Lenire — Bimodal Stimulation Treatment by Neuromod

[Heinrich_S7]

You obviously haven't been paying attention when you say there haven't been updates in months. For instance, did you skip over the photo they posted with the finished packaging? It's coming out soon. Sheesh...

I actually agree with you, but I will say that Neuromod really needs to communicate with their patients more. Delays are fine and there's a ton of hurdles. Like Logistics, Legal Red Tape, and Training Audiologists.

But it's no excuse for their radio silence for 7 months. They could give us a little update now and then on progress. I'm all for waiting until it's ready though.

I'm more or less a little frustrated on lack of communication than release.

 

[Autumnly]

Does the frequency of your tinnitus matter, does anyone know?

No, tinnitus pitch/frequency doesn't matter. "[...] the tonality, atonality, pitch of tinnitus is not relevant to the therapy" (question 12 of the interview)

 

[Jack Straw]

But it's no excuse for their radio silence for 7 months. They could give us a little update now and then on progress. I'm all for waiting until it's ready though.

I'm more or less a little frustrated on lack of communication than release.

Ding Ding Ding.

 

[Allan1967]

No, tinnitus pitch/frequency doesn't matter. "[...] the tonality, atonality, pitch of tinnitus is not relevant to the therapy" (question 12 of the interview)

Brilliant. Thank you.

Does length of time you've had it matter?

 

[GSC]

Does length of time you've had it matter?

That is something no one is sure about.

 

[Allan1967]

TMJ?

 

[KotaDomowa]

TMJ? Do you mean is that an exclusion criterion?

In the clinical trials, yes.

In sales, we do not know.

In general, we do not know who it will work for and who it does not.

 

[kelpiemsp]

TMJ? Do you mean is that an exclusion criterion?

In the clinical trials, yes.

In sales, we do not know.

In general, we do not know who it will work for and who it does not.

While TMJ/D was used as exclusion on paper, it's impossible to enforce this in real life. 33% of the population has what is considered by many, to be TMJ/D (disc displacement of the meniscus in the jaw). Undoubtedly, people with so called TMJ/D received treatment in the trial. I have TMJ/D, the treatment worked for me.

 

[Rafaa]

While TMJ/D was used as exclusion on paper, it's impossible to enforce this in real life. 33% of the population has what is considered by many, to be TMJ/D (disc displacement of the meniscus in the jaw). Undoubtedly, people with so called TMJ/D received treatment in the trial. I have TMJ/D, the treatment worked for me.

What's the best way to diagnose TMJ/D? I get fluid stuck in the ear, one of my tinnitus tones gets louder when I yawn / I feel my pulse when I open my jaw / I get some spasm of a blood vessel or nerve in the area. But I don't get any clicking, only a dull sore feeling from time to time.

 

[Jab4]

While TMJ/D was used as exclusion on paper, it's impossible to enforce this in real life. 33% of the population has what is considered by many, to be TMJ/D (disc displacement of the meniscus in the jaw). Undoubtedly, people with so called TMJ/D received treatment in the trial. I have TMJ/D, the treatment worked for me.

Where are they at with this Minnesota trial at the moment?

 

[kelpiemsp]

What's the best way to diagnose TMJ/D? I get fluid stuck in the ear, one of my tinnitus tones gets louder when I yawn / I feel my pulse when I open my jaw / I get some spasm of a blood vessel or nerve in the area. But I don't get any clicking, only a dull sore feeling from time to time.

TMJ/D is largely a psychological issue. If you think you have it, go see a pain psychologist ASAP. That was my point in saying 33% of the population has TMJ/D on an MRI, but very few are actually affected.

 

[GlennS]

But it's no excuse for their radio silence for 7 months.

There hasn't been any actual radio silence.

There have been 3 official mailings from Neuromod from their mailing list in the last 7 months.

12/19/2018
2/11/2019
5/8/2019

I get what you're saying. These aren't giving any concrete release dates, but they ARE communicating and the messages convey that they are moving towards a release ASAP. Releasing smiling executives circled around what looks like release-candidate packaging doesn't suggest this thing is some sort of vaporware. So cool your jets.

 

[Ricardo1991]

I intend to get this, for once in my sorry life this company isn't on the other side of the world (I'm an hour's flight time away) so however it gets released I'll do my best to get in there early on.

Same, I'm in the UK. Only problem is that I have no money! I've been trying to save up wherever I can but hopefully they can make payment plans haha.

 

[Heinrich_S7]

There hasn't been any actual radio silence.

There have been 3 official mailings from Neuromod from their mailing list in the last 7 months.

12/19/2018
2/11/2019
5/8/2019

I get what you're saying. These aren't giving any concrete release dates, but they ARE communicating and the messages convey that they are moving towards a release ASAP. Releasing smiling executives circled around what looks like release-candidate packaging doesn't suggest this thing is some sort of vaporware. So cool your jets.

When the device does come out, and if it does work, they'll be rich regardless.

