Lenire — Bimodal Stimulation Treatment by Neuromod

[jay777]

Did he mention anything about importation?

Mum's the word, it's an mp3 player right.

 

[Sytex75]

A question for the folks that have been assessed by Neuromod.

Do they measure your tinnitus loudness level which could in effect on a bad tinnitus day not let you hear some high tones that could make you ineligible for Lenire? On a good tinnitus day my hearing is superb, on a bad day, not so much...

 

[TheDanishGirl]

I did my first proper session this morning.

Initial thoughts;

• The tongue tip sensation is quite pleasant, not irritating like I expected it to be.
• The music/noises are a bit eerie, almost sad.
• There's white noise, electronic chirps, piano and some thunder/rain (I think).
• The sounds change a bit throughout the treatment, but it's basically the same music for 28 minutes and then wind down for 2 minutes.
• I felt really spaced out during and after the session, like meditation. That's most likely got more to do with do nothing for 30 minutes than the Lenire.

I read that another user described getting a bit frustrated after 20 minutes of doing nothing, and I am a bit confused about this... Can't one read a book or magazine while doing the session?

Seems odd if the only thing you are allowed to do is sit there and stare while the treatment sessions last.

 

[dayma]

Awesome news, I won't be the first one attempting this. Did he mention anything about importation?

Nobody is going to have a concrete answer. The rules for bringing items back are very nebulous on purpose. It allows customs to stop a lot of items with little reasoning and you have no real appeal.

In reality it all depends on who is looking at the import forms. They may have a bad day and that's it...

 

[KotaDomowa]

@ThomasW

Do you have a Lenire? What effects are you getting?

 

[ruud1boy]

I read that another user described getting a bit frustrated after 20 minutes of doing nothing, and I am a bit confused about this... Can't one read a book or magazine while doing the session? Seems odd if the only thing you are allowed to do is sit there and stare while the treatment sessions last.

They said reading a book would be fine, just as long as it is nothing too active - although thinking about it, this sort of things lends itself perfectly to running on a treadmill or on an exercise bike. I don't have either of those, so I'll be reading. As long as it doesn't occupy too much of your mind I guess.

 

[TheDanishGirl]

They said reading a book would be fine, just as long as it is nothing too active - although thinking about it, this sort of things lends itself perfectly to running on a treadmill or on an exercise bike. I don't have either of those, so I'll be reading. As long as it doesn't occupy too much of your mind I guess.

That's good to hear.

 

[Redknight]

I read that another user described getting a bit frustrated after 20 minutes of doing nothing, and I am a bit confused about this... Can't one read a book or magazine while doing the session?

Seems odd if the only thing you are allowed to do is sit there and stare while the treatment sessions last.

You are advised to do as little as possible, especially avoiding mentally taxing things. I asked about reading; they don't really know to be honest, they don't explicitly say not to read, but repeated that it was best to do as little as possible. In fact she went as far as to say that it was best to just "zone out" during the session.

I think of it like a 30 minute meditation session. I would hate to read or use my phone, to later find out I was disrupting the treatment and wasting my time and money.

I have started to think about doing it whilst walking the dog, but I'll confirm with Neuromod at my next review that it's ok.

 

[Liz Windsor]

I'm going to do my TM* (Hoping it might enhance the effect of the device)..
*Transcendental Meditation

 

[EDDTEKK]

I did my first proper session this morning.

Initial thoughts

• The music/noises are a bit eerie, almost sad.
• There's white noise, electronic chirps, piano and some thunder/rain (I think).

How such simple sounds can impress the tinnitus sensation? I wonder what's the difference to nature masking sounds which doesn't help much.
I can't imagine that simple sounds like the ones mentioned change the tinnitus pattern in the brain. Is it really so easy, just combine a bit electrical stimulation and that's it?

 

[Piney]

I think the sounds probably cover some highs and lows, and the electrical stimulation is the key. I would guess they change the electrical pulse rate after 6 weeks. I bet the sound is just fluff as far as what's heard in the headset.

Just my opinion, doesn't mean the product won't produce results.

