Member- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
MuteButton
- Thread starter Jim
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Yeah, they said that the frequency of your tinnitus doesn't matter. Which is nice for those of us with tinnitus outside the "normal" hearing range.
- Dec 19, 2018
- 108
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- ETD possibly, or neck and jaw, or maybe anxiety?
The only thing they measure is your hearing, so you get the clearest, best sound from the device. The tinnitus frequency, and tone, and all that doesn't matter. They are pinpointing the excessive neural activity. All the sound does is force your brain to activate the auditory cortex in a specific way, and the tongue stimulation helps drive the plasticity of that activity.
Like someone said here already, think of it like this. There's a drum line, playing in unison, then, from the rafters, a person starts banging a drum. Over time the drumline will get out of sync, and stop playing the sound.
The reason I think this will work with everyone (at least lowering it) is that it forces brain plasticity to decrease neural activity (at least in the DCN).
You have to factor in the context of what they're saying. That's where the confusion is because there's a disconnect between who they think this device can help (marketing-speak) and the filter criteria they've been using on test-subjects.
IMHO, because of the MuteButton debacle, I think they went overboard on the filter criteria on the last trial. I also seriously doubt they even enforced it that strictly on that last trial as the vast majority of tinnitus sufferers have high frequency ringing above their cutoff whether they're able to identify those tones or not.
- Dec 19, 2018
- 108
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- ETD possibly, or neck and jaw, or maybe anxiety?
Also, another thing that makes this device promising is who has joined Neuromod. Hubert Lim, Richard S. Tyler (big deal), Berthold Langguth, and Deborah Hall are all major players in this field (at least from what I gathered). ACRN, Neuromonics, and all of these other companies from before couldn't get any attention from the big tinnitus leaders. So this has to be good news right? What do you think @hans799?
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
That's certainly a reason to be optimistic. Hubert Lim's getting a pair of my knickers in the post if it works. Worn ones.
From what I understand there is no established averages for frequencies above 8 kHz, so for example to know if you have hearing loss above 8 kHz you would need to test against yourself, simply having say 5 dB @16 kHz does not mean much if you don't have a baseline to compare it to from a previous audiogram you have taken.
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
........Hubert Lim just quit and moved far far away where no postal service can ever find him.
Deborah Hall was part of ACRN (https://www.frontiersin.org/articles/10.3389/fpsyg.2017.01893/full) but generally I think and hope you're right...
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Regarding the TENT-A2 study, how far is that along? When asked in the interview he said the results won't be with us for another 12 months??
https://clinicaltrials.gov/ct2/show/NCT03530306
Updates can be seen here. Still ongoing I guess. Study completion date set to be Sept 19 and I think they often go beyond estimated completion.
- Dec 19, 2018
- 108
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- ETD possibly, or neck and jaw, or maybe anxiety?
I believe TENT-A is in peer review currently, and TENT-A2 is currently in the 12 month follow up (finishing probably in the fall I assume). Either way, it won't affect the launch date from my understanding.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Yes after a bit of digging it is the 392 patient TENT-A1 that is in peer review.
TENT-A2 is still ongoing, that's why we won't see results of that for another 12 months.
https://clinicaltrials.gov/ProvidedDocs/06/NCT03530306/Prot_SAP_000.pdf
There is the link for the A2. It is another follow up to confirm the safety and efficacy of TENT-A1 as you all know new tinnitus treatments are doubted. This is good because it shows Neuromod are serious at persuading the scientific community that there treatment works.
They are also exploring other factors as mentioned in the link that can further be explored to improve efficacy etc (use of different arms).
This is all very exciting, I just wish Neuromod will give a release date now leaving patients to decide for themselves to proceed based on the TENT-A1 study results once it is peer reviewed.
Of course we are all impatient when a potential new treatment is emerging that could reduce the phantom noises we all hear in our heads, but we've got no choice but to wait unfortunately.
