MuteButton

I didn't realize they were referencing dB with TFI / THI. Thanks for clarifying.

 

I don't think they are. They are measuring intrusiveness, not loudness.

 

Yeah that's the issue.

Now I'm not saying this is another LEVO, but if they had a good reduction in decibel, then why not mention it? It's possible they had the reduction, but the higher TFI number looks more impressive because there's a good measure of placebo involved in that.

 

Because you can’t reliably measure dB(a,c etc), you can do dBV, but there isn’t a good real world example of what dBV is.

Also placebo shouldn’t be involved because the user can’t differentiate between the timing signals. So they should (will know when study is out) be compared to placebo timings, not entry into study.

 

Having been involved in clinical trials in other areas of medicine, one has to understand how critical study design is to the achieving the primary endpoints. I'm not saying researchers deliberately 'game' their conclusions, but design can make or break a device getting through the FDA. I've seen it many times. No other variables changed, just the design of the study itself.

Regardless, this is good news. It's another approach to helping us. It's another avenue to some relief. I wish them well and hope their data is solid and survives peer review and PMA and/or IDE status with the FDA soon.

...and absolutely right about skewing the results by unintentionally unblinding participants via forums and the internet. If the data is solid, we will all be able to see it soon enough, hopefully alongside a device/therapy approval.

 

Sure dBV has some issues, but TFI is much more subjective. That's also where the placebo comes into play. Some people may feel "better" about their tinnitus because they're involved in a trial. The timing definitely isn't my concern about placebo.

 

It's not your first TFI that is used, it is likely/hopefully the TFI obtained from placebo timings versus the TFI obtained during "real" timings. Placebo comes into play when measuring the initial TFIs versus the placebo timing TFIs. Hopefully they are reporting the change from placebo timed TFIs to active timing TFIs and not trial entry TFIs to active timed TFIs.

 

I suspect they will choose to report the change that is most beneficial to their end game, which is to sell as many devices as possible and looks best in marketing. They are not benevolent, they are after cold, hard cash. One can hope the MuteButton II does something more than placebo.

 

This is quite true, but it is the pursuit of cold, hard cash, as you say, that brings forth the best technology for the targeted patient population. That's just the way it works in open market situations.

You know what would bring about a substantial gain in tinnitus treatments? In the United States, CMS (The Center for Medicare and Medicaid Services) is the organization that basically says what Medicare/Medicaid will and will not pay for as far as treatments, devices, drugs, etc. I think in the UK it is the NHS??

Anyway, currently CMS pay for NO tinnitus treatments, at least that I am aware of. So, that means the the bio-tech companies, especially the publicly held ones, do NOT see the payoff, the cash cow if you will, by doing any research and spending millions of dollars to do trials. The payoff is not there, and shareholders would go ballistic if they found out company leadership was going after therapies that don't payoff big time.

If you are really looking for change and help, call your Senator (in US) or other government official and ask them why there is no payment approval for tinnitus patients?? I have, and so far they don't have a good answer. Heck, CMS doesn't even pay for hearing aids! That is ridiculous.

As a side note, the Veterans Affairs, DOES pay for tinnitus treatments and hearing aids.

Sorry to go off topic, but while we hope and wait for companies like Neuromod to release some good news, I think it is important to realize WHY we are so desperately waiting for ONE company to release their study results. It should be 10 companies competing for THE treatment for tinnitus.

Research needs $$$$$ period. No way around it. Policy change needs to happen.

 

I think we may be talking about 2 different things. I have not been following this thread so do what you know to be best. -TC

 

Genuine question, do you think CMS payments would be adequate? The health systems we work with barely make even on Medicare rates.

 

@kelpiemsp I know you don't want to discuss your trial anymore due to wanting to keep the integrity of the research, but has there been any change with how the researchers are viewing the trials? Do they feel they are on the right track in terms of research, time to completion, and effectiveness?

I know they prob don't talk to you guys about this stuff, but I thought I would ask.

