Lenire — Bimodal Stimulation Treatment by Neuromod

[Flyingsheep]

I've never gone to an ENT in all my years of tinnitus and I got an appointment (for me to take or leave). Last time I was at my primary care I got some referrals but have yet to go because a) it's so close to Lenire coming out anyway and b) I know all they can do is give me an audiogram to let me know in black and white terms how bad my hearing loss is.

Sounds good. I completed the booking assessment. I've felt hesitant to start the process since my tinnitus is considered mild, but because spikes are lasting longer and getting louder (loud enough I can hear it over a highway) and it's happening more and more often, 2020 is far away so I might as well get the train going.

 

[Alue]

AM-101 was an early-stage clinical trial, basically a question asked by researchers "will this work?"

That's not true. AM-101 was in phase III of clinical trials after showing some promise in stage II. Phase III is the final phase before submission for approval and it generally takes a medication 10 years to get through all three phases and be approved for prescription.

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 criteria for clearing medical devices is lower than that of medications.

 

[hans799]

Okay, so I did some math.

The initial appointment takes roughly 1.5-2 hours. There are 3 follow-ups, let's estimate each takes 1 hour. That means serving one person is roughly 5 hours.
There are 131 working days = 1048 working hours left in 2019 in Ireland.

If they can only serve one person at a time, that means they can serve 210 people. The more people they can be with in parallel, the more this goes up. Let's estimate they have their pipeline fairly well figured out and can handle 5 people in parallel (so they have 5 audiologists, 5 product specialists etc), which means they can serve roughly 1000 people in 2019, or 2000 people/year.

500 million people in the EU, usual 10% statistic say 50 million have tinnitus, if only 1% of those are really bothered by it that's 0.5 million. It's safe to assume that if tinnitus really tortures you and you live in the EU, you can find a way to pony up 2500-3000 euros, so all of these are potential customers.

First conclusion:
The pool of customers who have the motivation and the means to get Lenire is enormously larger than the available number of treatment slots - with only their current clinic, serving everyone would take 250 years. If this thing really works, then either Lenire must involve other clinics very quickly, or we'll see wait lists spanning years, reminiscent of Soviet times.

Final conclusion:
If you are on the fence for Lenire, go for it and apply right now. You can always cancel your appointment if results coming in through the forum turn out to be discouraging. But a few more weeks of indecision and hesitation can very easily mean years before Neuromod can get to you.

 

[Cojackb]

I've thought about this too. I'm wondering what they tell you to do while you are doing the treatment. Are you thumbing through magazines or distracting yourself with other things? It makes sense to me that listening intently and paying attention to what's happening would yield better results. I have absolutely nothing to base this on and could be totally wrong. I've had so much time to ponder this device that I've kinda hit it from all the thought angles I could.

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

Did they give any indication on who is eligible and who is not?

They didn't unfortunately, but based on the people here who have appointments and the kind of questions they ask - I get the feeling their "acceptance" requirements are quite open. My opinion, they're vetting people who they deem will see the most benefit from the product and trying to stop people from making a financial commitment to something that may not be right for them. Additionally, a lot of these questions could be for creating their patient "profile" as each device is calibrated to that individuals profile.

They really seem to know their stuff when it comes to tinnitus, so I trust they're doing the right thing.

Did you get the feeling if it is too loud they will exclude you? I hope this is not the case. How loud did they make it for you? Did it feel uncomfortable?

Absolutely not, no - I'm under the impression that loudness has absolutely no bearing on being accepted or not. They play white noise until you no longer hear your tinnitus, I also have hyperacusis but at no point was it uncomfortable or too loud. I guess this is subjective though.

€250 is an exorbitant amount to pay for a piece of wire attached to a bit of metal, in anyone's language.

If this machine needs to be used on an ongoing basis, then Lenire is going to add up to a very costly little unit.

@annV could present a very convincing argument at this point, as to why she should deny us the spectacle that we all once thought was rightfully ours.

The treatment is designed at 1 hour of use, everyday, for 12 weeks which equates to around 84 hours I believe. Which means the tongue tip covers the treatment, and then some.

I agree €250 is expensive, but considering this treatment exists nowhere else and there's currently no other manufacturers making these replacement pieces - I feel they could have made it much more expensive if they'd wanted to.

