Neurosoft Bioelectronics: Implantable Electrodes to Treat Tinnitus

[Athens]

They don't know or can't prove where tinnitus originates from. They believe it is caused by a lack of auditory input which causes the brain (auditory cortex) to become hyperactive.

What is the most commonly held belief about the cause of hyperacusis? Is it damage to the cochlea causing the brain to turn up the volume because it is not getting the same input?

 

[Jerad]

They don't know or can't prove where tinnitus originates from. They believe it is caused by a lack of auditory input which causes the brain (auditory cortex) to become hyperactive.

Yeah, it's a shame. So the brain essentially tortures itself endlessly because it's obsessed with "possessing" that lost input. It's like a dog chasing its tail in endless circles. Crazy how the brain behaves that way.

In my case, it sucks extra hard, as I'm assuming I've lost some some hearing or something in the very high frequencies. I have this pulsating zap that feels like electricity shocking me. It's literally painful and random; happens several times a minute—often aggressively—and is impossible to habituate to, I fear, because of its randomness and the pain aspects of it. It's so high frequency and is not a sound you'd encounter in day-to-day life commonly, so it's dumb that the brain is obsessed with holding onto it.

Shame that the brain's gotta be that way. Why can't lost hearing equal less hearing? Literally. Which would mean silence. Nah, instead what's lost is replaced with a smorgasbord of hellish tones.

 

[Gb3]

What is the most commonly held belief about the cause of hyperacusis? Is it damage to the cochlea causing the brain to turn up the volume because it is not getting the same input?

No idea. I don't have hyperacusis. I haven't done any research on it.

 

[Ela Stefan]

Ugh, sounds invasive.

They already have these kinds of implants for chronic pain. They are placed under the skin of the skull and work 100 percent. I have talked with people who have had these implants placed when nothing else worked. I mean pain has enough hard mechanisms when it is centralized and all over the brain e.g., severe migraines.

Why in heaven's name can they not do this for tinnitus already?

 

[Tom_Tom]

Yeah, it's a shame. So the brain essentially tortures itself endlessly because it's obsessed with "possessing" that lost input. It's like a dog chasing its tail in endless circles. Crazy how the brain behaves that way.

In my case, it sucks extra hard, as I'm assuming I've lost some some hearing or something in the very high frequencies. I have this pulsating zap that feels like electricity shocking me. It's literally painful and random; happens several times a minute—often aggressively—and is impossible to habituate to, I fear, because of its randomness and the pain aspects of it. It's so high frequency and is not a sound you'd encounter in day-to-day life commonly, so it's dumb that the brain is obsessed with holding onto it.

Shame that the brain's gotta be that way. Why can't lost hearing equal less hearing? Literally. Which would mean silence. Nah, instead what's lost is replaced with a smorgasbord of hellish tones.

Hi Jerad,

I too have the electric shock. I haven't come across anyone else who has it before.

For me, it's like 2 ends of a nerve aren't quite touching correctly and every second some electricity jumps between them and zaps my inner ear causing pain. Sometimes it also causes the muscles around the ear to spasm. Along with it is a noise that can best be described as the sound of an electrical power plant.

I can also 'feel' the noise, as if there is a something psychically happening in my ear that is causing a constant buzzing that can be felt as well as heard.

Once in a while I will get a full body electric shock that goes from my ear, down my neck and into my fingers.

It's awful to say the least. Agree that hearing loss = silence would be heavenly.

Wishing you well & in solidarity.

 

[Tasty]

Yes, finally something to look forward to, not like other things e.g., hearing restoration. I mean, for me it would be useless since I don't have hearing loss associated tinnitus. And we don't know if hearing restoration would "reset" neural behaviors that came along with the hearing loss in these individuals.

I think Neurosoft's interventions are very valid and hugely important. If everything works and they can reduce/eliminate tinnitus, this will have a huge impact on society.

 

[Don Tinny]

So this also needs to take 10-20 years for us to know IF it works, right?

News and updates about this the next 3 years and then nothing. That's all.

 

[Ela Stefan]

The future of medicine is this anyway. The same way they put on the market pills, they will put on the market devices to change electric impulses in the nerves or cells to treat diseases. Meds will be replaced with energetic fields that treat by their power.

Yes, when... Time is the culprit here.

