Lenire — Bimodal Stimulation Treatment by Neuromod

That's how I felt without the Love Island.

 

Guys. Be patient.

I can imagine that people do want to get familiar with the device, do it correctly etc.
I doubt they have time and nerves right now to answer all the questions.
I am sure feedback will be supplied soon enough.

We have to wait anyway 8 to 12 weeks before anyone can say anything definitely.

 

I think that's a bit of a harsh judgement... there is a questionnaire designed for those who have appointments so surely the answers everyone is looking for will come out of that. Plus, haven't people only just got their devices?

With the greatest of respect to everyone, I appreciate this has been a long road for some but there is no need to get annoyed. Give it time x

 

Maybe they are waiting to see how it goes before giving feedback, as Redknight said it’s been a emotional day and I can imagine that. They have been given a lot of info and it may take time to digest and some just may not feel comfortable yet until they know what’s what.

I know I’d rather wait until they are comfortable sharing any info and have a detailed explanation, I know a lot people are placing everything on this device working and want all the information now as it seems like forever since the Q&A they did with Tinnitus Talk but damn give them time to digest everything first and chill the F out guys and gals.

 

I'm waiting for my assessment date.

People are very excited, I've watched the testimonials. Is €2500 gonna buy us out of this tinnitus torture, that has defied medical science. Some of the people in the videos didn't convince me.

I'm hoping but it's going to be a big shock if I get the relief I need from this.

I understand they are going in the right direction research wise and testing, but I feel neutral expectation wise.

This is a deep pit to climb out of, I always go with gut feeling.

 

I picked up my Lenire device very recently. I'll detail my experience here-

On the morning of my appointment I was very tired due to not being able to sleep the night before (unrelated to tinnitus). When you reach the Hermitage hospital drive passed the public entry car park and it will swing you back in front of the hospital, then if you keep driving you can get free parking if you climb the curb on the left beside other cars doing the same. Honestly, fuck paying for parking in a place where there's more land than they have use for. Charging for parking really rubs me up the wrong way. It adds inconvenience and hassle for sick people just for an extra euro or two per person to the hospital coffers (this is unrelated to Neuromod though).

I entered the Neuromod suite and a nurse popped her head from behind the clinic door and looked at me waiting for me to explain myself, as if I shouldn't be there. Is it really so fucking hard to say: "You must be here for a consultation, what's your name and I'll check you in?". I'd never start a conversation in that accusatory way, whether its to a binman or the fucking queen of Sheba. This made me very angry and set the tone for the rest of the visit.

I was told to sit and after a few minutes she returned with a form, I completed it and then there was more waiting. The AC is on and it's fucking Baltic, it must be 10 degrees Celsius which is really uncomfortable.

I waited another 25 minutes and then was ushered into the Audiologists room. There didn't seem to be any obvious reason for this delay, and there was no one in any hurry to process me whatsoever, it was almost as if I was an afterthought to their regular work. I was asked the exact fucking questions that I was asked the first time that I went for the initial consultation (maybe a few less), then my ears were rechecked, then I was put into the audiologists booth and told to reply when the noise masked my tinnitus (I guess to calibrate the audio levels for the music in the Lenire device).

I was then sent to the nurses room where she explained the operation of the device in detail. I was quite bored listening to the explanation of the device. The device is as basic to use as a fucking iPod, but this is not her fault, I mean, she has to do the same explanation to people who aren't naively tech comfortable.

Then I had to fill in the exact same multi-page form that I filled in while I was in the waiting room. Honestly. My thought here was: "I'm paying for the privilege of being used as this clinic's flatbed scanner".

I didn't have a sense that someone in the clinic would be able to explain in sufficient detail how the bimodal neuromodulation works, and maybe they wouldn't tell me anyway for IP protection, so I didn't ask.

Then I had to pay for the device. It's €2,000 outright but if you opt for the 12 month installlment plan the interest costs amount to 37%. 37 fucking percent. I knew this before the visitation. This level of extra costs amount to profiteering. It is their choice to do this but it demonstrates their profit motive, not a primary motive to improve people's lives. Credit card interest is typically 26% for fuck's sake. I anyone is looking for a loan for their Lenire device hit me up, I offer 30% interest on a 12 month loan by simply putting it on my credit card. You win, I win. I'm only half being facetious.

