Lenire — Bimodal Stimulation Treatment by Neuromod

[GlennS]

Not so good news from Munich.

Forgive me for not following this thread religiously but has Neuromod actually done the true "peer review"--of Phase 2? Is this it or some substitute?

As far as speculation goes, I think Neuromod has leaned heavily on COVID-19 as an excuse and stalling tactic. I think now that COVID-19 is receding in the developing world that the jury will soon be in on it. There is the approval question and its overall reputation. Approval does not necessarily, as we've seen, guarantee either safety or efficacy.

 

[Mathew Gould]

First post on Tinnitus Talk. I woke up in May of 2020 with tinnitus, and have had a difficult 13 months since. It's an 11,000 Hz tone that sits kind of in my left ear but when loud, is in my whole head. I suspect TMD/jaw tension/neck pain/jaw clenching brought it on, but I was also taking a course of antibiotics for a skin condition plus Effexor plus occasional Ibuprofen, could have been any of those.

In the year since it arrived, some days I can't figure out how to survive and some days I can barely hear it. Right now, I'm vacillating between my normal annoying but tolerable level and just coming down off a month long spike that left me wanting to jump off a bridge.

I've tried acupuncture, chiropractic, 6 weeks of a candida diet (no alcohol, sugar, gluten, corn, caffeine, etc), and am now working with a periodontist to re-align my jaw. None of these things has really helped. I paid Joey Remenyi $1500 for her program - didn't get anything out of it and dropped out (but may try again).

I've begun to think, as my sound is somatosensory (I can alter it by moving my jaw, pressing on my head), that either Lenire or Susan Shore's bimodal treatment holds promise. Dr. Shore is taking new people for her study in 2021 (was halted in 2020) but you have to live in Michigan/Ohio for 6 months (I'm in LA). I considered moving there for 6 months out of desperation but can't really see that as an option.

So I called Neuromod and talked to the Clinic Manager who answered the phone. At first, she said they do remote treatments, even for Americans, despite not being FDA approved - I just had to go to Dublin (or Germany). So I arranged an assessment, which was promptly cancelled and then the Clinic Manager got all weird and said she had wrong information and that they were no longer treating Americans even if they come to Dublin (which is in quarantine right now), and that there was nothing they could do. I offered to fly to Europe, but she claims they can only treat actual EU residents right now. It was a shocking turnaround, given that I know for sure Americans were being treated prior to COVID-19 - she admitted that until being 'corrected' and of course, your stories are here on this board.

I suspect someone came down on them for treating Americans, even those who travel to the EU, since they are not FDA approved. Has anyone experienced this or heard this from them? They literally will not treat people who aren't EU citizens, even if they pay out of pocket to travel to Dublin. And they won't discuss it - they just won't explain things and the Clinic Manager before hanging up suggested I even try changing my diet to help my tinnitus. I was pretty floored and am deeply unhappy with this situation.

I wonder if I can get a used Lenire and a new tongue tip. Anyone want to sell me their used one? I literally don't know what to do.

Seems like you got your tinnitus the way I did, from neck and jaw issues. Try doing physical therapy on the neck. I got a TMJ splint that knocked down my tinnitus from 4-5 sounds in my head to 1-2 and it took about 3 months after I got it to re-align stuff...

If that doesn't work, do the Dr. Shore thing.

 

[F-u-T]

I hope the FDA does approve Lenire. There is always a chance they can improve the device effectiveness after approval. At least they are out there trying to help us.

Maybe once Dr. Shore completes her trial, she could lease her patented device timings to Neuromod and then we could have an effective device available much sooner.

 

[AfroSnowman]

I hope the FDA does approve Lenire. There is always a chance they can improve the device effectiveness after approval. At least they are out there trying to help us.

Maybe once Dr. Shore completes her trial, she could lease her patented device timings to Neuromod and then we could have an effective device available much sooner.

I like how you are thinking about approval and improvement in Lenire, although I'm still pretty 'meh' on it as a long time user.

From a completely uninformed perspective I would think that they couldn't directly use Dr. Shore's timings as her device stimulates a different nerve. Additionally, I think the basic concept of Dr. Shore's device is to narrowly target hyperactive areas while I think Lenire conceptually more about a broad stimulation. I suspect her timings aren't transferable.

