MuteButton
- Thread starter Jim
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Even if we assume this is true, the low end of the worldwide percentage of sufferers is 10%. So even if only 1/1000 will buy it, then it still makes $1.5b.
We live in a noisy world. With an aging population and the modern increase in personal electronics they will find new customers everyday. Having arguably the first device to reduce tinnitus volume through something other than mind games is a license to print money. It's on them to make it widely accessible to the masses. It's a Field of Dreams moment. If you build it, they will come.
Well, I like to think differently. If they can get a good advertising campaign going even people without tinnitus will buy it! Ha! Do you know what people do for beauty alone??? People pay thousands of dollars for cosmetic surgery and nothing is hurting them physically. That's just because that's what people do when persuaded that they need something. Advertising at its best.
People go under the knife, women go to the hair salon every week, have their nails done, tanning rooms, gym, etc. I don't think being "hooked" to a machine for an hour is going to kill sales (that's how long a woman spends at a hair salon or a man at the gym.) Plus, you wont be "hooked" to a machine. I believe you will still be able to move around and go about doing other things while you have your treatment. It becomes part of your daily routine to improve your quality of life. It really comes down to a good advertising campaign.
I also think that there are more people with tinnitus than reported. Once you get these commercials in the air... people will notice their tinnitus! And BAM! @Bam
You have a buyer. Even those people who "learned to live with it" will run to buy them!Targeting audiologists, ENT's, doctors will also be great. Imagine: You go to your doctor because you have this awful ringing in your ears, you are so desperate and the doctor examines you and says: "Ok you have tinnitus and here's your prescription for a MuteButton, take it for 3 months one hour a day and tinnitus will be gone." If it is that bad and severe you will find a way to pay for it. Unless insurance covers it of course.
They need super GREAT Advertising/Public Relations and they will make it. If it really works.
Once
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
It will be nothing short of a miracle and might inspire some of us to go on in life and achieve things we never would have before.
Drone Draper
Member
If the efficacy of this device is good, I think the market will be substantial. 2,000 euros may be a lot to some, but there are plenty of people who can afford this comfortably who suffer from tinnitus.
I do agree, however, that this will probably not be offered via public healthcare anytime soon. This is one of the things that always makes me a bit sad about public healthcare.
Hopefully the improvements will be substantial, but I kind of don't see it happening. I see this being like Acoustic CR Neuromodulation, but a better performing version.
I do agree, however, that this will probably not be offered via public healthcare anytime soon. This is one of the things that always makes me a bit sad about public healthcare.
Hopefully the improvements will be substantial, but I kind of don't see it happening. I see this being like Acoustic CR Neuromodulation, but a better performing version.
In America health insurers will not cover this device based on the current studies. There are going to have to be a lot more independent studies with proven results. If that happens it could be covered. It's not the cost that would prevent a company like Atnea from coverage. It's the viability of the product that could.
- Dec 19, 2018
- 108
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- ETD possibly, or neck and jaw, or maybe anxiety?
Regarding FDA device approval, I found this fun chart that gives a good overview.
https://www.emergogroup.com/sites/default/files/emergo-fda-510k-data-analysis-2017.pdf
TL;DR: ENT devices from submission take roughly 167 days to get approved. When Dr. Ross O'Neill said he's hoping they get FDA approval by the end of 2019, there is a great chance he will. As far as selling the device, 2020 makes sense.
https://www.emergogroup.com/sites/default/files/emergo-fda-510k-data-analysis-2017.pdf
TL;DR: ENT devices from submission take roughly 167 days to get approved. When Dr. Ross O'Neill said he's hoping they get FDA approval by the end of 2019, there is a great chance he will. As far as selling the device, 2020 makes sense.
That's for a 510k submission, which is the quicker of the two routes for medical device FDA approval. 510k's are reserved for devices that are substantially similar to an existing approved device. The Neuromod device may require PMA approval since it is a novel treatment. The PMA process requires more rigor and can result in a longer approval timeline. It's not necessarily significantly longer, but it is a more thorough process.
- Dec 19, 2018
- 108
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- ETD possibly, or neck and jaw, or maybe anxiety?
Ahhhhhh that makes sense. I figured the process was similar regardless of the device.
Thanks for clarifying!
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Somebody on Facebook has reported they were on the trial and they received no benefit.
Sorry for the mess, that's 2 people I've found on the trial with no benefit.
Sorry for the mess, that's 2 people I've found on the trial with no benefit.
- Dec 19, 2018
- 108
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- ETD possibly, or neck and jaw, or maybe anxiety?
That's 2 out of the minimum 500 we have not heard from yet. Also, how do we know they aren't just saying it didn't work because it didn't completely zero it out.
I know of more people on just this forum having been able to modulate their tinnitus with this kind of tech so I'm sure it's still a big step forward.
Fabrikat
Member
- May 1, 2017
- 416
- Tinnitus Since
- 1973
- Cause of Tinnitus
- Otosclerosis then volume then viral infection
One in five reported no benefit, within Neuromod's strict study parameters.
