MuteButton

[annV]

Neuromod's accounts for year ended 30 September 2017

 

[dayma]

I know people are skeptical and there is nothing wrong with that. Based on the marketing Neuromod is doing it's probably safe to assume their latest test groups are showing some level of success though.

 

[dayma]

So I have been in contact with some folks in Ireland about the device. I will withhold the names.

I am being told that Neuromod themselves will be the one dispensing the device and not audiologists themselves. Meaning that you have to go directly to Neuromod and they will do the audiograms and tuning of the device.

Originally I thought the device would be handled like a hearing aide where audiologists and their practices basically act as a dispenser of the device.

I will keep people updated when I learn more, or if I learn more

 

[Paulmanlike]

I know people are skeptical and there is nothing wrong with that. Based on the marketing Neuromod is doing it's probably safe to assume their lastest test groups are showing some level of success though.

Don't forget about the speculated secured investment, people wouldn't be investing if they didn't believe it didn't work.

 

[hans799]

I am being told that Neuromod themselves will be the one dispensing the device and not audiologists themselves.

Great - the less middlemen there are, the better. Later on, they might need to introduce additional points of sale to be able to scale up, but this should help avoid friction caused by middlemen during the initial period.

 

[Paulmanlike]

So I have been in contact with some folks in Ireland about the device. I will withhold the names.

I am being told that Neuromod themselves will be the one dispensing the device and not audiologists themselves. Meaning that you have to go directly to Neuromod and they will do the audiograms and tuning of the device.

Originally I thought the device would be handled like a hearing aide where audiologists and their practices basically act as a dispenser of the device.

I will keep people updated when I learn more, or if I learn more

That sucks, this means you've got to head over to Ireland. More money. My audiologist said they found them interesting. I thought the device was ready and they were preparing for things like distribution for the device (through audiologists etc).

 

[Helheim]

So I have been in contact with some folks in Ireland about the device. I will withhold the names.

I am being told that Neuromod themselves will be the one dispensing the device and not audiologists themselves. Meaning that you have to go directly to Neuromod and they will do the audiograms and tuning of the device.

Originally I thought the device would be handled like a hearing aide where audiologists and their practices basically act as a dispenser of the device.

I will keep people updated when I learn more, or if I learn more

Shit. A lot of us won't be able to afford flying over there + the cost of seeing their audiologists, I'm not sure how I feel about this

 

[gorzakus]

That sucks, this means you've got to head over to Ireland. More money. My audiologist said they found them interesting. I thought the device was ready and they were preparing for things like distribution for the device (through audiologists etc).

If it works and they want to make money they will have to distribute it and train people to set it up in different countries which they surely will do.

 

[_Patrick_]

Relax people, they said their priority was to bring the product to the market as soon as possible for everyone. They will probably be dispensing the device at first to bring it to market ASAP, but no doubt they will send it over to distributors/partners and such.

The most important thing for me is that the product works. The rest is really secondary.

 

[PDodge]

Ya she's gonna be an expensive trip. Time to get another job :S

 

[annV]

I would take @dayma's information with a grain of salt, in the Q&A Ross O'Neill explicitly said to the contrary.

 

[dayma]

Yeah, I posted my comments NOT to freak people out. I don't think Neuromod dispensing the device themselves changes anything in the short-term. Heck, the contacts I have talking about it could be 100% wrong...

Either way I don't think that changes the price of the device.

 

[dayma]

I would take @dayma's information with a grain of salt, in the Q&A Ross O'Neill explicitly said to the contrary.

I am regurgitating what I am being told by professionals in the field in Ireland. It's also possible that Neuromod handles the initial rollouts and expands upon it to 3rd party practices. I dunno.

 

[_Patrick_]

I don't think any of that matters anyway, so let's focus on what's important, does this thing really work, when will it be out and what will be the price.

The first question being the most important one IMHO.

 

[Paulmanlike]

I don't think any of that matters anyway, so let's focus on what's important, does this thing really work, when will it be out and what will be the price.

The first question being the most important one IMHO.

Definitely. I will be waiting for testimonies to build up on here from long term members.

 

[AliceW]

@dayma,
And what do you think about the commercialization in other countries, how would they do that?

