Lenire — Bimodal Stimulation Treatment by Neuromod

#2,131
Alue said:
Back when I first got tinnitus I was accepted into the AM-101 trials. A few years ago AM-101 was the latest and greatest thing that showed promise in quelling tinnitus in its early stages.
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AM-101 was an early-stage clinical trial, basically a question asked by researchers "will this work?"

Lenire is a device that has already succeeded in its clinical trials and is now seeing a proper release, the researchers saying "this works, let's start distributing it".

The chances of success are much better here.

(Also because bimodal neuromodulation is the only game in town for at least a couple of years I'm terrified of it not working...)
 
#2,132
hans799 said:
AM-101 was an early-stage clinical trial, basically a question asked by researchers "will this work?"

Lenire is a device that has already succeeded in its clinical trials and is now seeing a proper release, the researchers saying "this works, let's start distributing it".

The chances of success are much better here.

(Also because bimodal neuromodulation is the only game in town for at least a couple of years I'm terrified of it not working...)
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Me too man. Those drugs will not come out until a few years time. To be honest if these drugs do work they should honestly let people take the drug as soon as possible. People are suffering at the moment and they should be allowed to take these drugs. It is up to them to make the choice on whether to take the drug or not.
 
#2,133
hans799 said:
Lenire is a device that has already succeeded in its clinical trials and is now seeing a proper release, the researchers saying "this works, let's start distributing it".
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No, the big Lenire trials haven't got past peer review yet.

I'm very excited and everything, but it will be better for the early adopters if and when those trials are published, that will be "succeeding in clinical trial".
 
#2,134
Not a big surprise, but they are already scheduling to 2020.
No problem to me. Within 6 months we all should have a better idea of how well this thing works.

Neuromod Medical has received your completed online booking assessment. We are aware that it is more than 14 days since you submitted your completed assessment. At this time we have allocated all available first assessment appointments until the end of 2019. We are working to confirm allocated appointments, which may allow us to offer you an appointment in 2019. If not, we will offer you the earliest possible appointment in 2020. We will aim to get back in touch with you with suggested appointment times as soon as possible.


Already in the first week of appointments we have seen a small number of last minute cancellations and no shows. We plan to contact all confirmed appointments to put in place a cancellation policy, which may free up some slots earlier in 2019.
 
#2,135
nuno1976 said:
Not a big surprise, but they are already scheduling to 2020.
No problem to me. Within 6 months we all should have a better idea of how well this thing works.

Neuromod Medical has received your completed online booking assessment. We are aware that it is more than 14 days since you submitted your completed assessment. At this time we have allocated all available first assessment appointments until the end of 2019. We are working to confirm allocated appointments, which may allow us to offer you an appointment in 2019. If not, we will offer you the earliest possible appointment in 2020. We will aim to get back in touch with you with suggested appointment times as soon as possible.


Already in the first week of appointments we have seen a small number of last minute cancellations and no shows. We plan to contact all confirmed appointments to put in place a cancellation policy, which may free up some slots earlier in 2019.
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Did you apply today? I applied 2 days ago and they didn't have the bit in about 2019/2020.
 
#2,136
Agrajag364 said:
No, the big Lenire trials haven't got past peer review yet.

I'm very excited and everything, but it will be better for the early adopters if and when those trials are published, that will be "succeeding in clinical trial".
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It is interesting how this company is going for mass production and commercialisation of a device when the data from the trials is not available to proof efficiency.
 
#2,137
Who is applying for a visa to Ireland?

Neuromod is being very very difficult in addressing the simple visa questions.

I am asking them to provide a simple appointment confirmation on a Neuromod letterhead and they are saying our policy is to confirm by email.

Ughhhh too many needless complications.
 
#2,139
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#2,140
Hopefully with the demand it will put pressure on them to roll this out soon in other countries in Europe. There were some rumors of it showing up in the UK this summer.

I will be curious to what their cancellation policy is going to be.
 
#2,143
BrStan@ said:
It is interesting how this company is going for mass production and commercialisation of a device when the data from the trials is not available to proof efficiency.
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They do have trial data related to efficiency. I think what they're missing is the peer review on the larger trial (which I don't want to diminish the importance of).
 
#2,146
Strengths and limitations of this study
  • The main strength of this study is that it is a large two-site, triple-blinded, randomised trial that will provide exploratory evidence of the relevance of stimulation parameters on the clinical efficacy of different bimodal stimulation parameters and will inform future trial design.
  • The study comprehensively characterises patients for subtyping and this will refine candidature for the intervention.
  • Among the limitations of this study are the variability in duration between screening and enrolment and the selection of the investigated stimulation parameters.
  • The online recruitment process may inadvertently introduce participant selection bias.
 
