Lenire — Bimodal Stimulation Treatment by Neuromod

[Skity]

This device seems really familiar to the one I've read in a book named The Brain That Changes Itself: Stories of Personal Triumph from the Frontiers of Brain Science.

The first case is about a woman who lost her "balance organ" and was always in a constant vertigo and senses like shes falling, she could not stand, so these scientists had an idea, they connected a gyro with an electrode to her tongue so she'll get a signal about her position directly to her tongue, and it worked! with the device connected she could stand immediately, no vertigo, but the real surprise came as the effects continued when the device got removed (first time effects continued for a half a min, then a min, half an hour, day, until it was pretty much permanent).

But in Lenire's case, the results are not instantaneous as the one in the book, but seems like it's working (or at least attempts to) in that same principle.

 

[Candy]

So, @Clare B used it for 12 weeks but it didn't disappear until 12 months. That's how I read it.

Is that the case, does anyone know? Was it gradual?

 

[Don Tinny]

I'm in a Tinnitus Clinic right know where they have lots of experience for many years but when I tell them there might be a cure soon they just say I should not think about it. It would hinder acceptance.

How is science supposed to advance with these kinds of doctors?

Can you send them a link with some information about Lenire? Anyway, I'm nearly sure they won't even read it...

 

[tarmaced]

My pet theory on all this is that the audio processing part of the brain has focused on a certain frequency set within the auditory brainstem. I think that the downstream processing regions adapt to this as part of the habituation process. When Lenire starts remodelling the auditory brain stem I would imagine that this would in turn negate the effectiveness of any habituation that has happened (note I am not implying that the subject is fully habituated) and the tinnitus may therefore be perceived as worse.

Again, this is good news in my book, sorry to flog a dead horse.

 

[Martin69]

I'm so excited, and I just can't hide it.

I'm in a Tinnitus Clinic right know where they have lots of experience for many years but when I tell them there might be a cure soon they just say I should not think about it. It would hinder acceptance. Instead they do CBT, acceptance and commitment and mindfulness. It's a joke if you ask me. Could have stayed at home and screwed on my trailer. But I give it a go. 5 weeks left between anorexic and borderliners.

Cheers from Germany!

Where are you? Which clinic?

German clinics have no clue about tinnitus!

 

[jay777]

German clinics have no clue about tinnitus!

Well they have caught up with the rest of the world.

 

[EDDTEKK]

I read somewhere that Germany is one of the few countries who have tinnitus clinics.

In most countries there is no such clinic "specialized" in hearing disorders like tinnitus.

Nowadays they recommend for severe cases to stay at a Psychiatry, since tinnitus is a neurological disorder. Neither clinic is able to help you in most cases.

And neither clinic is interested in any research or new treatment at all.
There is absolutely nobody here who has any serious interest to treat tinnitus. Too tricky for them...

German Tinnitus Association just invites you to participate for a walk in the nature or drink tea together - it's ridiculous and sad but true.

 

[Samantha R]

It's really easy to say but damned difficult when you're in it.

100% spot on Allan. I totally get how you are feeling.

I hope though that the changing tinnitus is a good sign that you'll respond to the device in a positive way, especially if others who've had success had a similar experience in the early days.

I'm pretty sure if my tinnitus was increasing that I'd be freaked out too!

Hang in there and I'm hoping so much that things improve for you.

 

[tarmaced]

Has anyone been accepted for Lenire treatment with non-constant tones? E.g. crickets?

 

[Mentos]

Has anyone been accepted for Lenire treatment with non-constant tones? E.g. crickets?

I also have a cricket sound and I'm interested in the same.

 

[Candy]

Yes I have hissing/cricket sound mainly.

 

[Ruse]

Has anyone been accepted for Lenire treatment with non-constant tones? E.g. crickets?

It has already been confirmed in the Q&A with Tinnitus Hub that tonality / atonality does not matter in treatment, neither does pitch.

 

[Stefaniie]

I also have a cricket sound and I'm interested in the same.

Go to 19:07. There's timestamps in the comments for other questions as well.

 

[Harley]

I'm so excited, and I just can't hide it.