 

[Cojackb]

You mentioned a spike in your visual snow. Has that calmed down, too?

It seems to be less noticeable at the moment, but that sun has gone in and it's been cloudy here for a couple of days so I suspect it's the light. My eyes aren't good with bright days!

Also I just wanted to drop an update, last night my tinnitus was at the lowest it's been since it got louder at the beginning of this year. I'd spent all afternoon / evening at a friend's BBQ, there were babies, music (not loud) and plenty of relatively loud people. I walked in the front door and realized almost immediately that I could hardly hear my tinnitus in comparison to most days. The static tone in my head was still there but the multiple rings were extremely quiet.

As of this morning, everything is back to normal - you win some, you lose some!

 

[KotaDomowa]

As of this morning, everything is back to normal - you win some, you lose some!

If I remember correctly, @kelpiemsp had the same - sometimes better, sometimes worse... up to almost-silence

 

[TheDanishGirl]

You are advised to do as little as possible, especially avoiding mentally taxing things. I asked about reading; they don't really know to be honest, they don't explicitly say not to read, but repeated that it was best to do as little as possible. In fact she went as far as to say that it was best to just "zone out" during the session.

I think of it like a 30 minute meditation session. I would hate to read or use my phone, to later find out I was disrupting the treatment and wasting my time and money.

I have started to think about doing it whilst walking the dog, but I'll confirm with Neuromod at my next review that it's ok.

I hate meditation, so that wouldn't work for me.

I don't think I will go for the treatment, but it is nice to know there may be one if my tinnitus starts to bother me very badly again.

 

[Redknight]

I think the sounds probably cover some highs and lows, and the electrical stimulation is the key. I would guess they change the electrical pulse rate after 6 weeks. I bet the sound is just fluff as far as what's heard in the headset.

Just my opinion, doesn't mean the product won't produce results.

There's something going on with the timing alignment of the chirps and the tongue tip pulses.

 

[Chris809]

Does anyone know if Lenire could be used for people with low-frequency hum/buzz/drone tinnitus? Mine seems to interact (i.e. stop) with external sounds/head rotation/travel (time lag) - somatic tinnitus I guess. Coupled with this, I have a constant mild high-pitched hissing.

 

[Redknight]

Do any of the other users get a temporary uplift in tinnitus for an hour or two after using the device?

Also, I'm getting mild and fleeting headaches that come on about half way through the session; has anyone else experienced this?

 

[FGG]

It seems to be less noticeable at the moment, but that sun has gone in and it's been cloudy here for a couple of days so I suspect it's the light. My eyes aren't good with bright days!

Also I just wanted to drop an update, last night my tinnitus was at the lowest it's been since it got louder at the beginning of this year. I'd spent all afternoon / evening at a friend's BBQ, there were babies, music (not loud) and plenty of relatively loud people. I walked in the front door and realized almost immediately that I could hardly hear my tinnitus in comparison to most days. The static tone in my head was still there but the multiple rings were extremely quiet.

As of this morning, everything is back to normal - you win some, you lose some!

Thanks for the update. My fingers are crossed for you!

I have visual snow but it's only bothersome at night. I would hate to think a tinnitus treatment would or could make it worse. Please keep us posted on your visual symptoms, too.

 

[TinMan2019]

Just started my first EVER treatment. I am finally back home in the US and starting treatment today. I was in a bit of a hurry when doing the fitment as I had a return flight to catch. Am I right in that the tongue tip sits on the TOP of the tongue and not bottom? I'm fairly sure that's the way they showed me, but with a thousand and one things going on, I am double guessing myself.

OK good luck to myself and all the others trying out this treatment. I'm US based so am pretty invested and really hoping this works. It's not uncomfortable at all. Even would say that you're saying to yourself this is so mild that is it even doing anything? But then you just remind yourself the years and years of research behind bi-modal stimulation. The sound is also fairly soothing. Definitely masks out the tinnitus. I am having a little drooling going, but was told that would be normal.

