MuteButton
- Thread starter Jim
- Start date
- Status
Member
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
So we can rest assured that what we spend thousands on will be another hit and miss work in progress and there will be another much hyped 'launch' of MuteButton3 in 2025 when they've spunked 25 million on more research and trials.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Bam I've been following tinnitus research since about 2008 and to date this is one of the largest clinical trials for tinnitus with some huge funding. Stay positive.
Is there anyway you can cut and copy the whole article - don't want to part with a pound to read it.
Well there you have it huh @Soren? First quarter 2019! That's January, February or March!
Is that right??
Unless it gets pushed out again, of course :/
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Hmmm generating revenue from investors or generating revenue from customers?
Hopefully they'll release some news this week.
I do not believe investment money can be called "revenue".
Also, the article mentions this "revenue" as an additional news item to potential investment money, not as the identical news item.
I would think that if it had to do with investors the word investment would have been used and not revenue.
Yes, "revenue" in this context is definitely customer revenue. That is, sales to us!
Or, this will be an actual HIT work and many of us will have our tinnitus measurably reduced, and there will be another much hyped 'launch' of MuteButton3 in 2025 which reduces tinnitus even further for even more people. Yes, I get it, MuteButton1 was a failure. So what? Progress is very rarely linear.
- Oct 17, 2017
- 643
- Tinnitus Since
- 2005
- Cause of Tinnitus
- unknown - possibly hereditary
Here is the full article!
Neuromod, a healthcare start-up developing treatments for tinnitus, is in talks to raise up to €24m in investment.
Accounts just filed for the business state that the directors are in "advanced discussions with third-party investors" and are "confident of securing additional investment of €24m" in the coming months.
The accounts also state that Neuromod expects to start generating revenue in the first quarter of 2019 following a successful period of clinical trials.
Headquartered in Dublin's Digital Hub, Neuromod specialises in non-invasive treatment to help patients suffering with tinnitus, a chronic clicking or buzzing in the ears which affects about 10% of the population.
"Building on the successful results of our large-scale multi-centre clinical trials, the company now plans to raise the capital to bring this revolutionary tinnitus treatment to the millions of patients whose clinical needs are currently unmet," said Ross O'Neill, the company's chief executive, in a statement last week.
With European regulatory approval already in place, Neuromod will make its product available to tinnitus sufferers in Europe from 2019.
The company also plans to pursue US Food & Drug Administration approval to launch the product in America in 2020, said O'Neill.
Neuromod was founded in 2010 by O'Neill as a spin-out from Maynooth University. It has already been backed by investors including Fountain Healthcare. In 2015, the company announced it had raised €5.5m, taking its total funding to €8m.
Thanks @annV!
Great news both for Europeans and Americans! This implies that 1. they plan to launch in multiple countries already in 2019 (otherwise they would have said just "Ireland"), and 2. they expect a reasonably quick release in the USA!
That fits my existing prediction, that 2019 will see this start to roll out in Europe and 2020 in the US.
Part of me wants to beg, borrow and steal to get the first units that come out regardless of hurdles, but I could cope with the wait by reading personal anecdotes from early adopters in Europe.
Part of me wants to beg, borrow and steal to get the first units that come out regardless of hurdles, but I could cope with the wait by reading personal anecdotes from early adopters in Europe.
I'm going to get it from Ireland when it's released.
Sooner I start my treatment the better. To hell with Health Canada.
Sooner I start my treatment the better. To hell with Health Canada.
Why can't the Irish health regulatory people just have a meeting with the FDA commissioners to share their ideas and get this approved very shortly after it is approved over there? Is there a good reason at all?
Well they need to spend more time figuring out if it will cause cancer
WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.
Alex Matyjasek
Member
I thought very much this product is going to fail. After so much publicity, the video, data etc... If this ends up being a useless device, Neuromod's reputation is gonna go down the drain. No one would give a damn about MuteButton 3 when/if MuteButton 2 is just a bunch of junk.