I'm in a Tinnitus Clinic right know where they have lots of experience for many years but when I tell them there might be a cure soon they just say I should not think about it. It would hinder acceptance. Instead they do CBT, acceptance and commitment and mindfulness. It's a joke if you ask me. Could have stayed at home and screwed on my trailer. But I give it a go. 5 weeks left between anorexic and borderliners.

Cheers from Germany!

You should demand your money back from these quacks.
That type of mentality is exactly the reason why there hasn't been any urgency to find a real cure.

Tinnitus is a physical problem and it needs a physical solution.
Be it regrowing the hair cells, or forcing it to abandon the neuron's bad behaviour through bimodal stimulation of sorts, etc.

This is equivalent of trying to talk someone out of a broken arm.
This is insulting to people's intelligence, yet for some reason touted as the ultimate solution.
They are trying to fix the symptom, not the actual cause and actually bragging about it.

In the end, they might be able to build a very unstable house of cards at best, which is not doing anyone any favours.
But what they really do excel at, is transferring the sufferers money into their pockets.

 

[Markku]

I have just now reached out to Neuromod to clarify the details about the hearing threshold requirements, as well as if there are any specific requirements from recent third-party audiograms (like in the case of @Cojackb where he didn't have to have an audiogram at their offices due to already having had one done recently). I hope to receive a response soon and copy it over here.

I can also say from our recent correspondence that Neuromod have agreed to be on the Tinnitus Talk Podcast for one of our next episodes. We will, as usual, ask you to submit questions before we record the episode (more on that later - we'll provide a special link to a form where you can submit questions).

If everything goes without a hitch, I could see the episode being out in late August / September. It will also be transcribed like all of our episodes.

As for the structure of the episode, I'd like there to be a Neuromod-specific segment for the Q&A, as well as one or two of our members talking about their experiences with the device. But if that becomes too much (too long), then we might do two separate episodes, one for the Q&A and one for user experiences.

EDIT/UPDATE
Received a response from Neuromod. They are preparing an answer and will send it to me next week.

Here's Neuromod's response:

In the online booking assessment, information is provided about the hearing thresholds for which Lenire® can be configured. This information was added to the booking assessment approximately three weeks ago.

For question 9 of the booking assessment, if the answer is yes to: Do you have hearing loss? then the following advice is provided:

Please note that Lenire® can only be recommended for you if you have hearing level (AC pure tone audiometry) thresholds of no more than 40 db HL at 250 Hz, 500 Hz and 1000 Hz, and not more than 80 db HL at 2000 Hz, 3000 Hz, 4000 Hz, 6000 Hz and 8000 Hz in either ear at one frequency or more. You may want to consult your audiologist before accepting an appointment if you are unsure of your hearing level thresholds. If you have a copy of your Pure Tone Audiogram, please bring it with you if you accept an appointment with Neuromod Medical.

The following illustration may be informative; if a patient's audiogram dips below the red/blue lines at any point for either ear, then Lenire® cannot be configured for their hearing profile.




For question 8 of the online booking assessment, if the answer is yes to "Have you had your hearing tested by a qualified Audiologist?" it is advised "If possible, we advise that you bring a copy of your most recent audiogram to your appointment in Neuromod Medical"

The Neuromod Medical audiologist will review this audiogram, and using his or her expert audiological clinical knowledge will determine whether to conduct a hearing test at Neuromod Medical.

The Neuromod Medical website provides more information about the Tinnitus Assessment visit;

Neuromod Medical offers tinnitus assessments and treatment with the Lenire™ tinnitus treatment system, a breakthrough evidence-based home-use medical device from Neuromod Devices. At Neuromod Medical you will meet a dedicated team of professionals led by an audiologist specialised in tinnitus, who will conduct a thorough diagnostic assessment and provide recommendations on treatment options. For any treatment other than Lenire™, Neuromod Medical will be happy to refer you to an appropriate specialist.

What to expect when you visit Neuromod Medical

Full Diagnostic Assessment

An assessment visit to Neuromod Medical will take approximately 90 minutes and cost €250. Upon arrival, you will be asked to complete a number of medical history forms and tinnitus questionnaires in the waiting room. You will then meet the clinical audiologist, who will review your medical history, discuss your tinnitus and your treatment goals, and conduct a number of standardised clinical assessments. If Lenire™ is an appropriate treatment option for you, you will meet the fitting specialist who will demonstrate the device and thereafter a member of the administrative team will explain the cost of the treatment plan and organise a date for your first treatment visit (approximately 2 weeks later). If Lenire™ is not an option for you, we will be happy to suggest alternative options and refer you to another specialist outside of the Neuromod Medical.

