Neurosoft Bioelectronics: Implantable Electrodes to Treat Tinnitus

[ErikaS]

Hello! Here is what I can share from my discussion with Dr. Nicolas Gninenko:

• The goal/plan is to conduct a human trial on the SOFT TINNIT implant placement this time next year. Most likely small sample size.
  
  
• He confirmed that they are seeking FDA approval first to take product to launch in the USA. The UK would follow after.
  
  
• When asked about reactivity, hyperacusis, etc., he shared that each case is unique obviously. For example, given my case where I had a viral infection invade the inner ear and I have tinnitus and also very sound sensitive/reactive component, he wonders if the viral load may have greatly impacted nerve function and/or surrounding structures in the inner ear or the auditory nerve itself, therefore the reactivity could be nerve based, but this was just his thought. In saying that, and because their implant is strictly brain based, he basically said it may not have an effect on something that is inner ear nerve based. He said something like "this is just a hypothesis but perhaps the implant would significantly decrease or eliminate your tinnitus, but then you may still have sound sensitivity and inner ear sensations if they are not brain based."
  
  
• So, to summarize, there is no telling at this point how it would affect each individual's components other than tinnitus, but if it's not brain based, it's less likely to have an effect.
  
  
• I asked where is the likelihood of electrode placement, he said an area near the auditory cortex where they have found to be heavily linked to somatosensory input.
  
  
• He could only answer so much as they are still in early phase, but he said they have "the best" team on board and they are very optimistic and hopeful for the year ahead.
  
  
• He and others completed a trial of fMRI guided Neurofeedback for tinnitus and he said the results were very good and he very much enjoyed this trial. He shared that his expertise is brain imaging and figuring out how to use technology to manipulate/change the brain to improve the condition, with a focus on tinnitus. The fMRI allowed them to do this and results will show that; he said it should be published by January or sometime after. @Nick47, sorry, I missed your questions until after I spoke with him, so I didn't get to ask about specific sites that he found most common or best place to target, but he emailed me after to talk so I will ask that in a follow-up email.
  
  
• He himself has very mild tinnitus, but that's not what got him into this area. He said he kind of just fell into it and has really been intrigued by it since.
  
  
• Here is the link he shared with me of the trial they completed with fMRI and Neurofeedback.

 

[Nick47]

The UK would follow after.

Blimey something in blighty at last?

 

[DeanD]

Hello! Here is what I can share from my discussion with Dr. Nicolas Gninenko:

• The goal/plan is to conduct a human trial on the SOFT TINNIT implant placement this time next year. Most likely small sample size.
  
  
• He confirmed that they are seeking FDA approval first to take product to launch in the USA. The UK would follow after.
  
  
• When asked about reactivity, hyperacusis, etc., he shared that each case is unique obviously. For example, given my case where I had a viral infection invade the inner ear and I have tinnitus and also very sound sensitive/reactive component, he wonders if the viral load may have greatly impacted nerve function and/or surrounding structures in the inner ear or the auditory nerve itself, therefore the reactivity could be nerve based, but this was just his thought. In saying that, and because their implant is strictly brain based, he basically said it may not have an effect on something that is inner ear nerve based. He said something like "this is just a hypothesis but perhaps the implant would significantly decrease or eliminate your tinnitus, but then you may still have sound sensitivity and inner ear sensations if they are not brain based."
  
  
• So, to summarize, there is no telling at this point how it would affect each individual's components other than tinnitus, but if it's not brain based, it's less likely to have an effect.
  
  
• I asked where is the likelihood of electrode placement, he said an area near the auditory cortex where they have found to be heavily linked to somatosensory input.
  
  
• He could only answer so much as they are still in early phase, but he said they have "the best" team on board and they are very optimistic and hopeful for the year ahead.
  