Chances are that the fail rate could be much higher once real world tinnitus sufferers try the device. And by 'real world' I mean the whole gamut of tinnitus sufferers, whether they be with greater hearing loss, more intrusive volume, multiple tinnitus causation factors etc.
As usual we're left to speculate.
That's certainly disappointing, but as always I think you mostly hear from unsatisfied people more than happy ones.
Given Neuromod claims there were 80% responders against 20% non-responders, out of a 500 test subjects that would be 100 of them for whom the trial had no effect. So it's not weird to find them on social media.
Also, and this is an assumption, but I can imagine that if you're cooperating on a trial for a product and asked not to speak about it online for optimal effectiveness of the trial, I think you're more likely to obey this command if it worked for you, and you're thankful for the company that has given you so much. If it didn't work, you're more likely to be frustrated, maybe angered, and perhaps less likely to do what they ask you. Maybe a certain urge to 'warn' people, because it did not do anything for you.
Also, and this is an assumption, but I can imagine that if you're cooperating on a trial for a product and asked not to speak about it online for optimal effectiveness of the trial, I think you're more likely to obey this command if it worked for you, and you're thankful for the company that has given you so much. If it didn't work, you're more likely to be frustrated, maybe angered, and perhaps less likely to do what they ask you. Maybe a certain urge to 'warn' people, because it did not do anything for you.
Drone Draper
Member
I think it's good to have a bit of skepticism towards this product, but right now it's all just speculative. I think the lady who did get "cured" of her tinnitus (which I believe was mild - morse code in one ear) did say she met a few other users who didn't get any benefit.
Exactly. I actually got sent an e-mail by accident from someone who had benefit from the Desyncra system (I know, not bimodal). She wanted to thank the Tinnitus Clinic by e-mail, who I was scheduled to see a few weeks later. The hapless assistant at the Tinnitus Clinic cc'd me in by accident when she replied. The lady had originally said she was very happy because she couldn't hear her tinnitus today thanks to the new adjusted tones.
Drone Draper
Member
Do you know anything more about their situation, e.g., age, cause and duration of tinnitus, hearing loss, loudness of tinnitus, etc?
Two on here with benefit - Clare B and one other, Kelpiemsp is it? I've seen one on Facebook with no benefit. Frankly even if the improvement rates aren't the 80% quoted in the trial data released to date the device will still have great value - if it works to help even 20%.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
No the guy just wrote that he was in the trials and it did nothing for him.
I'm just hoping they have answers to those who weren't receiving benefits - that they have figured out why. At least with the Desyncra device, there had to be a tonal tinnitus below 10 kHz for it to work/have a higher chance. We have no clue as of yet who Neuromod will benefit and who it won't.
I've got to say though out of all my time reading papers there always seem to be responders even when given sham treatments, so I hold the 80% response rate with caution.
At least with Neuromod they have included minimum masking level on top of emotional responses to tinnitus. Suppose that's a reason to be positive.
Drone Draper
Member
Yeah. I think the success stories on their site indicate that noise induced tinnitus is definitely one case where it can benefit - you have the runner who listened to music, the workie, the bouncer and the student. But we don't get any indication of the extent of their hearing loss (if any).
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
It could be that the non-responders had another cause for their tinnitus. If you look at the eligibility criteria, there is no specific clause that it has to be for noise-induced tinnitus. And there are many, many causes for tinnitus, perhaps the non-responders had an underlying cause other than noise or hearing loss.
Ross O'Neill admits though that their theory to why tinnitus generates is through a hearing loss.
Ross O'Neill admits though that their theory to why tinnitus generates is through a hearing loss.
Fabrikat
Member
- May 1, 2017
- 416
- Tinnitus Since
- 1973
- Cause of Tinnitus
- Otosclerosis then volume then viral infection
I could get profoundly depressed about all this really.
MuteButton may or may not work depending on your variety of tinnitus. Probably suits only mild cases. Who knows?
Dr. Rauschecker has never heard of bimodal stimulation and he's meant to be one of the knobs in the biz! Wtf!! He's getting feverish about finding a cure... maybe in ten years!
The hearing aid industry is publishing ten year projections of billion dollar profits with more and more units being sold. Not a single mention of any threat approaching such as Frequency Therapeutics etc. They're not worried at all! And they're not the kind of people who put their heads in the sand. They're big business.
So it's all feeling like we're being hoovered into sweaty expectation about stuff that is just, you know, throwing some stuff at the wall and seeing what sticks.
Some researchers seem to be playing musical chairs hopping from one lab to the other, leaving you asking why when the job hasn't even been finished at the first place.
It's not that we're being hoodwinked, but possibly are just hoodwinking ourselves.
MuteButton may or may not work depending on your variety of tinnitus. Probably suits only mild cases. Who knows?
Dr. Rauschecker has never heard of bimodal stimulation and he's meant to be one of the knobs in the biz! Wtf!! He's getting feverish about finding a cure... maybe in ten years!
