Lenire — Bimodal Stimulation Treatment by Neuromod

[grate_biff]

Such a late date. When did you fill the form?

1-2 weeks ago I suppose. At least I get to read some feedback of Lenire users so I can get an overview of what to expect.

 

[OnceUponaTime]

Yeah it feels like they bit off more than they could chew. FDA approval and roll out definitely won't happen until 2020 or 2021 in the United States.

Oh dear... 2021!!???

 

[jmasterj]

I got this response from them today about travel and compressing visits.

The Lenire(R) device is CE-marked in Europe, but has not been reviewed by any regulatory authority outside of Europe. The device is not available in the United States. We are working hard on the process to engage with and seek clearance from the US FDA to allow us to make the product available in the United States. We announced last month that we had expanded our leadership team to facilitate this process. https://www.neuromoddevices.com/newsroom/2019/neuromod-broadens-senior-leadership-team Unfortunately, we cannot provide any accurate guidance about when this process will be complete.

We cannot advise that you fly from the US to Ireland to access treatment. If you choose to travel to Neuromod Medical in Dublin Ireland, there are a number of important points to note:

1. A standard course of treatment with Lenire® will cost €2,500 and will include four appointments with Neuromod Medical over the course of three months (including the first assessment visit). The first appointment is an assessment visit. You should expect to spend at least 45 minutes and up to 90 minutes with the clinicians at Neuromod Medical. The tinnitus assessment appointment will include a detailed medical history collection and a full hearing test, as well as an examination of your ears and measurement of your tinnitus loudness and pitch. In addition, you will be asked to complete questionnaires that the audiologist will use to determine how tinnitus impacts on your daily life. The audiologist will discuss your treatment expectations and suitability for treatment with Lenire®. Lenire® is not suitable for everyone with tinnitus. If the audiologist determines that you are not suitable for treatment with Lenire® and that an alternative treatment is more appropriate, you will be provided with a detailed referral recommendation. If you are suitable for treatment with Lenire®, you will be given an appointment to return a few weeks later for your fitting visit, when you will get the Lenire® device. At the second visit the Lenire® device will be provided and will be customised to your unique hearing profile and tongue sensitivity levels. The purpose of the third and fourth visits are to adjust the stimulation settings on the device to optimise the potential for therapeutic benefit. Lenire® is a single patient device and cannot be shared or leased. You may continue to use the device on an ongoing basis as recommended by the audiologist after your fourth visit. You may also arrange additional appointments with Neuromod Medical, if desired.
   
   It is highly recommended that you are available and prepared to attend all four recommended visits. Experience with Lenire® indicates that the best results can be obtained when stimulus settings on the device are adjusted during treatment. Adjustment can only be carried out by a trained clinician.
   
   
2. It is important to be aware that until such time as the treatment is approved for use in the United States, no healthcare professionals in the United States will have information and training on the recommended use of the treatment, and in the event that any technical support or replacement parts are required, the company will not be able to assist you without US FDA clearance.
   
   
3. There is no way to compress the visits.
   
   
4. The Lenire(R) device will not be provided at the first fitting assessment. Please expect that if you the audiologists recommends Lenire(R) for you, your fitting appointment will be 4 to 6 weeks after your appointment

Thank you for your interest in Lenire(R)

 

[Shelly75]

Perhaps they had to wait to see what uptake would be like before they ordered 100s/1000s of the device to be made? Plus they need time to factor in 3 follow-up visits for each patient. They've probably got a limited number of devices at the moment plus a finite number of new appointments they can factor in around follow-ups.

 

[GlennS]

Oh dear... 2021!!???

Even though he used the word "definitely", Jack is still just speculating like the rest of us.

 

[GlennS]

They've probably got a limited number of devices at the moment plus a finite number of new appointments they can factor in around follow-ups.

Another thought is that they might be wanting to keep the initial rollout (over the first six months) limited because this is for all intents and purposes a beta-test product.

 

[ruud1boy]

It pains me to consider this possibility, but those that are struggling to get an appointment might end up being thankful if the 'first wave' report back that Lenire is another TinniTool.

 

[Jack Straw]

Perhaps they had to wait to see what uptake would be like before they ordered 100s/1000s of the device to be made? Plus they need time to factor in 3 follow-up visits for each patient. They've probably got a limited number of devices at the moment plus a finite number of new appointments they can factor in around follow-ups.

I find this a little surprising. 20-30% of the population has tinnitus and they were worried about producing too many devices? Are they joking me? Tinnitus will never go away and new people will develop it every day.

Neuromod seems to be very science and tech savvy but not with business or public relations.

I will officially offer my services to run their whole business department and get this show on the road. Of course I will receive a free Lenire device for my services on top of a million dollar salary.

 

[JohnAdams]

I find this a little surprising. 20-30% of the population has tinnitus and they were worried about producing too many devices? Are they joking me? Tinnitus will never go away and new people will develop it every day.

