Lenire — Bimodal Stimulation Treatment by Neuromod

@DaveFromChicago

Do hearing aids help some? Make sure you get plenty sleep. One ENT says it goes to your brain.

Calling the noise annoying is an understatement. I still haven’t found anything that consistently shuts it off.

 

@ruud1boy

Have you been on PS1 setting for the whole year?

 

From the Tinnitus Talk survey it was clear that people with high pitch tinnitus respond better to the treatment. What is actually meant by high pitch (among the survey group)?

Were there any people in this group with tinnitus higher than 12kHz and experience some improvement?

Elsewhere I read that Lenire only goes up to 8kHz. Is that true?

 

Mine is higher than 12 kHz and I experienced modest improvement. Not sure what the profile is for the sound portion of the treatment. It is a wide spectrum noise that is supposed to capture both high and low frequencies. Because of this they don't measure the pitch of your tinnitus when they set up your treatment, only set the volume to your audiogram. That being said it is based of a standard audiogram that tops out at 8 kHz so I don't know if any of the frequencies in the static noise goes about 8 kHz. I certainly can always hear the tinnitus above the treatment sounds.

 

Yes, that was a weird result. We only asked the patients if their tinnitus was "Very High" or "High" etc without any further elaboration.

I had a look at the results again. There is no correlation between pitch and hearing loss or pitch and hyperacusis (something that was looked at in Report 1). However, every patient who has very high pitch either has hyperacusis or no hearing loss! I guess we don't really have enough data.

You can see some of the overlap below.

 

Would it be possible to ask those people to provide their tinnitus frequency (if they are able to measure it) and implement it into the survey?

I would also ask if they experience residual habituation and if their tinnitus is somatic.

Maybe we will find out that above certain frequencies the treatment is ineffective. My tinnitus is somewhere between 13-14kHz. After 4 weeks of using Lenire I don't see any progress. Also I don't see how the device would target those high frequencies. My guess is that it is through that broadband white noise but does this noise go all the way up 14kHz? Wish they would provide some specifics of why they use certain sounds, what is their frequency range, etc...

 

The Tinnitus Talk stat results do show clear signs of improvement for certain sub types. That said, I've often felt the user experience anecdotal reviews leaned more towards the negative, which is strange. Furthermore, where there was improvement it appeared the user would need to rely on hyperbole to articulate exactly what that improvement was.

I don't want to come out and state that I believe Lenire is a dead duck. Having said that, I'm more puzzled now than I ever was about the efficacy of the device.

 

Still no peer review, and it's now July 2020. Alarm bells ringing here and not just in my ears.

I had high hopes for Neuromod, although realistic, but I cannot for the life of me, have hope anymore. Bear in mind I've watched various trials and products released over the years.

I remember purchasing a Tinnitool. Behind it was a commercial study from the inventors which stated that 60-70% got improved tinnitus (out of about 70).

Lenire is just not convincing to me who knows a little about tinnitus.

If I honestly believed I had a 70/80% chance of lowering the volume of my own tinnitus, I would not hesitate to jump a plane to Ireland or Germany and part with 3k to do this.

I can honestly say as well that I have some days where I think hey it's a lower today, followed by weeks of torment. I can't even confidently say the volume changes, maybe it's just my perception of it changes. That's just how tinnitus works.

 

Yeah, but they can always use COVID-19 as an excuse.

 

As they’ve already done. Advising me, from an office in Dublin, that the worsening I experienced was due to stress from COVID-19. A dastardly way to rationalise the real dangers of their “tinnitus management device”. I would therefore not give much credibility to the results if and when they are published.

Lenire has shown itself to be an elaborate hoax, no matter how much “positivity” i.e self delusional spin some other early adopters put on it.

Placebo is the best you can hope for from Neuromod's bimodal neuromodulation tinnitus treatment. You have been warned.

 

To MadsWithT:
You are utterly correct. I originally had these deeply ingrained suspicions right after I listened to those tepid, so-vaguely-unconvincingly posted trial interviews on YouTube.

 

For the sake of consumer-advocacy alone I'd like to see Tinnitus Talk have a reckoning with Neuromod. I know they've indicated that it would be a waste to continue to invest time in it but I do think it's important for closure's sake.

 

That does not surprise me since the entire clinical definition of hearing loss is based on a 125Hz-8000Hz pure tone audiogram. It's probably safe to assume people with very high pitch tinnitus have an undocumented hearing loss.

I came across some people with tinnitus who don't have loss even on an extended audiogram, but it's a minority.

I really don't understand why this isn't studied more. Audiologists keep quoting the same stupid numbers even though when pressed they must admit the data is flawed and more research is needed. How hard would it be to let a Ph.D. candidate run a study in a tinnitus clinic? All it takes is 5 extra minutes in the audio booth.

I've seen a preliminary study suggesting that when performing an extended audiogram, the group "without hearing loss" suddenly shrinks by a lot.

