Q&A: Tinnitus Hub Meets Neuromod (Lenire)

[RCP1]

Pay up and ghost them so you can treat yourself for eternity

It did sound that they are not really decided on that yet since they didn't say a price. Maybe their pricing model will be more Netflixy.

If you pay thousands of euros you will of course be able to keep the device which intrinsically isn't worth much.

There's no way that they could charge those fees for a rental + people may want to keep using the device...

 

[RCP1]

I thought I remember him saying there was an improvement in hyperacusis as well. Maybe I am not remembering it right.

No, he said there was no improvement in LDL for Hyperacusis - just that the tinnitus levels in Hyperacusis patients improved twice as much as the rest...

 

[RCP1]

Great job @Markku and @Steve! Finally watched the whole thing.

Must say that by the Q&A I am positively surprised and will now sell all my things to be able to live in Ireland from now on to be close to where the action is.

Only thing I am missing is when will it be out

@Autumnly,
I have the same issue but I really would take the pain to get my hands on this unit.

If you need an Irish address to make the appointment and see the audiologist I can help with that... I don't think it'll be a problem.

 

[Jcb]

No they didn't say that - What they said was Catastrophic Tinnitus was not included in the trial as it would skew the results as people with Catastrophic Tinnitus are on meds + the effect would not be purely due to the device perhaps... Also people who have Catastrophic Tinnitus would be unlikely to get worse, only better, so it would again skew the results...

It's purely statistical and doesn't affect eligibility to use the device.

Yeah that makes sense. Cheers mate.

 

[TuxedoCat]

So will you be renting this and then have to return it after the 12 weeks or once you buy it's yours?

Unknown at this point, Jcb. Neuromod have been so involved with the clinical program they haven't yet decided many of the business aspects. -TC

 

[RCP1]

Good night - sleep well - help is finally on the way. The Irish cavalry is on the way!

 

[JohnAdams]

Why is that bookshelf so empty?

 

[Eric N]

Can someone please clarify the availability for people outside of Ireland?

Will I be able to travel from Canada and try this device as soon as it's released?

It is mentioned that you need to be under the care of an audiologist. I'm not sure what that means, is he talking about the audiologist that gives you a hearing test and all that?

 

[RCP1]

Why is that bookshelf so empty?

Don't start! Go to bed! Enough of the Neuromod bashing or I'll get you added to the blacklist and you'll never get one! Lol

 

[RCP1]

I think what I'd do is four 12 week sessions with a week in between... Four treatments in the year lol. 4 reductions.

After session 1 0.7T
After Session 2 0.49T
After Session 3 0.343T
After Session 4 0.24T

Effectively 1/4 of tinnitus remaining after 1 year...

 

[RCP1]

So much time went into this - I am going in now to donate $20 to Tinnitus Talk - If everyone does the same it'll give something back for the guys time... What you all think?

 

[OnceUponaTime]

Fantastic job!!! @Steve, @Markku and @Hazel how can we ever thank you enough for all you have done. Sending you much love and my respect.

Ok, so when the question was asked if people from other countries could go and buy the device in Ireland he did not say no. My understanding is, that he said, that people need to have a hearing test done and be under the care of an audiologist for the 12 month period.

I think (MHO) is that he cannot say yes for different reasons but kinda left it open for me to think that yes, I can have my husband go to Ireland and buy it and bring it here (NY) and have my audiologist set it up for me.

What do you guys think?

He said the device is simple to setup. Any audiologist can do it with no training.

Once he mentioned the FDA and the back and forth process that it might take with them, it kinda bummed me out a bit. Knowing how the FDA works it might take a long time for them to approve it here in the USA. (sigh)

But did he say if they are already in process with the FDA? Breaks my heart to think something that can help me, and many others, is so close and yet so far! Talk about patience.

He also did not mention a specific date on 2019.

Once...

 

[TuxedoCat]

I have multiple tone tinnitus and 40 dB hearing loss. I have no hyperacusis but some reactiveness. Can the treatment still work for me? On which patients did it not work?

The device is programmed to your hearing loss so the tone and type of tinnitus is not a determining factor.