"The technique developed by Lim and his colleagues is designed to promote the activation of brain circuits in response to many different sounds to drown out phantom noise. "The idea is that eventually your brain gets sensitive to many different things," Lim explains. "In a way, you have suppressed the tinnitus neurons but only by elevating the other neurons." Another group led by Susan Shore, a professor of otolaryngology at the University of Michigan, developed a similar device with a different approach: instead of increasing sensitivity to a broad spectrum of sounds, the team's method pairs a sound that matches the phantom one heard by patients with a specifically timed electrical pulse to the head or neck."

New Tinnitus Treatment Alleviates Annoying Ringing in the Ears​

 

[F-u-T]

I like how you are thinking about approval and improvement in Lenire, although I'm still pretty 'meh' on it as a long time user.

From a completely uninformed perspective I would think that they couldn't directly use Dr. Shore's timings as her device stimulates a different nerve. Additionally, I think the basic concept of Dr. Shore's device is to narrowly target hyperactive areas while I think Lenire conceptually more about a broad stimulation. I suspect her timings aren't transferable.

"The technique developed by Lim and his colleagues is designed to promote the activation of brain circuits in response to many different sounds to drown out phantom noise. "The idea is that eventually your brain gets sensitive to many different things," Lim explains. "In a way, you have suppressed the tinnitus neurons but only by elevating the other neurons." Another group led by Susan Shore, a professor of otolaryngology at the University of Michigan, developed a similar device with a different approach: instead of increasing sensitivity to a broad spectrum of sounds, the team's method pairs a sound that matches the phantom one heard by patients with a specifically timed electrical pulse to the head or neck."

New Tinnitus Treatment Alleviates Annoying Ringing in the Ears​

I didn't realize the difference between Lenire and Dr. Shore's methodology. I thought they were both trying to calm the excited neurons causing tinnitus.

If Lenire is trying to stimulate additional neurons to essentially drown out the excited neurons causing tinnitus then I can see why they may be having adverse reactions. I never could figure out why the Lenire timings were so different from Dr. Shore's but now that makes total sense.

Dr. Shore's method is based on calming the excited neurons causing tinnitus which I think could have a much more beneficial impact if it really works.

Lenire is more about habituation whereas Dr. Shore's is more about calming and reducing the tinnitus. That gives me a lot more hope about Dr. Shore's method vs the lackluster results we have seen from Lenire.

 

[AfroSnowman]

I didn't realize the difference between Lenire and Dr. Shore's methodology. I thought they were both trying to calm the excited neurons causing tinnitus.

If Lenire is trying to stimulate additional neurons to essentially drown out the excited neurons causing tinnitus then I can see why they may be having adverse reactions. I never could figure out why the Lenire timings were so different from Dr. Shore's but now that makes total sense.

Dr. Shore's method is based on calming the excited neurons causing tinnitus which I think could have a much more beneficial impact if it really works.

Lenire is more about habituation whereas Dr. Shore's is more about calming and reducing the tinnitus. That gives me a lot more hope about Dr. Shore's method vs the lackluster results we have seen from Lenire.

Yeah, I just ran across that article the other day. I have a Lenire and it sort of explains the soft positive (almost not particularly worth the time) reaction to it. I do seem to do slightly better on it but in a really subtle way. Again more like a habituation than anything else.

I'm looking forward to the Dr. Shore device but I am slightly concerned that due to the required auditory stimulation she might have trouble treating ultra high pitched tinnitus, because there ain't much hearing up that high.

 

[Lurius]

Yeah, I just ran across that article the other day. I have a Lenire and it sort of explains the soft positive (almost not particularly worth the time) reaction to it. I do seem to do slightly better on it but in a really subtle way. Again more like a habituation than anything else.

I'm looking forward to the Dr. Shore device but I am slightly concerned that due to the required auditory stimulation she might have trouble treating ultra high pitched tinnitus, because there ain't much hearing up that high.

How high would you consider "ultra high pitched" to be? In terms of Hz?

 

[AfroSnowman]

How high would you consider "ultra high pitched" to be? In terms of Hz?

I don't know what others define it as, but mine lives at and above 14 kHz and I consider it ultra high pitched.

