Q&A: Tinnitus Hub Meets Neuromod (Lenire)

[GlennS]

Remember that there are three similar technologies moving in parallel. As more encouraging data comes in, don't be surprised to see more players emerge. Putting all your hopes on Neuromod and Neuromod alone may not even be necessary. Not only that, some perspective is in order. Let's say this will eventually represent a cure. Imagine the life of everyone else who came before us, born too early to ever even hope to attain relief. We place a lot of unfair expectations on the medical industrial complex to achieve what was once thought impossible. We should be grateful this stuff is in the pipeline.

 

[Helheim]

We should be grateful this stuff is in the pipeline.

I mean I'm grateful as hell, but I'd be even more grateful if they finally released this thing already lol

 

[Paulmanlike]

Just on their Twitter - 80% of 500 patients have reported an improvement. I mean wow. Just wow. I can't wait to get hold of this device.

 

[SignalExec]

Sorry, but as a staff member I have to respond to this, even though it's just an aside in your comment. While I realize your criticism was directed more at Neuromod than at us

Rereading my post, I realize that it was slightly ambiguous. When I say 'the interview could have been compressed', I meant that, at times, the interviewee seemed to use a lot of words to convey very little information. This has absolutely nothing to do with the interviewer, the editing or postprocessing. You reported, in a professional way, what Neuromod had to say.

Indeed, if you had edited the responses in any way, people here would be asking what you cut out and why.

If you feel I was criticizing your work, please accept my apologies.

 

[pochito]

@Markku,

Do you think it would be possible you ask Neuromod directly if they have some kind of idea about the launch date now that you have a discussion already running with them?

I mean after they teased us really hard with the Q&A, then the videos on the website, it would be quite legitimate they keep us updated on the schedule.

What do you all think? lol

Please

 

[Fabrikat]

So far, the only thing I've seen Neuromod doing is to excelling at marketing (creating a buzz in the community).

Yes, it's hard not to feel a little suspicious about this company and it's device. Their message seems all so tightly controlled as to how effective this device really is. Of course, as hopeful members of the public, it's because we're all trying to feel our way in the dark at this stage.

When the peer review is finally published and especially when some trusted voices on Tinnitus Talk report back after using the machine, naturally things should become much clearer.

But with minimally expansive responses to a variety of questions, which by the way, is no reflection whatsoever upon the good work performed by dedicated Tinnitus Talk staff, together with what appears a very selected trial group, chosen for their less than severe tinnitus handicap scores, added to very selected video testimonials and finally, radio silence about promised release dates, it all raises understandable doubts in the prospective customer.

They don't need to be so cagey really. Even if this machine is only mildly effective, business is going to boom!

 

[Markku]

Do you think it would be possible you ask Neuromod directly if they have some kind of idea about the launch date now that you have a discussion already running with them?

I mean after they teased us really hard with the Q&A, then the videos on the website, it would be quite legitimate they keep us updated on the schedule.

What do you all think? lol

Neuromod are reading these threads here. They are well aware of the visitors and members' eagerness to know the (adjusted) launch date.

I have also already sent them an e-mail asking about this over a week ago - I haven't received any response.

My thinking is that they are not going to give us an exclusive update on the launch date, instead they will update everyone at once via their social media, website and newsletter. Everyone will know the moment they have something to share.

I can only imagine they might be taking their time to post an update because they don't want to risk disappointing people a second time by not being able to live up to the launch date. For example, they might have some tasks pending completion that are beyond their control before they can launch.

Of course the speculation runs high when there are little in terms of updates.

But I will of course update here if I hear any news.

 

[Paulmanlike]

In the video they base that tinnitus is the result of hearing loss.

My question would be would it work on those without hearing loss (or not measurable on an audiogram)?

Also, what if somebody got tinnitus from medicine or withdrawal from a benzo?

Would it still work then?

 

[Agrajag364]

Just on their Twitter - 80% of 500 patients have reported an improvement. I mean wow. Just wow. I can't wait to get hold of this device.

That's great but that needs to go in a peer reviewed paper, not Twitter! Well hopefully they are preparing that.

EDIT - I just saw on Twitter someone else asking them the same question and they said "Results from TENT-A1 will be submitted for publication in early 2019". It can take quite a few months from submission of a paper to acceptance and publication.

They did an initial small pilot study with no placebo which they've already published, and this subsequent bigger "TENT-A1" trial is the one that @Clare B was a part of, presumably.

However in the EU proper clinical trials do not have to be published before a device can be sold to the public.

Updates to the trial can be viewed here - https://clinicaltrials.gov/ct2/show/NCT02669069

Pilot study here - https://www.neuromoddevices.com/content/1-company/2-clinical-advancement/e018465.full.pdf

Protocol for the larger controlled TENT-A1 trial here - https://www.neuromoddevices.com/content/1-company/2-clinical-advancement/e018465.full.pdf

 

[Agrajag364]

Here's a slide I found on Twitter of the data from the TENT trial presented at a conference hashtagged IOS2018.

 

[PDodge]

View attachment 25769

Here's a slide I found on Twitter of the data from the TENT trial presented at a conference hashtagged IOS2018.

Line goes down = good?

 

[Helheim]

Line goes down = good?

I really friggin' hope so lol. Can't see shit.

 

[Agrajag364]

Line goes down = good?

Has to be I guess as they say green outperforms the other arm.

 

[Tinniger]

Just discovered the subtitles.

They are a great help for non-native speakers!
Or even when any noise is annoying.

 

[Markku]

Below is the latest from Neuromod we received today - so it's just about waiting some more now. A more detailed update should come sometime in the future...

