Q&A: Tinnitus Hub Meets Neuromod (Lenire)

[Autumnly]

Does this work on hyperacusis?
Does it work on reactive tinnitus?

It didn't reduce hyperacusis but people with hyperacusis responded particularly well. They tested their LDLs at the beginning and at the end of the trial if I remember correctly, and they hadn't really changed, so the device doesn't seem to improve hyperacusis.

I don't think reactive tinnitus was mentioned in the Q&A but there was a man in the patient stories who said his tinnitus isn't as reactive anymore. His tinnitus would for example spike if he was near a refrigerator and that doesn't happen anymore.

 

[spedgas]

The next question I would have for them is, after the first treatment what is the next step? Does the treatment repeat after a year? Would it have a compounding effect over time?

This was a big mystery for me as well. They don't seem to have a current plan for patients after a year. That's as long as they tracked anyone. I don't have any reason to think the effects wear off after a year. This was a question I posted in the original Q&A post. If repeated treatments are needed do future treatments lose efficacy. Like a person building tolerance to certain drugs.

 

[RCP1]

I'm feeling skeptical when @Steve asked Ross if he has any brain imaging data to measure the improvement (Question 28). His answer didn't convince me at all.

There are no definitive imaging that show tinnitus on any machine in existence...

 

[Steve]

This was a big mystery for me as well. They don't seem to have a current plan for patients after a year. That's as long as they tracked anyone. I don't have any reason to think the effects wear off after a year. This was a question I posted in the original Q&A post. If repeated treatments are needed do future treatments lose efficacy. Like a person building tolerance to certain drugs.

I did ask that question. There isn't anything to say that it will wear off and there isn't anything to say that the effect should be any different. The official line from Neuromod can only be the data they have collected from the clinical trials - which is the 12 month follow up.

 

[Jack Straw]

I did ask that question. There isn't anything to say that it will wear off and there isn't anything to say that the effect should be any different. The official line from Neuromod can only be the data they have collected from the clinical trials - which is the 12 month follow up.

I hope they do testing with those groups again to see if there is a difference.

 

[Rings-a-Bell]

TRT claims it helps 90% of the people who do it. The interview says there is a clinically significant effect on 67%.

Can someone help me by clarifying why this is a better claim?

 

[Jack Straw]

TRT claims it helps 90% of the people who do it. The interview says there is a clinically significant effect on 67%.

Can someone help me by clarifying why this is a better claim?

TRT is bullshit and isn't peer reviewed or accurate statistical results. That's why.

 

[GregCA]

There are no definitive imaging that show tinnitus on any machine in existence...

There is, with an fMRI.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3692468/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4334979/

If you search for "fMRI tinnitus" in pubmed, you'll get a few studies to peruse.

 

[Don Tinny]

TRT claims it helps 90% of the people who do it. The interview says there is a clinically significant effect on 67%.

Can someone help me by clarifying why this is a better claim?

They say that this device reduces the volume of your tinnitus. It is a physical effect. TRT "improves" your perception via habituation.

 

[Bam]

Does that mean my family doctor has to send them a request? Under the care is very vague term, what are they expecting the physician or audiologist to do. is it just for reporting the side effects?

Bottom line I need to try this ASAP. I'm not doing well at all. I don't think I can wait another year or so. I wonder if living in Canada will complicate matters more or not.

Eric if you're really desperate all you need to do is fly to Ireland, rent a holiday home, visit a clinic that sells it, do an audiogram, buy it, give your rental address if totally necessary (probably not even required) and then go on your way.

I can't see why being from another country is any bar whatsoever to getting hold of this and indeed when @Steve and Ross where discussing this neither did they.

The real issue is will it work for you and what is your reaction going to be if you fly around the world, drop 5k on it when all is said and done, and it doesn't work at all?

Can you mentally deal with that outcome?!? Might you be better off waiting for some reviews from Tinnitus Talk members and making a more informed judgement further along the line?

 

[winstona]

Thank you @Markku and @Steve for your efforts in getting this Q&A to us!

This is my first post in the forum but I have been lurking around in this board since the onset of my tinnitus a little bit more than a year ago, just never found a reason to post yet.

I too wish to know more about importing this device into Canada as I don't live in the EU and I am afraid the wait is just going to be too long for this device to finally make its way to North America. I am willing to travel to Dublin but hope to be able to just buy the device and have an audiologist adjust it here.

I have tinnitus that fluctuates and it varies in intensity and volume day in and day out in a somewhat predictable cycle. I seem to have heard from the video that tinnitus sufferers like us can also benefit from this treatment so I am hopeful that it will help me too.

I am somewhat sensitive to high pitch sounds, whenever I hear them my ears can get either itchy or painful depending on the day of the cycle. I am not sure if this classifies as a very mild form of hyperacusis but I also hope I can be in the group of hyperacusis and tinnitus combo where this machine is most effective on.