Those are my thoughts on the clinic experience. I thought it was really amateur hour, I didn't feel like I was cared for by the staff, except for the nurse that explained the device to me. Your mileage may vary.

I've only had a few sessions with the device. You put the probe in your mouth and the earphones on your head and start off a 30 minute session by pressing the play button. The device is well designed for it's application, with excellent LED status design so you always know how your session is progressing. They use off the shelf Bluetooth headphones, to be honest I would prefer to use my Bose headphones but I'll use the provided AGM headphones for the duration of my treatment.

The sound you hear when you have the device on is combination of the following:
A white noise almost like seashore sounds. I think it rises and attenuates but not certain.
There's individual notes being played from what seems to be a Baroque scale. The strong notes are accompanied by "fuzzed" identical notes.
The melodies repeat and change slightly.
Each session seems to be identical.

I have not had ANY changes in tinnitus levels but I don't really expect them at this early stage. I started this post while in the middle of a session and I've found significantly more typos and extra words and spelling mistakes in my text than I normally make. When the session finished, I was back to my regular level of grammar, comprehension and vocabulary. By this I think the electrical stimulation is doing something, I just don't know what. In a tDCS device the probe runs a DC current across parts of the brain and if the probe for the Lenire device is only in our mouth, where is it drawing the current across? Simply the tongue, right? This is why I'm still sceptical. I still don't know if I've been sold a 2000 Euro Ipod with an electrical probe. My experience of the clinic didn't allay my fears but that's not to say it won't work.

In closing the clinic really need to organise themselves better to streamline the process. There is no need for an initial consultation, you should be able to have a consultation and pick up the device in the same appointment.

I'll endeavour to answer any further questions you have on the matter.

 

See below:

The answers to these questions aren’t on their website...

 

You guys who are lucky to be able to try Lenire, please be understanding. Just like you, some people are in real pain and are so happy for you that they are wishing to get any update that would cheer them up. That's plain simple.

Many of us here applied day 1 and didn't even get an appointment (that's my case, and my tinnitus is very severe).

So as much as I can understand it can be annoying to get so many questions, try and be nice, please.

 

I'm curious to know how they'd advise on this topic but I doubt they know yet how mental focus / attitude impacts the treatment because it's such a huge variable.

 

I was a bit disappointed and speechless after @drcross's post. First of all, thank you very much for telling us your experience in such a detailed way. Thank you very much.

It is a pity that your impression and the experience have not been entirely good... Sad. It seemed that other people had felt cared for by the staff in the clinic, and because of that I thought that the service is going to be good and friendly. I don't know now.

Your experience and feelings were better at the first appointment?

Were they confident you'd get relief?

 

@drcross, thanks for the write-up!

 

Yeah, this experience has somewhat drown out the wind from my sail of hope, but I have to say that the mood and professionalism of the staff is not that important to me as of now. We don't know if they're just contractors, or direct Neuromod employees, what is their relationship within Neuromod etc. We need to be more oriented on treatment results that might be available in the next weeks.

I can guarantee that every single person there and fellow members who are going to pick up their devices soon wish that it will bring some positive changes/brings any relief. And for the rest of us who won't have an opportunity to try it in the next few months or years, we're pretty dependent on their experiences.

It seems to me that they're not aware that this might be a breakthrough, or they're not confident about it at all, or they just don't know and the only person who knows what's going on is the Scientific Board (Dr. O'Neill, Dr. Lim etc...), not trained audiologists or device-fitters.

If anyone will remember this during their visit at Neuromod/Clinic - could you please simply ask why they just can't ship the device after the initial assessment and do the device fitting session remotely via Skype, Teams or similar? I do understand that every device needs to be adjusted and set based on the first assessment/visit outcomes, but to travel there again for the same session in a phone booth, double or triple fill the same questionnaire and get fitting instructions...? C'mon!

 

How about a selfie with your unit?

 

I would just like to say after my initial assessment yesterday, that I found all the Neuromod staff I met to be very professional, understanding and they absolutely seemed focussed on a good outcome for me. No pressure was applied to purchase the device. They said I could contact them at any time if I had any more questions.