Another thing I've picked up on is that you won't meet criteria for hearing loss >40 dB up to the 1 kHz range and hearing loss in the >80 dB range between 2-8 kHz. An audiogram picked up that I have 30 dB loss in the 6 kHz range (will get retested next week as I have wax stuck on my middle drum) but this won't exclude me anyway even if it's sensory hearing loss.
But what I'm curious about what if one has >80 dB loss above the 8 kHz range that nobody seems to test? Would that exclude you then?
TENT-A2 is still ongoing, that's why we won't see results of that for another 12 months.
https://clinicaltrials.gov/ProvidedDocs/06/NCT03530306/Prot_SAP_000.pdf
There is the link for the A2. It is another follow up to confirm the safety and efficacy of TENT-A1 as you all know new tinnitus treatments are doubted. This is good because it shows Neuromod are serious at persuading the scientific community that there treatment works.
They are also exploring other factors as mentioned in the link that can further be explored to improve efficacy etc (use of different arms).
This is all very exciting, I just wish Neuromod will give a release date now leaving patients to decide for themselves to proceed based on the TENT-A1 study results once it is peer reviewed.
Of course we are all impatient when a potential new treatment is emerging that could reduce the phantom noises we all hear in our heads, but we've got no choice but to wait unfortunately.
Another thing I've picked up on is that you won't meet criteria for hearing loss >40 dB up to the 1 kHz range and hearing loss in the >80 dB range between 2-8 kHz. An audiogram picked up that I have 30 dB loss in the 6 kHz range (will get retested next week as I have wax stuck on my middle drum) but this won't exclude me anyway even if it's sensory hearing loss.
But what I'm curious about what if one has >80 dB loss above the 8 kHz range that nobody seems to test? Would that exclude you then?
Yeah that's how I understand it too. I'm hoping they're launching early 2019 because they have trust in their product, not for less... charitable reasons.
https://clinicaltrials.gov/ct2/show/NCT03530306
I edited my post a few minutes after posting because I mixed it up with TENT-A1. TENT-A2 seems ongoing yes and it's the TENT-A1 that is in peer review.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
That is correct.
If the release date comes before the peer review is published, who's going to buy it before then? Risky.
I believe that's pretty normal for medical devices. In the EU you don't need to do a big nice clinical trial before using it on people. It's far too lax and many have campaigned for the rules to be tightened. However this is more relevant for medical devices that are implanted within the body because the potential for irreversible severe complications is higher. For a device like this in theory one might imagine the risks are not so high.
However the Neuromod guy did discuss some patients worsening during the trial in the Q and A.
- Oct 17, 2017
- 642
- Tinnitus Since
- 2005
- Cause of Tinnitus
- unknown - possibly hereditary
I believe @Paulmanlike referred to the financial risk. The device won't come cheap and we have already been ripped off enough times.
Alex Matyjasek
Member
There's one thing that's getting me confused.
Let's say I haven't got hearing loss but my tinnitus frequency is above 8 kHz (I'd say mine is between 11 - 12 kHz), does this mean i'm not eligible for treatment? I know you answered me but not sure if I understood completely.
Let's say I haven't got hearing loss but my tinnitus frequency is above 8 kHz (I'd say mine is between 11 - 12 kHz), does this mean i'm not eligible for treatment? I know you answered me but not sure if I understood completely.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Myself included, it will be upwards of €2,500 for a device that may not do anything for you and if you buy it before the peer review is published you won't have access on what might to expect.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Because a standard audiogram does not go beyond 8 kHz, possibly, if you have tinnitus you may probably have hearing loss not detectable in the standard audiogram test.
As mentioned they included people up to 80 dB of loss from 2-8 kHz in their trial, so that's a positive right there as 80 dB is quite a bit of a loss.
Can you still hear 11-12 kHz on a stimulator? If so, I suspect this treatment will work for you as you probably haven't lost all dB in that frequency.
He also mentions tonality, intonality doesn't matter.
They are not basing this treatment on your tinnitus frequency, rather they are tailoring to your hearing profile so the right frequencies all get enough stimulation from the audio part.
