Lenire — Bimodal Stimulation Treatment by Neuromod

Would love to know if that was from Neuromod or someone just speculating.

 

I don't recall that ever being said, but it is possible. You are only supposed to use it for three months, it would seem kind of strange to have to get it switched out after two months. I would think you could just sanitize it after use.

 

It was for sure stated in the Neuromod thread, but it could've been speculation... I do not remember it sadly. I also read somewhere on Neuromod being rented, too. Eesh, so hard to remember and recall.

 

Yes, with the first edition of MuteButton you had to replace the tongue tip after several hours and it wasn't cheap either, it is somewhere in the MuteButton thread. I don't know if this is also the case with the new device.

 

I found an old article from ENT and Audiology news for the first MuteButton. It's dated Jan/Feb of 2015. It states "The tonguetip is a consumable supplied with the device to be replaced after 90 hours of use. For patients using their device for 30 minutes a day, this would equate to a replacement after six months." I'll try to link it here.

Until we hear from them I'm going to assume this is still true. Clearly this part of the device would be subject to wear and tear that could alter its effectiveness.

https://www.entandaudiologynews.com/media/4231/entjf15-spotlight-new.pdf

 

@Hazel, nice one on the Lenire introduction post - very good and informative, especially for newer members who are unaware about the history of MuteButton/Neuromod/Lenire etc.

@Markku, I'm surprised. I thought they had given Tinnitus Talk an update.

My take on the whole no communication thing is this. I’ve personally sent them a few emails and they’ve responded every time. On one of them I had asked about why the inclusion criteria was as it was, they replied saying they will pass it onto somebody and within a week or so I got a reply.

What I will say is this. They have no obligation to talk to us but they have already done so in the Q&A. They have already replied to our emails even though they haven’t given some of you the direct answer you wanted. They are a business. They run like any other business. Like it or not, they’re not disclosing some information as of yet.

Also, it was clearly explained by Ross O’Neill that they don’t want to undermine the peer review process - take that as they are not yet ready to discuss queries into some aspects as the peer review process may not have been completed as of yet.

I feel the frustration along with everyone else. Yesterday I watched a film called Silence and in it some girl lost her hearing through a car accident. When it goes in her first person, a high pitched ringing noise appears with the muffled sound. I have no idea how this relates to MuteButton as I’ve completely forgotten what I was trying to say. Oh that’s it, I can relate to it, it’s crap, we’re all in the same boat of tinnitus.

 

I would be interested in this as well. I can understand their market share shrinking because of other devices potentially coming into the market like Michigan. I can also see their explosive growth internally from investors due to being the first device of its kind that actually works, but I don’t see either of these as being an issue. They will be the first on the market and get a huge surge of the market.

 

I'll give Lenire a try. I'm heading to a clinic this week in the meantime for TRT because of a tinnitus spike. God, I'd gladly pay even $10K just for treatment that reduces my volume to manageable levels :/

 

Let’s stay optimistic... the three most promising treatments for tinnitus today are all founded on bimodal stimulation and one of them is going to be launched very very soon!

Remember Clare B’s testimony

And according to me, if the device didn’t work, Neuromod wouldn’t launch it a second time on the market... to lose total credibility and money in a few months...? Hubert Lim came to work with Neuromod’s team because the device is interesting and effective, it seems very positive!

Hope, hope, hope!

 

Do you know if Lenire might also improve hyperacusis?

 

@erik

I have witnessed this too. I think newbies to tinnitus should be cautious. I’m not expecting anything, I am interested in it, but just not expecting anything. Who knows though Erik this could be a real treatment unlike the others, but let’s not put all our eggs in one basket.

Anyway over the next year we will find out if it’s as good as they say and will have both the papers from both trials and real life testimonials here.

I’m sitting back and watching the evidence unfold whether it works or not before parting with any cash.

 

O'Neill said it's not a treatment for hyperacusis. While people with hyperacusis were super-responders and had a response rate of over 90%, their LDL (Loudness Discomfort Levels) hadn't statistically changed.

Spoiler

Ross O'Neill:

• No, and that is a very important point: These are tinnitus patients who have a concomitant hyperacusis, but what the data is saying to us is, it's not a treatment for the hyperacusis. We defined hyperacusis as sound sensitivity to loudness discomfort levels (LDL) of 60 decibels sound level (dB SL) or less; and when we looked at the hyperacoustic patients' LDL scores before and after, they hadn't statistically changed, but, their tinnitus scores changed dramatically.
• The response rates are over 90% in that group [meaning hyperacoustic people]. The levels of response that they are getting are twice what the rest of the people are getting. And then there’s just the rest of the tinnitus population.
• So, the more hyperacoustic you are, the more responsive you are to this treatment, the more benefit you will get from it.

All quotes can be found in the interview.

 

@Paulmanlike - Do you know why the inclusion criteria was as it was? I'm sorry if you've answered this question and I cannot find it, but could you share this information?

 

My question was why was tonal tinnitus part of the inclusion criteria for the TENT-A2 study. The reason I asked this was that in the Q&A they mentioned the tonality/atonality/pitch doesn’t matter as to why I was concerned that you had to have tonal tinnitus for the second large scale study.

The reply was as follows:

Thank you for your interest in Neuromod and for your enquiry. Clinical trials are designed to ask and inform specific research questions. The evidence to answer these research questions is gathered by enrolling patients according to pre-defined inclusion and exclusion criteria. The evidence is then used to support regulatory applications, where the recommended use is published in the approved labelling. Specific inclusion and exclusion criteria will vary from trial to trial, as the research questions for each trial may vary. Evidence from multiple trials may be considered when determining the appropriate use of a treatment. The inclusion and exclusion criteria for TENT-A1 and TENT-A2 differ in a number of respects; the reasons for the differences are related to the underlying goals and objectives of the clinical trials.