As Redknight said it was quite overwhelming and currently sitting in Dublin airport waiting for a flight home. Definitely requires time to get your head round the fact this could maybe help some of us.

Just my experience so far. I go back in late August to pick up the device. I don't watch Love Island. Maybe I should!

 

Thank you for sharing your experience.

Did you do any research on the device before purchasing? I ask because you seem to be displeased with what you got when they have all of the information you are confused about on the website.

It stimulates your tongue and sends signals to the brain via the trigeminal nerve.

 

Hello everyone,

New here. I have had hyperacusis and tinnitus for many years. My first assessment in order to purchase Lenire is in late October.

Should I be worried about the noises and the threshold test for tinnitus masking? This might trigger my hyperacusis.

Can anyone with hyperacusis who already had the first assessment visit could share some info on that?

Thank you!

 

I asked this a few weeks ago. @Cojackb replied with this:

They tell you to do nothing, literally sit back, relax and zone out during the treatment. They also recommend you stay sat upright throughout.

 

Although nobody can tell you for sure that it won't trigger your hyperacusis, I personally had no adverse effects from the white noise masking test (I get mild hyperacusis and it has previously spiked to more severe levels). Nor have I seen or heard anybody else who's been for the assessment complain about the white noise masking making them uncomfortable.

As a matter of fact, Lenire claim they actually see better results from people with hyperacusis, so although it's a pain to live with - it may actually work in your favour!

 

Redknight/Andrew - Blog #1 (Assessment)

16/07/2019 - Neuromod Medical, Old Lucan Road, Dublin.

This will be my first blog post, I plan to do so something similar at each notable stage of the journey. All my comments are mine alone, I have no affiliation with Neuromod; some are facts, some are speculation (I'll denote any speculation for clarity).

Some quick context; I've had very mild fleeting tinnitus as long as I can remember, but it would always go away after a few hours. In February and March 2019 I developed a feeling of pressure in my sinuses and headaches that lasted a few weeks. When the symptoms went away (10th March 2019) I had more permanent tinnitus that is still there today. I also experienced a loud screech whilst on the London underground on the 5th March, this is notable because I remember my ears hurt afterward, probably not a good sign.

I will try and go through my experience at Neuromod, but not go over things that have already been discussed at length in the Tinnitus Talk Q&A and in this forum thread, unless relevant.

I will not mention Neuromod staff names or personal details, or details of other patients that I met at any of my appointments unless they want to share their details themselves. No one asked me to keep any of this private, I just don't feel it's appropriate or relevant.

------

I arrived at Neuromod around 15:00 for a 15:45 appointment and they saw me early I think. There's a window and a Nest Doorbell, with a sign that says to press here and someone will be with you soon. The person on the front desk gave me an iPad with a quick questionnaire to complete; pretty much the same as the one you complete when applying online, but with a digital signature field to sign.

I was then introduced to the clinical director/audiologist who would perform some tests and evaluate me for the device.

I was asked about my tinnitus and my hearing, how I cope with it and how I felt generally. I explained that my tinnitus varies wildly throughout the day, from a barely audible hiss (2 out of 10) to a louder 'eeeeeeeee', which sometimes developed a noise to it 'SSSHHHHEEEEEEE' (4 out of 10). I already know I have very mild loss around 4 kHz from a previous audiogram, which I was asked to bring with me to give a baseline for discussion. I was asked about whether I'd used hearing aids before, but given my very mild loss, there was no indication that they would benefit my tinnitus.

I was asked about my mood and whether I'd ever been diagnosed clinically with depression or any other psychiatric disorders. I have not been, so the questions ended there. SPECULATION - I believe I would have been probed much more in this area if I did suffer from proper depression or other psychiatric issues which may lead to not being recommended for the device.

The audiologist then looked inside my ears and confirmed that I had a tiny amount of wax in my right ear, nothing to be concerned about. SPECULATION - I believe if I had significant wax build-up (enough to cause hearing loss), I would have been told to get that sorted and come back another day. The audiologist was probably looking for eardrum issues, like the line of light they see, etc, but there was no comment made about mine.