That being said, it may not be suitable product for somebody who has severe/profound hearing loss, however who knows where this treatment will go, didn't they mention about further investigating it into hearing aids for example so those with severe loss can also get relief?
Only time will tell where this technology is going to go, we only have the information that's available to use. Bimodal neuromodulation may be the treatment that has much been in demand.
If this technology takes off I would definitely look at how to invest in them as well as being a customer, you don't get talks of €24 million in investment for shite. The investors must have seen some pretty convincing data.
So is Neuromod its own small startup company trying to treat tinnitus or is it part of a larger conglomeration of pharmaceutical products companies?
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
It's a small company founded by Dr. Ross O'Neill that is commercialising work from Universities.
Some points to consider:
- They have performed some of the largest clinical trials of high quality in tinnitus to date.
- They have some of the leading worldwide experts in tinnitus on board.
- There is growing evidence of bimodal neuromodulation being potential for effective tinnitus treatment that actually reduces it (or even reverses it in some cases)
- They are in talks of securing €24 million in investment although nothing has been confirmed.
- They have done something not usually done in tinnitus past - large clinical trials, peer review process etc. Something that has historically lacked and blocked pathway towards a cure.
- They are open and transparent for both scientists and patients.
- They are further along in commercialising a treatment than Susan Shore.
- They aren't a group of sales people looking for a quick buck, the way they have gone about this has been right for both a patient viewpoint and a business viewpoint.
It looks possible, that the first ever treatment that actually reduces or alleviates tinnitus could be nearer than we think.
IMHO, this treatment could be the mainstream treatment for tinnitus - helping millions. This will generate strong profits and Neuromod will be the main player with the guys on board there. The next big thing that will come after will be hearing loss restoration that will be after 2023.
No wonder this thread is long, it is definitely exciting that we are a step closer to curing/treating tinnitus.
Now for the criticisms:
- If history repeats itself, this could all lead to much hype and neuromodulation not helping many. There are millions of us worldwide and so far they have got results from almost 600 people.
- Tinnitus is a very subjective condition. You'll find people who swear that LLLT, Ginkgo biloba, etc. helped them. The truth is the placebo effect is more powerful than anything.
- Tinnitus could be a lot more complex and as of today, there is no definite answer to exactly where it generates from. It is a theory. However, I will add that many psychiatric conditions are based on theory and how the drugs work are still theory.
- There was much hype with ACRN a few years back on Tinnitus Talk, who involved the same professor, yet find me 10 testimonials where this helped them. Also, not many people with tinnitus have heard of ACRN or DeSyncra, if it was that good, believe me, it would be headline news. It isn't.
I hope you are all cautiously positive.
I've had tinnitus for so long, if this treatment helps me, I'm sending Dr. Ross O'Neill a box of chocolates with a picture of me in my leopard skin thongs to say thank you.
- Aug 21, 2014
- 5,049
- Tinnitus Since
- 1999
- Cause of Tinnitus
- karma
- Aug 21, 2014
- 5,049
- Tinnitus Since
- 1999
- Cause of Tinnitus
- karma
In the video they did with Steve they mentioned that their early funding came from a few rich benefactors with tinnitus, but that the funding required for their larger trials was much more extensive, and so some VC firm or other is involved.
I wouldn't read much into that besides "VC firm thinks Neuromod has 1 in 20 chance of doing well", since the VC model is to lose money on 95% of things, but make so much money on the other 5% that it doesn't matter.
source: worked in VC backed company for 4 years before we got acquired by giant multinational.
- Aug 21, 2014
- 5,049
- Tinnitus Since
- 1999
- Cause of Tinnitus
- karma
I'm not sure what you're asking?
In the video Steve did with Neuromod, the Neuromod exec made it pretty clear that venture funding has a lot to do with how far they've gotten. What are you confused about / what are you asking specifically?
My other comment was just to indicate that I don't think the status of this project as VC backed, says much one way or the other about how well it will work.
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