Q&A: Tinnitus Hub Meets Neuromod (Lenire)

We should probably try to keep it to one thread as well.

 

I feel you, it’s frustrating. People are excited of a new treatment that has been in development for years. It will be released though this year, and hopefully there will be some great media attention to it providing the evidence base builds up for it.

 

Sorry if I missed this, but is the transcript published yet?

 

Indeed. This may also lead to a snowball effect. Perhaps Minnesota and Susan Shore will release their Bi'Modal devices sooner after they see what a success this device was.

 

I've seen somewhere that their studies finish in February.

Does this mean that after this we can expect the launch of the device very soon?

 

Yes. In Ireland and Europe, USA will take another year I imagine.

 

I was wondering if there is any possible interference involved in using this device before getting a drug in your body that Frequency Therapeutics is working on?

If neuroplasticity is involved in the principal of the Neuromod device and if what Frequency Therapeutics is working on (drug FX-322) will be successful, wouldn't the outcome of the usage of the Neuromod device shut down the paths for the FX-322 drug in cases where people have hearing loss?

Are they aware of each other?

 

FX-322 is first and foremost for hearing loss.

Neuromod is for tinnitus.

Neuromod if successful won’t have any implication for FX-322 as they are targeting 2 separate issues.

They will probably be aware of each other but Neuromod is not in competition with them - FX-322 is not even a treatment yet (if ever).

Neuromod's competitors are the hearing aid manufacturers (built in masking devices, CBT therapies to manage the noise etc).

 

What I mean was if our brain is trying to fill the empty frequencies (due to a hearing loss) with the noise (tinnitus) and if I used Neuromod and it lowered down my tinnitus by modifying the paths or something wouldn't it be a problem if later if I had the FX-322 and it worked as well and got my hair cells back (etc.)?

The path would be modified already by using the Neuromod device and if the cells grow again (by using FX-322), how the brain would know it and RE-path it back in place?

I hope I'm clear in my thinking sorry if not.

 

I had this question too. Does a successful neuromodulatory tinnitus treatment "plug up" the missing hearing pathways, thus effectively blocking the positive effect of any subsequent aural hearing regeneration?

My intuition tells me that if the hearing is regenerated at the peripheral (aural) level, it will gradually reintegrate neurally. Of course, my intuition is not worth much in this sort of thing. For some reason I'm not overly concerned about this though.

 

Of course, the Neuromod stuff we're talking about comes in 2020 or 2021 or later, and Frequency Therapeutics much much later in time but I wouldn't want to be in a situation where I lowered or got rid of the tinnitus by using Neuromod (great!) and then to hear "Oh the FX-322 won't work now for you because you've neuroplasticied the paths by the Neuromod device. Sorry".

That's why I wonder if these two companies are aware of each other and their methods -- not because of the competition. Just hypothetically speaking.

 

Q1/2019 for Neuromod is supposedly the timeline.

 

Since FX-322 has nothing to do with tinnitus, you should be ok.

 

They said on Twitter they would submit a study for peer review in early 2019. This does not mean the study will be published soon, necessarily, peer review can take a while. But they don't need to wait for the study to be published before releasing the device under current EU rules, as I understand it. They gave @Markku an update which is earlier in the thread if you look, they said to him - "As you know we are still in the process of completing TENT-A2 12 month follow up and are finalising the publication of TENT-A1 results."

 

That's a stretch...

 

Oh? Can you show me some of their literature even discussing tinnitus?

 

I believe @kelpiemsp is right. These products do not overlap. One targets and is injected into the ear. The bimodal stimulation has a completely diffetent target. Tinnitus is an afterthought for Frequency Therapeutics. If FX-322 happens to help with tinnitus then that’s a bonus and additional market for them.

 

Probably not. But hearing loss causes tinnitus. Regaining our hearing could thus alleviate it. It is plain logic IMO. Agreed nothing is proven yet, as far as we know. But it has the potential to have everything to do with tinnitus. So to say there is no correlation, I think is a stretch.

BTW, you will find tons of literature discussing this in the Frequency Therapeutics thread

 

@Markku Thank you for the update.
Good news.

 

Off label use is different, right? So the poster's initial question was whether one treatment would/could disqualify you from the other. I'm saying that since they are entirely different in their scope, it should not be a problem. The Frequency Therapeutics thread has tons of "stuff" but it very quickly deviated away from anything approaching peer reviewed literature.

 

It shouldn't disqualify you since what Neuromod is basically doing is fixing the neurons from firing in unison and creating tinnitus sound.

A person who has no tinnitus but has hearing loss, does not have this issue so if Frequency Therapeutics works for a person without faulty neuron signaling. it should logically work for a person who got alleviation from Neuromod.

I would say chance of Frequency Therapeutics not working for tinnitus is bigger without getting rid of neurons firing faulty than with.

 

Chances are it will help but I have often thought that even if you get the hearing loss sorted out (and it is the main issue) you may still need to give tinnitus a bit of a nudge to get it out of the brain.

 

I think tinnitus in most cases is caused by sudden (in short time) hearing loss and brain just doesn't have time to adapt itself.

I probably had some hearing loss accumulating over the years, but tinnitus didn't show itself until I suddenly lost a bit of hearing in my left ear.

And now even when hearing is restored (at least on audiogram) tinnitus barely got quieter. Even if you account for synapse loss my hearing is definitely much better. I regained 25 dB according to multiple audiograms, yet tinnitus is blasting.

I'm pretty sure that something got stuck in my brain and needs fixing.

 

Hi,

Can someone please tell me in a nutshell what's up with Neuromod?

 

How do you think that happened?

 

Is there any possibility that all this ends in nothing? I hope not.

 

Yes. Wouldn’t be the first time, the tinnitus community should be used to disappointments by now.

 

They see our money as already safely in their account so why rush to do anything. It’s not like we’re going to get fed up waiting and buy something else.

 

TENT-A1 is going through peer review before the results are published. This can take between 3-6 months (positive results according to Neuromod).

TENT-A2 is ongoing and we won’t see these results peer reviewed for another 12 months or so. This 192 patient is to confirm the safety and efficacy and further improve patient sub-types that will benefit from treatment, explore different arms for efficacy etc.

Release date is the first quarter of this year however there is that element of risk before buying it that you won’t have access to the papers. It depends how desperate or impatient you are.

To wrap up, bimodal neuromodulation is promising as a new treatment that addresses the tinnitus rather than just focus on the emotional aspects of dealing with it.

 

1) TENT-A1 and TENT-A2 are clinical trials I suppose?

2) Can you please explain shortly what bimodal neuromodulation is?