Even with a few bad reports about the product, word would spread quickly and they wouldn't even have a chance to make money. So far it has been the other way around. Anyway time will tell. Fingers crossed. This sh't is a real life spoiler. It's sad imagining a future that you can't have
Even with a few bad reports about the product, word would spread quickly and they wouldn't even have a chance to make money. So far it has been the other way around. Anyway time will tell. Fingers crossed. This sh't is a real life spoiler. It's sad imagining a future that you can't have
I "think" it's the 510k process for medical devices. I am not in that part of the medical field to be 100% though.
Why can't we accept the UK's process and just have the commissioners meet up and agree to skip the things that have already been done there?
John, come with us via airline! We all deserve to have some symptom relief ASAP. Didn't @kelpiemsp have amazing results with the Minnesota machine? And his tinnitus is far worse than mine. And IIRC he could only hear it when his ear was pressed against his pillow?
Then when FX-322 comes out we can throw a party and hire a thrash metal band.
I believe in this device, as well as Minessota and Susan Shore's. It's just frustrating we have to suffer even one more day with this wicked monster.
- Aug 21, 2014
- 5,049
- Tinnitus Since
- 1999
- Cause of Tinnitus
- karma
I'm already spoken for; the occasional 3-way is fine but I'm not looking to get into long-term polyamory, let alone with a highly bureaucratic and paperwork obsessed federal agency.
I'm open to the idea of a one night stand with the department of the interior, though.
For the first several months I was on this thread I thought @kelpiemsp was a woman and every time I see his gender pronoun used it still reminds me she is a he.
It would be a terrible idea for the FDA to be more lax than they already are. Watch the Bleeding Edge on Netflix. The U.K.'s MHRA are even more X
Fabrikat
Member
- May 1, 2017
- 416
- Tinnitus Since
- 1973
- Cause of Tinnitus
- Otosclerosis then volume then viral infection
You've struck on my pet issue #linearb!
Purdue gets stuff it wants because it lobbies directly in the corridors of power. The tinnitus community has no one lobbying for us.
Until we have someone going office to office speaking directly to lawmakers, we really will appear as as a disparate group of largely sufferers and charitable organisations pleading for an ear.
Our best ally is the US military, simply because of the huge cost burden borne by the taxpayer for vet's disability compensation. But do they lobby lawmakers? Who knows? They do contribute funding to labs, I know that.
Lawmakers need to be hassled. One by one, just like Purdue etc. do. Educated and then promises extracted to impact directly on viable solutions, fast tracking of FDA procedures where possible and then answering back to us, the concerned stakeholders.
With so many organisations, such as the ATA, BTA and those representing the deaf, you'd think we could afford at least one lobbyist working the halls on our behalf. This should be the work of the ATA etc. and where our energies should focus.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
It's important to remember Susan Shore has published results of the 20 people that were treated before getting too hyped that this will be a 'cure'.
This is promising, but it is important to keep in mind what is actually in the paper.
First, the average reductions in TFI in the active treatment and active washout phases are 7.51 and 6.71 points, respectively. These were both significantly different from 0, but they are both much less than 13 which is the cutoff for clinical significance. Additionally, the mean reduction during the sham phase is about 2 points, and the sham washout has a mean reduction of a bit less than 2. Thus, the effect of the treatment itself (active - sham) is about 5.5 to 4.7 points - not large. Either way, on average the treatment has a statistically significant but clinically insignificant effect on the TFI.
Second, 10 of the 20 subjects did have a clinically meaningful reduction of at least 13 points during the active treatment. This is good. However, we don't know what reductions these individuals had during the sham phase. In fact, 4 participants had clinically significant reductions during the sham phase, and 2 participants had clinically significant reductions during BOTH phases. The authors do say that the two who experienced reductions during both phases experienced larger reductions during the active phase, but they don't provide the information so that the reader can understand the differences. It would have been useful to see individual level data. This would be possible with only 20 subjects, and it would allow the reader to see the degree to which individuals who saw improvement in the active phase also saw improvement in the sham phase. (Ideally you would like to see responses during the active phase and no response during the sham phase for each person. Assuming they are correct that the sham is truly a sham, it acts like a placebo so if you see a reduction in TFI or loudness during the sham period this is due to the placebo effect. That's why you need to subtract out the effect of the placebo in order to determine the effect of the treatment.)