But how many people in that demographic will actually benefit from this is the question. We definitely know that there is exclusion criteria, hence the screening process.

 

[Jack Straw]

But how many people in that demographic will actually benefit from this is the question. We definitely know that there is exclusion criteria, hence the screening process.

Everyone here with noise induced tinnitus have all been accepted. We actually haven't had anyone get disqualified yet.

 

[JohnAdams]

Everyone here with noise induced tinnitus have all been accepted. We actually haven't had anyone get disqualified yet.

Accepted for the treatment or for an appointment to be screened?

 

[RaZaH]

Not sure that is entirely correct, none of them have gone for the assessment.

 

[ruud1boy]

Everyone here with noise induced tinnitus have all been accepted. We actually haven't had anyone get disqualified yet.

And how many people have had their assessment appointment yet?

 

[acute]

I got a reply to my question about gap

I got this response from them today

Reading along the thread I think I must be the only person in this thread to whose emails Neuromod does not respond to.

 

[Skinjob]

They are now telling people one month between assessment and fitting. I'm out. I cannot afford four round trip fares plus the treatment. I'll wait until the treatment comes to North America, whenever that is. I am cancelling my September 6 appointment.

 

[RaZaH]

Reading along the thread I think I must be the only person in this thread to whose emails Neuromod does not respond to.

No, I have not gotten an answer either.

 

[Jack Straw]

Not sure that is entirely correct, none of them have gone for the assessment.

And how many people have had their assessment appointment yet?

I don't think they would screen people with the questionnaire and bring them in and say no. I'm sure it can happen but I think it is a very low chance.

 

[Demigod]

@acute

Reading along the thread I think I must be the only person in this thread to whose emails Neuromod does not respond to.

To be honest with you, if it's true what you state on your profile, that you've had tinnitus only for 2 months, that would be quite a good reason to be excluded or at least to not be considered for the first allotted spots, as you may well know for a great part of tinnitus sufferers the tinnitus subsides or goes away after the first few months. On the other hand I would find it unprofessional from any clinic not to communicate back something like that. For my part, the two working weeks since I applied are over and I still haven't heard from them. I gather it might be because I have not done an MRI, and maybe a lack of it would be considered an exclusion criterion.

 

[GlennS]

Neuromod seems to be very science and tech savvy but not with business or public relations.

And you, Jack, what are you qualifications? Have you ever tried mass producing a physical device, Jack? Do you know all of the ins and outs of this? Can you imagine that there are more factors at play than anticipating demand? Do we know Neuromod's balance sheets enough to determine if they have the capital to place a large initial order even if they anticipated demand? Not every company can just run up tens of billions in debt like Tesla.

Startups always go through growing pains. Always. (And yes I worked in and currently work for one). You can't go from a handful of researchers and a few hundred prototypes to cranking out units like they are iPods overnight through an army of trained staff fast-tracking people through audiograms and the like. It's just impossible and if you were dropped into the front-lines I think you'd have a rude awakening.

 

[Markku]

I gather it might be because I have not done an MRI, and maybe a lack of it would be considered an exclusion criterion.

That isn't an exclusion criterion. Many tinnitus sufferers haven't had an MRI done, besides an MRI is usually only indicated if your tinnitus is unilateral (which is much rarer than bilateral tinnitus, and doctors then want to rule out acoustic neuroma with an MRI).

 

[Jack Straw]

And you, Jack, what are you qualifications? Have you ever tried mass producing a physical device, Jack? Do you know all of the ins and outs of this? Can you imagine that there are more factors at play than anticipating demand? Do we know Neuromod's balance sheets enough to determine if they have the capital to place a large initial order even if they anticipated demand? Not every company can just run up tens of billions in debt like Tesla.

Startups always go through growing pains. Always. (And yes I worked in and currently work for one). You can't go from a handful of researchers and a few hundred prototypes to cranking out units like they are iPods overnight through an army of trained staff fast-tracking people through audiograms and the like. It's just impossible and if you were dropped into the front-lines I think you'd have a rude awakening.

I don't think they have a good team in place planning their business model to fit demand or outlook. They have had a large amount of investment money put into them recently which could easily get them someone to help them with their business model. I know some start ups with a lot less money invested than Neuromod that handled releases significantly better than Neuromod both in planning and public relations.

My number one gripe is that their release is currently lack luster when originally they made it seem like it would be a wide spread release all across Europe. They also backpedaled on release dates this entire year even at last years BTA conference. This was no handheld very well. They learned their lesson eventually and didn't talk about any release dates, which is better than having scheduled release dates pass.

This is no indication on their product and research only how they are conducting their business.

 

[Lilah]

Everyone here with noise induced tinnitus have all been accepted.

Any of these people have severe somatic symptoms?