 

That's a great question and a very reasonable concern for every taxpayer in the US.

I was in the cardiac implantable device industry for decades. During that time, I saw CMS approve device after device even if it did not decrease mortality rates, just morbidity, though they usually increased QOL. Just to give you a bit of how much money that is, we are talking $60-$80K for one procedure including the cost of the device. Did this money save lives? Yes, in many cases. Did it help people live better lives? Again, yes. However, that being said, the majority of cases were just slowing the slide to ultimate death. I won't head off into the moral debate (what is your life worth for 2 more years, your mom's, etc.?), but I will say I saw an obscene amount of money spent by the federal government in just one area of medicine. Billions.

Now, what is your hearing worth? What is a cure for tinnitus worth? I think, as a society, to restore normal hearing to your citizens is critical to leading a productive and happy life. So, why won't CMS pay $3-$5K for hearing aids to possibly enrich someone's life for 10, 20, 30 years, etc., but they will pay $80K for a Cardiac Resynchronization Therapy Implantable Defibrillator that may help someone for 3, 5, at the longest 10 years?? This is a very sick patient population, but the federal government has no problem with this. Why?

You have to look at the money at stake. The companies involved have worldwide resources to get their devices trialed and into the marketplace quickly. Multi-billion dollar market. Entire law firms at their disposal that do nothing but lobby Congress and the FDA.

The increase in CMS payouts is growing every year. The reimbursement to physicians has not been reduced in decades (in the area I worked in). The AMA's lobby and power in Washington is astounding. This money goes out the door, and Congress keeps kicking that can down the road. It has not stopped the cardiac industry, so in answer to your question, why should it stop the hearing health industry from getting a foothold and helping improve people's lives?

Deficit spending in the US healthcare market has been the standard since the 1970's. Technology continues to march along, and that is a good thing. Why the hearing health industry has been left out, I have no idea. It's not a question of can CMS afford it (of course they can't, but it hasn't stopped them in 50 years from approving and increasing reimbursements), it's a question of will they?

I might add that private insurance reimbursement rates generally follow what CMS decides. So, not all of this money is coming from the federal government. Probably 40% will come from private insurers in this scenario.

Call or write your representatives. It only takes a couple of hours of your time. If they open the money tap for tinnitus treatment reimbursements (VALID ones with blinded, randomized trials), this patient population will go from suffering and chasing the next so-called treatment, to one that has real options and therapies, and hopefully a cure, at their disposal. It can be done.

 

This would be an interesting study. We know how expensive tobacco and alcohol are to society, but I'd bet hearing loss is pretty expensive too. You'd think paying (at least part of) the cost to restore hearing would be a net + investment for our health system.

 

I understand where you are coming from with this but it's just not reliable enough to loudness match IMHO.

There are a lot of factors at play, you could have a random good or bad day that is nothing to do with the treatment cycle, you could achieve a suppression from the matching that you didn't receive previously, any event really that could cause a quick change in your tinnitus.

I would personally love to see a reliable form of measuring the actual tinnitus but we're just not there yet. At this point in research THI and TFI are about as good as it gets unfortunately, they do at least allow studies to be compared against each other in terms of the points change.

Off topic but we could change it with questions on how your tinnitus has been masked by sounds, how reactive it has been and whole load of other questions that are more relative to our day to day experiences and how it intrudes. Something relatively small as a supplementary questionnaire to try and understand more about the perception of volume.

 

So does it work or not? Easy question.

Why does there always have to be a brick wall between this community and any tangible information?

It's like we are floating through the void and there's whispers of various treatments or cures on the horizon and when we actually turn to look there's never anything there.

 

Ross O'Neill 9:23 PM

Hi Robert, Many thanks for your message and your interest in our technology.

Our Chief Medical Officer, Mr. Brendan Conlon ENT, presented the positive 12-month data from our 326-patient double-blind randomised TENT-A1 trial to the US ENT community at American Academy of Otolaryngology in Atlanta yesterday.

