperacusis were also super-responders. "The response rates are over 90% in that group [meaning hyperacoustic people]. The levels of response that they are getting are twice what the rest of the people are getting." He also said: "So, the more hyperacoustic you are, the more responsive you are to this treatment, the more benefit you will get from it."

 

[Dizzyhead888]

Yeah but what if 3% of people had a permanent worsening?

My pessimistic random speculation about what's hidden in the data they have not published, is just as reasonable as your rose-tinted view.

The number of people who want to fall on a dagger here to defend the right of a for-profit company to work in secrecy is hilarious to me. Haven't we learned anything from the last 50 years of tinnitus treatment efforts?

I want these techs to work as much as anyone and I tend to be fairly bullish on them because I used the UMich device and wish I owned one, but I have no illusions about the motivations of various actors, or the realities of various timelines. I want Lenire to work and have few side effects; if that's the case, and if they truly have a 500-person cohort that would demonstrate that in a way which would withstand peer review... they why haven't they published that?

I also note that UMich appears to be completely ignoring Lenire, as in, not doing anything to their own timelines in response... which is more or less what I'd expect from a legitimate, science-based research apparatus.

There is no secrecy my friend.

Neuromod CEO said "it will be published in 12 months" 9 months ago which was when the interview was done. So give it 3-6 months and it will be published. They just started the "follow up" phase, 9 months ago, and they follow up for up to a year.

They had the option to release the device early or wait for the results to be released. Commercially it makes sense to release the device as soon as possible given possible competition down the road. So I was the CEO, I would have released this device. If someone is not satisfied with the old clinical trials and strictly wants to wait for the new results to be published, they have the option too.

What we learn from 50 years is to spot a scam. Scams are easy to spot. Not to waste our money on scams just because we are desperate. But this is completely not the same as trying a device scientifically evident to work. Now there is chance it works for you or not. If it works, there is a chance you get a significant reduction or a slight reduction. That's how life is and most medical treatments are. Antidepressants are known to work in some and not in others. Some had to try 2 or 3 antidepressants to find one that works for them.

 

[Dizzyhead888]

Anyone in Dublin tomorrow or on the 10th? Would love to grab a beer while I am in town!

I arrive at the 12th, will you be there?

 

[Agrajag364]

6 weeks passed and nobody has anything positive to report... I think our euphoria has been dampened. It looks like it's not that quick "cure" everybody was hoping for

So sad.

There have been positive reports. About three people so far, of those who have purchased the device rather than being in the original trials. Others saying it is too early to tell or no improval.

 

[hans799]

Anyone in Dublin tomorrow or on the 10th? Would love to grab a beer while I am in town!

I'll be there on the 10th, definitely up for a beer! I recall someone saying that the clinic is like a block away from a Guinness place, maybe we could head there to discuss our assessments. I'll be done around 16:00 Irish time, give or take.

 

[erik]

I have stayed (mostly) silent on this thread because people who have had successful reduction or elimination of their tinnitus using bimodal stimulation (including @kelpiemsp) noticed no change until at least two months in. You are all suffering from premature expectations and impatience. I am distrustful of any early positive reports from my experience with my own remarkable placebo effect when I used Neuromonics 12 years ago. My tinnitus almost completely disappeared for a time and I was overjoyed. Then it came back. The placebo effect is a real thing. So is the nocebo effect.

This is slow going and everyone is going way too fast. It took months in @kelpiemsp's and @Clare B's cases. It's too early to be expecting anything at all.

Agreed! Placebo effect is always enhanced by high expectations. That doesn't specifically mean that a device like Lenire doesn't work, but rather other factors are at play. The brain and body's perceptions tends to change when you receive treatment or think you are. This effect generally stabilizes and wears off after the first few months or so but can last several months or longer.

I will continue to be optimistic, see what happens the next 6-12 months, as by then we should have a good idea of the true outcome of this device. Until then debating over its effectiveness is pointless at this time.