MuteButton

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I emailed mute button this is their reply :
At the moment we have paused sales of mutebutton until further notice. Therefore, we are not taking any new appointments. The reason being that we are dedicating most of our resources into preparing the mutebutton technology for a global launch. Preparation for a global launch requires significant investment to be able to scale up our manufacturing capability.

We are building on positive clinical outcomes to date to begin preparing for this global launch. We are aiming for an international launch of the product in 2018.
 
I might have the possibility to be part of a mute button study.

It's not placebo controlled but aims at finding the right parameters for treatment.

If I'm in, I will let you know about my impressions
 
What on earth happened to the mutebutton?

I was actually on the trial for the Mutebutton. I used it for an hour before I went to bed and the tinnitus would change - a bit of a spike but not a bad one. Then in the morning it would have gone down a good bit. One or two mornings I woke up and the tone was turning on and off but the white static noise that accompanies it was the same. Overall it helped but not drastically, maybe 10 - 15%. My tinnitus was caused by Brain Injury 12 months ago so the brain is still reorganizing itself up to 18 months after the injury so it could be recovering plasticity (had to use the buzzword!).
 
I just do not see how anyone with acoustic trauma related T would benefit from this, if it requires that you wear a head-set.

I wore a head set once watching a TV show on low and my T increased /changed tone. No way in hell would I consider any type of sound therapy if I have to wear headphones.
 
I corresponded with the company and like @erik said, they've decided to put a pause on a national rollout in order to focus on an international 2018 launch.
 
I asked them when the device becomes available. Today I received an answer.


Dear,

Many thanks for contacting us.

At the moment we have paused sales of mutebutton until further notice. The reason being that we are dedicating most of our resources into preparing the mutebutton technology for a global launch. Preparation for a global launch requires significant investment to be able to scale up our manufacturing capability.

We are building on positive clinical outcomes to date to begin preparing for this global launch and are aiming for an international launch of the product in the next 2/3 years. Updates will be posted on our website, so please keep an eye on that in the near future.

Kind regards,
 
I asked them when the device becomes available. Today I received an answer.


Dear,

Many thanks for contacting us.

At the moment we have paused sales of mutebutton until further notice. The reason being that we are dedicating most of our resources into preparing the mutebutton technology for a global launch. Preparation for a global launch requires significant investment to be able to scale up our manufacturing capability.

We are building on positive clinical outcomes to date to begin preparing for this global launch and are aiming for an international launch of the product in the next 2/3 years. Updates will be posted on our website, so please keep an eye on that in the near future.

Kind regards,
They said the global launch will be in 2018 and now they are saying in 2/3 years. I am confused. (n)
 
I hate to be cynical, but my gut feeling here is that it will be never! More likely MuteButton dies in the wind like its numerous predecessors, although, like others, I hope for better.
 
They are burning up the remaining VC money in the next couple of years, they know the device doesn't work but they want to spend all the funds before announcing they failed.
 
Neuromod hires research expert in move to bring tinnitus device to market
Irish medtech start-up seeking to commercialise non-invasive device for condition

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Dr Hubert Lim, who has joined Neuromod as chief scientific officer, is a researcher at the cutting edge of auditory neuroscience, neuromodulation and neuroplasticity.

Neuromod has hired a top global researcher as it looks to commercialise a device to help patients suffering with tinnitus – a chronic and, at times, debilitating ringing, clicking or buzzing in the ears.

Dr Hubert Lim, who has joined Neuromod as chief scientific officer, is a researcher at the cutting edge of auditory neuroscience, neuromodulation and neuroplasticity – the study of the brain and how it adapts and changes to different stimuli over time. These changes can lead to issues such as phantom limb syndrome or tinnitus.

Essentially, Dr Lim's research studies the ability of the brain to reprogramme over time and examines how that can be harnessed to help patients, including those with tinnitus.

Neuromod, founded in 2010 by chief executive Dr Ross O'Neill at NUI Maynooth, has developed a non-invasive approach using a neuromodulation device called a Mutebutton, to address tinnitus.

The company, which has to date raised about €9 million from investors including Irish venture capital group Fountain Healthcare as well as Enterprise Ireland and entrepreneur Robert Moffett, is currently conducting critical phase-three trials of its device.

Dr Lim says he has been familiar with the work of Neuromod for some time but had not planned on coming to Dublin. "Then I was approached and asked if I was interested in coming aboard to develop the science side of the business," Dr Lim said.

Inclusive approach
He said Neuromod's very inclusive and transparent approach, including its openness to advice from experts in the field, appealed to him. The US National Institute of Health has been backing this approach, he said, where companies say up front what they are doing and targeting, rather than retrospectively setting parameters that may better fit already gathered trial results.

Dr Lim, who moved to Dublin with his family in December, sees his role as threefold. One priority is advancing the work that Neuromod has done to date identifying parameters for treating different subtypes of patients suffering with tinnitus – work that chimes with his experience over almost two decades.

He says that, until now, the tinnitus field has adopted a one-size-fits-all approach but it is now moving to figuring out patient subtypes and approaching them in a more tailored manner.

"All patients who have been treated with the Neuromod Mutebutton are doing well but not all are doing as well as certain subtypes," he notes.

More immediately, he will focus on completing the trials currently ongoing in Germany and in Ireland. These are due to finish next month and the next challenge will be proceeding with trials in the key US market.

He will also be interacting with the scientific community. "We don't want to oversell but we do want to get the message out there of what we have done with our technology," he says.