Would they open a « Neuromod office » in each country to release the device directly?

 

[_Patrick_]

Definitely. I will be waiting for testimonies to build up on here from long term members.

I hope you'll count on mine as a positive one!!!

 

[dayma]

@dayma,
And what do you think about the commercialization in other countries, how would they do that?

Would they open a « Neuromod office » in each country to release the device directly?

No clue. I think there are questions still outside of just the sufferers. This is not a bad thing. It's just a process for rollout.

 

[Greg Sacramento]

Their focus being subjective tinnitus and hyperacusis mostly caused from excessive noise seems to have some promise.

Other forms of tinnitus interconnecting as they expressed isn't included in their formal research equation.

1. Neurological tinnitus: Usually caused by a disorder, such as that primarily affects the brain's auditory functions.
2. Somatic tinnitus: Related to the sensory system.
3. Objective tinnitus: Caused by involuntary muscle contractions or vascular deformities. When the cause is treated, the tinnitus usually stops entirely. This is the only form of tinnitus per physical therapy that has the potential for a permanent fix. 3A-4. Pulsatile tinnitus: Change in blood flow, etc.

From my other post of tongue and brain pathway, there has been a lot of university study on some conditions by use of tongue electros with no success. Cranial nerve damage, motor neuron disease, clot damage to the vertebral nerves, damage to facial nerves, sarcoidosis, Guillian-Barre syndrome and multiple damage to the oral cavity and/or tongue. Physicals would have to be healthy so their product won't help me with 1-4 above. I hope it helps you.

 

[Marko Nakovski]

My primary concern is the price of the device. If they could put a price of 1000-1500 euros I would buy it the first day of its release, however this is unlikely ... It would be over 2000 euros for sure and that is a lot of money

 

[TimmyC]

Since I have been following this thread for a while, I would like to throw my 2 cents in to some things I have been reading.

1. In the Interview, Ross said they did these large clinical trials BECAUSE they are seeking FDA approval. For medical devices, especially new ones, they need large scale trials to prove efficacy. The first Neuromod device DID NOT FAIL, in fact, the 2 people on this thread who tried it, never came back to Tinnitus Talk, so to me that's good news (it probably worked for them). Clearly they stopped sales so that they could focus on the FDA process and building evidence for their device.

2. There is non stop worry about the somatic vs non-somatic tinnitus. I'm no expert, but let's break this down in a simple way. You get some kind of hearing damage (even very temporary like me), whether that be by drugs, acoustic trauma, flu, etc. Your brain freaks out and turns up the volume (also explains the hyperacusis in a lot of people). That constant freak out of neurons is the same for all of us, which is why we all hear stuff in our head. Calming down those neurons with modulation makes a ton of sense, and theoretically makes sense for all conditions of tinnitus. I read that something like 80% of people with tinnitus can modulate their tinnitus, so I'm sure many people in the trials could, it just wasn't the base tinnitus sound.

3. It wouldn't make sense for Neuromod to have to be the ones to do your audiogram, then track the device. I'm confident it will be like most treatments, and have a simple procedure for audiologists to follow, and they will be the ones administering the treatment. Relax, it will be available soon (most likely) from many audiologists and clinics.

4. For the 20% that it didn't work for, we must understand there are always a ton of reasons for that number that go beyond the tinnitus. They could have different conditions, they could have been too lax on their treatment (many people forget, or do not do it long enough, or skip days, etc), age (it's possible age could play a part, we just don't know), or it honestly didn't work for reasons unknown. Either way, 80% success is insanely good for any product, and given the fact that this kind of research is starting to grow very fast means they are onto something great.

I'm new to tinnitus (only 3 months of this hell so far), so I can see why so many are skeptical, considering they have had it for years. But from my knowledge so far, it sounds like this is going to be a great thing, and a start to great research on tinnitus. Many drugs and devices are coming through the pipeline, so there is good news ahead.

For now, I think greater awareness form the community here would benefit the cause a lot more. Try tweeting at famous people with tinnitus, donate to research (especially Dr. Rauschecker), raise awareness on social media, or simply let people around you know about it. I only stick to this forum because a lot of this site is very toxic, with people wallowing in the pain and reinforcing the struggle. There are great people on here, but some are so negative, it actually reinforces the suffering for a lot of people.