I really hope this is it, finally something that helps!

Winston

 

[spedgas]

I did ask that question. There isn't anything to say that it will wear off and there isn't anything to say that the effect should be any different. The official line from Neuromod can only be the data they have collected from the clinical trials - which is the 12 month follow up.

You did a great job Steve, please don't take that comment as anything negative. I appreciate that Neuromod is only going off the data they current have. I certainly don't want them to start guessing the future when they don't have that data yet. None of us want that. He answered as best he could with what he had. They left me with no reason to doubt that the effect would be any different a year out from treatment.

 

[EDDTEKK]

Is there currently any trial still running? Sorry I couldn't catch that properly from the discussion.

 

[PDodge]

How many units are out there? Cause they're gonna need a lot haha PLZ B REEL

 

[Manny]

Hey there TC. Thanks for discussing this with me.
I want to reply to your post section by section.

Hi Manny,

Indeed there were 3 arms and there were improvements in all 3. However, compared to the other groups, the group that used high frequency synchronized stimulation had better sustained effects after they stopped using the device.

This was an exploratory study, so really the purpose was to choose the best frequency and timing of the stimuli to program into the device and carry that forward in additional studies.

Yes. I did notice after I posted that this was categorized by Neuromod themselves as an exploratory study, and I do agree that that is a reasonable explanation for the lack of a pure placebo arm. Relatedly, the current TENT-A2 study is also described as a parameter optimization and patient sub typing study, and it also lacks a pure placebo arm. (https://clinicaltrials.gov/ct2/show/NCT03530306)
But, the fact remains that a claim of 80% or 67% efficacy is not well substantiated, due to the possibility of the placebo effect.

Coming up with a true placebo for a device study can be extremely difficult. Ideally, all the subjects entering a study should have the same level of expectation for efficacy of the treatment they receive. If there were to be a group that simply put the headphones on and put the tongue tip in but never heard any sound or felt no pulses on their tongue it's doubtful they would have any expectation for efficacy at all and so they would be unblinded.

Agreed. It may even be impossible to come up with a convincing placebo that is also ethical (perhaps a random stimuli sequence could worsen tinnitus?). But again, the fact remains that there was no placebo.

Also, in situations like tinnitus where the condition and treatment is unique to an individual, analyzing change from baseline as the statistic can be appropriate. In that situation the patient is serving as his or her own control.

The patient can effectively serve as their own control, but it would equate to a zero-intervention control, not a placebo control.

IMHO, addressing the topic of negative control and proper statistical analysis is something Neuromod probably struggled with while setting up their clinical program. This is one of the reasons peer review is important. No doubt Neuromod bashed things out among themselves including with some well known tinnitus researchers and key opinion leaders and made some decisions. Next they may have to go back and forth during peer review to defend and educate about their choices. Further complicating matters is the fact that clinical research for tinnitus treatments is pretty much in its infancy, so Neuromod are doing some real trail blazing here.

Agree. I was definitely impressed with the video in general and I do think they're at least onto something. O'Neill dropped all the right pieces - Susan Shore, central gain, Schaette, Charles Liberman...
I am impressed by and grateful for their work and they do seem to to be doing some trailblazing, and that's awesome.

I just haven't seen a placebo-controlled trial yet, so I don't see the video's 80%/67% claim as well-substantiated. That's what I find quite unsettling!!

Would be interested in hearing your further thoughts on the matter.

 

[Bndsmheowqhe]

I think the long and the short of this is that it will be a less effective version of the University of Michigan device but it will clearly be beating them to market. I just hope it doesn't turn into a VHS/Beta situation where the better product loses steam and dies off.

 

[Starthrower]

- @Steve took time out of his busy schedule to travel to Dublin to meet Neuromod;
- @Hazel spent 8h curating and structuring the interview questions, another few hours advising on video production, and will spend probably about 10h on the – yet to be created – sub-titles (volunteers are welcome!);
- I myself spent about 30h on video editing and production. It's definitely the biggest video project we ever did!
- @Ed209, @Jack Straw and @TuxedoCat functioned as our review panel, providing valuable feedback.

We hope you find this video useful and informative. If you do, please share the video on your social media and help get it out to more tinnitus patients!

Thanks to @TuxedoCat, @Ed209 and @Jack Straw also.

 

[Philip83]

Another big question that I felt wasn't answered;

They say that the device is setup after what type of hearing loss you have, which is all fine.

But to what frequency range is this being made? For a huge amount of people, me included, my main tinnitus is a 10 kHz+ tone/hiss, but almost all hearing tests only go up to 8 kHz. If you (and your ENT, audiologist) don't have the profile data for your hearing loss above 8 kHz, how do you calibrate the machine for that loss?