We know from Neuromod that two thirds of patients with tinnitus had a clinically significant improvement. So the odds or chances of it working are in your favor.

My recollection is that Neuromod have not yet identified whether those for whom the device doesn't work can be identified ahead of time. But they would like to know that and are looking at the data for clues.

 

[Jack Straw]

This will hopefully get fast tracked because it is the first treatment for tinnitus.

Yes, I am saying LEVO and TRT is bullshit.....

 

[Eric N]

Ok, so when the question was asked if people from other countries could go and buy the device in Ireland he did not say no. My understanding is, that he said, that people need to have a hearing test done and be under the care of an audiologist for the 12 month period.

So if it is that easy to set up, what is the issue? Audiologists are all over the place in Canada. I am not sure what under the care of an audiologist means though? What do they need to do apart from giving a hearing test which I have countless of over the 6 years.

 

[RCP1]

Fantastic job!!! @Steve, @Markku and @Hazel how can we ever thank you enough for all you have done. Sending you much love and my respect.

Ok, so when the question was asked if people from other countries could go and buy the device in Ireland he did not say no. My understanding is, that he said, that people need to have a hearing test done and be under the care of an audiologist for the 12 month period.

I think (MHO) is that he cannot say yes for different reasons but kinda left it open for me to think that yes, I can have my husband go to Ireland and buy it and bring it here (NY) and have my audiologist set it up for me.

What do you guys think?

He said the device is simple to setup. Any audiologist can do it with no training.

Once he mentioned the FDA and the back and forth process that it might take with them, it kinda bummed me out a bit. Knowing how the FDA works it might take a long time for them to approve it here in the USA. (sigh)

But did he say if they are already in process with the FDA? Breaks my heart to think something that can help me, and many others, is so close and yet so far! Talk about patience.

He also did not mention a specific date on 2019.

Once...

My take on it was that as they have European approval, the members of European Union he was ok with, but as they don't have FDA approval he would be uncomfortable selling to a US citizen.

That was my take - It doesn't mean it can't happen - Money is money and these will be priced with a huge margin. When they start selling them we can make enquiries for you...

 

[RCP1]

This will hopefully get fast tracked because it is the first treatment for tinnitus.

Yes, I am saying LEVO and TRT is bullshit.....

Yep they're all; BS - All of them. The Tinnitus Clinic in London may as well shut their doors with their BS desentisisation treatment or whatever and their BS ACRN... Is Pawel Jastreboff still alive?

Fck em all!

 

[OnceUponaTime]

So if it is that easy to set up, what is the issue? Audiologists are all over the place in Canada. I am not sure what under the care of an audiologist means though? What do they need to do apart from giving a hearing test which I have countless of over the 6 years.

Not sure what that means either.

My take on it was that as they have European approval, the members of European Union he was ok with, but as they don't have FDA approval he would be uncomfortable selling to a US citizen.

That was my take - It doesn't mean it can't happen - Money is money and these will be priced with a huge margin. When they start selling them we can make enquiries for you...

Yes, I kinda understood that as well. I'd very much appreciate you inquiring about that. So happy for all you in Ireland that get to try these out soon. So exciting!

 

[TuxedoCat]

Once he mentioned the FDA and the back and forth process that it might take with them, it kinda bummed me out a bit. Knowing how the FDA works it might take a long time for them to approve it here in the USA. (sigh)

Generally speaking, FDA approval of a device in the US does not take as long as a drug approval. Having said that, FDA has become more rigorous in recent years when it comes to device approvals. Neuromod has a regulatory consultant who will help them thru the process.

As far as bringing a device into the US, one thing to ask about is how the device is powered. Electricity in Ireland is higher voltage than in the US so an adaptor would be needed to plug it into a US socket. If its battery powered, I don't know if Irish batteries are the same as US. Maybe @Steve knows. Plus you'll have to bring it thru customs- but depending on the cost you may or may not have to declare it. Remember, you don't want to mess with customs agents, they can make your life extremely unpleasant!

TC

 

[RCP1]

Not sure what that means either.

Yes, I kinda understood that as well. I'd very much appreciate you inquiring about that. So happy for all you in Ireland that get to try these out soon. So exciting!