I'm assuming you were deemed eligible and are on the list to receive a device. I'm dying for someone on this forum to say they are getting one of these. The anticipation is driving me crazy.

Yes, I have an appointment for a device fitting in roughly a months time. Still have some decisions to make though


I also just want to add that my comments about the experience / assessment are purely my own opinion and interpretation of Lenire. I do not speak on behalf of them and nothing I say is absolute gospel. I'd still recommend people direct any questions about exclusions or acceptance to Lenire directly.

 

[Martin69]

- Then you go through with a hearing test and also a check for how much white noise it takes to mask your tinnitus.

My tinnitus fluctuates. Currently, I have luckily a lower period (some days). I would rate it a 4/10 (which I have very seldom). Normally it is between 8/10 and 10/10.

Hence I am wondering how they adjust to this when doing the initial assessment.

 

[david c]

Note that some of the people in the testimonial videos look like they are in their 50s and 60s. If they really thought this would be ineffective beyond a certain age I think they'd be actively turning people away on that basis rather than highlighting success stories with older people.

That being said, I think some sort of mental prep would help with this device because based on my understanding of neuroplacicity, it's a form of learning. You know how if you are in a classroom setting that if you are physically writing down notes, just the process of listening and translating that to hand motion actually makes the brain commit things to memory better. It seems to make no sense but it just works. Same deal with using music. So my theory is that the circumstances surrounding the treatment sessions, the environment, the emotional state, fatigue, etc... all play a factor in effectiveness and could explain some of the variability. I was thinking of starting a topic on this but it's probably better left to when we have a lot of members actively using the device and looking to brain-hack for better results.

I think they are unlikely to want to turn away older customers as they represent a very large segment of tinnitus sufferers seeking treatment. But I think that even the older customers promoted in their literature experienced only moderate improvement.

As part of the Lenire User Experience Group, will it be tracked involving amount of hearing loss and success rate?

Let me try and be clearer. I believe the only person who said their tinnitus is completely gone had no hearing loss.

Possibly the success rate drops the more hearing loss you have.

Would that be worthy of tracking?

This would be the sort of information that would definitely be worth tracking.

 

[Hayls32]

Would be really interested to know why people haven't been turning up!!!

From Neuromod:

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.

We thank you for your continued patience as we respond to the significant demand for assessments at Neuromod Medical

 

[Don Tinny]

Hope this doesn't fall in the hands of GAES. That hideous company charges €7000 for its outrageous TRT therapy.

I just sent an email to a GAES center in my country asking them if they will offer Lenire.

"We already offer a treatment for tinnitus" (sound therapy).

 

[Jack Straw]

I just sent an email to a GAES center in my country asking them if they will offer Lenire.

"We already offer a treatment for tinnitus" (sound therapy).

Maybe you can try and inform them it is an alternative treatment to sound therapy and that it doesn't work for you?

 

[Don Tinny]

Maybe you can try and inform them it is an alternative treatment to sound therapy and that it doesn't work for you?

It's so hard. Days ago I sent an email to a local researcher asking her opinion about bimodal neuromodulation and she didn't even answer me.

And these clinics... I guess they're busy working, "selling" what they already have. And I don't know how many Argentines will pay so much for a medical device.

Anyway it will be nice to know that relief is somewhere on the planet.

Edit: I sent GAES an email with the link to Neuromod, of course.

 

[GlennS]

I got a form-letter back from them telling me I have two days to confirm or I lose my spot, which is pretty much what I was expecting. They obviously don't have time to be able to manually field questions even via email anymore. So it looks like I am going to have to make at least one trip to Ireland as a hedge against the US rollout being significantly delayed.

 

[jmasterj]

I got a form-letter back from them telling me I have two days to confirm or I lose my spot, which is pretty much what I was expecting. They obviously don't have time to be able to manually field questions even via email anymore. So it looks like I am going to have to make at least one trip to Ireland as a hedge against the US rollout being significantly delayed.

I am in the same boat. I will just make it a nice little five day vacation in Ireland and go from there. Best of luck to you!

 

[spedgas]

I got a form-letter back from them telling me I have two days to confirm or I lose my spot, which is pretty much what I was expecting. They obviously don't have time to be able to manually field questions even via email anymore. So it looks like I am going to have to make at least one trip to Ireland as a hedge against the US rollout being significantly delayed.