Neuromod estimates that, with more than 10 per cent of the global population affected by tinnitus, the market for an effective treatment "has untapped multibillion-dollar demand". The company expects to be raising further funds after the European trials report as part of then preparation for US trials and commercialisation.

While Neuromod is targeting tinnitus, it is just one of a number of groups working with applications for neuromodulation in areas such as stroke recovery, epilepsy, depression, rheumatoid arthritis, irritable bowel syndrome and even sleep conditions.

These include another Irish company, Mainstay Medical, which is using the same approach to address chronic lower back pain in patients
 
Not one, independent double blind clinical trial has ever been done. Big red flag there.

It doesn't work until independent trials say it does. Until then, it's no better than a "Ring Stop" supplement.
 
Seems very much like Susan Shore's device - anybody know how it's different?
@Paulmanlike:

I believe that MutteButton is about vagus nervous stimulation combined with sound therapy. There is another device called Salustim that supposed to work on dual stimulation also (electrical+ sound). Very skeptical that this is getting anywhere beyond being more sophisticated than just sound therapy.
 
@Paulmanlike:

I believe that MutteButton is about vagus nervous stimulation combined with sound therapy. There is another device called Salustim that supposed to work on dual stimulation also (electrical+ sound). Very skeptical that this is getting anywhere beyond being more sophisticated than just sound therapy.

I was also skeptical but they've just hired that top professor on board and their site looks promising, still got more faith in Susan Shore's device though.

Neuromodulation is also one of the themes they will be talking about in TRI 2018.
 
An update from the presentation and conversations at the BTA conference.

The device (I forgot to ask if it will still be called MuteButton) is not far from going to market. Looking at end of this year / early next year to launch in Europe, the global launch may be 2/3 years away. They presented results from the recent trial and they have another trial near to completion.

The results presented by Berthold Langguth showed that it performed particularly well for hyperacusis, not something I would have expected but very interesting. Overall the early results that were presented are positive. Although, like any treatment currently available, it will not be universally effective.

I'm personally withholding judgement until all results are presented (some are still to be completed) but they have conducted this with a much larger patient group than you usually see so the results should be representative. It does seem that bi-modal stimulation is effective based on what is known about it so far, also thinking of Susan Shore's research.

I really have tried to pry details from them about the audio element. To date I've been unsuccessful despite the amount of beer involved, but I do know that they are using multiple audio types rather than just a single approach. I'm hoping that this means it's going to be tailored to the individual.
 
Hi Steve
When was the BTA conference? Is there any video about it available?

Hi there, the conference was last Friday. We spoke to the Neuromod folks quite extensively, and conducted a video interview with them. But it will take us quite a while to sort out the footage, edit it, etc. So stay tuned.
 
Hi there, the conference was last Friday. We spoke to the Neuromod folks quite extensively, and conducted a video interview with them. But it will take us quite a while to sort out the footage, edit it, etc. So stay tuned.
Does anyone know any information on MuteButton or if there are other devices coming out to help ease tinnitus?
 
An update from the presentation and conversations at the BTA conference.

The device (I forgot to ask if it will still be called MuteButton) is not far from going to market. Looking at end of this year / early next year to launch in Europe, the global launch may be 2/3 years away. They presented results from the recent trial and they have another trial near to completion.

The results presented by Berthold Langguth showed that it performed particularly well for hyperacusis, not something I would have expected but very interesting. Overall the early results that were presented are positive. Although, like any treatment currently available, it will not be universally effective.

I'm personally withholding judgement until all results are presented (some are still to be completed) but they have conducted this with a much larger patient group than you usually see so the results should be representative. It does seem that bi-modal stimulation is effective based on what is known about it so far, also thinking of Susan Shore's research.

I really have tried to pry details from them about the audio element. To date I've been unsuccessful despite the amount of beer involved, but I do know that they are using multiple audio types rather than just a single approach. I'm hoping that this means it's going to be tailored to the individual.
I have read papers that hypothesized that tinnitus and hyperacusis with pain are two sides of the same coin, this is interesting if true.
 
I have read papers that hypothesized that tinnitus and hyperacusis with pain are two sides of the same coin, this is interesting if true.
David Baguley's presentation on hyperacusis at the conference was really good. He talked about the Tyler paper and his 4 categories, and really laid bare just how much more we need to understand about hyperacusis.

It will be especially interesting if the Neuromod trials are able to make a distinction between pain and sound tolerance hyperacusis, or even propose their own splits where bi-modal stimulation may be most effective.
 
Is this device supposed to actually reduce the tinnitus volume or is it supposed to help people habituate like the Levo system?
 
Is this device supposed to actually reduce the tinnitus volume or is it supposed to help people habituate like the Levo system?

It's supposed to create structural changes in the brain that reduce the tinnitus itself. I'm not very good at explaining it, so you'll have to do some reading if you want to learn more.

You can read about the details of the set-up here: https://bmjopen.bmj.com/content/7/10/e018465

The outcome measures used are the Tinnitus Handicap Inventory and the Tinnitus Functional Index. These don't directly measure volume I suppose, since it's self-reported, but I would surmise they indirectly capture that? [I'm no expert in these measures, so anyone else feel free to clarify here.]

A quote from this article that may provide the perspective you're looking for: "There is a recognised need for evidenced therapeutic options that reduce or alleviate the symptoms of tinnitus instead of simply helping sufferers to manage the cognitive, emotional and behaviour impacts of their long-term condition."
 
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