 

[spedgas]

And you, Jack, what are you qualifications? Have you ever tried mass producing a physical device, Jack? Do you know all of the ins and outs of this? Can you imagine that there are more factors at play than anticipating demand? Do we know Neuromod's balance sheets enough to determine if they have the capital to place a large initial order even if they anticipated demand? Not every company can just run up tens of billions in debt like Tesla.

Startups always go through growing pains. Always. (And yes I worked in and currently work for one). You can't go from a handful of researchers and a few hundred prototypes to cranking out units like they are iPods overnight through an army of trained staff fast-tracking people through audiograms and the like. It's just impossible and if you were dropped into the front-lines I think you'd have a rude awakening.

I agree with what you have said here. I certainly don't know the answers to these questions nor do I have any experience with releasing products. I know this process will get better as time goes on.

I think my disappointment lies in the amount of time they had to get ready for this release and this being the result. Six months ago the release was mentioned as coming soon. They worked on the details of this launch for six months. I'm glad we've gotten to this point, but it took half a year for this tiny rollout where first appointments are being made six months out. None of us could have predicted that it would take four appointments to maximize the effects of the device. It's clear to me that their clinic size and having to block out four appointments for each person is problematic for them. Obviously the follow up appointments for the patients that get the device will get priority over new patients.

I'm still struggling to figure out why there is such a lag in the initial assessment and getting the device.

I believe in this product. I'm convinced it can help. I think I'm just concerned about what releases in larger markets than Dublin will look like and how long it will take. This is the result of six months to prepare for a small release in their home clinic. Imagine the time it will take in larger countries.

 

[spedgas]

Yeah it feels like they bit off more than they could chew. FDA approval and roll out definitely won't happen until 2020 or 2021 in the United States.

I think they get FDA approval long before it's actually available. Just because they get approval doesn't mean they will be ready to take on US sales and distribution.

 

[GlennS]

I don't think they have a good team in place planning their business model to fit demand or outlook.

When it comes to back-seat driving I think the biggest mistake they made is not running a TENT-A3 trial with patients that match exactly those they're going to let use the device. I would have run one of these or done a "soft launch" and make it clear that the initial patients would be deliberately limited.

I mean, from a patient perspective, we want these things airdropped like candy across the world---yesterday, but this is assuming it works as advertised. From their perspective, I think they are jumping the gun and risk repeating the MuteButton situation. Do I think it's a high risk? Probably not, but it's still a risk.

So it might be a good thing for this to filter out slower whether it's their strategy or not, just in case the results aren't all that.

 

[Jack Straw]

When it comes to back-seat driving I think the biggest mistake they made is not running a TENT-A3 trial with patients that match exactly those they're going to let use the device. I would have run one of these or done a "soft launch" and make it clear that the initial patients would be deliberately limited.

I mean, from a patient perspective, we want these things airdropped like candy across the world---yesterday, but this is assuming it works as advertised. From their perspective, I think they are jumping the gun and risk repeating the MuteButton situation. Do I think it's a high risk? Probably not, but it's still a risk.

So it might be a good thing for this to filter out slower whether it's their strategy or not, just in case the results aren't all that.

I agree that this is a tricky situation and that they have a lot of risk going on right now. I too am confused why they didn't test this device on people who had tinnitus longer than 5 years. I would like to know their reasoning seeing that an estimated 80% of their market will have had tinnitus for more than 5 years.

Again, we can point this back to bad planning. I feel they did jump the gun instead of doing additional testing on a wider range of patients. BUT their investors could have pressured them to release to get a return on investment. Remember that people have been invested in them since before 2010. I would want my returns as well if I was an investor and the product was ready to be released.

 

[Autumnly]

I too am confused why they didn't test this device on people who had tinnitus longer than 5 years.

In the TENT-A2 trial, patients with tinnitus up to 10 years were eligible.

Source

 

[Jack Straw]

In the TENT-A2 trial, patients with tinnitus up to 10 years were eligible.

Source

You should have your own tag of "archivist" or "librarian" because you always have the links to information!

@Markku make it happen! Lol

 

[Ringeee]

Is the Lenire device supposed to treat somatic tinnitus? What kind of tinnitus is it NOT supposed to treat?

I don't know the cause of my tinnitus, but I am interested in signing up for the Lenire device.

Thank you.

 

[DaveFromChicago]

From this very insightful, gratifying conversation I regarded ruud1boy's comment as most telling and cogent:

I have been waiting so long for a seriously effective treatment that I must be careful not to project my aspirations onto one that has not yet been thoroughly substantiated as meeting all of my imagined expectations (and that perhaps never made any such assurances).

If, however, you first courageous, intrepid pioneers produce astoundingly positive reports, I would imagine that various Venture Capitalist Consortiums throughout the US would be more than eager to provide ASAP the financing for Lenire's countrywide USA distribution.

If those useless ACRN "therapies" such as Desyncra can obtain FDA approval, then it should be a clear and fast fait accompli for Lenire.