I was then asked to sit in the soundproof booth and I did the normal 'push the button when you hear a sound' test. They made it clear that it was the quiet sounds that mattered the most and indeed, this was by far the quietest hearing test I've ever had, it was almost entirely made up of sounds I could barely hear (again, I have only very mild loss, almost not worth mentioning). It is worth noting though, that the audiologist had a copy of a very recent, professional audiogram done in Belfast. They may have assumed good hearing at louder levels and not needed to test those. I was not given a copy of this audiogram and did not ask for a copy. I did not do the 'can you hear these spoken words over other noises' test that I've done before.

I did, however, do a tinnitus masking test. This was really hard for me, my tinnitus tends to increase in volume as I introduce noise. As I sat there in a quiet booth, the tinnitus was barely a low hiss, but as the white noise was introduced my tinnitus ramped up, or at least my perception of it. I had a stab at telling where it was masked but wasn't 100% sure. I was asked to go again, with louder noise and again a third time, each with louder white noise. By the third, I was pretty sure it was masked (I'll talk a little about exclusion criteria later).

Once out of the booth the audiologist confirmed that I would be recommended for the device and we had a chat to talk more freely about Neuromod, Lenire and as many of the questions I've read on here that I could remember, without being rude (spoiler - I was tired and could only remember a few). I'll just list these as they come to me;

Q. What would exclude someone from Lenire and have you excluded many people?
A. Obviously, the contra indicators which are mentioned when you complete the online form are crucial, any of those could exclude you based on medical/safety grounds.

Non-acceptance of the realistic chances of benefitting from Lenire (we have all seen the results from the trials by now), if someone believes, and cannot be dissuaded from a notion that Lenire is going to cure or definitely reduce their tinnitus, then they would not be recommended the device. That's not to say that you would be refused if you just had the wrong idea about it. If someone walked in because their friend got silence and they had to have it explained to them, but they then accepted the realistic chances of that, they would still be eligible. Neuromod doesn't want unhappy customers, if you are essentially saying that you will not be happy with anything less than silence or x% reduction, you will be unhappy.

Obvious things that could reduce your tinnitus, that haven't been tried yet might mean coming back at a later date. Not to say you are refused, but rather, go away and try something and come back in x weeks. Examples of this were people with hearing loss that had never tried hearing aids or didn't wear them enough. Also, if you had a significant build-up of wax that would impair hearing, you would be asked to sort that first and come back. We didn't discuss any more examples, but if you present with something obvious to try first, they will ask you to do that. SPECULATION - there was no discussion of supplements during my visit, I don't believe supplements would be something they would consider 'an obvious thing to try', but if you had a medical need for medications, that might fall into this category.

Hearing loss. This is discussed more accurately elsewhere, but you need enough hearing to hear the sounds. If in doubt, send an audiogram to Neuromod before traveling.

Psychiatric issues. This was a big one an not easily answered. We did discuss this in-depth, and I know that some of you will be annoyed by this comment. I believe exclusion criteria are there for a reason and our conversation was had after my assessment and it would be unfair on everyone to outline what to say or not say to avoid exclusion. All I will say is to answer the questions honestly, for everyone involved's best interests.

Yes, many people have been excluded, no numbers were given though.

Q. What about the exclusion criteria in the clinical trials and some of the other things I've read on Tinnitus Talk? Here I was specifically querying whether age, tonality, length of time with tinnitus or cause of tinnitus was a factor.
A. Not in the selection/exclusion criteria. The clinical trial needed defined parameters and people of a similar cohort. The only exclusion criteria that we see in this area is that you have to have had tinnitus for more than 3 months. SPECULATION - To be categorised as having chronic tinnitus.

Tonality, cause of tinnitus, somatic or non-somatic, one ear or both don't matter.

Loudness does matter, as your tinnitus must be able to be masked at an acceptable volume of white noise. The acceptable level was not defined in dB, but the audiologist is looking to ensure you can listen to the sounds at an appropriate volume and that you don't need sound blaring in your ear for an hour to mask it.

All that said, there may be data in the future that suggests that specific forms of tinnitus may be better or worse affected by Lenire, they just don't know yet.