  
• He and others completed a trial of fMRI guided Neurofeedback for tinnitus and he said the results were very good and he very much enjoyed this trial. He shared that his expertise is brain imaging and figuring out how to use technology to manipulate/change the brain to improve the condition, with a focus on tinnitus. The fMRI allowed them to do this and results will show that; he said it should be published by January or sometime after. @Nick47, sorry, I missed your questions until after I spoke with him, so I didn't get to ask about specific sites that he found most common or best place to target, but he emailed me after to talk so I will ask that in a follow-up email.
  
  
• He himself has very mild tinnitus, but that's not what got him into this area. He said he kind of just fell into it and has really been intrigued by it since.
  
  
• Here is the link he shared with me of the trial they completed with fMRI and Neurofeedback.

This is really interesting!

And, I have suspected my reactivity is due to nerve damage (my case caused by a botched microsuction), where sound irritates the damaged nerve triggering the reactivity.

 

[Joeseph Stope]

@ErikaS, @Markku, a Tinnitus Talk Podcast candidate?

@ErikaS, this is the guy you will be talking to.

It seems he has experience in tinnitus research.

You could ask him about:

• His findings on non-invasive stimulation. The best places to target?
• Does the hearing status of the patient change the type of surgery and expected outcome? For instance, I have profound hearing loss unilaterally.
• As we have both got sound reactive tinnitus, what's his thoughts on this. Nerve issues?

Your alertness and passion for the subject and your knowledge base is much appreciated.

It keeps me and I'm sure many others soldier-ing on.

 

[ErikaS]

I have suspected my reactivity is due to nerve damage (my case caused by a botched microsuction), where sound irritates the damaged nerve triggering the reactivity.

What gets me is I had no nerve damage in my left ear, yet my reactivity/sound sensitive tinnitus is in both ears. I have a pure tone sound in my left ear that gets louder by just the sound of putting my finger in my right ear. So nerve based but also maybe some brain? UGH I would do absolutely anything to rid ourselves of the sound sensitive aspect. We both would be able to carry on with annoying tinnitus that didn't react to noise.

 

[ploughna]

My thinking on this is that if the tinnitus level can be significantly reduced through this or whatever method, then the reactivity aspect should automatically become less because of the compression of the loudness range. E.g., imagine your tinnitus at its worst and that can be reduced to an acceptable level, then it doesn't matter how reactive it is anymore as your new range is now hopefully shifted from very low at its best to acceptable levels at its worst.

 

[DeanD]

What gets me is I had no nerve damage in my left ear, yet my reactivity/sound sensitive tinnitus is in both ears. I have a pure tone sound in my left ear that gets louder by just the sound of putting my finger in my right ear. So nerve based but also maybe some brain? UGH I would do absolutely anything to rid ourselves of the sound sensitive aspect. We both would be able to carry on with annoying tinnitus that didn't react to noise.

I do wonder if it's because all the nerves are linked, so the arm of one auditory nerve is connected to the other - and so causes a trail of damage or hypersensitivity across both ears. Although I'm not one that thinks TRT and noise maskers help with sound reactivity, I wonder if eventually the nerves heal, calm or settle, reducing the reactivity over the 24-48 months that is often shown in the success stories.

But yes, remove the reactivity, and our worlds become a whole heap easier - I hope through trial and error or just some random success somewhere we manage to rid of it!

 

[ErikaS]

I do wonder if it's because all the nerves are linked, so the arm of one auditory nerve is connected to the other - and so causes a trail of damage or hypersensitivity across both ears. Although I'm not one that thinks TRT and noise maskers help with sound reactivity, I wonder if eventually the nerves heal, calm or settle, reducing the reactivity over the 24-48 months that is often shown in the success stories.

But yes, remove the reactivity, and our worlds become a whole heap easier - I hope through trial and error or just some random success somewhere we manage to rid of it!

Then if it is nerve based, why did 300 mg of Gabapentin make me worse?! You just wish whatever it is, like nerve damage or sensitivity, that something for nerve pain/damage would help. At this point I want to try a straight Lidocaine injection to both ears to see if that would give temporary relief.

Anyway, the conversation was very good. I'm glad I talked to him. I'm also very impressed that human trials will be in a year.

 

[DeanD]

Then if it is nerve based, why did 300 mg of Gabapentin make me worse?!