 

[EDDTEKK]

Dr. Hauptmann was part of the team of doctors in Jülich - ACR neurostimulation. He worked with Prof. Peter Tass closely. I wonder when they will start clinical trials. It's invasive - I doubt there will be many patients willing to try this.

 

[Tasty]

For high-risk medical devices, the EMA and FDA follow similar procedures.

Here's a summary of an article that explains how long it would take to get a medical device approved by the FDA

Summary
As with new drugs, the U.S. Food and Drug Administration's approval process is intended to provide consumers with assurance that, once it reaches the market place, a medical device is safe and effective in its intended use. Bringing a device to market takes an average of 3 to 7 years, compared with an average of 12 years for drugs. However, there are concerns that Food and Drug Administration processes may not be sufficient to meet the assurances of safety and efficacy as intended. This second part of a 2-part series reviews the basic steps in development and Food and Drug Administration approval of medical devices, and summarizes post-marketing processes for drugs and devices.

Link:
Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices

So this means we can expect this to be available in 2025 - 2029?

 

[addot]

What is the most commonly held belief about the cause of hyperacusis? Is it damage to the cochlea causing the brain to turn up the volume because it is not getting the same input?

There seems to be two big theories nowadays: an inner ear theory and a middle ear theory.

The inner ear theory says that type II afferents in the cochlea act as pain receptors. This is a relatively new discovery; for the longest time no one knew what these type II afferents did. You can think of these afferents as the channels by which your hair cells transmit information to the brain. These afferents carry painful signals to the brain in response to loud noise or damage to tissues in the inner ear.

The middle ear theory says that loud noise can cause the tensor tympani muscle (TTM) to become hyperactive. This triggers inflammation, which leads to many of the symptoms of pain hyperacusis (burning/stabbing pain; ear fullness; distorted or muffled hearing; etc). This causes the muscle to contract even more, and become even more inflamed, leading to a vicious cycle. At some point in the process the brain becomes involved, which leads to hyperacusis becoming a chronic. This is the paper that proposed this idea.

None of these theories have been conclusively proved yet, and many questions remain. For instance, there might be other muscles involved in the inflammatory cycle other than the TTM; it might also be possible that both theories are true, and explain different parts of the pathology of hyperacusis. The brain is also pretty clearly involved, but in ways that I (or perhaps the researchers?) don't really understand yet (from what I can gather, the brain can lead to an increase in central gain AND the centralization of pain that shifts hyperacusis from acute to chronic).

 

[Athens]

There seems to be two big theories nowadays: an inner ear theory and a middle ear theory.

The inner ear theory says that type II afferents in the cochlea act as pain receptors. This is a relatively new discovery; for the longest time no one knew what these type II afferents did. You can think of these afferents as the channels by which your hair cells transmit information to the brain. These afferents carry painful signals to the brain in response to loud noise or damage to tissues in the inner ear.

The middle ear theory says that loud noise can cause the tensor tympani muscle (TTM) to become hyperactive. This triggers inflammation, which leads to many of the symptoms of pain hyperacusis (burning/stabbing pain; ear fullness; distorted or muffled hearing; etc). This causes the muscle to contract even more, and become even more inflamed, leading to a vicious cycle. At some point in the process the brain becomes involved, which leads to hyperacusis becoming a chronic. This is the paper that proposed this idea.

None of these theories have been conclusively proved yet, and many questions remain. For instance, there might be other muscles involved in the inflammatory cycle other than the TTM; it might also be possible that both theories are true, and explain different parts of the pathology of hyperacusis. The brain is also pretty clearly involved, but in ways that I (or perhaps the researchers?) don't really understand yet (from what I can gather, the brain can lead to an increase in central gain AND the centralization of pain that shifts hyperacusis from acute to chronic).

I have had hyperacusis for almost two years. I fortunately experience very little to any pain. I just experience sounds as uncomfortably loud and annoying. I also experience tinnitus in one ear which seems to be more pronounced than last year. The paper that you attach discusses how anxiety can be involved and that reducing it can result in an improvement of symptoms. I saw an ENT recently who referenced that a return to my normal sleeping patterns would help with the hyperacusis. I developed hyperacusis and tinnitus after a few months of significant insomnia and stress. I am currently experiencing an improvement in my sleep and trying to move forward with my life and expose myself to normal levels of sound without using earplugs for commons everyday noise (even if it bothers me such as running water in the sink).