Q. What are your thoughts on people traveling from across the globe to get Lenire?
A. (Controversially) Whilst we can't legally stop people coming, they are doing so at their risk and take up an appointment slot for someone else. The thinking here is that, despite what many say, a large number of people just don't come back after their first appointments when they have traveled from far afield. MY THOUGHTS - being faced with an actual device, financial bill and the stark realities of how likely you are going to get silence or a significant reduction, many just decide to stop or wait a while before continuing. I had those feelings myself, I was convinced I was doing it until I got there, and I had a wobble when presented with the information in the clinic. It's nothing I don't already know, but don't assume you will be in the 80% who get a benefit, be prepared to be in the 20% and overjoyed if you're in the 80%.

Q. To the device fitter, not the audiologist, because I forgot earlier. Has anyone had Lenire permanently increase their tinnitus during the trials?

No, not permanently. Many people experience changes in their tinnitus during the treatment and for a time afterward. Of those that had an increase in their tinnitus, all resolved shortly afterward and returned to baseline or continued to reduce. Some chose to leave the trial as a result of changes, they were tracked and returned to baseline. Neuromod cannot 100% guarantee that you will not get an increase in your tinnitus because of or during treatment, even permanently. All they can do is tell you what they saw in the trial data. MY THOUGHTS - EEK! That sounds scary.

Q. Is the device effective beyond 12 weeks?
A. To be clear, the trial length was 12 weeks, simply because it had to have a start and an end. Some people starting seeing benefit a few weeks in, some months, some never. We don't know what would happen if you used it for three, six or 12 months and you should absolutely continue to use it until you see fit to stop. If you need follow up appointments, those can be arranged at a charge, but you are by no means left without assistance, should you need it.

In theory, a person could see results when using the device and need to use it every day to maintain those results permanently, we just don't know.

Q. Have you had many trial members return to buy the device?
A. Yes, many. Quite a few were seeing progressing results but returned to baseline after the trial ended and wished they could have continued using it. SPECULATION - I think if people who were mild responders in the trial could use it for six to twelve months they would see better results.

That's all I can think of at the moment, it was a bit of a blur, to be honest.

--------

I was then taken through to the device fitter.

The device was demonstrated to me, although as a demo model, it didn't light up or produce the electrical tongue stimulation. Other than the obvious buttons on it, there were a few notable things;

The device is set to a particular volume and tongue tip intensity, based on your assessment. They adjust this as necessary throughout each review appointment. Yes, they ask you the same questions and put you through the same tests to do this. Interestingly (to me anyway), you can adjust the volume up or down in case you are using the device in a quieter or louder than normal environment, there is no clinical benefit to this, other than you need to be able to hear the sounds and you don't want to cause discomfort to those with hyperacusis. You can adjust the tongue tip intensity depending on your preference, but again, this has no effect on clinical benefit, it's just for comfort (down to reduce the tingle or soreness, and up to know it's doing something).

The tongue tip has numerous metal connections on it. If they lose connection with your tongue for 30 seconds, the device will pause the sound and wait for you to reconnect.

You can pause the device for a maximum of 5 minutes, to take a call or something, but no longer or you will need to restart the treatment.

They suggest you do nothing during the treatment, just zone out. Some read whilst doing it, but you should refrain from watching TV (subtitles), posting online, playing games, etc. SPECULATION - They inferred that it might be beneficial to even not read during the treatment i.e the less you do the better. That said, sleeping is not allowed and you should sit straight up to reduce the chances of the tongue tip slipping out and you nodding off.

You should split the treatment into two, thirty-minute sessions per day. It doesn't matter when you do the treatment but aim to do them at the same time each day. I suggested once in the morning before going to work and once in the evening when the kids are in bed and she agreed. I believe you could do it for a single sixty-minute session, but that seemed to be less preferred than two, thirty-minute ones.

The device/treatment/contract has a 3-year life/warranty.

Only people from the Republic of Ireland can choose option 3 on the pricing sheet.

You cannot share the device. You cannot privately sell the device without written permission from Neuromod. You cannot resell the device. It's all in the attached terms and conditions.