If you ask me, all they needed was a better PR team. If this device is as good as Minnesota's or Dr. Susan Shore's methodology, then all of this will be irrelevant in the coming weeks/months and we will have either significantly reduced tinnitus or our tinnitus will be gone =)

To be quite frank, I'm far more concerned with the efficacy of the device than I am with the release date or their communication.

 

[Don Tinny]

There hasn't been any actual radio silence.

There have been 3 official mailings from Neuromod from their mailing list in the last 7 months.

12/19/2018
2/11/2019
5/8/2019

I subscribed twice but I never got any information. Could it be due to my country of residence?

 

[Ricardo1991]

To be quite frank, I'm far more concerned with the efficacy of the device than I am with the release date or their communication.

Exactly, me too. I don't have the money to spend on devices, etc. If it has a good success rate I will try and buy it somehow. Not sure how but I will try!

 

[Heinrich_S7]

Exactly, me too. I don't have the money to spend on devices, etc. If it has a good success rate I will try and buy it somehow. Not sure how but I will try!

I don't see why you can't either fax over your information, or have them get into contact with our local audiologists and teach them how to set it up.

Once it's set up to your audiogram, you're all set. I don't see why we can't just buy one from them and have them ship it here.

By the time you need a second visit, it'll probably be out in North America.

 

[PureNoise]

Thanks to Lenire I don't consider my tinnitus to be a permanent issue in my life. It may not wipe out my tinnitus completely but it would probably make it so low I'd be happy. I trust this is the real deal.

Then that will give me hope to live life to the fullest until a possibly better device is released by Minnesota or Michigan.

 

[Ricardo1991]

it'll probably be out in North America.

Yes, I agree. I am in the UK, I can make it over to Dublin easily but just thinking of prices. Hopefully the NHS can cover the device or they will have them here.

 

[Allan1967]

I don't see why you can't either fax over your information, or have them get into contact with our local audiologists and teach them how to set it up.

Once it's set up to your audiogram, you're all set. I don't see why we can't just buy one from them and have them ship it here.

By the time you need a second visit, it'll probably be out in North America.

It won't be as easy as that. There'll be a set process to follow and they won't deviate from it, otherwise they'll be running around like blue arsed flies trying to accommodate everyone's individual needs.

I imagine it will go like this:

1. You'll receive an email [assuming you signed up] announcing its release and what to do next.
2. You'll fill in a questionnaire, which will be reviewed and if you're suitable you'll be told.
3. If you are suitable, you'll get a list of providers or directly deal with Neuromod.
4. You'll secure your appointment, go for an audiogram/chat and if all is well you walk away with one.
5. You'll be £3500 lighter than when you walked in. I imagine they will have finance plans if you can't afford a one off payment.
6. You'll go back in X amount of time to see how it's going etc.

 

[Allan1967]

I subscribed twice but I never got any information. Could it be due to my country of residence?

No. I live an hour away by plane. I haven't received anything - at least not through the purple website.

 

[david c]

Yes, I agree. I am in the UK, I can make it over to Dublin easily but just thinking of prices. Hopefully the NHS can cover the device or they will have them here.

Unfortunately not. The NHS is very limited by funding constraints in terms of the drugs and devices it is able to support. In any case, for any drug or device to be approved for NHS use it has to be approved by NICE which is a long and complex process requiring data evidence from several clinical trials so if Lenire ever does get approved by NICE it won't be until quite some time in the future.

 

[AliceW]

@annV,

Do you have any other information about the release date?

Still June 24th?

Do you think the device will be launched only in Ireland first?

 

[annV]

Still June 24th?

Do you think the device will be launched only in Ireland first?

Date hasn't changed. They already showed how the retail packaging will look like. It will be available in Ireland and Germany from day 1.

 

[vermillion]

She advised me not to waste my money.

But she encouraged you to waste your money on TRT

 

[Tanni]

But she encouraged you to waste your money on TRT

It's NHS so it's free - but yes, she is still being paid I suppose. Just luckily not by me!

 

[Dizzyhead888]

Date hasn't changed. They already showed how the retail packaging will look like. It will be available in Ireland and Germany from day 1.

Where did you read June 24th?

 

[acute]

Where did you read June 24th?

Here

June 24 Monday is what I'm hearing. The source that has close ties to Neuromod knows they are aiming for that but it could be a week or two later. They are waiting for the confirmation of some regulatory red tape. They will update their lenire.ie website and Twitter immediately when you can start booking appointments.

Pricing wise I'm hearing just a notch under €4000 (which would mean no boob pics). They can charge this because of the two large clinical trials that none of the other tinnitus treatment devices have undergone.

Take with a grain of salt. My source is dependable but things can change.

 

[Ruse]

Strikes me as a little odd that this could be released later this month without any marketing in the build up.

Not that I'm complaining if it is!

 

[acute]

Strikes me as a little odd that this could be released later this month without any marketing in the build up.

Not that I'm complaining if it is!

Yeah I think the same

Do you guys think, with the information that we have, Lenire will help with static white noise-type tinnitus?