 

[Chinmoku]

"In a way, you have suppressed the tinnitus neurons but only by elevating the other neurons."

Am I the only one who finds this sinister and a little scary? How can it work this way? And is this what Lim was trying in Minnesota?

I'm a layman but this doesn't sound right.

Dr. Shore's approach, if not her speed of delivery, looks much more reasonable and encouraging.

 

[GBB]

Am I the only one who finds this sinister and a little scary? How can it work this way? And is this what Lim was trying in Minnesota?

I'm a layman but this doesn't sound right.

I also thought this was screwed up - it's not reversion to normalcy but compensatory, additional deviation.

 

[Gee82]

Am I the only one who finds this sinister and a little scary? How can it work this way? And is this what Lim was trying in Minnesota?

I'm a layman but this doesn't sound right.

Dr. Shore's approach, if not her speed of delivery, looks much more reasonable and encouraging.

While using the device, I had the feeling that new connections were forming randomly between neurons, but instead of suppressing my tinnitus they resulted in more tones in my head.

Most of these tones faded thankfully, but Hubert Lim can go home.

 

[tinmandan]

Sorry if this has been asked many times before, but I can't seem to find any information about it.

Do people know when either Lenire or Dr. Shore's device will be available to folks in the US?

Can US citizens travel for Lenire treatment? Not considering COVID-19 restrictions of course.

Thanks for any information.

 

[Toby1972]

I wrote to my hearing care professional that I would purchase Lenire. I get a special price. I will report to you competently

 

[Ken219]

I hate junk science!

 

[LivingGhost371]

Neuromod seems to be neither encouraging nor discouraging U.S. citizens from traveling to them. The potential issue of importing an unapproved medical device into the U.S. has been discussed, but it seems customs and the airport people are more concerned about bombs and cocaine than something that looks like a goofy Walkman.

The timeline for Dr. Shore seems to be "whenever she feels like it, plus a couple of years".

 

[AfroSnowman]

Neuromod seems to be neither encouraging nor discouraging U.S. citizens from traveling to them. The potential issue of importing an unapproved medical device into the U.S. has been discussed, but it seems customs and the airport people are more concerned about bombs and cocaine than something that looks like a goofy Walkman.".

I've traveled back and forth all over the place including the USA with Lenire in my carry on, no one had any interest or consideration of it. In fact the customs form that you check off on before entering says nothing about unapproved medical devices. I wouldn't give it a second thought.

 

[PeterPan]

I have been working in Canberra recently (about a four hour drive from my place in Sydney). I've driven to or from there six times now. On each occasion I have had zero tinnitus the next day (6 out of 6, not a coincidence!). Something seems to be going on related to the sounds when driving and maybe the electrical stimulation when being jostled about in the driver seat...!

 

[UHPTS]

I have been working in Canberra recently (about a four hour drive from my place in Sydney). I've driven to or from there six times now. On each occasion I have had zero tinnitus the next day (6 out of 6, not a coincidence!). Something seems to be going on related to the sounds when driving and maybe the electrical stimulation when being jostled about in the driver seat...!

See, you can start business with this. Driving tinnitus sufferers from Canberra to Sydney and back. Comparing with Lenire, your treatment has already one super responder!

 

[Toby1972]

I may get Lenire next Wednesday. I will keep you updated.

 

[MadsWithT]

I wrote to my hearing care professional that I would purchase Lenire. I get a special price. I will report to you competently

Lenire is a well-marketed money grabbing scheme, based on shady science. I am surprised you haven't figured that out, based on your stock market skills. You should study the Lenire User Experiences thread. It is very informative.

Just out of curiosity, what price did they offer you?

 

[Toby1972]

Lenire is a well-marketed money grabbing scheme, based on shady science. I am surprised you haven't figured that out, based on your stock market skills. You should study the Lenire User Experiences thread. It is very informative.

Just out of curiosity, what price did they offer you?

No, Lenire will kill my 8.5/10 tinnitus completely for sure. Hah, I am in the stocks-hyping mode.

I have a special deal with my hearing care professional, but I'll be silent about it until Wednesday.

I feel obliged to report back to you about my Lenire experience in the form of a competent test report because the FREQ share gains that have arisen, among other things, from the temporary hype here. That's worth a couple of bucks to me.

