Lenire — Bimodal Stimulation Treatment by Neuromod

[GregCA]

There is latency even with wired headphones just for everyone's information (although of course Bluetooth will be longer).

The issue isn't so much whether there is latency or not (as you pointed out, there is always latency, albeit sometimes very minimal), but whether the latency is predictable and somewhat constant or not.

For a wired connection, you can calibrate the software for that latency, and it's unlikely it will change much from one patient to another.

For a BT connection, latency variations due to the environment can dwarf the precision needed in the bimodal timing (which is in the order of a few milliseconds, if I remember the study correctly), so I'm unsure how they're dealing with it.

 

[Wfg3]

Hello, I emailed Neuromod over the weekend to ask if there were any special accommodations to alleviate the amount of travel for people from outside countries.

The response was very polite, but stated there are no accommodations, and Neuromod does not seek to encourage people to travel from other countries for treatment.

They are working as quickly as possible to bring their product to other regions.

They did not actually say No, but this reply was not very encouraging.

Guess I'll have to wait until it's available in the U.S.

 

[Clint Azzopardi]

@Lucifer @gorzakus @Watasha

Hi there. Neuromod came back to me after emailing them about braces and dental retainers (I was actually impressed that they replied!).

Their reply was:

"The Instructions for Use described in the User Manual for Lenire® states: "Contact between the tonguetip® and dental retainers or metal fillings may cause temporary discomfort"

Having temporary or semi-permanent dental appliances or a metal wire behind teeth would not prevent a healthcare professional recommending treatment with Lenire®. During a fitting visit, it is likely that the fitting technician would work carefully to ensure that the tongue stimulation level of the tonguetip® be calibrated to take into account potential sensitivity."

So bring on the Guinness

Stay well.

 

[jmasterj]

I have suggested this to Neuromod again recently, as has @Hazel in a follow-up message, along with other relevant ideas and suggestions.

Still waiting for response. They have always been very friendly, and I understand perfectly well they are swamped with everything that's going on, but I do feel there's room for improvement in patient communications.

Thanks Markku and Hazel for reaching out for us. I am still hopeful they will work with you after all the time spent with the first Q&A video.

 

[KotaDomowa]

I am beginning to seriously suspect that the question about the intention to travel + the request for a national code (+00) were exclusion criteria.

But this is just a paranoid self.

 

[Clint Azzopardi]

I am beginning to seriously suspect that the question about the intention to travel + the request for a national code (+00) were exclusion criteria.

But this is just a paranoid self.

Chill out

 

[kelpiemsp]

The issue isn't so much whether there is latency or not (as you pointed out, there is always latency, albeit sometimes very minimal), but whether the latency is predictable and somewhat constant or not.

For a wired connection, you can calibrate the software for that latency, and it's unlikely it will change much from one patient to another.

For a BT connection, latency variations due to the environment can dwarf the precision needed in the bimodal timing (which is in the order of a few milliseconds, if I remember the study correctly), so I'm unsure how they're dealing with it.

If the headphones had a small chip you could easily just have a very small cache, say a couple of seconds. I think that would solve it.

 

[GlennS]

For a BT connection, latency variations due to the environment can dwarf the precision needed in the bimodal timing (which is in the order of a few milliseconds, if I remember the study correctly), so I'm unsure how they're dealing with it.

Being a techie myself, I have to say that this is a genuine question. They really should have gone with wired headphones because even if they're compensating somehow it is violating the KISS principle bigtime. It would be nice if someone with proper IEEE creds got their hands on one of these and actually ran a timing diagnostic to see if the synchronization is steady between the audio and the stimulation. If it's all over the map then this would be a sign that Neuromod was shockingly careless in engineering this device.

 

[Paulmanlike]

I can't wait for the reviews of this thing...

My ears were ringing like fuck today.

 

[Lucifer]

@Lucifer @gorzakus @Watasha

Hi there. Neuromod came back to me after emailing them about braces and dental retainers (I was actually impressed that they replied!).

Their reply was:

"The Instructions for Use described in the User Manual for Lenire® states: "Contact between the tonguetip® and dental retainers or metal fillings may cause temporary discomfort"

Having temporary or semi-permanent dental appliances or a metal wire behind teeth would not prevent a healthcare professional recommending treatment with Lenire®. During a fitting visit, it is likely that the fitting technician would work carefully to ensure that the tongue stimulation level of the tonguetip® be calibrated to take into account potential sensitivity."

So bring on the Guinness

Stay well.

Thanks for the update @Clint Azzopardi. I'm glad having a metal wire behind my teeth will still be fine using the device.

 

[GregCA]

If the headphones had a small chip you could easily just have a very small cache, say a couple of seconds. I think that would solve it.

I don't think I understand how it would solve it. Wouldn't you still need to get the initial sync right?

 

[Heinrich_S7]

Hopefully things begin to pick up soon. At this rate things are moving pretty slow.

 

[El BUZZ]

I can't wait for the reviews of this thing...