#2,147
Jazzer said:
Perhaps I have an unusual mindset re: tinnitus.
From the moment I awoke in June 2014 my Tinnitus has never budged one tiny scrap.
'Loud - permanent - eternal.'

Do I really have faith that anything will turn this thing off, or turn it around?
No - not really.

I am making every attempt to live for now.

Don't get me wrong though Nanny - I wish everyone well, will be really interested in their progress, and would love to be proved wrong.

If the unsolicited reviews turn out well of course then my feelings might change.
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I think @Jazzer that you are taking a sensible attitude to this device. It may well work for some people but it is unlikely to work for all tinnitus sufferers. One thing I remember is that the lady (Clare I think) who had had fantastic results in the clinical trial of this device said that particularly older participants in the trial with some age-related hearing loss hadn't experienced the same benefits.
 
#2,150
GlennS said:
As far as I know, they have already started doing assessments. When you see appointments scheduled months in advance you're talking about those not lucky enough to be first in line. I mean, if they are only one office how many assessments can they do each day? Maybe 4-6 tops if it's one at a time and it's over an hour for each assessment. So the odds of anyone here being among the very first through the door are low.
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We kind of know how it works based on users' appointments. Mine and Liz Windsor's are 45 minutes apart. We also know the audiology part takes about 30 minutes, before you're moved on to the options and finance parts etc.
 
#2,151
They mentioned that they have seen "a small number of cancellations and no shows"?

How important to me is receiving this treatment?

Even if I had to hike through the Okeefenokee Swamp for a scheduled assessment, I would still be on site and on time.
 
#2,152
Back at Dublin Airport after my assessment today. The ladies at the clinic are extremely friendly and very clued up on tinnitus / their device.

I'll try to summarise the appointment and provide any extra info I picked up.
- Arrival, you'll need to fill out an assessment questionnaire on a tablet (it's a THI questionnaire, same as the initial one when applying for the appointment).
- You'll then meet the main consultant and she will discuss your tinnitus with you, also asking about things like hyperacusis and any other treatments you may have or are currently undergoing.
- Then you go through with a hearing test and also a check for how much white noise it takes to mask your tinnitus.

I feel like this is the part they carry out their final vetting for eligibility and will either advise against you having the treatment or refer you onto their treatment list.

- If you get referred onto the list, you'll be sent in to see their product specialist who will take you through Neuromod, explaining the components and what it comes with.
- She will also go through the treatment plans and the kind of support you have access to, follow up appointments and payment plans. There are details here about replacement tongue pieces / cost.

- Finally you'll pay for the assessment and meet with another member of the team who will book your fitting and first 2 follow up appointments (each within 6 weeks of each other where possible).

The devices will be available in 4 weeks from what I was told, they did say if they become available sooner they will follow up with people.

Overall, very impressed with the experience and how thorough Neuromod are being in building a picture of their patients.

Apologies for the brief and probably broken update, writing from a phone while boarding a plane.

I'll try and add more info when I get back home.
 
#2,153
Thanks Cojackb for sharing your experience thus far. Appreciated.

We also have another member who had their appointment today - they reached out to us privately sharing their experience, but they are wanting to keep it out of the public for now. I asked if I can copy paste it here without mentioning their username.
Cojackb said:
There are details here about replacement tongue pieces / cost.
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For those interested, the other member in question said that the tongue piece costs €250, and needs to be replaced every 180 hours.
 
#2,154
For what it's worth, I haven't gotten a reply to my last question via email. They are probably too swamped to read my waffling War and Peace essay but we'll see if they eventually get back to me.
 
#2,156
Redknight said:
No one knows that yet, I'm just a guy on the internet making logical assumptions.
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Since the tips are only rated for 180 hours you'd have to buy a new one every 22 days if you used them 8 hours a day.

We'll see how long the positive effects last. If the treatment has to keep being repeated downstream then Neuromod will have a razors/razorblade cash-cow on its hands with those tips. How much of the lack of durability is by design rather than unavoidable depends on how cynical you are.
 
#2,159
Dizzyhead888 said:
Who is applying for a visa to Ireland?

Neuromod is being very very difficult in addressing the simple visa questions.

I am asking them to provide a simple appointment confirmation on a Neuromod letterhead and they are saying our policy is to confirm by email.

Ughhhh too many needless complications.
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To be fair, they have said before that they don't advise patients to travel for treatment and their current offering is "available to people in Ireland". Anyone traveling from outside of the EU is doing so on their own risk etc.
 
#2,160
david c said:
I think @Jazzer that you are taking a sensible attitude to this device. It may well work for some people but it is unlikely to work for all tinnitus sufferers. One thing I remember is that the lady (Clare I think) who had had fantastic results in the clinical trial of this device said that particularly older participants in the trial with some age-related hearing loss hadn't experienced the same benefits.
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What if you're young with moderate hearing loss??? Would Lenire not work :(?
 

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