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Lenire — Bimodal Stimulation Treatment by Neuromod

I wonder if the paying monthly option is available for foreign customers (not Irish citizens)? How would they ever be able to come after US citizens if they stop paying the monthly fees?
 
I wonder if the paying monthly option is available for foreign customers (not Irish citizens)? How would they ever be able to come after US citizens if they stop paying the monthly fees?
I would imagine they have an agreement with a third party loans provider, and as part of that process you would be credit checked.

No credit history in Ireland would mean no loan.
 
On the Lenire page I go to the FAQ section - it doesn't load for me the answers despite a little + sign? Do other people have the same problem? If not can somebody kindly post me the answers to the questions.
 
@Allan1967 I know you had your initial assessment this week. I hope everything went well and you got some good news from Neuromod. I'm dying to hear about your experience with them and what your thoughts are about it.
 
"Dear Michael,
Neuromod Medical has received your completed online booking assessment. We are aware that we haven't replied to you 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.

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

With best wishes
The Neuromod Medical Team"
Well... if anybody doesn't want their spot or won't be able to make it (whether you changed your mind) I'd gladly take something earlier than 2020. I reached out in response to this "rumor" back on the 2nd of June, only to find out it's actually happening and so I did the form within 72 hours of its release. I waited and got the response above. It seems a lot of people are interested.

If nobody is able to donate their spot, I'd gladly pay. I'm ready to travel and have the funds to pay for this. If it'd even slightly remove some of the noise, it'd help greatly with work. I have been unable to work for half a year now, so any investment with a possibility of me returning to work is all I have left. Cheers.
 
On the Lenire page I go to the FAQ section - it doesn't load for me the answers despite a little + sign? Do other people have the same problem? If not can somebody kindly post me the answers to the questions.
@Paulmanlike - sure, here they are:

Will the device work for me?
Lenire™ is a medical device used as part of a treatment plan supervised by a qualified and experienced clinician. Evidence from clinical trials indicates that Lenire™ can soothe and relieve tinnitus when used in accordance with the instructions for use. However, as with all medical treatments, many factors may influence the result. If you are not satisfied with the results, consult with your clinician who may change the settings of Lenire™ or recommend an alternative course of treatment.

If I have pulsatile tinnitus will the device work for me?
There are many different subtypes of tinnitus. Pulsatile tinnitus is described as a noise that is rhythmic and seems to follow a steady beat. In some cases, the underlying cause of the noise can be identified and treated separately. Where an underlying cause cannot be identified, Lenire™ may be considered by your clinician. To date, Lenire™ has not been thoroughly evaluated in pulsatile tinnitus without an underlying cause. If you experience tinnitus as a pulsatile noise you should discuss with your clinician.

I hear different types of sounds, will the device work for me?
Each person's experience of tinnitus can be different. If you hear different sounds consult your clinician to find out if Lenire™ is recommended for you.

If I don't like the results from the device can I get my money back?
Lenire™ is a medical device used as part of a treatment plan supervised by a qualified and experienced clinician. If at any time you are not satisfied with the results, you should discuss with your clinician prior to discontinuing treatment. Depending on the duration of treatment completed, your clinician may be able to offer you reduced treatment costs if you choose to discontinue. Lenire™ is not a consumer device and so no money back guarantee can be offered.

How much does the device cost?
Lenire™ is a medical device used as part of a treatment plan supervised by a qualified and experienced clinician. Neuromod Devices manufactures the device and offers guidance to clinicians about the recommended retail cost of the treatment, however, each clinician will determine the price of the treatment programme taking into account the cost of their time and expertise as well as the device. To find out more about the cost of the treatment programme, please visit your local clinic.

Can I get the device in the United States?
Lenire™ is not yet available in the United States.
 
So I've been out of the loop with this thing. Are they only taking appointments at this time or do they plan on releasing it soon to everyone?
It appears they are only doing business by appointment. Some people already have had their initial assessments and are pending the next appointment in which they will receive the device. Tinnitus Talk is tracking our own User Experience Group.
 
In the research study, people with hyperacusis were super-responders, meaning they responded better than people with just tinnitus.
Not surprised since having random levels of tinnitus, my hyperacusis annoyance level is equal to that given tinnitus level.

I'm so envious of First World countries getting this all in advance. I'm waiting on Tinnitus Talk forum members' experiences, then I'll be hyped.

I really hope this makes a difference because I'm happy to see the Tinnitus Talk community excited about something.
 
I emailed Neuromod to ask whether they are planning a release in the UK and they replied they have no such plans yet.

This is quite worrying as in many ways the UK would be their closest market at the moment.

Their current Dublin headquarters cannot meet the demand that's coming up in reasonable times.
 
Not surprised since having random levels of tinnitus, my hyperacusis annoyance level is equal to that given tinnitus level.

I'm so envious of First World countries getting this all in advance. I'm waiting on Tinnitus Talk forum members' experiences, then I'll be hyped.

I really hope this makes a difference because I'm happy to see the Tinnitus Talk community excited about something.
First world? You're being way too generous man, we are in the dark ages.
 
OK, got a quick response from Hazel! The information is publicly available in the thread, so here it is (apologies if I have made any errors). This is valid as of yesterday.

Some dates have been estimated where users have stated Mid September or similar.