 

[spedgas]

Eric if you're really desperate all you need to do is fly to Ireland, rent a holiday home, visit a clinic that sells it, do an audiogram, buy it, give your rental address if totally necessary (probably not even required) and then go on your way.

I can't see why being from another country is any bar whatsoever to getting hold of this and indeed when @Steve and Ross where discussing this neither did they.

The real issue is will it work for you and what is your reaction going to be if you fly around the world, drop 5k on it when all is said and done, and it doesn't work at all?

Can you mentally deal with that outcome?!? Might you be better off waiting for some reviews from Tinnitus Talk members and making a more informed judgement further along the line?

You bring up a really good point. I'm just spontaneous enough to go to a great struggle to get this device. However, individually we all need to take a step back and answer these questions for ourselves. I'm still fairly new to tinnitus and don't even have certainty at it's cause. I'm nearly convinced its my TMJ. They said bluntly that this device is not for that type of tinnitus. The benefit I have of being in the US is that it isn't immediately easily available to me. This gives me time to really get to the bottom of the devices claims and the source of my own tinnitus.

 

[Rings-a-Bell]

They say that this device reduces the volume of your tinnitus. It is a physical effect. TRT "improves" your perception via habituation.

This sounds good... of course there is no way to measure the volume other than perception. But I think that perhaps the difference is, someone doing these therapies might say:

TRT - "I notice it much less throughout the day and it emotionally bothers me less, but when I listen for it is still just as loud"

MuteButton - "When I listen for it the volume appears to be much reduced compared to how I remember it. As a side effect of the reduction in volume I am noticing and being bothered by it less throughout the day."

 

[Mike T]

Thanks @Markku and @Steve for posting this video. I really hope this takes off and hopefully helps the countless people out there suffering as soon as possible.

 

[Ecip]

Wow, ok. Interesting. Neuromod actually seems to got something going on. I'd totally fly out to Ireland to give this thing a try.

Very curious about price point though... I expect somewhere between 3000 to 5000.

 

[RCP1]

I too wish to know more about importing this device into Canada as I don't live in the EU and I am afraid the wait is just going to be too long for this device to finally make its way to North America. I am willing to travel to Dublin but hope to be able to just buy the device and have an audiologist adjust it here.

FDA approval within 2019 - Won't be too long before you guys can get it. By then you will have the benefit of many user experiences.... Hang tough.

 

[Don Tinny]

I think the long and the short of this is that it will be a less effective version of the University of Michigan device but it will clearly be beating them to market. I just hope it doesn't turn into a VHS/Beta situation where the better product loses steam and dies off.

But Shore's device is only for somatic tinnitus. Am I wrong?
Neuromod excluded somatic cases for trials.
Maybe there is a big difference...

 

[spedgas]

I think the long and the short of this is that it will be a less effective version of the University of Michigan device but it will clearly be beating them to market. I just hope it doesn't turn into a VHS/Beta situation where the better product loses steam and dies off.

Can anybody think of a reason an individual couldn't use both devices? Neuromod to hold you over until the Shore device shows up. I'd like to give that a go.

 

[MarkLud]

I think the long and the short of this is that it will be a less effective version of the University of Michigan device but it will clearly be beating them to market. I just hope it doesn't turn into a VHS/Beta situation where the better product loses steam and dies off.

I tend to agree with this sentiment at the moment, too, based on all that we know. Hoping it's even better than anticipated but until we know more I think like many of us I'll be pondering trying this or waiting for the Michigan/Minnesota devices (that may be better off) to come out.

 

[dayma]

FDA approval within 2019 - Won't be too long before you guys can get it. By then you will have the benefit of many user experiences.... Hang tough.

Not if I come to Ireland first

 

[OnceUponaTime]

I'll be pondering trying this or waiting for the Michigan/Minnesota devices (that may be better off) to come out.

Do we even know when this is coming out??

 

[RCP1]

Not if I come to Ireland first

Ah now I think I'll have to have a word with Ross O'Neill about all these folk coming across to our lovely island with the sole purpose of stealing our technology... We'll have to arrange a little brown envelope scenario;

I'll wait outside the door and you can pass me your offering in a little envelope.

At the end of the day if myself and Ross have enough to get 2 flaggens of cider and a chicken bucket from KFC we will remotely trigger the devices to perform properly during usage - otherwise users will be forced to listen to Boney M for 12 weeks.

 

[DonLeon]

I tend to agree with this sentiment at the moment, too, based on all that we know. Hoping it's even better than anticipated but until we know more I think like many of us I'll be pondering trying this or waiting for the Michigan/Minnesota devices (that may be better off) to come out.

Did the other two upcoming devices release more info about the % it helps or something? I'm not seeing anything that shows MuteButton is any more or less effective than the others, so where is everyone getting this from?