Lenire — Bimodal Stimulation Treatment by Neuromod

[grate_biff]

How do they calibrate the device for tinnitus higher than 8 kHz, which I would argue is the worst kind.

This is a relevant question. Can´t believe we did not enter that into the Q&A?

 

[jmasterj]

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Also, in general the audiogram resolution is seriously outdated, for example the 3 kHz tone would miss my sharp dip at 3.2 kHz.

Building new technology on top of outdated technology seems like a bad bet to me.

Audiograms can certainly go above 8 kHz. Most ENTs and audiologists only test up to that range because that is the human voice range. I have seen at least 16 kHz and I believe some even test to 20 kHz. It sounds like they have found that one of the arms in the test works best for all tinnitus. We really won't know until we see the studies though.

 

[GregCA]

How do they calibrate the device for tinnitus higher than 8 kHz, which I would argue is the worst kind.

The calibration is independent from your tinnitus kind (tonal/atonal/etc) and/or your tinnitus frequency. What is required to configure the device is your hearing thresholds, presumably to make sure the volume of the stimulation is such that it can be heard by the patient.

 

[RaZaH]

Audiograms can certainly go above 8 kHz.

Of course they "can", just nobody does them. And they are highly inaccurate.

 

[RaZaH]

What is required to configure the device is your hearing thresholds

Which makes the hearing thresholds at the relevant frequencies important.

 

[GregCA]

Which makes the hearing thresholds at the relevant frequencies important.

There are no relevant frequencies. You are assuming that your tinnitus frequency is a key element, but it's not, according to them. Your tinnitus frequency is not an input at all in the configuration of the device. Again, that is according to them.

This is unlike other therapies such as ACRN or windowed white noise or notched therapy, where the tinnitus frequency is a key input into the sound generator.

It may sound counterintuitive, and there are reasons why you (and I) would think that perhaps it matters, but they claim it doesn't.

 

[erik]

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.

What evidence and facts outside of what the rest us have seen leads you to this conclusion?

 

[erik]

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.

The results are always typical of a device like this. That is why they all eventually come to market.

 

[MarkLud]

The results are always typical of a device like this. That is why they all eventually come to market.

This is the first time we have any type of statistical evidence of tinnitus levels decreasing. There have been studies and there is actual evidence to back it up. Unless I'm missing something, EVERY other "tinnitus treatment" that has been marketed or attempted to be sold has never had legitimate research evidence to back it up before. @kelpiemsp's results from the Minnesota trial -- which uses a similar bimodal technique -- is the most encouraging thing I've ever read on tinnitus.

If it was just BS, they wouldn't have any statistical evidence to back it up. They actually do. We can, in fact, be encouraged!

 

[RaZaH]

Yes, it is encouraging, I am just super jaded at this point

 

[Piney]

Was the sound threshold ever stated that could benefit from the device? Meaning < or > 80 dB which the device won't work for as an example.

 

[Alue]

Interesting. But why it's not the same?

Minimum masking level is going to be much louder than the actual perceived tinnitus volume. Think of it this way, you have two noises going on in your room. If they are the same volume you can hear both of them. How much louder does the second noise need to be than the first so that you cannot hear the first at all?

 

[Alue]

Yes, it is encouraging, I am just super jaded at this point

Everyone becomes that way if they have intrusive tinnitus for long enough.

 

[erik]

If it was just BS, they wouldn't have any statistical evidence to back it up. They actually do. We can, in fact, be encouraged!

Even "My Pillow" has clinical sleep studies to back it up.

I will say that I am most encouraged by Susan Shore's device. She is legit in the tinnitus research world. The initial study (other than animals) was with 20 participants. There is a larger clinical happening this year which should be more telling of the device's efficacy. As will everything, only time will tell.

 

[JohnAdams]

Does the word "Lenire" actually mean something? Or is this just some random dumb word a marketing team came up with?

 

[annV]

Does the word "Lenire" actually mean something? Or is this just some random dumb word a marketing team came up with?

It's Latin and means to soothe.

 

[JohnAdams]

Even "My Pillow" has clinical sleep studies to back it up.