OK. Some tips for anyone heading out to the Neuromod offices. Its €2.50 per hour to park. You also have to factor in the eflow.ie M50 toll. You have to pay this the same day from a computer. It's license plate recognition. So just make sure you make a copy of your license plate and pay later. From the airport it's not all that far. But i just rented a car for convenience. Cab would probably have been less expensive. You could also get away with not paying the Hermatige medical center car park rates if you don't mind a 5 min walk. I chose to just pay.

As for what I'll do for my hour a day during treatment? I'll just edit pics on Lightroom / Photoshop. That in itself is therapeutic and time flies.

Good luck to all starting treatment. I'll give an update in a couple of weeks.

 

[GlennS]

I'm US based so am pretty invested and really hoping this works.

How did you deal with customs? My main concern is the packaging. It's easier to pass it off as a simple MP3 player if I got rid of the packaging and stuck an Apple sticker on the back to disguise it.

 

[Redknight]

Just started my first EVER treatment. I am finally back home in the US and starting treatment today. I was in a bit of a hurry when doing the fitment as I had a return flight to catch. Am I right in that the tongue tip sits on the TOP of the tongue and not bottom? I'm fairly sure that's the way they showed me, but with a thousand and one things going on, I am double guessing myself.

OK good luck to myself and all the others trying out this treatment. I'm US based so am pretty invested and really hoping this works. It's not uncomfortable at all. Even would say that you're saying to yourself this is so mild that is it even doing anything? But then you just remind yourself the years and years of research behind bi-modal stimulation. The sound is also fairly soothing. Definitely masks out the tinnitus. I am having a little drooling going, but was told that would be normal.

OK. Some tips for anyone heading out to the Neuromod offices. Its €2.50 per hour to park. You also have to factor in the eflow.ie M50 toll. You have to pay this the same day from a computer. It's license plate recognition. So just make sure you make a copy of your license plate and pay later. From the airport it's not all that far. But i just rented a car for convenience. Cab would probably have been less expensive. You could also get away with not paying the Hermatige medical center car park rates if you don't mind a 5 min walk. I chose to just pay.

As for what I'll do for my hour a day during treatment? I'll just edit pics on Lightroom / Photoshop. That in itself is therapeutic and time flies.

Good luck to all starting treatment. I'll give an update in a couple of weeks.

Did I speak to you at the Neuromod office on the 2nd?

• Yes, top of the tongue, with the curved bit resting on your lips/teeth.
• They advised me not to use a computer/phone or watch TV (subtitles).

 

[Cojackb]

Am I right in that the tongue tip sits on the TOP of the tongue and not bottom? I'm fairly sure that's the way they showed me, but with a thousand and one things going on, I am double guessing myself.

As for what I'll do for my hour a day during treatment? I'll just edit pics on Lightroom / Photoshop. That in itself is therapeutic and time flies.

Good luck to all starting treatment. I'll give an update in a couple of weeks.

Congratulations mate! That's a long way to travel to commit yourself to the treatment, my fingers are crossed that you see an improvement.

As for the tongue tip, yes, it sits on the tip of your tongue or every so slightly further back, whatever is more comfortable!

Try a session where you sit and do absolutely nothing for 30 minutes against a session where you're engaged in your editing and see if you notice a difference. I find sitting and doing nothing, just relaxing, you feel the sensations in your tongue much more than if you're mentally focused elsewhere.

I'm glad you mentioned the drool thing. I've paused the session on the odd occasion to intervene before I turn into a dribbling mess.

 

[linearb]

How did you deal with customs? My main concern is the packaging. It's easier to pass it off as a simple MP3 player if I got rid of the packaging and stuck an Apple sticker on the back to disguise it.

Why the heck are you people still talking about trying to fool customs rather than just going through the correct process?

It's not that hard, at all.

Are there any circumstances when I could purchase or bring an unapproved drug or device into the U.S.?

The FDA has guidance for personal importation of drug or device products. Below provides information regarding situations for which this might be allowed:

• Product is for the treatment of a serious condition ( Prescription Drug Products):
  • The product is for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.
  • There is no known commercialization or promotion of the product to persons residing in the U.S.
  • The product does not represent an unreasonable risk.
  • The consumer affirms in writing that the product is for personal use.
  • The quantity is generally not more than a three month supply and either:
    1. Provide the name and address of the doctor licensed in the U.S. responsible for your treatment with the product, or
    2. Provide evidence that the product is for the continuation of a treatment begun in a foreign country.