Perhaps the Gabapentin wasn't strong enough or needed more time to do its magic, but in the meantime perhaps the brain was trying to make sense of the reduce hyperactivity and caused what may have been a temporary spike? But I totally get why you stopped - did it make any difference to the tinnitus itself?

I was prescribed Nortriptyline by my neurologist to calm the system. I haven't taken it yet - but maybe this should have been Gabapentin. For what Gabapentin does to the neurons, I'm so surprised everyone with tinnitus doesn't get better in some way from it.

It's amazing you managed to get the interview - so hopeful reading updates like these of real world attempts to tackle this thing!

 

[Jammer]

Well, just think for one moment: Switzerland population... not more than 10 million (I think). USA population... 330 million. Both are fairly good on the income per capita scale but the USA is really the prize. If they get FDA approval, it would easily open the door to other places like EU, UK etc.

But hey! implanting electrodes in the brain! Yay, I dunno! Would they have to surgically saw off a part of your skull to insert them? Has keyhole surgery come on enough to get the job done? That might be more palatable.

It's actually easier to get approval first in the EU. Most companies collect data via US doctors to submit to the FDA in a step towards US commercialization.

 

[Nick47]

Interview with CEO:

 

[ZFire]

he said the results were very good and he very much enjoyed this trial

Am I the only one, or does someone always make this claim with every new tinnitus treatment initiative?

The truth is, the absence of objective measurements for tinnitus means there's no dependable or reliable way to determine (with high confidence) whether potential treatments are actually improving tinnitus.

I'm guessing he has had to depend on self-reports and rating scale measures to evaluate the effectiveness of fMRI-guided Neurofeedback for tinnitus. There's a good chance that (like with many previous tinnitus treatments) this falls short of expectations then.

We really need to get our priorities in order...

 

[Cmspgran]

I do wonder if it's because all the nerves are linked, so the arm of one auditory nerve is connected to the other - and so causes a trail of damage or hypersensitivity across both ears. Although I'm not one that thinks TRT and noise maskers help with sound reactivity, I wonder if eventually the nerves heal, calm or settle, reducing the reactivity over the 24-48 months that is often shown in the success stories.

But yes, remove the reactivity, and our worlds become a whole heap easier - I hope through trial and error or just some random success somewhere we manage to rid of it!

With you on that. I'm in the same position as both of you and it's soul destroying. Six months in and I often sit and think is this going to be the same in two years? If so, how will I live with it.

About to start Gabapentin so wish me luck.

 

[DeanD]

With you on that. I'm in the same position as both of you and it's soul destroying. Six months in and I often sit and think is this going to be the same in two years? If so, how will I live with it.

About to start Gabapentin so wish me luck.

Fingers crossed for you with the Gabapentin!

Let us know how it goes!

 

[Nick47]

When are they planning to do human trials?

November 2024.

 

[ploughna]

About to start Gabapentin so wish me luck.

Do please report back on how you do with the Gabapentin - thanks!

 

[ErikaS]

Am I the only one, or does someone always make this claim with every new tinnitus treatment initiative?

The truth is, the absence of objective measurements for tinnitus means there's no dependable or reliable way to determine (with high confidence) whether potential treatments are actually improving tinnitus.

I'm guessing he has had to depend on self-reports and rating scale measures to evaluate the effectiveness of fMRI-guided Neurofeedback for tinnitus. There's a good chance that (like with many previous tinnitus treatments) this falls short of expectations then.

We really need to get our priorities in order...

I agree, I just also know we are never working with ideal scenarios, so I do appreciate those who, at least, care enough to run these type of clinical trials with something like fMRI results/data to help guide treatment that will, hopefully, give more chance to positive outcomes.

 

[ErikaS]

Interview with CEO:

Thanks for sharing this @Nick47. Interesting that they did the epilepsy study in Texas. I didn't even think to ask where the tinnitus study would possibly take place, I just assumed over in Switzerland, but I wonder if it will be in USA too?

 

[Nick47]

About to start Gabapentin so wish me luck.

