Lenire — Bimodal Stimulation Treatment by Neuromod

[GSC]

I hope it works for all of you.

 

[Heinrich_S7]

Well, here we go boys, whether we can get it or not right now. We are going to see how the first wave of patients respond!

Those of you who are going, make sure to give us updates on your treatment!

 

[Damiano]

Opinions on the questionnaire?

Do you think they'll filter out anyone based on this?

I was wondering as well. Also,

"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."

Any idea of what factors would lead to exclusion from treatment?

 

[Tanni]

You can have ETD and not have it be the cause of your tinnitus, just like you can have TMJ and not have it be the cause of your tinnitus.

To think they would deny you treatment because it may be a factor would be stupid on their part.

The popping came two days after tinnitus so I imagine they are connected, but who knows

I hope you're right and they don't exclude it. I will hopefully give them a ring and report back!

 

[Manny]

I'm shocked it's priced as low as it is. With the time and effort they put into the development they could have justified charging much more. As desperate as this population is at times they still would have sold a ton even at a higher price.

To me this is an indication that they have at least some confidence in the device. A "hit 'n run" like Levo might be priced higher.
Just my speculation.

 

[Jack Straw]

To me this is an indication that they have at least some confidence in the device. A "hit 'n run" like Levo might be priced higher.
Just my speculation.

On their website they even say that if the treatment doesn't work you may be able to get a partial refund from the audiologist.

 

[OnceUponaTime]

THIS! Jack you are so clever...

Exciting times my friends!!!!

I'm extremely happy today. I wish everyone who tries this the best of luck!

Hopefully it will get approved by the FDA soon enough... and us on this side of the world can get a chance to try it as well.

(Sprinkling sparkles of joy and luck to everyone)

 

[NoBigDeal]

Maybe people who are having another medical treatment, especially taking antidepressants and/or benzodiazepines, are not eligible? (I take both).

I remember reading about another similar treatment where they stated these types of medications could interfere.

Does anyone have any information about that?

 

[Lilah]

There should be a question on whether Lenire decreased eye floaters in the survey.

 

[Markku]

The user experience group sign up form is ready

Check the top of the thread for the banner link.

Please only fill the form if you intend to get the treatment soon. Also, you need to be committed to responding to follow-up questionnaires with which we track your progress. The data you submit may be used for research purposes and shared with researchers, but it will be anonymized before doing so.

Other updates

Once the first batch of devices are out there in the wild, we are also considering cleaning up this thread to start fresh (seeing so many of the current posts are about "when will it come out"), editing the first post to include a more detailed update of the current state of things, possibly alongside a Q&A - maybe even an updated one with Neuromod if they're open to that. Also like stated before, besides the more science-y user experience group, we are planning to have a separate users' thread where only those who are currently using the device can post in (everyone can read).

 

[winstona]

Finally! But having to go for 3 more follow up appointment kills the chance for me to get this early directly from Neuromod. I wanted to fly over there but doing that 3 more times makes it less realistic.

 

[winstona]

I wonder if it's possible to cut the number of visits down to 2?

According to Neuromod Medical website:

1st appointment assesses whether it's right for you
2nd appointment configures the device for you
3rd appointment is to assess the progress
4th appointment is to talk about long term plan.

1st and 2nd appointment technically can be done in one day. 3rd appointment can be done remotely in my opinion. 4th appointment may require reconfiguring of the device so that should be the second visit.

 

[vermillion]

Can somebody sum it up and tell me how can we obtain the device at the moment?

 

[Autumnly]

For anyone interested in knowing how the 4 appointments are scheduled:

 

[Heinrich_S7]

Can somebody sum it up and tell me how can we obtain the device at the moment?

There is pretty much only one clinic as of today. They said they are going to roll it out worldwide eventually.

You have to book an appointment, and then over the course of three months you will have 4 visits total to the audiologist.

But at least it's released, now we will see how well this thing works!

 

[Jack Straw]

For anyone interested in knowing how the 4 appointments are scheduled:

View attachment 30087

Based on this it seems that the device will continue to be used after the 12 week treatment has ended. Interesting!

I hope they have some data or reasoning behind this backed by science.

 

[drivera2592]

I am very happy that they are now taking appointments. Honestly, I am still skeptical if it truly works. I know there is data and people have come forward saying that it works. I truly pray that it will work for almost everyone.

To make those 4 trips and purchase the device I would spend about $6500 USD. I have the money, I just need to make sure it works. As soon as someone on this forum tries it and it works please report back.

 

[jmasterj]

The popping came two days after tinnitus so I imagine they are connected, but who knows

I hope you're right and they don't exclude it. I will hopefully give them a ring and report back!

Tanni, I have the popping as well and I think it is more common than you think. I asked about it and the two ENTs I saw says this is the sound of your Eustachian tubes opening and closing. It seems that people with tinnitus either hear this more and we are more in-tune to it. I wouldn't worry about it being an exclusion criteria, but it wouldn't hurt to check and make sure.