The journal publication is in preparation by our Chief Scientific Officer, Prof. Hubert Lim, and our Science Advisory Board, Professors Berthold Langguth, Sven Vanneste and Deborah Hall, and will be submitted to a high-ranking journal shortly to go through the peer-review process.

We cannot publicly disclose the data at this time as it would undermine the peer-review process and jeopardize the publication.

However, I can promise you that the journal paper will be open access when published so that everyone can access it for free.

Thanks again for you patience in waiting for the data and your continued interest in our company. Keep an eye on the company Twitter feed for updates.

Kind regards, Ross

Ross O'Neill

 

So we should wait 15 weeks for the trial data?

 

Behavioral based initiated disease processes (smoking, sedentary lifestyle, poor diet [you could throw excessive drinking into this category]) like coronary artery disease, diabetes, etc. cost this country enormous amounts of money not only in health care costs, but in lost productivity costs as well.

We are talking about 100's of billions of dollars over the last decade alone. Yes, billions.

I cannot imagine that the hearing health industry can come even close to this payout even in it's worst presentation. Yes, it would pay huge dividends to all of us if we could get the federal government to recognize the enormous problem here, and realize it is fixable in most cases. The clinical research I see in tinnitus and NIHL is in it's infancy compared to the cardiac and orthopedic industries. There is NO comparison.

If those kinds of resources could be directed, even 10% of those, to hearing issues, I'm not sure this forum would even exist other than to tell our success stories...

 

No not at all - I've just asked Ross when they will be available and via me you will have a very quick and honest appraisal. I'm buzzing a bit now as after 4 weeks of a spike it seems to have softened...

Hang in there guys. the Irish will sort this monster out!

Ross O'Neill is the 2nd coming of Jesus!!!

 

Either it works or it doesn't. These people need to understand that we urgently need relief. Why would this need 15 weeks?

 

It will likely take that long because the peer review process takes 3-4 months to complete.

 

One of a researcher's greatest nightmares is being discredited during the peer review process. If your data doesn't survive this scrutiny, then you are basically sunk along with your therapy, drug, device, idea, etc.

Not pretty.

Scrutiny by several accredited sources takes time. That's just what is needed to make sure the data is solid.

I know, easy to say while we all sit here and listen to.....eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee......!

 

Still it'll be 1 year before Shore's...

 

You are right about that. This is definitely better than nothing.

 

Right, but it'll get CE mark and approval way before FDA approval if history is any predictor of the future. We always use to get our devices approved in the European markets first while waiting for the FDA to come back from their months long coffee breaks [in their defense, they are so incredibly under-funded and under-staffed to this day].

If all goes well, you Irish will get it soon, so why don't you buy a bunch and see some of your Tinnitus Talk friends in the States??

 

Can you buy a bunch? - | Hey Ross Bob here - throw us over 12 of those MuteButtons will ye and a packet of crisps!

Lol.

Dude if something can be arranged I'll do it for sure... Need to make sure it does something, first phase did fck all I think.

 

Oh how so I disagree. I think the medical establishment in western civilization is a shame. Why does the peer review process need to take so long? Seems like a very arbitrary time frame anyway. Is it because of a lack of resources? That's pitiful.

 

I think it is lack of resources.

 

I'll absolutely help if I can in any way I can. I realise how urgent things are... If I can get multiple machines I will - they need to be fitted individually though? Look we'll cross that bridge when we come to it...

Guys we're all in the same boat - the clock is ticking. We all need a cure soon otherwise it's curtains - I understand fully.

I spent the day working at home and looking at pictures of the Cliffs of Moher wondering what it would be like to just go....

There's no group of people I would like to help more... My Tinnitus Brothers and Sisters.

Who we really need on the case is Elon Musk... He would sort this sh*t out in no time.

If we all send him a tweet and said Elon - 700 Million People would be cured if you just helped Susan Shore get her device to market... He could bite, you never know.

The guy is a genius and very unorthodox.

I'll be honest. I already sent him a tweet to that effect... We need help.

All the best,

R