The hearing aid industry is publishing ten year projections of billion dollar profits with more and more units being sold. Not a single mention of any threat approaching such as Frequency Therapeutics etc. They're not worried at all! And they're not the kind of people who put their heads in the sand. They're big business.
So it's all feeling like we're being hoovered into sweaty expectation about stuff that is just, you know, throwing some stuff at the wall and seeing what sticks.
Some researchers seem to be playing musical chairs hopping from one lab to the other, leaving you asking why when the job hasn't even been finished at the first place.
It's not that we're being hoodwinked, but possibly are just hoodwinking ourselves.
Drone Draper
Member
Indeed, sir. Mine is 100% caused by hearing loss with a basic bitch cookie bite audiogram to go with it, so I'll see this as no concern thus far.
From what I gather, most of the redpillers here think that too, even if this is hidden loss that's not measured in a standard audiogram. What say you?
Don't forget, not everyone who has the need for a hearing aid has tinnitus. Neuromod would be useless for people with moderate to severe hearing loss without accompanying tinnitus and hyperacusis, like my parents. My audiologist says he sees cases of people with severe hearing loss and no tinnitus to accompany it all the time. These people would probably be more interested in regeneration of cochlea, but my hunch (and it is a big one) is that a lot of these people are more accepting of the hearing loss as part of ageing.
On that note, don't forget that we're seeing an ageing population in the West. Currently, the life expectancy for young people in the UK is about 85-86 (I know because I work in pensions) and I'm going to go out on a limb and say there's little chance of hitting that age without some sort of need for a hearing aid (or FX-322, naturally
). Cashing in on the grey pound is probably a safe move. Better buy some stock in Starkey and Depend before the end of the Boomer generation hit retirement age 
Very possibly, sadly.
There is no certainty that tinnitus is cureable, however much research is done, however much money is thrown at it.
I know of no great successes with regard to nerve damage and subsequent regeneration.
Christopher Reeve never walked again, despite the wealth of Hollywood behind him.
I know that the efficacy of psychological therapies is dismissed out of hand in many quarters.
I wonder if there is a possibility that advances could be made there; could there be better targeted treatments perhaps in the area of hypnotherapy?
Just a thought.
I know of no great successes with regard to nerve damage and subsequent regeneration.
Christopher Reeve never walked again, despite the wealth of Hollywood behind him.
I know that the efficacy of psychological therapies is dismissed out of hand in many quarters.
I wonder if there is a possibility that advances could be made there; could there be better targeted treatments perhaps in the area of hypnotherapy?
Just a thought.
I too wonder about those who claim it did nothing at all for them. I wonder whether there could be some extenuating circumstances as to why, like they weren't doing it right somehow, tongue misplaced, etc...
It just doesn't make sense that the treatment would be highly effective for one person and completely ineffective for another. I could understand the level of effectiveness varying but it seems like it should have had some positive effect for everyone.
It just doesn't make sense that the treatment would be highly effective for one person and completely ineffective for another. I could understand the level of effectiveness varying but it seems like it should have had some positive effect for everyone.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
The treatment was recorded during the trials; that is the time used each day and even the amount of electrodes stimulating the tongue were all active and attached. It was well monitored if they were compliant and using it effectively. As far as I can tell, it has been a quality study.
It makes sense in a tinnitus world. Unlike epilepsy, where there's a focal point where it happens, tinnitus has no focal point.
What Neuromod are doing are trying to stimulate all the areas from a bottom up approach that passes through the different areas of the brain in order to drive plasticity. Plasticity is the ability to change the neurons in the brain. So basically it's like they are looking for a nail with a hammer. Some of those nails will be missed.
Perhaps @Greg Sacramento who appears to have good knowledge can explain what they are doing in more layman's terms.
What I would also point out, look at psychiatric drugs such as antidepressants. The question what antidepressant works best the answer is: what works best for you. There is no definite answer because there is no definite answer. If science was an exact science it wouldn't be science.
Yes, there seems to be a lot of confusion about what science is. It's sometimes seen as a hard, definite thing. To the contrary: the very essence of the scientific method is that knowledge is always tentative. You posit a theory, you try to prove or falsify it, and if you perform enough experiments that seem to validate it, it is accepted for the time being until the next, more general/more detailed theory arises and the cycle repeats.
Same goes for Neuromod: they did something, based on experiments it seems to be good enough, so they'll release it to the general population, based on feedback they'll probably create an even better version, and so on and so forth. It will never ever be 100% working for 100% of the people, and it also will never offer a 100% complete explanation of the mechanism of tinnitus.
Drone Draper
Member
Precisely. A good scientist will always welcome free inquiry, even if it is at the cost of needing to disregard existing knowledge.
- Oct 17, 2017
- 642
- Tinnitus Since
- 2005
- Cause of Tinnitus
- unknown - possibly hereditary
The device will be called Lenire. It's currently in the trademark phase, opposition period ends in May 2019. I can say with certainty that they are not releasing it before June. We have more months to wait...It's almost March 2019 and still no release date by Neuromod...
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