 

[Paulmanlike]

Their focus being subjective tinnitus and hyperacusis mostly caused from excessive noise seems to have some promise.

Other forms of tinnitus interconnecting as they expressed isn't included in their formal research equation.

1. Neurological tinnitus: Usually caused by a disorder, such as that primarily affects the brain's auditory functions.
2. Somatic tinnitus: Related to the sensory system.
3. Objective tinnitus: Caused by involuntary muscle contractions or vascular deformities. When the cause is treated, the tinnitus usually stops entirely. This is the only form of tinnitus per physical therapy that has the potential for a permanent fix. 3A-4. Pulsatile tinnitus: Change in blood flow, etc.

From my other post of tongue and brain pathway, there has been a lot of university study on some conditions by use of tongue electros with no success. Cranial nerve damage, motor neuron disease, clot damage to the vertebral nerves, damage to facial nerves, sarcoidosis, Guillian-Barre syndrome and multiple damage to the oral cavity and/or tongue. Physicals would have to be healthy so their product won't help me with 1-4 above. I hope it helps you.

In the interview Ross said it doesn't matter whether it's somatic or non-somatic. Also there was no mention of tinnitus being sound induced that the treatment will work for. It was hoewevee part of the exclusion criteria for objective tinnitus I recall.

. In the Interview, Ross said they did these large clinical trials BECAUSE they are seeking FDA approval. For medical devices, especially new ones, they need large scale trials to prove efficacy. The first Neuromod device DID NOT FAIL, in fact, the 2 people on this thread who tried it, never came back to Tinnitus Talk, so to me that's good news (it probably worked for them). Clearly they stopped sales so that they could focus on the FDA process and

Pretty sure reading on the FDA site all that's needed for clearance is that it won't harm you. Large trials like this are not necessarily required just for FDA approval.

 

[dayma]

Pretty sure reading on the FDA site all that's needed for clearance is that it won't harm you. Large trials like this are not necessarily required just for FDA approval.

That is my understanding also. This is not a pharmaceutical release where the rules are different.

Still does not make the FDA exactly speedy though.

 

[Greg Sacramento]

The muscles of the tongue does have a pathway for stimulating brain structures and inducing neuroplasticity, but I don't think it will make a difference for somatic, objective and pulsatile tinnitus. Reason being that they use most of the same pathways to the brainstem. Most with non subjective tinnitus have some input of vascular, nerve, artery, and muscle/ oral deformities within the same pathways.

The hypoglossal nerve innervates the tongue with signals from the brain. It's the 12th carnial nerve that emerges from the front of the medulla which is located at the bottom part of the brainstem in the pre olivary sulcus. It passes through the subarachnoid space and penetrates into the dura mater next to the hypoglossal canal (an opening in the occipital bone of the skull).

From here the nerve extends to a branch from the anterior ramus of C1 traveling close to the vagus nerve and spinal division of the accessory nerve.

Then it curves down from behind the vagus nerve, passing between the internal carotid artery and internal jugular vein slouching on the carotid sheath. From the hypoglossal nucleus (located in the brainstem) from where this nerve arises in form of various small rootlets, it creates a passage for itself through the hypoglossal canal and down to the neck and again passes over the tongue muscles. The hypoglossal nerves are located on the left as well as on the right side of the body.

Physical problems will most likely need to be repaired first.

I have already tried device stimulation for burning tongue. The doctor and I had a good discussion for the above (physical tinnitus) as he was part of the US army research team for tongue pathways and disease. Other studies from the University of Wisconsin (TCNC), Montreal Neurofeedback Center, Oregon University and Rush University have tried tongue stimulation for many conditions and all had signal blocking before reaching the brainstem when disease or structural problems existed in the oral/cranial pathways.

I'm inclined to think that the Michigan and Minnesota programs will benefit physical tinnitus more.

 

[Paulmanlike]

The muscles of the tongue does have a pathway for stimulating brain structures and inducing neuroplasticity, but I don't think it will make a difference for somatic, objective and pulsatile tinnitus. Reason being that they use most of the same pathways to the brainstem. Most with non subjective tinnitus have some input of vascular, nerve, artery, and muscle/ oral deformities within the same pathways.