My ears were ringing like fuck today.

Make some room for me on that boat. Since the release of Lenire the already loud intensity of my tinnitus has doubled.

I'm in Spain. I have lived in Ireland for a long while. I know Dublin inside out. I have family and friends willing to lend me the money to give the thing a shot. It can't get more maddening at this point. I'm about to pack and jump in the next plane.

Also reading stuff here plagues me with even more paranoia. This thread is becoming a form of tinnitus itself. It's stuck in my mind 24/7 and need to get rid of it as soon as fooking possible.

 

[Lucifer]

I have family and friends willing to lend me the money to give the thing a shot.

That's so nice to have family and friends willing to give you their money to give this device a shot.

 

[El BUZZ]

That's so nice to have family and friends willing to give you their money to give this device a shot.

They've witnessed the good load of shit I've been through due to this junk. Almost four years ago my life changed in a twisted creepy way. I don't know how I've managed to keep my sanity and don't lose my job, a good chunk of my social life and so on... My main hobbies (reading & music) have been badly biten by this mofo. And now there's something being cooked in Ireland which may allow me to grab back part of my old life by its balls? Sorry but there's no price for that. Maybe I am the perfect target for rotten soul con artists but can't think of a better reason than getting rid of this junk.

 

[Lucifer]

They've witnessed the good load of shit I've been through due to this junk. Almost four years ago my life changed in a twisted creepy way. I don't know how I've managed to keep my sanity and don't lose my job, a good chunk of my social life and so on... My main hobbies (reading & music) have been badly biten by this mofo. And now there's something being cooked in Ireland which may allow me to grab back part of my old life by its balls? Sorry but there's no price for that. Maybe I am the perfect target for rotten soul con artists but can't think of a better reason than getting rid of this junk.

Whenever it comes to health you would pay anything to make it go away. I completely agree with you.

 

[JohnK]

I wonder what range of tinnitus frequencies they tried in the clinical trials. Mine is quite high around 14400 Hz. I'm hoping the efficacy would be frequency-agnostic as long as you still have hearing capabilities in that range because I've still got that...

 

[Meiro]

Hello, I emailed Neuromod over the weekend to ask if there were any special accommodations to alleviate the amount of travel for people from outside countries.

The response was very polite, but stated there are no accommodations, and Neuromod does not seek to encourage people to travel from other countries for treatment.

They are working as quickly as possible to bring their product to other regions.

They did not actually say No, but this reply was not very encouraging.

Guess I'll have to wait until it's available in the U.S.

No need to worry about it - the Clarion Hotel is 15 mins walk from the Hermitage Medical Clinic and the Airport shuttle service bus number 777 brings you directly to it. €130 per night depending on the season.

 

[Ivkopivko]

By the way, what happened with Germany/Regensburg, regarding Lenire availability?

Is Prof. Langguth (member of Neuromod Science Advisory Board from University of Regensburg Hospital) currently on the road riding the truck full of Lenires somewhere close to Belgian-German border with sirens on thinking of how the email announcing availability in Germany will look like?

 

[Agrajag364]

There are various theories about plasticity and things happening on a different timeline. My read on that exclusion criteria for this study is that they're a VC-backed for-profit company trying to maximize the efficiency they can demonstrate to make it easier to get to market.


I'd say I'm agnostic on the first issue, but agree that the second is a significant concern. Double blind RCTs are the gold standard; double blind RCTs are what UMich is doing, and this makes me a lot less suspicious of the UMich data despite smaller sample sizes. (I think UMich, so far, has shown somewhat less dramatic gains than what Neuromod is claiming? If so that all lines up neatly).

I'm agnostic on the first issue because we don't really know enough yet to say with any certainty at what point plastic changes happen in various brain regions, and I don't think it's impossible that bimodal stimulation could work better in general on people who have had tinnitus for X time frame or less. I am not privy to Neuromod's initial data, and they may have some reason to think so. On the other hand, UMich doesn't seem to care, because they're more interested in finding out as much as they can about how this stuff works and who it works on, than they are with the typical insane VC rush-to-market. So, we can say all the usual things about Neuromod that can be said about VC-backed capitalist endeavors, but I personally don't resent them for their existence; when it comes to capitalistic silliness, I hate the game a lot more than any specific player (excluding really dramatic examples of bad-faith actors like Dow Chemical or the petrochem industry).

I agree that the lack of placebo is more significant than the 5 year cut off in the first trial. I was just saying having tinnitus for more than 5 years can't be considered a "confounding" factor in scientific terms as they do state the device is for use in tinnitus. I agree the brain might be more plastic with regards to tinnitus changes in early years. But then again that may be probably why some people have a natural perceived volume reduction in their tinnitus in the first few years.

That is interesting that UMich are doing a double blind trial, thanks.

 

[gorzakus]

@Lucifer @gorzakus @Watasha

Hi there. Neuromod came back to me after emailing them about braces and dental retainers (I was actually impressed that they replied!).