To date we have not seen evidence that the tonal or atonal nature of tinnitus experienced influences an individual’s suitability for the treatment.

Once the device is approved and available in your region, your healthcare professional will be trained on the recommended use and the evidence that supported the regulatory approval. Your healthcare professional will determine on an individual patient basis whether the treatment should be recommended taking into account many factors including tonality/atonality.

We thank you for your question

With best wishes

Neuromod

 

Response to @erik:
My sentiments exactly.
I can't go through with a very costly, time consuming, and unbearably disappointing experience (as I did with Desyncra) again.

I feel like this is a case of Charlie Brown and Lucy and the football.

 

So in the end tonality does count?

 

All we can do is be positive that at least in 2019 another product is coming to market that claims to have an impact on tinnitus. Not only that, they have had the largest clinical trial to date... these things costs thousands and everything else in the past had a very limited evidence base.

For those newbies, let me rewind to 2008.

The internet was full of miracle snake oils and the only thing that to me looked genuine was the TinniTool (a laser device with a fancy scientific reasoning to how it worked to regenerate the cochlear). Then there was Dr. Wilden. Of course, you might find one or two testimonials today but these things need a lot of testimonials to be proved effective. Bimodal neuromodulation was unheard of. Hearing regeneration was a dream of the future and Frequency Therapeutics, Decibel Therapeutics didn’t exist. Auris Medical was in the very early stages of trials. Dr. Josef Rauschecker, Hubert Lim, Susan Shore, Thanos Tzounopoulos were never talked about in the tinnitus community. Tinnitus Talk didn’t exist. Just a small forum on RNID back then. Very little research. A lot has happened over the last 10 years. Just search on Google on the amount of papers submitted on tinnitus and how it has grown. Tinnitus Research Initiative didn’t exist. Hearing Health Foundation on the search to cure deafness.

Now go back to 1998 and the only thing what was available was maskers, hearing aids and TRT. A cure was not seen as anytime soon or even a treatment. Imagine if you are new to tinnitus and being in 1998... you’d just be left to deal with it with no hope of it ever getting better. Just plain old habituation. P.S. I’m habituated, that doesn’t mean I like it, but I tolerate it without the immense feelings of depression and anxiety.

It’s a good time to be alive... tomorrow is a step closer to a treatment and to a cure. But it is also a step closer to the day you die.

I can honestly see the next ten years bringing some exciting things on the market. I didn’t get the cure I hoped for but remember this:

The prevalence of tinnitus is only going to drive the development of products or drugs to meet this need. There is huge incentive to get something on the market because like you, I would pay a lot to get rid of it. They know that. And fair enough constructive cynicism is fair. Lots of crap has hit the market but we are only going to know if Lenire is another one of those in the next 6-12 months.

@Aaron123, we really want to hear your thoughts on Neuromod and bimodal neuromodulation.

 

I feel both happy and saddened by your post Paul :-(
I remember in 2013 thinking there was a cure coming in 2017 and in 2018. Then I read 2020. Then I read about the failures of drugs and more and more I read that these novel treatments may or may not hit the market, or there will be treatments, just not for a certain type of tinnitus etc. Etc. I've had tinnitus for 21 years and I wonder if I'll ever be helped. X

 

I'll say this, we do know that it can be modulated both up and down, that is a fact. Which means if adequate resources are employed, there can be a treatment and that it's entirely possible.

 

To my knowledge there has not been any bimodal stimulation device of this kind on the market before. There have been sound treatments before but the bi means that there are 2 inputs at once. In this case both electrical stimulation and sound stimulation. I would also wager that the other treatments i.e. sound only don't have a lot of empirical evidence to back their claims up.

 

Do you know if Lenire might have any kind of side effects?

Maybe we will all get Alzheimer's 5 years after the treatment ahahah.

 

Although it is not a treatment for hyperacusis, I remember reading that after getting rid of tinnitus @Clare B also got rid of the sensitivity to specific sounds that she had, like cleaning plates. I am in no way an expert in how this technology works down to the smallest detail but I suspect, that it might also help some people with their hyperacusis to some extent.

 

So what does this mean about tonality/atonality? I was under the impression it didn't matter how loud or how many noises you had or the frequency of your tinnitus.

Can someone please explain?

 

The answer is in the text you are quoting:

Is that not what you are asking?

 

I think the email is saying even further that it doesn't matter how loud your tinnitus, how many noises you have or what is the frequency of your tinnitus.

 

A friend of yours didn't try Lenire. I think it's highly unlikely this will burst on the scene and everyone who tries it doesn't fare better than placebo. For some people it WILL make a noticeable difference. Maybe not 80% as advertised, but some, and then it will be up to us all to make an individual decision whether to gamble our money.

 

Here is something that has never been addressed.

They need an audiogram to calibrate the device, audiograms only go up to 8 kHz.
How do they calibrate the device for tinnitus higher than 8 kHz, which I would argue is the worst kind.

Also, in general the audiogram resolution is seriously outdated, for example the 3 kHz tone would miss my sharp dip at 3.2 kHz.

Building new technology on top of outdated technology seems like a bad bet to me.

 

Maybe so, but the results they've gotten so far have been accomplished in spite of said outdated technology. So that's the baseline and it can only get better from there.