 

[Athens]

They don't know or can't prove where tinnitus originates from. They believe it is caused by a lack of auditory input which causes the brain (auditory cortex) to become hyperactive.

I saw an ENT recently who seemed to recommend hearing aids for tinnitus perhaps based on the idea that restoring my hearing loss at certain frequencies might result in the brain receiving the auditory input that it has lost. You do not read about many people who have tried hearing aids for this purpose, but I have read a few postings from people who seem to have had some success.

 

[Ela Stefan]

I have had hyperacusis for almost two years. I fortunately experience very little to any pain. I just experience sounds as uncomfortably loud and annoying. I also experience tinnitus in one ear which seems to be more pronounced than last year. The paper that you attach discusses how anxiety can be involved and that reducing it can result in an improvement of symptoms. I saw an ENT recently who referenced that a return to my normal sleeping patterns would help with the hyperacusis. I developed hyperacusis and tinnitus after a few months of significant insomnia and stress. I am currently experiencing an improvement in my sleep and trying to move forward with my life and expose myself to normal levels of sound without using earplugs for commons everyday noise (even if it bothers me such as running water in the sink).

But if you expose yourself to noises when your body is giving you signals (increase in tinnitus/hyperacusis), is that not a sign to stop? If you push through, it won't become worse?

 

[Joe Cuber]

I saw an ENT recently who seemed to recommend hearing aids for tinnitus perhaps based on the idea that restoring my hearing loss at certain frequencies might result in the brain receiving the auditory input that it has lost. You do not read about many people who have tried hearing aids for this purpose, but I have read a few postings from people who seem to have had some success.

I heard the same advice from several audiologists. I'm trying to get fitted for hearing aids since I have mild hearing loss. Once I do, I'll try them out and maybe post about my experience.

 

[AfroSnowman]

I saw an ENT recently who seemed to recommend hearing aids for tinnitus perhaps based on the idea that restoring my hearing loss at certain frequencies might result in the brain receiving the auditory input that it has lost. You do not read about many people who have tried hearing aids for this purpose, but I have read a few postings from people who seem to have had some success.

For the record I've tried hearing aids for that reason and they didn't do a lick of good.

 

[InfiniteLoop]

I heard the same advice from several audiologists. I'm trying to get fitted for hearing aids since I have mild hearing loss. Once I do, I'll try them out and maybe post about my experience.

Most hearing aids are only good up to 8 kHz. If your hearing loss is in the high frequencies (as is mine), hearing aids will be useless.

 

[Athens]

But if you expose yourself to noises when your body is giving you signals (increase in tinnitus/hyperacusis), is that not a sign to stop? If you push through, it won't become worse?

I can't say that there has been an increase in the symptoms since I tried this approach recently.

The tinnitus seems worse compared to last year, but I am not certain. I am not exposing myself to sounds above a certain limit. I wear earplugs when I play golf (at least when I hit the ball and then take them out). I think that there is value in sound exposure within careful limits. Otherwise, I may as well just stay in my room wearing earmuffs and never go out.

It has been almost two years now and fortunately, I do not experience any pain (just annoyance and discomfort). One person warned that sound exposure might lead to pain hyperacusis, but I am generally being careful.

 

[Athens]

I heard the same advice from several audiologists. I'm trying to get fitted for hearing aids since I have mild hearing loss. Once I do, I'll try them out and maybe post about my experience.

Yes, please let me know. I am concerned about the fact that I am already hearing sounds as too loud and hearing aids would amplify it even further. The ENT seemed to indicate that the hearing aids would be set to only amplify sounds at the frequency of my hearing loss.

 

[AfroSnowman]

Yes, please let me know. I am concerned about the fact that I am already hearing sounds as too loud and hearing aids would amplify it even further. The ENT seemed to indicate that the hearing aids would be set to only amplify sounds at the frequency of my hearing loss.

Yup that's how they work, they also cut out at any unsafe volume, so there is a limit to how loud they go.

 

[Ela Stefan]

Yup that's how they work, they also cut out at any unsafe volume, so there is a limit to how loud they go.

So if the environment is 85-90 dB, they will cut back the sound at 70 dB?

 

[AfroSnowman]

So if the environment is 85-90 dB, they will cut back the sound at 70 dB?

I mean I guess it gets set to the individual so maybe that cap varies a little if you have severe hearing loss at a frequency, but yes it cuts out at a level that won't damage your ears. Sometimes it is annoying if I am using it as earbud and want to crank it up louder to listen to music because it won't allow it.