Yep it is exciting - What I am delighted about is that the negativity has evaporated from the board now - He came across so well - so genuine, knowledgeable and well meaning that I don't think anyone could doubt the authenticity of the venture after watching the whole interview.

 

[RCP1]

Right really am going to bed now. Feeling very positive - Good night's sleep ahead hopefully.

Thanks to @Markku, @Steve and @Hazel for their huge efforts in bringing such a positive and informative interview to us.

The first genuine Tinnitus Treatment is now on the way - Truly groundbreaking.

As historic as Alex Honnold's Free Solo of El Cap ... Maybe even more so

Laters

 

[OnceUponaTime]

As far as bringing a device into the US, one thing to ask about is how the device is powered. Electricity in Ireland is higher voltage than in the US so an adaptor would be needed to plug it into a US socket. If its battery powered, I don't know if Irish batteries are the same as US. Maybe @Steve knows. Plus you'll have to bring it thru customs- but depending on the cost you may or may not have to declare it. Remember, you don't want to mess with customs agents, they can make your life extremely unpleasant!

Thank you TC!! Great points. Yes, they did not mention a set price yet.
@RCP1 Must be great to live in Ireland today!!!! Good nite!

Quite frankly, not sure that any of my questions were completely answered. Still up in the air. But it is all good.

I just want to order it online, put it on my ears and be done with it! Easier said than done...maybe in the future.
Once...

 

[TuxedoCat]

I just want to order it online, put it on my ears and be done with it! Easier said than done...maybe in the future.

Now, wouldn't that be nice! Take care, TC

 

[Manny]

I am a bit confused. It is mentioned that the most recent study contained three arms, with differential stimuli frequency and synchronicity comprising the difference between arms.

But, all three protocols appear to have been expected to provide some tinnitus benefit, and there seems to have been no purely placebo arm (i.e. a stimulus and frequency combination that is not expected to have any effect).

If so how can results be quantified to the exclusion of the placebo effect? Perhaps placebo accounts for the improvement quantity of the least effective arm (for example), across all arms?

 

[Jack Straw]

I am a bit confused. It is mentioned that the most recent study contained three arms, with differential stimuli frequency and synchronicity comprising the difference between arms.

But, all three protocols appear to have been expected to provide some tinnitus benefit, and there seems to have been no purely placebo arm (i.e. a stimulus and frequency combination that is not expected to have any effect).

If so how can results be quantified to the exclusion of the placebo effect? Perhaps placebo accounts for the improvement quantity of the least effective arm (for example), across all arms?

I am pretty sure they did do a placebo group.

 

[Pianist_Will]

Do we know what their definition of 'clinically meaningful reduction' is?

It's one of their primary end points and I suspect there might be a standard definition used across tinnitus research (e.g. a certain percentage reduction on THI). Would just be useful to clarify.

 

[Martin69]

@Markku, @Steve and @Hazel,

Thank you so much for all your efforts.

I really hope that the device works, although I stay skeptical (but that is me).
I am one of the very severe cases and take meds to cope. Hence I will only believe in this once real patients report success. I was wondering that they did not invite people who are TOP sufferers and see how it behaves for them - even though they could be excluded from the normal trial. Helping severe cases with their device would be the best marketing they could get.

Nevertheless, the video is excellent. And the questions are excellent. The CEO answered very openly. He was very professional.

Let's hope that one of the devices developed currently will provide relief for all of us.

@RCP1, I understand your optimism. But don't let it grow too high. The height of fall could be huge.

 

[Autumnly]

Only thing I am missing is when will it be out

Initially, they want to make the device available in Ireland in 2019. After that, they're looking at a number of other European countries in 2019 but they couldn't specify which countries yet. In parallel, they're pursuing FDA approval for the US. So it will be available in a limited capacity in 2019 in certain European countries.

 

[Pianist_Will]

Did he also address why the old MuteButton didn't work and why this one was different?

 

[EDDTEKK]

Dear @Markku, @Steve and @Hazel! Thanks so much for this action! I do appreciate it.
I hope this thing will be soon available in Germany, otherwise I need to travel to Ireland.

I am glad to hear that the tinnitus sound and duration don't affect the outcome and are not so relevant.