Physical problems will most likely need to be repaired first.

I have already tried device stimulation for burning tongue. The doctor and I had a good discussion for the above (physical tinnitus) as he was part of the US army research team for tongue pathways and disease. Other studies from the University of Wisconsin (TCNC), Montreal Neurofeedback Center, Oregon University and Rush University have tried tongue stimulation for many conditions and all had signal blocking before reaching the brainstem when disease or structural problems existed in the oral/cranial pathways.

I'm inclined to think that the Michigan and Minnesota programs will benefit physical tinnitus more.

What do you go Greg, are you from a science background? As 90% of tinnitus is subjective, don't you think Neuromod will capture most of the tinnitus market?

 

[ruud1boy]

Neuromod's accounts for year ended 30 September 2017

Beat me to it - I was just going to go looking for these.

 

[TimmyC]

The muscles of the tongue does have a pathway for stimulating brain structures and inducing neuroplasticity, but I don't think it will make a difference for somatic, objective and pulsatile tinnitus. Reason being that they use most of the same pathways to the brainstem. Most with non subjective tinnitus have some input of vascular, nerve, artery, and muscle/ oral deformities within the same pathways.

Physical problems will most likely need to be repaired first.

I have already tried device stimulation for burning tongue. The doctor and I had a good discussion for the above (physical tinnitus) as he was part of the US army research team for tongue pathways and disease. Other studies from the University of Wisconsin (TCNC), Montreal Neurofeedback Center, Oregon University and Rush University have tried tongue stimulation for many conditions and all had signal blocking before reaching the brainstem when disease or structural problems existed in the oral/cranial pathways.

I'm inclined to think that the Michigan and Minnesota programs will benefit physical tinnitus more.

I have no doubt in my mind that the device will not work for Pulsatile and Objective Tinnitus because, as you stated, those are definitely physical problems.

However, the reason most of us do not agree about somatic is because somatic generally doesn't cause an issue, it can just have an effect on it. For example, my head tinnitus is constant and does not change. When I modulate, I'm adding a sound, not changing. I think the Neuromod device will repair that brain noise, but possibly not the tinnitus from my clenching. I do not think my tongue will "block" the electrical current.

But it will be interesting to see what happens, and I'm thinking because it is so similar to Susan Shore's device, I'm sure it will work for a lot of us.

 

[gorzakus]

The muscles of the tongue does have a pathway for stimulating brain structures and inducing neuroplasticity, but I don't think it will make a difference for somatic, objective and pulsatile tinnitus. Reason being that they use most of the same pathways to the brainstem. Most with non subjective tinnitus have some input of vascular, nerve, artery, and muscle/ oral deformities within the same pathways.


Physical problems will most likely need to be repaired first.

I have already tried device stimulation for burning tongue. The doctor and I had a good discussion for the above (physical tinnitus) as he was part of the US army research team for tongue pathways and disease. Other studies from the University of Wisconsin (TCNC), Montreal Neurofeedback Center, Oregon University and Rush University have tried tongue stimulation for many conditions and all had signal blocking before reaching the brainstem when disease or structural problems existed in the oral/cranial pathways.

I'm inclined to think that the Michigan and Minnesota programs will benefit physical tinnitus more.

Do you still have the burning mouth syndrome and did it develop around the same time as your tinnitus?

 

[Greg Sacramento]

@Paulmanlike

don't you think Neuromod will capture most of the tinnitus market?

Yes and it probably will be helpful for those with subjective tinnitus.

We once had a frequent flyer 20 years ago, who came to the ER once or twice a week. He would come in saying that his brain hurt. He also had oral facial muscular imbalance and tongue dysphagia. One of the nurses said why don't you get him some treatment for this. He was given outpatient tongue and facial stimulation treatment. He told us afterwards that his ring in his head is gone caused by Cal Expo fireworks.

 

[Greg Sacramento]

Do you still have the burning mouth syndrome and did it develop around the same time as your tinnitus?

Mine started a few months later.

My cause - some tongue rubbing against my palate from a defect in sensory peripheral neural mechanisms - oral nerve damage with severe pain from an implant procedure.