At least from the people that post here you seem to be one of the few not living in Europe that have an appointment with them. That's an enviable thing to have. I'm certainly jealous.

 

[Nanny chocolate]

@Cojackb

Thank you so much for your extensive report on your visit to Neuromod.

There have been negative/wary opinions about the device and, on that basis, I had a sleepless night of worry. I've got my appointment and booked my flight.

Who knows if I will fit the criteria but I suspect that your post is a reassurance for those planning their trip.

Best wishes from Devon
Eve.

 

[JohnAdams]

@Cojackb

Thank you so much for your extensive report on your visit to Neuromod.

There have been negative/wary opinions about the device and, on that basis, I had a sleepless night of worry. I've got my appointment and booked my flight.

Who knows if I will fit the criteria but I suspect that your post is a reassurance for those planning their trip.

Best wishes from Devon
Eve.

How did the audiologist cause your tinnitus if I may ask?

 

[GlennS]

It helps that I live in the Northeast hence the flight distance to Ireland is shortest. I still think the backlog in Dublin gives maybe a false impression of how the rollout will take place. There's a lot of time between now and the end of the year when these appointments are clustered. Plenty of time for them to open more offices in Europe and beyond if they have a clear and actionable strategy to do so. It's definitely a critical test of their corporate leadership.

 

[Jcb]

@Cojackb

Thank you so much for your extensive report on your visit to Neuromod.

There have been negative/wary opinions about the device and, on that basis, I had a sleepless night of worry. I've got my appointment and booked my flight.

Who knows if I will fit the criteria but I suspect that your post is a reassurance for those planning their trip.

Best wishes from Devon
Eve.

Haven't seen you for a while Nanny, hope it all goes well for you and good luck. Try and not worry too much. Hope Devon is treating you nicely

 

[Nanny chocolate]

@JohnAdams

My tinnitus goes back a very long way John. I'd had a severe virus that left me with slight hearing loss. I went to a NHS Hospital for a hearing test WITHOUT TINNITUS. Who knows what the audiologist did but instantly I had tinnitus. I was then hospitalised and given oxygen treatment but to no avail.

Much more severe tinnitus started about 18 months ago and I suspect Sertraline.

 

[Nanny chocolate]

@Jcb

Devon is lovely in spite of the local authorities determinedly and endlessly digging up roads!
I haven't been on Tinnitus Talk much at all until a friend outside the U.K. alerted that Lenire was all systems go.

Hope you are well in spite of the ear din.

Best wishes
Eve.

 

[Jcb]

@Jcb

Devon is lovely in spite of the local authorities determinedly and endlessly digging up roads!
I haven't been on Tinnitus Talk much at all until a friend outside the U.K. alerted that Lenire was all systems go.

Hope you are well in spite of the ear din.

Best wishes
Eve.

They seem to be digging every road up in the UK. It's a tinnitus sufferer's best friend, all that noise haha, well here's hoping it all works out for you, I know you've had a tough journey.

 

[Watasha]

@JohnAdams

My tinnitus goes back a very long way John. I'd had a severe virus that left me with slight hearing loss. I went to a NHS Hospital for a hearing test WITHOUT TINNITUS. Who knows what the audiologist did but instantly I had tinnitus. I was then hospitalised and given oxygen treatment but to no avail.

Much more severe tinnitus started about 18 months ago and I suspect Sertraline.

How soon after starting Sertraline did it change?

 

[Nanny chocolate]

@Watasha
Almost immediately. I'd been on it at a low dose for tinnitus ironically!! My GP upped the dosage, went back to low dosage but severe tinnitus remained.

 

[Candy]

@Nanny chocolate This condition is a mine field, literally damned if you do, damned if you don't. So many anecdotal experiences of syringing, a balloon, an alarm, antidepressants... none of it will be of course recognised.

They should all be recognised, then we'd have recourse.

 

[El BUZZ]

I just sent an email to a GAES center in my country asking them if they will offer Lenire.

"We already offer a treatment for tinnitus" (sound therapy).