Please do report back. On the Gabapentin thread under Treatments though.

 

[UKBloke]

I'd be a lot more excited about this tech if they trialled it on schizophrenia patients as well as epilepsy.

 

[Joeseph Stope]

I'd be a lot more excited about this tech if they trialled it on schizophrenia patients as well as epilepsy.

I've noticed in the scientific literature, which I mostly can't follow, a lot of people have noted some similarity between epilepsy and tinnitus. Schizophrenia seems to be a broad umbrella term for another sense of reality. Mental rather than physiological I would have thought.

 

[UKBloke]

I've noticed in the scientific literature, which I mostly can't follow, a lot of people have noted some similarity between epilepsy and tinnitus. Schizophrenia seems to be a broad umbrella term for another sense of reality. Mental rather than physiological I would have thought.

What I find intriguing about schizophrenia is its similarity to tinnitus where auditory hallucinations are concerned. It seems to me that related (albeit dysfunctional) mechanisms that create or allow these hallucinations to seep over into conscious perception may also underlie tinnitus generation.

I've come to believe these mechanisms are actually gating systems and that many of them operate within the various unconscious processing centres in the brain - keeping stuff ordered and in its place. But in individuals with tinnitus (and possibly schizophrenia too) specific gates are broken (perhaps even from birth) with the resultant "noise" eventually seeping across the defunct barrier and into our conscious perception.

It gets me down when I watch interviews (like the one with the CEO chap a few posts above this one) where researchers constantly talk about the heterogeneity of tinnitus - viral, Meniere's, loud noise exposure etc etc, and then go on to state that treatments therefore will probably be different.

This is dogmatic and I think they're complicating things. I believe tinnitus is just tinnitus; the triggers may vary, however, it is the underlying pre-disposition with a faulty gating system ultimately responsible for the perception of the noise. Fix that and you fix tinnitus.

If researchers were prepared to take a punt on a universal gating model of tinnitus (ala Rauschecker's "there has to be something else going on upstream of the cochlea") and use all of the facilities available to them (including AI) to search for underlying differences in the physical construction of the gating systems in the 15% of the world's population that suffer with this condition, I believe they would stand a much better chance of homing in on the root cause.

Instead they appear to just keep treading the same ground chucking mud at the problem in the hope that eventually some of it will stick. In my view, unless they fundamentally change their thinking, this situation is just going to go round and around.

 

[ZFire]

I agree, I just also know we are never working with ideal scenarios, so I do appreciate those who, at least, care enough to run these type of clinical trials with something like fMRI results/data to help guide treatment that will, hopefully, give more chance to positive outcomes.

I can see where you're coming from. If my previous post came across as if I'm diminishing hope, I apologize. That wasn't really my intention, certainly not towards you. I've just been frustrated with the way things are currently in the field of tinnitus research.

 

[Nick47]

3 to 7 years seem really optimistic in the last case imo.

In the interview posted a month ago they said 4-5 years. I'm betting 2028.

 

[Nick47]

A bit about Neurosoft in the media:

• They have applied to the FDA to use in epilepsy and expect it commercially available in about a year for this indication. In epilepsy it is implanted temporarily to read seizure activity and then removed.
  
  
• Tinnitus trial to start in 12-18 months. This will be a permanent implant. It will identify hyperactive neurons and use electrical signals to reduce the activity in the auditory cortex.

→ Neurosoft: This Startup Is an Elon Musk Rival in the Making

 

[ErikaS]

A bit about Neurosoft in the media:

• They have applied to the FDA to use in epilepsy and expect it commercially available in about a year for this indication. In epilepsy it is implanted temporarily to read seizure activity and then removed.
  
  
• Tinnitus trial to start in 12-18 months. This will be a permanent implant. It will identify hyperactive neurons and use electrical signals to reduce the activity in the auditory cortex.

→ Neurosoft: This Startup Is an Elon Musk Rival in the Making

I wish them the best success because if this makes it, this will be one of the biggest game changers and potential "cures" in my opinion.