View attachment 30652

People are saying the device fitting date is about 4 weeks after the initial appointment (although Neuromod originally stated it would be about 2 weeks):

View attachment 30653
How long do you use the device at home for? Nobody knows if tinnitus could get way better after, say, 6 months or a year of use, correct?

Have all of the people on the list taken the Tinnitus Handicap Inventory test which is 25 questions long and the scare ranges from 0 to 100?
 
I hear different types of sounds, will the device work for me?
Each person's experience of tinnitus can be different. If you hear different sounds consult your clinician to find out if Lenire™ is recommended for you.
Which clinician - I will be driving 10 hours to be told it may not be suitable? Aargh.
 
Do you know if the results of TENT-A2 are published yet?
They haven't been published yet, however, if I remember correctly, @annV still has a video and PowerPoint PDF of a presentation Neuromod gave where some of the results were being discussed.
What is Neuromod's definition of hyperacusis?
Ross O'Neill said in the interview: "We defined hyperacusis as sound sensitivity to loudness discomfort levels (LDL) of 60 decibels sound level (dB SL) or less." So that's how they defined their hyperacoustic patients and this group responded the most to the device in terms of tinnitus improvement. However, their LDL levels did not improve enough to assume that the device improves pain-hyperacusis. (Question 4 in the interview with TinnitusHub: "Is the treatment more effective on tinnitus, hyperacusis, or both?")
I still have not filled Neuromod's form because I relied on Lenire becoming available in Germany. Hopefully this was not a mistake...
Same here, it doesn't look like a summer launch in Germany and the UK is going to happen.
 
As has been stated earlier, Neuromod's business policy and preparation is curious. They have a potential commercial bomb in their hands, that will trigger worldwide demand (and with a little smart advertising this could really explode further) and they don't even have a plan to make this available in the UK, the closest country? This is crazy. They cannot continue like this. I hope they do have a plan but are keeping it reserved, because if they really have no plan as they say then this is very bad news.

Are they waiting to see how sales go in Ireland and how the device performs before committing to international release? I really don't understand, they already have a very long waiting list.
 
I'm so envious of First World countries getting this all in advance. I'm waiting on Tinnitus Talk forum members' experiences, then I'll be hyped.
Agree. I think it will take many years to reach the third world countries. It's unlikely that people with mild / moderate tinnitus will spend so much money. It will only be an option for severe cases, so the market is small. And doctors prefer to offer TRT and other risk-free "therapies" that don't require training.

Yesterday I read in the Research News section that Susan Shore's device will be launched in 2020 (before finishing the trials). Maybe the people in the United States can choose between two options. Wow!
 
As has been stated earlier, Neuromod's business policy and preparation is curious. They have a potential commercial bomb in their hands, that will trigger worldwide demand (and with a little smart advertising this could really explode further) and they don't even have a plan to make this available in the UK, the closest country? This is crazy. They cannot continue like this. I hope they do have a plan but are keeping it reserved, because if they really have no plan as they say then this is very bad news.

Are they waiting to see how sales go in Ireland and how the device performs before committing to international release? I really don't understand, they already have a very long waiting list.
They have said in interviews they have a plan for their roll out beyond Ireland. Some of this is going to be dependent on approval from organizations like the FDA but they still have a plan.

I would not put too much stock in someone scheduling appointments with communicating strategy to customers.
 
As has been stated earlier, Neuromod's business policy and preparation is curious. They have a potential commercial bomb in their hands, that will trigger worldwide demand (and with a little smart advertising this could really explode further) and they don't even have a plan to make this available in the UK, the closest country? This is crazy. They cannot continue like this. I hope they do have a plan but are keeping it reserved, because if they really have no plan as they say then this is very bad news.

Are they waiting to see how sales go in Ireland and how the device performs before committing to international release? I really don't understand, they already have a very long waiting list.
It may well be they are waiting to see if they can get their trial data past peer review. That would tell them more about their likely future position, I guess, enabling them to make plans.

Neuromod previously said they were submitting data from the TENT-A1 trial in early 2019.

Screenshot 2019-06-28 at 18.07.29.png


If they did so, and if the trial still has not been published, then it may be Neuromod were asked for more analysis of the data by the peer reviewers. On the TENT-A1 clinical trials page it now says the study completion date is July 2019. It defines study completion as:
  • "The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit)"

So either Neuromod's data analysis took longer than they thought and they have not submitted the paper for peer review yet.

Or, they did submit for peer review in early 2019 as they said they would, but were asked to go back and do different analyses of the data.

Either way it might explain uncertainly about their future plans.
 
They have said in interviews they have a plan for their roll out beyond Ireland. Some of this is going to be dependent on approval from organizations like the FDA but they still have a plan.

I would not put too much stock in someone scheduling appointments with communicating strategy to customers.
Good point. I had written to their "info" email address rather than appointments, but I guess the admins of the info email may not know corporate strategy. Still, putting in writing that they have no plan is curious. They could have said that they are preparing and will let us know later. Also, release in the EU should not be problematic, there is no FDA hurdle as Lenire is approved in the EU. The UK (well at least until Brexit) would be an ideal place to start for many reasons.
 
Yesterday I read in the Research News section that Susan Shore's device will be launched in 2020 (before finishing the trials). Maybe the people in the United States can choose between two options. Wow!
Can you link to the article about that release date?
 

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