Their reply was:

"The Instructions for Use described in the User Manual for Lenire® states: "Contact between the tonguetip® and dental retainers or metal fillings may cause temporary discomfort"

Having temporary or semi-permanent dental appliances or a metal wire behind teeth would not prevent a healthcare professional recommending treatment with Lenire®. During a fitting visit, it is likely that the fitting technician would work carefully to ensure that the tongue stimulation level of the tonguetip® be calibrated to take into account potential sensitivity."

So bring on the Guinness

Stay well.

Thanks for the info! Good news!

 

[acute]

Neuromod does not seek to encourage people to travel from other countries for treatment.

I am beginning to seriously suspect that the question about the intention to travel + the request for a national code (+00) were exclusion criteria.

But this is just a paranoid self.

Yes, I'm feeling the same... The only people that have got appointments are in Ireland...

Also, I do not trust that the treatment will be as good in other countries as at Neuromod's offices in Ireland, basically this:

Is anyone else skeptical that, outside Neuromod, we may not be getting the same "text book" service?

These people are professionals and I'm sure they will do their best to make this a success story.

On the other hand, once this rolls out I'm worried of possible "who cares if it works or not as long as we make money"!

By no means I think every audiology clinic is bad but I believe this is a valid concern considering how audiology/tinnitus market has worked so far.

We know that the Neuromod staff is professional, but can we expect the same from clinics in other countries? Will they know how to use the device properly? Will the treatment be the same? They will not know the device as well as the company that made it. I do not trust in Spanish clinics.

Maybe my concerns are stupid but... I'm worried.

 

[jmasterj]

Yes, I'm feeling the same... The only people that have got appointments are in Ireland...

Also, I do not trust that the treatment will be as good in other countries as at Neuromod's offices in Ireland, basically this:

We know that the Neuromod staff is professional, but can we expect the same from clinics in other countries? Will they know how to use the device properly? Will the treatment be the same? They will not know the device as well as the company that made it. I do not trust in Spanish clinics.

Maybe my concerns are stupid but... I'm worried.

I am guessing they are busy training other providers to configure the device properly. They very well could be having other clinicians at Neuromod during these first appointments to show them the ropes. I wouldn't really worry about that. I am sure Neuromod will work hard on making sure clinicians are proficient with this device. It does have their name on it and it puts money in their pockets and their investors. They want this to be a success.

 

[Ruse]

The issue isn't so much whether there is latency or not (as you pointed out, there is always latency, albeit sometimes very minimal), but whether the latency is predictable and somewhat constant or not.

For a wired connection, you can calibrate the software for that latency, and it's unlikely it will change much from one patient to another.

For a BT connection, latency variations due to the environment can dwarf the precision needed in the bimodal timing (which is in the order of a few milliseconds, if I remember the study correctly), so I'm unsure how they're dealing with it.

Software can account for variation in latency as well.

Let's look on the flip side though - if they haven't taken any of this into account imagine how much more improvement they could get out of the device.

 

[linearb]

It would be nice if someone with proper IEEE creds got their hands on one of these and actually ran a timing diagnostic to see if the synchronization is steady between the audio and the stimulation.

It would be nice but I'd settle for some random Tinnitus Talk person with a couple oscilloscopes and more DSP knowledge than me trying to black box test it, I trust that about as much as I trust Neuromod's marketing engine

 

[GregCA]

Software can account for variation in latency as well.

I'm afraid I don't see how. If you know the answer, please explain.

Let's look on the flip side though - if they haven't taken any of this into account imagine how much more improvement they could get out of the device.

They must have, because we know (from Dr. Shore) an error by a few milliseconds can have negative consequences in bimodal stimulation, so they either figured out how to sync with millisecond accuracy, or their type of bimodal stimulation is different in timing requirements vs UMich's.

 

[Mandalay]

Hi guys,

I guess at the moment Neuromod is just overwhelmed.
It will improve over time (I hope), and I keep my fingers crossed that this device seriously helps.

Reading all your posts makes me realise how serious this condition can be.
Actually I would dance with the devil to find a cure to produce relief.

I check this thread every day and I have learned so much after joining Tinnitus Talk.
I can't stop reading. There is so much valuable information in here.
Thanks for all that and I'm with you,

Mandalay

 

[Ricardo1991]

I guess at the moment Neuromod is just overwhelmed.

Yes, they are probably backlogged and going to be for a while. In the meantime, we have endured. And we'll continue to until it's our time

 

[Cojackb]

Just received a phone call from Neuromod and they've booked me in for an appointment on the 25th!

Everything crossed for the assessment and hoping I'm eligible for the treatment, super nervous!

 

[jmasterj]

Just received a phone call from Neuromod and they've booked me in for an appointment on the 25th!

Everything crossed for the assessment and hoping I'm eligible for the treatment, super nervous!

Are you located in Ireland?

Nevermind, I see you are in England. I am glad they are going out of country. Initially it seemed they were calling only those in Ireland. Best of luck to you!