Hope that the filthy bunch of thieves never get their hands on this, otherwise they're going to screw us and squeeze til the last cent from our lives. Bloody mofos charge €7000 for a TRT treatment which they know it doesn't work. They act like scavengers from the very first moment you step in their clinics. It scares the shit out of me to read in Neuromod's website that "each clinic will charge what they consider right depending on how they value their time". Sorry but I don't even consider a wise move to let GAES know what's going on with Lenire. They'll use their claws and fangs to be the ones handling it in Latin-American/Spanish market and we better don't want to know what amount of cash they can ask for. Then they are useless morons when it comes to tune hearing aids, etc... Don't talk about the Devil, compadre o nos vana reventar la cartera y la vida estos hijos de perra.

 

[Don Tinny]

It scares the shit out of me to read in Neuromod's website that "each clinic will charge what they consider right depending on how they value their time". Sorry but I don't even consider a wise move to let GAES know what's going on with Lenire. They'll use their claws and fangs to be the ones handling it in Latin-American/Spanish market and we better don't want to know what amount of cash they can ask for. .

I didn't know GAES was like that. The problem is that traveling 4 or 5 times to Ireland and buying the device would cost almost like a new car for me (plus: language problems).

I fear the worst. I will be telling that "in Europe there is a device that reduces tinnitus" in front of the incredulous gaze of Latin doctors for the rest of my life.

 

[Watasha]

@Watasha
Almost immediately. I'd been on it at a low dose for tinnitus ironically!! My GP upped the dosage, went back to low dosage but severe tinnitus remained.

How long had you been on it at a low dose?

 

[Bndsmheowqhe]

Okay, so I did some math.

The initial appointment takes roughly 1.5-2 hours. There are 3 follow-ups, let's estimate each takes 1 hour. That means serving one person is roughly 5 hours.
There are 131 working days = 1048 working hours left in 2019 in Ireland.

If they can only serve one person at a time, that means they can serve 210 people. The more people they can be with in parallel, the more this goes up. Let's estimate they have their pipeline fairly well figured out and can handle 5 people in parallel (so they have 5 audiologists, 5 product specialists etc), which means they can serve roughly 1000 people in 2019, or 2000 people/year.

500 million people in the EU, usual 10% statistic say 50 million have tinnitus, if only 1% of those are really bothered by it that's 0.5 million. It's safe to assume that if tinnitus really tortures you and you live in the EU, you can find a way to pony up 2500-3000 euros, so all of these are potential customers.

First conclusion:
The pool of customers who have the motivation and the means to get Lenire is enormously larger than the available number of treatment slots - with only their current clinic, serving everyone would take 250 years. If this thing really works, then either Lenire must involve other clinics very quickly, or we'll see wait lists spanning years, reminiscent of Soviet times.

Final conclusion:
If you are on the fence for Lenire, go for it and apply right now. You can always cancel your appointment if results coming in through the forum turn out to be discouraging. But a few more weeks of indecision and hesitation can very easily mean years before Neuromod can get to you.

They will need at least 10-15 clinics in operation before they can recoup their investment. That's assuming they continue to operate at full capacity. It will be interesting to see how this plays out.

 

[Flyingsheep]

The future and availability of Lenire feels like watching to see if Bitcoin will really hit 100k. Ok, maybe not quite as drastic as that, but it definitely feels like no man's land until we're there and see what really happens. I'm really looking forward to it but also have this eerie unknown feeling. But if I get an appointment it would be quite exciting to be part of something cutting edge.

 

[ChrisBoyMonkey]

The future and availability of Lenire feels like watching to see if Bitcoin will really hit 100k. Ok, maybe not quite as drastic as that, but it definitely feels like no man's land until we're there and see what really happens. I'm really looking forward to it but also have this eerie unknown feeling. But if I get an appointment it would be quite exciting to be part of something cutting edge.

I've been looking at both, but I feel more optimistic about Lenire. If I had the money to fly to Ireland and pay for the treatment, I'd rather use it for that than on cryptocurrency. Since I don't have enough money to do that right now, I have some money in cryptocurrency and am hoping to be able to profit and use that to help paying for the treatment.

 

[Flyingsheep]

I've been looking at both, but I feel more optimistic about Lenire. If I had the money to fly to Ireland and pay for the treatment, I'd rather use it for that than on cryptocurrency. Since I don't have enough money to do that right now, I have some money in cryptocurrency and am hoping to be able to profit and use that to help paying for the treatment.

Hahaha, same, I've been watching both equally. I actually sold some BTC but I didn't have very much. Thought it might drop too much. But yeah, Lenire's success is more valuable in my opinion.