My newest deal: I got into BioNTech very late, but the price earnings ratio is ridiculously cheap. It will become a cash cow soon. Hopefully no one will find out about the side effects I had too...

 

[DaveFromChicago]

To @Toby1972:

The tone of your commentary regarding Lenire has the (quite justified) level of disgust that mine had when I reported on Desyncra (and for the same reasons).

What concerns me is the slight worsening you reported (and even if this cannot be conclusively attributed to Lenire, nonetheless it's obvious purpose is to prevent this).
Both of these unsubstantiated treatments are grotesquely overpriced (and, even though you will receive a partial refund, will your cost still be approximately $1,100.00?).

FGG reported that the FDA's bar for approval of such devices if far lower than that for drugs (and she characterized Lenire as "crap"). Still, given the number of similar reports, I find it difficult to believe that this will receive FDA approval in the USA.

However, thanks ever so much for being an exploratory pioneer so that we can be alerted to it's uselessness.

 

[Dizzyhead888]

I have not followed this thread properly.

Were there any users reporting any side effects from Lenire, other than worsening of tinnitus? If so, what side effects?

 

[Martin69]

No, Lenire will kill my 8.5/10 tinnitus completely for sure. Hah, I am in the stocks-hyping mode.

I have a special deal with my hearing care professional, but I'll be silent about it until Wednesday.

I feel obliged to report back to you about my Lenire experience in the form of a competent test report because the FREQ share gains that have arisen, among other things, from the temporary hype here. That's worth a couple of bucks to me.

My newest deal: I got into BioNTech very late, but the price earnings ratio is ridiculously cheap. It will become a cash cow soon. Hopefully no one will find out about the side effects I had too...

View attachment 45165

Better to spend your money on BioNTech stocks than on Lenire. Lenire is useless. I can remember ONLY one person on the forums that had an improvement.

If you can get your money back, do it.

Best regards (aus Essen),
Martin

 

[Branyan]

My tinnitus got a lot worse about 18 months ago. All I can say is you somehow adapt over time. Don't write yourself off yet.

May well be able to cope further along the road.

Lenire seems to be causing real harm to some. Are Neuromod getting any feedback on this?

That pains me to hear. Your story of success with TRT was the last thing I was holding on to.

 

[TrevorSanders]

8/10 means driving a car + radio music masks my tinnitus sounds.

8/10 tinnitus is definitely not maskable by your car and radio. I think you have your scale skewed a bit, unless you're basing your scale off your own tinnitus.

 

[Toby1972]

8/10 tinnitus is definitely not maskable by your car and radio. I think you have your scale skewed a bit, unless you're basing your scale off your own tinnitus.

I didn't quite understand your last sentence. I would rate the scale 1-10 as follows:

• 1 = 5 percent of the day I hear the ringing (if I want to)
• 10 = 100 percent of the day I hear the ringing

Whereby levels 1 to 5/10 don't influence me in everyday life.

I would say my tinnitus was 4/10 from 2010 to 2020. Always audible when I wanted to, I needed podcasts to fall asleep, but I was always able to sleep through the night and sometimes sleep for 10 to 11 hours at a time.

At 6/10 to 10/10 it is audible for more than 50 percent of the day.

 

[AfroSnowman]

I didn't quite understand your last sentence. I would rate the scale 1-10 as follows:

• 1 = 5 percent of the day I hear the ringing (if I want to)
• 10 = 100 percent of the day I hear the ringing

Whereby levels 1 to 5/10 don't influence me in everyday life.

I would say my tinnitus was 4/10 from 2010 to 2020. Always audible when I wanted to, I needed podcasts to fall asleep, but I was always able to sleep through the night and sometimes sleep for 10 to 11 hours at a time.

At 6/10 to 10/10 it is audible for more than 50 percent of the day.

Thanks, I thought I was having an ok tinnitus day, but now I realize that I have a 10/10 day.

 

[F-u-T]

On that scale I pretty much always have 10/10 tinnitus. Can't really mask it with any noise level that doesn't hurt due to my hyperacusis.

At least I have no trouble sleeping as I am always exhausted due to my sleep apnea.

 

[Padraigh Griffin]

Neuromod to expand sale of its tinnitus medical device

Further distribution expansion. Pity the product is not that great.