 

[Jcb]

I hope this works for everybody, or at least get some reduction. I don't want to get too excited as it'll be a while before I can afford this but I'm looking forward to reading everybody's experiences with this and of course @annV getting her boobies out

 

[winstona]

I am really happy for those who live close to Dublin and are able to try this first hand. I hope that all of you can find relief by the end of summer and report back with your findings!

Good luck!

 

[Iowa54]

I think I have ETD as well. ENT docs say I don't, but my ears are constantly popping when I swallow so not sure what else it could be.

I don't think Neuromod mentioned this as part of the trial exclusion criteria (if that's the right term), so maybe it won't be part of the exclusion criteria for the actual treatment either...

Might give them a ring and ask what exactly would exclude someone from using the treatment. Would save getting the ferry all the way to Ireland to find out in person!

This might be ignorant, but are your ears not supposed to pop every time you swallow?

 

[spedgas]

To make those 4 trips and purchase the device I would spend about $6500 USD. I have the money, I just need to make sure it works. As soon as someone on this forum tries it and it works please report back.

I'm in a similar situation. I have the money and could make the time for the trips. However, I'm trying to decide what's the best thing for me. The cost and inconvenience of four trips or waiting months/year + until availability closer to me in the US. If I did go I would consider staying in country for the time between the first and second appointment.

 

[Heinrich_S7]

I only have tinnitus in my left ear, it's mild and I have a little of hyperacusis with it. It's only really bad when it spikes.

I know Lenire has been claimed to be a spike killer and giving significant tinnitus reduction. I'm hoping for total elimination.

 

[lcho]

The user experience group sign up form is ready

Check the top of the thread for the banner link.

Please only fill the form if you intend to get the treatment soon. Also, you need to be committed to responding to follow-up questionnaires with which we track your progress. The data you submit may be used for research purposes and shared with researchers, but it will be anonymized before doing so.

Other updates

Once the first batch of devices are out there in the wild, we are also considering cleaning up this thread to start fresh (seeing so many of the current posts are about "when will it come out"), editing the first post to include a more detailed update of the current state of things, possibly alongside a Q&A - maybe even an updated one with Neuromod if they're open to that. Also like stated before, besides the more science-y user experience group, we are planning to have a separate users' thread where only those who are currently using the device can post in (everyone can read).

@Markku Thank you so much for doing this; this will be really helpful for all of us, and especially those considering trying this as soon as we've had some real user experience from people on this site.

Would you be able to tell us how many people have already signed up for the user experience thread - to give us an indication of how many people are planning on being first-phase users?

 

[Tanni]

Tanni, I have the popping as well and I think it is more common than you think. I asked about it and the two ENTs I saw says this is the sound of your Eustachian tubes opening and closing. It seems that people with tinnitus either hear this more and we are more in-tune to it. I wouldn't worry about it being an exclusion criteria, but it wouldn't hurt to check and make sure.

Thanks jmasterj I hope so, but mine is more like trapped air that I can move about by moving my jaw. Unless this is just me doing something weird with my tubes?? I think it's either ETD or TMJ, and TMJ would exclude me entirely...

Keeping fingers crossed for all of us!

 

[Tanni]

This might be ignorant, but are your ears not supposed to pop every time you swallow?

Well mine certainly didn't until I got tinnitus! Maybe everyone's pops a little bit but we don't notice unless it gets really bad? Or like @jmasterj said, we become more aware when we get tinnitus...

 

[Agrajag364]

UPDATE on June 5th, 2019

We are currently working on a quick form where people who have firmly decided to try Lenire can submit their details.

The form's intent is to collect details of the people who are willing to report back to us via future surveys on a regular basis about their experience using the device. Using this data, we can analyze and publish findings in a way that would not be possible with a discussion thread format.

In addition to that, we are planning to have a separate users' experience thread here on Tinnitus Talk, in a format that allows more instantaneous feedback. These are two separate things, the more regulated and structured surveys and the thread.

If you have interest in helping us with the brainstorming, formating, etc. around this, please send me a PM.

This is awesome. The real life data on this thing is going to be available double quick.

 

[GlennS]

TENT-A2 exclusion criteria is not indicative of the release product exclusion criteria. For instance, that patients have tinnitus for less than 5 years. There's no way they'll limit this device that much, which is one reason the first round of early-adopters are in fact beta-testers. The exclusion criteria did cook the books a little bit, IMHO.

 

[annV]

TENT-A2 exclusion criteria is not indicative of the release product exclusion criteria. For instance, that patients have tinnitus for less than 5 years. There's no way they'll limit this device that much.

It might be they limit it that way. Why would they want to sell the device to people who they think it won't work for? That would get bad press and negative reviews for them. If someone says their tinnitus started over 5 years ago and Neuromod declines to sell the device then we will know for sure.

Who was right about the June release? The price was lower than what I had got from my source! Soon near you a pair of well-aged boobs will make their appearance.

 

[AliceW]

They will limit the patients with tinnitus for less than 3 months for sure... They ask about it in the medical booking assessment survey.