 

[Mathieulh]

Here's Neuromod's response:

In the online booking assessment, information is provided about the hearing thresholds for which Lenire® can be configured. This information was added to the booking assessment approximately three weeks ago.

For question 9 of the booking assessment, if the answer is yes to: Do you have hearing loss? then the following advice is provided:

Please note that Lenire® can only be recommended for you if you have hearing level (AC pure tone audiometry) thresholds of no more than 40 db HL at 250 Hz, 500 Hz and 1000 Hz, and not more than 80 db HL at 2000 Hz, 3000 Hz, 4000 Hz, 6000 Hz and 8000 Hz in either ear at one frequency or more. You may want to consult your audiologist before accepting an appointment if you are unsure of your hearing level thresholds. If you have a copy of your Pure Tone Audiogram, please bring it with you if you accept an appointment with Neuromod Medical.

The following illustration may be informative; if a patient's audiogram dips below the red/blue lines at any point for either ear, then Lenire® cannot be configured for their hearing profile.

View attachment 31262


For question 8 of the online booking assessment, if the answer is yes to "Have you had your hearing tested by a qualified Audiologist?" it is advised "If possible, we advise that you bring a copy of your most recent audiogram to your appointment in Neuromod Medical"

The Neuromod Medical audiologist will review this audiogram, and using his or her expert audiological clinical knowledge will determine whether to conduct a hearing test at Neuromod Medical.

The Neuromod Medical website provides more information about the Tinnitus Assessment visit;

Neuromod Medical offers tinnitus assessments and treatment with the Lenire™ tinnitus treatment system, a breakthrough evidence-based home-use medical device from Neuromod Devices. At Neuromod Medical you will meet a dedicated team of professionals led by an audiologist specialised in tinnitus, who will conduct a thorough diagnostic assessment and provide recommendations on treatment options. For any treatment other than Lenire™, Neuromod Medical will be happy to refer you to an appropriate specialist.

What to expect when you visit Neuromod Medical

Full Diagnostic Assessment

An assessment visit to Neuromod Medical will take approximately 90 minutes and cost €250. Upon arrival, you will be asked to complete a number of medical history forms and tinnitus questionnaires in the waiting room. You will then meet the clinical audiologist, who will review your medical history, discuss your tinnitus and your treatment goals, and conduct a number of standardised clinical assessments. If Lenire™ is an appropriate treatment option for you, you will meet the fitting specialist who will demonstrate the device and thereafter a member of the administrative team will explain the cost of the treatment plan and organise a date for your first treatment visit (approximately 2 weeks later). If Lenire™ is not an option for you, we will be happy to suggest alternative options and refer you to another specialist outside of the Neuromod Medical.

It certainly looks like I am eligible then https://www.tinnitustalk.com/attachments/c32437-pdf.30392/

I have completed the booking assessment on July 21st (9 days ago) but I haven't been replied to so far. I did say I got my tinnitus less than 3 months ago, considering by the time I do get to an appointment it'll likely be long past the 3 months limit (I am already over 2 months in).

 

[Fabrikat]

That's rough for people whose hearing is outside those ranges. Unfortunate too, for people whose hearing qualifies with hearing aids, but not without. That feels very unfair, considering your brain would hear whatever sound is played through the headphones with hearing aids in. What's the difference?

And bad luck too, if one ear does make the cut, but the other doesn't, if I've read it correctly, that precludes one as well.

Now I'm starting to wonder if Susan Shore's device will have the same restrictions. It would be so disappointing for many people if it did.

 

[Allan1967]

Quick update. Neuromod have been very quick to get back to me.

Basically it was very common in the trials for people to experience increases and fluctuations and most who stuck it out saw eventual improvements.

Those that quit or didn't see improvements ALL returned to baseline and nobody suffered permanent worsening and patients were monitored for a good 12 months afterwards.

I was also advised if need be to drop to 1 session a day or take a break for a few days, lower the volume but keep the tongue piece at its preset setting... don't go higher. Even if you can't feel it, it's still buzzing you.