Third, assuming the treatment truly does have a clinically significant reduction for a significant proportion of people who are treated, it would be useful to know ahead of time who might benefit. In this case, there were no demographic differences between the people who improved significantly and those that didn't. This may be due to the very small sample. Assuming the results persist in a larger sample, perhaps observable differences will observe.
Fourth, there is a reduction in loudness during the treatment of about 8 dB. Unlike the reduction in TFI, this effect becomes smaller during the active washout. Thus, it appears that any sustained reduction in perceived loudness requires continued use of the device. However, the 8 dB reduction isn't all due to the treatment. The effect during sham treatment is a reduction in loudness of about 3.5 dB or so (hard to say exactly from the figure). Thus the net reduction due to the treatment is about 4.5 dB. (In Figure 6C, it's interesting that there is a similar relationship from sham to sham washout that there is between the active and active washout.)
Fifth, 2 people did report the elimination of tinnitus "toward the end of the active treatment period" though there is no information the durability of that result.
So there are promising results here, but they aren't earth-shattering. It's important to remember this is a small study with some promising results. We won't really know more until they do a larger study which is or will soon be underway.
This is promising, but it is important to keep in mind what is actually in the paper.
First, the average reductions in TFI in the active treatment and active washout phases are 7.51 and 6.71 points, respectively. These were both significantly different from 0, but they are both much less than 13 which is the cutoff for clinical significance. Additionally, the mean reduction during the sham phase is about 2 points, and the sham washout has a mean reduction of a bit less than 2. Thus, the effect of the treatment itself (active - sham) is about 5.5 to 4.7 points - not large. Either way, on average the treatment has a statistically significant but clinically insignificant effect on the TFI.
Second, 10 of the 20 subjects did have a clinically meaningful reduction of at least 13 points during the active treatment. This is good. However, we don't know what reductions these individuals had during the sham phase. In fact, 4 participants had clinically significant reductions during the sham phase, and 2 participants had clinically significant reductions during BOTH phases. The authors do say that the two who experienced reductions during both phases experienced larger reductions during the active phase, but they don't provide the information so that the reader can understand the differences. It would have been useful to see individual level data. This would be possible with only 20 subjects, and it would allow the reader to see the degree to which individuals who saw improvement in the active phase also saw improvement in the sham phase. (Ideally you would like to see responses during the active phase and no response during the sham phase for each person. Assuming they are correct that the sham is truly a sham, it acts like a placebo so if you see a reduction in TFI or loudness during the sham period this is due to the placebo effect. That's why you need to subtract out the effect of the placebo in order to determine the effect of the treatment.)
Third, assuming the treatment truly does have a clinically significant reduction for a significant proportion of people who are treated, it would be useful to know ahead of time who might benefit. In this case, there were no demographic differences between the people who improved significantly and those that didn't. This may be due to the very small sample. Assuming the results persist in a larger sample, perhaps observable differences will observe.
Fourth, there is a reduction in loudness during the treatment of about 8 dB. Unlike the reduction in TFI, this effect becomes smaller during the active washout. Thus, it appears that any sustained reduction in perceived loudness requires continued use of the device. However, the 8 dB reduction isn't all due to the treatment. The effect during sham treatment is a reduction in loudness of about 3.5 dB or so (hard to say exactly from the figure). Thus the net reduction due to the treatment is about 4.5 dB. (In Figure 6C, it's interesting that there is a similar relationship from sham to sham washout that there is between the active and active washout.)
Fifth, 2 people did report the elimination of tinnitus "toward the end of the active treatment period" though there is no information the durability of that result.
So there are promising results here, but they aren't earth-shattering. It's important to remember this is a small study with some promising results. We won't really know more until they do a larger study which is or will soon be underway.
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