It's very easy to check boxes 1, 2, 3 for this device. Box 4, you write one sentence. Box 5, you get your PCP or other friendly doctor to say "yeah I have treated this person for tinnitus which sucks and lacks effective treatments in the US). Box 6, you will have your paperwork from Lenire proving your treatment started there.

This all seems like a very slight pain in the ass, compared to the small but extremely obnoxious outcome of "I lied about what this was and they confiscated it and I'm out 10 grand, also I am now permanently on a CBP list of people who did bad stuff".

Do whatever you want. Personally I'm waiting a year or two to see what happens with UMich and also to have more actual peer-reviewed data on Lenire, something I still feel dubious about. But, if I were going to spend thousands trying to do this... I'd follow the process... because it's not very hard?

Seems smarter than gambling with thousands of dollars, unless y'all got way more money to burn than me. Yeah, I bet in 99% of cases you can bring it back as an MP3 player, especially if you (like me) have TSA Pre+ or even better CBP GlobalEntry. It's still illegal and it's still a bad idea that might cost you $5000.

Note that if you did happen to get caught trying to do this the wrong way, I imagine that you end up on all sorts of lists in US government databases, and your next attempts to leave and enter the country might be a lot more difficult than it would have been to simply spend the 90 minutes following this process and declaring your device correctly.

It's also VERY likely that you can just bring all this documentation, bring your device through, and not even get asked... but if you do, you're covered. I think your odds of getting asked are low if you're middle classs, white, travel a fair amount, have GlobalEntry and have no criminal history, and then get worse the less of those boxes you can check.

 

[linearb]

I read that another user described getting a bit frustrated after 20 minutes of doing nothing, and I am a bit confused about this... Can't one read a book or magazine while doing the session?

Seems odd if the only thing you are allowed to do is sit there and stare while the treatment sessions last.

That sounds very odd to me, when I used the Shore device they just said "play video games, work, do whatever you usually do at that time".

 

[linearb]

Hmm, reading the experience thread --- people reporting tinnitus increases at the beginning of treatment freak me out a little. No such warning was given by UMich, and no such thing happened.

I feel like I'm getting more skeptical of Neuromod by the day at this point, hopefully that trend reverses.

 

[Allan1967]

Past 3 days have been bad. Previous 3 days good. No real change in my pattern really.

Still early days. Not even 2 weeks yet.

 

[Bob den Hartog]

That sounds very odd to me, when I used the Shore device they just said "play video games, work, do whatever you usually do at that time".

My guess is, the most important thing is that the mind picks up on all of the sounds. I know people that can get so caught up in a book or video game that all of the world disappears around them and they won't hear you if you yell their name.

I think such activity should be avoided, because Neuromod doesn't want to take the risk you're not paying attention and it negatively impacts your results. And because they can't judge what kind of a reader you are, or how invested you can get in video games, they stay on the safe side and tell everybody to zone off on it.

I'm sure leafing through a magazine is fine, just make sure you also remain aware of what the headphones are giving you so it consciously reaches your mind and brain.

 

[El BUZZ]

Just sharing...

Someone I know who prefers to remain anonymous has been using the device for around one week now and despite having experienced some spikes (which starts to seem common) has also found various moments of his tinnitus being at its quietest spot since onset...

 

[GlennS]

Why the heck are you people still talking about trying to fool customs rather than just going through the correct process?

Gee. Ask a simple question and have someone jump down your throat over it.

 

[El BUZZ]

Thanks for the update. My fingers are crossed for you!

I have visual snow but it's only bothersome at night. I would hate to think a tinnitus treatment would or could make it worse. Please keep us posted on your visual symptoms, too.

I don't want to derail the thread but that's weird... Visual snow and floaters are generally more bothersome during day time. Open spaces, blue skies are their favourite menu.