I was assured that they are a phone call away, with any concerns to get in touch and just update them if I do make changes.

I feel a bit better about it having spoken to other users. Plus, I'm like fucking Beaker from the Muppets at times.

As @Cojackb just said to me... Don't be in the position in a few years time where you're left wondering 'what if'?

 

[JohnAdams]

Plus, I'm like fucking Beaker from the Muppets at times.

Aren't we all?

 

[Heinrich_S7]

Maybe there is a certain subset that this works wonders for but they aren't exactly sure and are using this roll out as a continued trial of sorts?

I suppose that's possible. No doubt in my mind that they are soft launching Lenire. No way would they stick to one location for several months if they weren't soft launching.

Hopefully they 'put their feet down on the gas pedal' a little more now that it's out in the wild. This thing could be the cure all for tinnitus, but it doesn't help us if we don't have access to it.

I'm hoping that after the first wave of people finish their treatment, they'll begin rolling Lenire out worldwide.

 

[ajc]

This thing could be the cure all for tinnitus

It's not a cure. Even in the clinical trials most people only benefited as much as someone would from CBT.

This treatment should not be hyped. It's a band aid at best until hearing regeneration comes available.

 

[Heinrich_S7]

It's not a cure. Even in the clinical trials most people only benefited as much as someone would from CBT.

This treatment should not be hyped. It's a band aid at best until hearing regeneration comes available.

I was saying in the context of 'if it even was a cure'. =]

 

[Ivkopivko]

It's not a cure. Even in the clinical trials most people only benefited as much as someone would from CBT.

This treatment should not be hyped. It's a band aid at best until hearing regeneration comes available.

You're right with the hearing regeneration, but at least low amount of healthy hype should be preserved, here's why >

1. 2 more devices (UMich, UMinn) are on their way, most probably in the next 24-36 months from now.
   
2. A few members here (Clare B, Clearance, kelpiemsp) and a few people from the TENT-A2 trial (those I had opportunity to talk to and ask) and hopefully a few more people from this forum that already got Lenire in their hands will join them in the next 10-12 weeks = all of them benefited rapidly from bimodal neuromodulation and their tinnitus is completely gone, or it's not a problem anymore as they hear it only when plugging their ears in quiet rooms, it's not reactive and it doesn't not spike anymore.
   
3. There is evidence of improvement that TENT-A2 by Neuromod improved THI significantly more compared to the results of CBT in a much shorter time. Interesting results were marked in pictures.
   
4. We and Neuromod don't know yet what happens If the treatment goes beyond 12 weeks and what the continued use will bring, it might be another improvement for non-responders or even better results for people who did respond, or we will sing Irish anthem in the middle of night from our sleep, we will see

 

[JayBowson]

It's not a cure. Even in the clinical trials most people only benefited as much as someone would from CBT.

Yes it's not a cure. If you look back on the results that were posted, CBT achieved an average of about 12 points across a YEAR of treatment. Where Lenire in the TENT-A2 scored double that in 3 months. Not even taking into account that we're talking about a reduction of symptoms as opposed to a few getting used to it counselling sessions.

This treatment should not be hyped. It's a band aid at best until hearing regeneration comes available.

There's nothing that says hearing regeneration wouldn't be a band-aid either. I don't happen to think hearing loss repair is the endgame that some people seem to. Just anecdotally within my family for example:

My father is essentially deaf as a post , hasn't a hint of tinnitus and never has done, same for my grandparents when they were alive. Meanwhile my audiogram shows completely normal undamaged hearing according to my audiologist and I've been suffering this b***h for 2 years now. There are clearly other factors at play here, brain chemistry/genetics/diet/drugs/environment whatever else you care to mention. The simple answer is we just don't fully understand yet. But I'd bet my apartment there won't be a silver bullet.

While I think it's good to manage expectations about this particular treatment and those who leap in head first expecting a cure are likely to be disappointed there's plenty to be hyped about too. This is the very first iteration of treatment of its kind. As such it'll likely be the least effective and others that build upon it will show better results(if indeed it wasn't all a hoax).

Lastly, as someone who's fed up hearing that learning to cope is our only form of treatment I'm hyped about a shift in paradigm towards treatment that actually physically reduces symptoms.