I heard an interview with Mike Lindell, the My Pillow guy, where he said he was strung out on crack for several years. He said he would get all high on crack rocks and get so paranoid that he would be peeking out the window thinking people were spying on him and stuff.

https://www.cnbc.com/2017/09/20/how...om-crack-addict-to-self-made-millionaire.html

 

[Clint Azzopardi]

I thought that 'My Pillow' had something to do with curing tinnitus at first. Loooool.

I googled "my pillow + tinnitus"

I felt like the biggest dumbass ever!

 

[jmasterj]

Even "My Pillow" has clinical sleep studies to back it up.

I will say that I am most encouraged by Susan Shore's device. She is legit in the tinnitus research world. The initial study (other than animals) was with 20 participants. There is a larger clinical happening this year which should be more telling of the device's efficacy. As will everything, only time will tell.

Sadly, I don't think Susan has the resources and is moving at a snail's pace. I think the Minnesota device probably has a better chance at coming out sooner. They are actually creating a wearable hearing aid type devices presently. If you don't know Hubert Lim was the PI (principal investigator) at the University of Minnesota study and started a lot of this. He is now at Neuromod. Don't quote me on this but I believe Susan Shore based her treatments on the initial studies done at Minnesota.

 

[GlennS]

I will say that I am most encouraged by Susan Shore's device. She is legit in the tinnitus research world.

I'm having trouble following your logic. On the one hand you are implying that Neuromod is nothing more than another nefarious get rich quick scam, and yet its device is operating under the same basic principles as Susan Shore's device, principles that distance it from the earlier failed devices that burned you. The only difference is the physical point of stimulation. Assuming optimal stimulation parameters, there's no reason to believe Lenire wouldn't work and Shore's device would.

The implication in your posts is that Neuromod are corrupt capitalists and true innovation is better achieved through academia. We've had that debate already. From my vantage point I see Neuromod being far more motivated to bring a product to market whereas Susan Shore is operating at about this pace.

A clinical study with only 20 participants is outright pathetic. Just pathetic. Researchers tend to want to research for the sake of research. Too often they lose sight of the fact that research is useless if it never leaves the lab.

 

[Alex Matyjasek]

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?

I asked the same question, and now suddenly no one can answer this question.

 

[GregCA]

I asked the same question, and now suddenly no one can answer this question.

I answered it yesterday in this thread.

 

[KotaDomowa]

In my opinion for example hum is atonal. But I could be wrong.

 

[Nics2drescue]

I will move to Ireland to get this. Get us a launch date ASAP Neuromod!

Just because it's manufactured in Ireland doesn't necessarily mean it will be available in Ireland only, first. Many products are manufactured in Ireland and they are not available here. Most recently, a device to help Parkinson's disease; product was manufactured in Ireland, however then exported. Irish patients had to travel to the UK in order to purchase the Irish made product. So no reason to believe this. Also, most of Neuromod's customers are going to be international in any case (US, UK etc.) as Ireland is such a small country, with more than likely less cases of T.

P.S. I live in Ireland.

 

[spedgas]

I asked the same question, and now suddenly no one can answer this question.

The answer hasn't changed since the last time you asked it. As it stands right now these things do not matter. This was explained during the interview with Tinnitus Talk. There has been no new information from them stating otherwise.

Their latest response is "To date we have not seen evidence that the tonal or atonal nature of tinnitus experienced influences an individual's suitability for the treatment."

 

[annV]

Just because it's manufactured in Ireland doesn't necessarily mean it will be available in Ireland only, first.

It was mentioned in the Questions and Answers video by the CEO Ross O'Neill that they will release it in Ireland first, other European countries to follow later.

 

[Clint Azzopardi]

Hi @spedgas, sorry for asking but what is meant by 'tonal or atonal nature of tinnitus'? I don't know what is the meaning and difference of tonal and atonal.

 

[hans799]

Hi @spedgas, sorry for asking but what is meant by 'tonal or atonal nature of tinnitus'? I don't know what is the meaning and difference of tonal and atonal.

A pure tone (eeeeeee) is tonal. A static, buzz, or hiss (bzzzzzzz or ssssssssh) is atonal.

 

[grate_biff]

or hiss (bzzzzzzz or ssssssssh) is atonal.

I would call it multi-tonal

 

[Clint Azzopardi]

thanks @hans799. So I can say that I have somatic atonal tinnitus thanks to this forum Thanks for your reply.