What about those with hearing loss and no tinnitus?
According to Dr. De Ridder, they must have something in the brain that does not try to compensate for hearing loss by mal-adapting and introducing noise in the system.

 

Just had a good read last night of the excellent study done by Tinnitus Talk and @PeterPan.

It seems the small sample size corresponded with Neuromod's trial results.

• If you have hypercausis and no hearing loss, you can potentially get excellent results and more likely to be a responder.
• If you have no hypercausis and no hearing loss, you can potentially get good results.
• If you have hearing loss and no hypercausis you chances are slimmer.

Seems too coincidental that this matches.

Are there anymore plans to keep on collecting data from Lenire users? Obviously the numbers are too small, but if it was collected over a couple of years, or results published like every 6 months. Obviously people have their lives to lead, but what about an ongoing survey created that people can add to that wouldn't involve all the work.

 

I'd like for the people who dropped out due to increased symptoms to be followed up on, ideally.

I know that this might not be possible -- it might not be responsible to contact them and remind them about their tinnitus -- but if their symptoms have improved/returned to normal, as Neuromod claim they will, that would be game changing. It would mean that for a lot of people it would be worth a try. I think without this info, we can't know how successful Lenire is from the Tinnitus Talk study alone.

 

Seems like the majority of people here fall into group 3 unfortunately.

 

It's not that one's chances get slimmer in this category. The symptoms actually got worse.

Agreed. If 100% of those whose symptoms became worse after 12 weeks of treatment returned to baseline in a reasonable period of time I'd be willing to take a punt.

 

A lot of people have reported this, as did some of the Lenire testimonial users; their tinnitus hasn't necessarily changed, but their feelings about it have and they can cope with it a lot better. I know it's not what people were hoping for, but it's definitely at least a partial success.

 

@Lurius - what timing did they put you on, PS4 or PS10?

 

What caused your tinnitus?

 

I don't know for sure, but probably PS4. They only ever referred to it as "the 2nd setting".

It says in my profile, but doing the Valsalva maneuver after being sick for a week. I blew way too hard.

 

Please tell me this is a joke? Pathetic. The person whom said this should be slapped.

 

I was on their default settings throughout.
IIRC it was PS2 to start with, then PS4 for the next stage, then back to PS2 - the names might be wrong & I've no idea what they mean, but they changed the settings at my first review (3rd visit to the clinic) and then changed them back again, as per their normal protocol. I couldn't discern any difference between the different settings and, as I've noted previously, neither of them did anything for my tinnitus.

 

This is possibly the best description of 'problem', 'intrusive' tinnitus I've ever read.

I find myself constantly asking - myself, since no-one else gives a shit - how can this be allowed? How is it possible that I can be tortured like this, day after day, month after month, year after year, and all the medical community have to offer is 'it's a benign condition - it won't do you any harm'. Thanks for that - it'll be of great comfort when I eventually string myself up from the tree I've selected in the woods near our house. Tell my kids it was only 'a benign condition'.

 

@Lurius Do you have hearing loss and/or hyperacusis?

 

I had some nasty hyperacusis for the first 5 months after I got tinnitus. It's gone now, though.
I have a dip of -60 dB in the 6 kHz range in either left or both ears. It's a little hard to tell, because I've done multiple tests and some of them showed the dip only in the left ear, others showed the dip in both ear. I only have tinnitus in the left ear. I hope that answers your question

 

To ruud1boy:

I find it utterly incomprehensible that a condition that involves the reception of intrusive, foreign voices such as schizophrenia is thoroughly researched with the utmost seriousness (since, among other reasons, the suicide rate is appalling.)

Why hasn't the Worldwide Medical Community still not ascertained that what constitutes a very similar condition involving the reception of unwanted, constant, intrusive, foreign sound is every bit as disabling?

And, therefore, in dire need of such thorough research and treatment?

 

Unfortunately I know what you are going through. It's a big fail of our society not paying attention to this terrible condition. Neuromod is the first to do something but why they don't publish science behind the device or why is one setting for all... well that's a huge mystery to me. All they ask at the interview is "describe your tinnitus". I wonder how they could possibly improve their device with the information they have from their patients.

Then there was Trobalt. Super effective drug to alleviate tinnitus for a few hours that helped many. The mechanism of the drug is known. Why on earth only one team works on the successor of this drug? Why are they having trouble with funding? US army generates thousands of tinnitus sufferers every year. Their daily spendings are in hundreds of millions yet there's a problem to support some research and help propagate the drug that millions would profit from greatly.

 

I know what you are talking about, often I think "how on earth can this be allowed???".

But today is quite a good day, for me I think Lenire works, but veeery slow, I'm approaching 5 and a 1/2 months.

Lenire is still the best shot on the market guys. I'm still trying to figure out how it works, but it does something.

 

It's this exactly what I don't get. People reported tinnitus relief/reduction, something little else had ever managed to do. Why didn't they jump right on it given the huge market?

Right, because it won't actually kill us. Tell that to our minds and adjustments in life just because a condition is benign doesn't mean it's not utterly debilitating.