 

[Nanny chocolate]

@Allan1967

Good luck Allan. Grace Kelly called me today (yes I know!) about something. They really want this device to help their patients.

Lenire might be a significant positive to your life, we certainly hope so.

Eve

 

[FGG]

This device seems really familiar to the one I've read in a book named The Brain That Changes Itself: Stories of Personal Triumph from the Frontiers of Brain Science.

The first case is about a woman who lost her "balance organ" and was always in a constant vertigo and senses like shes falling, she could not stand, so these scientists had an idea, they connected a gyro with an electrode to her tongue so she'll get a signal about her position directly to her tongue, and it worked! with the device connected she could stand immediately, no vertigo, but the real surprise came as the effects continued when the device got removed (first time effects continued for a half a min, then a min, half an hour, day, until it was pretty much permanent).

But in Lenire's case, the results are not instantaneous as the one in the book, but seems like it's working (or at least attempts to) in that same principle.

How exactly can the tongue measure position once the gyroscope is removed? I get that nerves can potentially interact in the way to redirect function partially from one to another but in this case, wouldn't talking and moving her tongue cause her to fall over?

Which "balance organ" was affected? The semicircular canals? Vestibular nerves? Unilateral or bilateral? You can completely lose vestibular function on one side and part of the other and still walk with physical therapy alone. This sounds like an interesting case but the specifics would help understand what exactly the scientists are observing. I just wonder if the gyroscope allowed her to balance enough (without extreme dizziness) to stand and essentially start the physical therapy process.

 

[Skity]

How exactly can the tongue measure position once the gyroscope is removed? I get that nerves can potentially interact in the way to redirect function partially from one to another but in this case, wouldn't talking and moving her tongue cause her to fall over?

Which "balance organ" was affected? The semicircular canals? Vestibular nerves? Unilateral or bilateral? You can completely lose vestibular function on one side and part of the other and still walk with physical therapy alone. This sounds like an interesting case but the specifics would help understand what exactly the scientists are observing. I just wonder if the gyroscope allowed her to balance enough (without extreme dizziness) to stand and essentially start the physical therapy process.

I read it a while back so I had to re-read it now to refresh my memory.

Apparently this woman took an antibiotic named Gentamicin which was extremely ototoxic, which damaged her Vestibular system, which in turn ruined her ability to balance, stand, walk, couldn't even follow a moving objects with her eyes, or do anything basically, she was in a constant free-fall sensation, which pretty much was incurable.

They had a few theories on why its effects lasted after they removed the device, among them were the creation of new pathways to the not so functional vestibular system, and it helped "clearing" the noisy signal that came out of the vestibular system, reducing noise that left only clear signal.

If you want to read the entire story, go to https://www.amazon.com/Brain-That-Changes-Itself-Frontiers-ebook/dp/B000QCTNIW/

Click on "Send a free sample", it is the first chapter, which is free on the sample, very detailed, more than I could possibly try and explain.

 

[JohnAdams]

I'm interested if I'd qualify for the treatment. In the Q&A it was said that profound hearing loss would disqualify you from getting to try the device. Profound is 90 dB. In EU, the safety limit for how loud a device that uses headphones can be is 85 decibels.

There's a rule that if you exceed the 85 decibels, up to 100 is allowed, you need to put in a warning into the device that displays every 20 hours, I doubt Neuromod went that route and the limit for Lenire is probably 85 decibels or maybe even less.

My audiogram has a sharp dip to 85 decibels at 8 kHz. I can hear speech fine in most cases. It probably means I won't qualify. Not sure if the cutoff point is 80 or 85, they did say it needs to be profound so maybe 85 will still qualify?

Also, maybe my hearing is worse than that in the higher frequencies that I haven't tested. Not sure. It would be good if they had mentioned exact numbers in the Q&A.

Can we get an update?

 

[EDDTEKK]

I don't understand why the hearing threshold must be below 40 dB for the very low frequencies? Is there any reasonable explanation for it?

 

[namaste]

I have 50-55 dB loss at 1000 Hz, but am above the red/blue line on everything else. What are the 40 dB limits for? The device can't amplify beyond 40 dB at 125-1000Hz? That's a pretty quiet volume level, most charts would say "quiet office" for 40 dB, it's 10 dB above whisper volume.

Any mp3 player can amplify way above those levels so this seems very odd.