You do keep the device after

That's about all I remember, for now, I had a lovely coffee with a Tinnitus Talk member afterward and drove home after paying for my car-parking

My return dates are as follows;

02.08.19 - Device Fitting - 4 weeks is a guideline, purely based on timetable availability, there is no legal, financial or medical reason for the 4 weeks. I got a free spot in the diary.
20.09.19 - Review 1
01.11.19 - Review 2

 

I might be wrong but I find @drcross's account a bit questionable.

First of all...

- the unit isn't €2000, it's €2150 in total (or €1900 on pick up) if you buy it outright and it isn't clear which you chose. If you chose option 2 or 3 you'll be paying more than the incorrect figure of €2000.
- I've been following this thread and so far I don't recall seeing one post by you saying you're going for it, you've picked it up and you've used it a few times, especially when you must know there's a community here waiting for every tidbit of info.
- WTF has air conditioner got to do with it, or parking? After a sweaty balled journey to get there I'd be happy for a bit of cooling down and just how long were you sat there for?
- Nobody else has reported being treated as an afterthought... just you. I was mistaken for an earlier appointment as I was early, but I got a handshake and politely pointed in the direction of the canteen.
- I wasn't given a form, I was given an iPad .
- Who was the audiologist you saw?
- Considering we've all been waiting with baited breath for this, I would be listening intently to what was being said and not being 'bored' by the experience.

Happy to be proved wrong, but this account just doesn't click for me.

 

I asked Caroline Hamilton about that and she said they only saw that in the TENT-A1 trial but not in the follow up.

 

@Elliott.S keep on calling regularly as they may have cancellations...

 

AGM headphones? You mean AKG?

 

I found the Neuromod staff (they are staff, not contractors, and at least one of them was very senior in Neuromod) to be extremely knowledgeable, friendly and caring. At no point were they rude, pushy or uncaring. It's fair to say that the clinical director was professional and realistic, but never uncaring.

 

They won't tell you that, they don't know.

 

You could replicate the test at home, for good or for bad. Does the volume of white noise taken to mask your tinnitus trigger your hyperacusis in a super negative way? That's the test. If you find your hyperacusis is killing you and you haven't been able to mask your tinnitus then you have your answer.

 

@Redknight

Thanks for the post RK... I'm a bit confused though... at one point you say loudness does matter (I assume tinnitus loudness) and you must be able to mask it but when I was there the CA took it quite high and then almost stopped it herself. I was getting the white noise in my left ear but on that morning my tinnitus was primarily in my right so I could hear it even with quite a high level of masking. Even on bad days my tinnitus can be masked by the shower which isn't particularly high (80 dB perhaps?) but shit I couldn't imagine tolerating an hour a day of volume levels like what they blasted me with on the assessment.

But what I'm actually confused about is you mention the volume can be turned up or down whilst using the device, which I've read before so that says to me that being able to mask it isn't important and as you say, it would be difficult for those with hyperacusis to withstand 30 minutes twice a day and would probably cause hearing damage!

Hope that makes sense.

 

Totally agree. The Lead Audiologist was as high as you could go in that chain of command.

 

@allan

To be honest, I was a little confused myself, for the same reasons. She did tell me that someone could be excluded if their tinnitus couldn't be masked at a safe level. But when I was being tested and I could still hear it a bit on the third go, she seemed happy enough to stop there. I'm totally speculating here, but I believe it's about hearing the sounds, not masking your tinnitus. If your tinnitus is so loud that you can't hear certain sounds they play, then maybe that nullifies the treatment. I could still hear everything, but could also hear my tinnitus over the white noise, to some degree throughout the testing. White noise is a bad sound for me to mask with, if I use high pitched beeping noises or bird chirps, I can mask it at just a very low volume. I might point that out to her next time I'm there.

Mine is complicated by the fact that going louder doesn't mask my tinnitus, to a certain extent keeping it quiet does. My tinnitus is loudest in noisy environments, it rockets up above everything. Yet, I can make it go very low in a quiet room.

 

This is an incredibly accurate summary of the process I experienced at my appointment. Thank you for taking the time and going to the trouble of explaining it so well. I would definitely have struggled to remember everything you have mentioned. I'm not referring to your individual questions or circumstances obviously. Looking forward to your future updates!