 

[Ela Stefan]

I mean I guess it gets set to the individual so maybe that cap varies a little if you have severe hearing loss at a frequency, but yes it cuts out at a level that won't damage your ears. Sometimes it is annoying if I am using it as earbud and want to crank it up louder to listen to music because it won't allow it.

Yes, but I get spikes, for example, from A/C, driving a car, traffic, when more people talk around as they modulate their voices. I have normal hearing for my age, but some audiologists will say mild hearing loss at some frequencies.

If I get spikes from the above, would hearing aids help?

 

[AfroSnowman]

If I get spikes from the above, would hearing aids help?

I mean for me they really don't help at all. But hell, it's worth a try, right?

 

[Joe Cuber]

Most hearing aids are only good up to 8 kHz. If your hearing loss is in the high frequencies (as is mine), hearing aids will be useless.

I didn't know that @InfiniteLoop, thanks for pointing that out. My hearing loss is also in the high frequency but starts to drop to 20 dB hearing loss around 2 kHz and then goes down to almost 60 dB hearing loss at 10 kHz.

So if the environment is 85-90 dB, they will cut back the sound at 70 dB?

I'm getting fitted for behind-the-ear type hearing aids, so that the ear canal stays open for the lower pitches where my hearing is fine. So if the environment is 85-90 dB, my ear will still receive that. The hearing aid amplification can be programmed to not amplify pitches to an uncomfortable level for the pitches it amplifies. I believe they call this compression like @AfroSnowman is describing. So, in a normal environment, those pitches won't get amplified to an uncomfortable level.

In a loud environment, I'm not sure yet what the hearing aids will do. I'll have to ask.

 

[Christiaan]

Neurosoft is revolutionising the way we interface with neural tissue (Garth, 2022)

Neurosoft Bioelectronics, a spin-out company from EPFL, the Swiss Federal Institute of Technology in Lausanne, is laser focused on developing new implantable electrode technologies to interface with the nervous tissue. With over 9 years of neurotech expertise, research, and development, the team at Neurosoft has developed small, thin implantable electrodes that can both stretch, flex and reducing dramatically the foreign body reaction and scarring associated with traditional implantable devices.

These unique mechanical properties allow enhanced long-term performance, even in hard-to-reach areas such as the brain sulci and can reduce scar tissue formation around the electrodes. When implanted, these soft, thin, and flexible electrodes can both record and stimulate the brain, which Neurosoft believes may be able to help in indications such as tinnitus and epilepsy. Ultimately, the goal of Neurosoft is to leverage its technology and build fully implantable brain-computer interfaces to treat severe neurological disorders.

"Therapeutic outcomes from clinical neural implants are limited by their mechanical properties," explains Nicolas Vachicouras, Founder and CEO of Neurosoft Bioelectronics. "Their stiff and rigid designs present a mechanical mismatch compared to the soft and curved tissues they interface with, thereby constraining the physiological motion dynamics of the nervous system. At Neurosoft Bioelectronics, we are addressing this issue by engineering elasticity in thin film materials to manufacture implantable electrodes that are much softer and flexible, and that can seamlessly interface with the nervous system."

Vachicouras, always dreamt about the possibilities of biomedical engineering since he learned about the mechanisms of the retina at high school. To pursue this dream, Nicolas threw himself into studies of microelectronics at EPFL and in 2012 he joined the Laboratory for Soft Bioelectronic Interfaces, ran by Professor Stéphanie Lacour, where he worked on soft microelectronics for neural interfaces.

Inspired by the medical potential of these devices, he pursued various research projects in that field at EPFL and Harvard Medical School, and eventually started a PhD with Prof. Lacour on the translation of these technologies to the clinic. He initiated the start-up one year before the end of his PhD and in 2018 Ludovic Serex, a long-time classmate of Nicolas', joined the team to share his expertise in microtechnologies (specifically cleanroom microfabrication).

Neurosoft is a pioneering company in soft bioelectronic interfaces. Other companies competing in this area tend to use plastic-based technologies which can be flexible but, due to the intrinsic rigidity of these materials, must be manufactured very thin and can have very sharp edges. When creating an interface with the brain, sharp edges and stiff materials can cause damage to brain vessels and put a patient's safety at risk. Neurosoft Bioelectronics is one of the only companies in the world that are developing truly soft, stretchable, and flexible electrodes. This soft electrode technology can drastically reduce the risk of damaging neural structures, as the devices are 1000x softer and 2x thinner than current clinical electrodes.

Additionally, they are MRI compatible and can easily be folded in the sulci, allowing unprecedented access to typically unreachable brain regions. Finally, the electrode sites integrated on the devices can be 100x smaller in surface area, providing high resolution for both recording and stimulation.

Patients implanted with Neurosoft's electrodes should benefit from the lower risk of scarring and device failure, avoiding complications which can require costly surgical device removal and re-implantation. Furthermore, the high resolution recording performance of these electrodes improves the ability to detect disease-related electrical biomarkers such as for epilepsy. Moreover the high-resolution stimulation reduces the risk of off-target stimulation which can typically lead to unwanted side-effects.

Neurosoft Bioelectronics has a portfolio of 24 patents, including 11 granted in the USA, Europe and China, relating to its proprietary connector technology, its soft electrode technology and other specific embodiments of their technology. With more than nine years of research and development already completed, the level of expertise in this field will be hard for another company to emulate.

"Many of the technologies that are on the market today are all made with the same materials and techniques, regardless of what neurological target they have," says Vachicouras. "It's my core belief that having soft devices is a smarter way if you are interfacing with softer tissues, like the brain or spinal cord"

One of Neurosoft's main goals is to treat severe tinnitus using cortical neuromodulation. To ensure this goal is met, the company have partnered with one of the leading experts in the world, Professor de Ridder, who pioneered cortical neuromodulation for tinnitus, and showed that there is strong scientific evidence of neuromodulation efficacy when applied to tinnitus , but didn't pursue this further when he lacked the correct electrode materials for interfacing with neural tissue.

Other academic and research collaborations include partnerships with EPFL and Stéphanie Lacour's laboratory, where most of the company's infrastructure and manufacturing capabilities currently reside. The company also has a strong relationship with the Wyss Center, a private foundation that helps start-up companies in the field of neurotech and is known as one of the best neurotech incubators in Europe. Its soft electrode technology is also currently being tested with other clinical collaborators at Harvard Medical school and Massachusetts Eye and Ear Infirmary.

To ensure it can collect data on its materials and devices, Neurosoft Bioelectronics has also made strategic relationships with various hospitals and clinics, including Utrecht medical centre, which is one of the largest epilepsy centres in Europe, the Geneva University Hospital (HUG) and the Lausanne University Hospital (CHUV).

 

[Christiaan]

Neurosoft has also released a report of their upcoming technology. One thing that might peak our interest is the statement about their SOFT TINNIT device: clinical proof of concept of SOFT TINNIT is expected in late 2023.

More info: Neurosoft report is included in the attachment of this post.

 

[Ela Stefan]

Neurosoft has also released a report of their upcoming technology. One thing that might peak our interest is the statement about their SOFT TINNIT device: clinical proof of concept of SOFT TINNIT is expected in late 2023.

View attachment 50711

More info: Neurosoft report is included in the attachment of this post.

Tinnitus perception is associated with hyperactivity in the auditory cortex and altered functional connectivity in the brain due to peripheral deafferentation in chronic tinnitus. Peripheral deafferentation leads to thalamic deactivation which in turn disrupts normal thalamocortical interaction. So, impossible to accomplish. No re-organization possible. There is no medication that can do this either. The only way is by sound therapies that are largely unsuccessful for most.

So ultimately, how will this help the correct the maladaptative processes in the brain?

 

[hopes]

Thanks for sharing.

I'm not sure I understand the "late 2023" deadline here.

Is this deadline for when they will start to apply FDA for Phase 1/2/3 with their procedure?

What kind of surgery is needed here? Does this require two severe surgeries like DBS? Because I guess they have to drill a hole in the skull anyways to implement the electrodes and a "remote system" like they do in DBS.

 

[DimLeb]

So ultimately, how will this help the correct the maladaptative processes in the brain?

All this procedure, of how tinnitus happens that you're describing, is just theories as of now. Some of those might be true to some degree, but no one knows for sure without proper, more advanced, imaging and diagnostic tools.

Even if the implant calms the hyperactivity down a bit through stimulation, I believe it's a step towards the right direction. DBS has already shown some promising results in neurological disorders and tinnitus, so it really isn't impossible to reverse it somehow.