We are working diligently to make the product available to patients as soon as we can. As you know we are still in the process of completing TENT-A2 12 month follow up and are finalising the publication of TENT-A1 results. In addition we are working hard to ensure that all of the necessary steps are completed to support qualified clinicians in fitting and overseeing treatment with the Neuromod device. And as outlined in the Q&A with Ross, we are working hard to engage with regulatory authorities in the United States and elsewhere to apply for marketing clearance.

We continue to work hard to make the product available as early as possible in 2019, however, early 2019 should not be interpreted to mean January. We are confident that the treatment will be available soon and are working with leading experts in the field to make this possible. We will provide a more detailed update at the appropriate time. We have asked interested parties to sign up for information about product availability in their region at https://www.neuromoddevices.com/signup

We understand and are encouraged by the strong interest in the treatment, and are doing all we can to address that interest. We are a regulated medical device company seeking to bring evidence-based treatments for tinnitus to the market, and the process of making the product available in the appropriate setting cannot be rushed unfortunately.

Thank you for keeping us informed and aware of your members' requests.​

 

[Paulmanlike]

Thanks @Markku for the update on behalf of everybody here!

Finally... a treatment for tinnitus. 2019 was the year it happened!!

Can't wait to have this treatment and hopefully get some relief.

What's interesting is that we still don't know if we use the device for a longer period of time and it may go away completely, I'll be happy using it for 30 mins a day forever if it gave me silence!

 

[dayma]

Below is the latest from Neuromod we received today - so it's just about waiting some more now. A more detailed update should come sometime in the future...

We are working diligently to make the product available to patients as soon as we can. As you know we are still in the process of completing TENT-A2 12 month follow up and are finalising the publication of TENT-A1 results. In addition we are working hard to ensure that all of the necessary steps are completed to support qualified clinicians in fitting and overseeing treatment with the Neuromod device. And as outlined in the Q&A with Ross, we are working hard to engage with regulatory authorities in the United States and elsewhere to apply for marketing clearance.

We continue to work hard to make the product available as early as possible in 2019, however, early 2019 should not be interpreted to mean January. We are confident that the treatment will be available soon and are working with leading experts in the field to make this possible. We will provide a more detailed update at the appropriate time. We have asked interested parties to sign up for information about product availability in their region at https://www.neuromoddevices.com/signup

We understand and are encouraged by the strong interest in the treatment, and are doing all we can to address that interest. We are a regulated medical device company seeking to bring evidence-based treatments for tinnitus to the market, and the process of making the product available in the appropriate setting cannot be rushed unfortunately.

Thank you for keeping us informed and aware of your members' requests.​

Just wanted to say thanks @Markku for keeping us up to date! Your efforts don't go unrecognized

 

[Manny]

Below is the latest from Neuromod we received today - so it's just about waiting some more now. A more detailed update should come sometime in the future...

We are working diligently to make the product available to patients as soon as we can. As you know we are still in the process of completing TENT-A2 12 month follow up and are finalising the publication of TENT-A1 results. In addition we are working hard to ensure that all of the necessary steps are completed to support qualified clinicians in fitting and overseeing treatment with the Neuromod device. And as outlined in the Q&A with Ross, we are working hard to engage with regulatory authorities in the United States and elsewhere to apply for marketing clearance.

We continue to work hard to make the product available as early as possible in 2019, however, early 2019 should not be interpreted to mean January. We are confident that the treatment will be available soon and are working with leading experts in the field to make this possible. We will provide a more detailed update at the appropriate time. We have asked interested parties to sign up for information about product availability in their region at https://www.neuromoddevices.com/signup

We understand and are encouraged by the strong interest in the treatment, and are doing all we can to address that interest. We are a regulated medical device company seeking to bring evidence-based treatments for tinnitus to the market, and the process of making the product available in the appropriate setting cannot be rushed unfortunately.

Thank you for keeping us informed and aware of your members' requests.​

Thank you Markku!

I'm disappointed.

 

[Paulmanlike]

Thank you Markku!

I'm disappointed.

They want to bring evidence based products to the market and this can't be rushed. Remember this isn't TinniTool - with a small study on it and selling it for £300. This is a pioneering new tinnitus treatment that actually targets the actual volume/pitch.

 

[Bndsmheowqhe]

"We continue to work hard to make the product available as early as possible in 2019, however, early 2019 should not be interpreted to mean January"​

Didn't they specifically say January at one point? Why can't they just admit that they were off on their original release date instead of gaslighting us? This kind of behavior is not inspiring confidence.

 

[Eren101]

If you can show me one audiogram with a flat line at 0 zero that goes past 8 kHz, I'd love to see it.

You're the one making the claim, not me. A lot of children, teenagers, many people under 40 have that flat line.

Also, a flat line at zero is not a good indicator. What if you're able to hear +1 dB HL but not zero? In your audiogram, this will show as a +5 dB HL reading. This doesn't indicate loss at all. The zero line represents the AVERAGE hearing of 12-18 year olds at those frequencies. I have a lot of zeros, and even some negatives (even past 8 kHz).

 

[EDDTEKK]

Sounds like the device will be available in autumn or later in 2019.

They are still in clinical study (TENT-A2) and didn't open the peer review of the first study TENT-A1. I fear this can take several months.

All the audiologists must be trained and contracts must be negotiated. This will take time. The device is ready, but the environment is not.

 

[spedgas]

Sounds like the device will be available in autumn or later in 2019.

They are still in clinical study (TENT-A2) and didn't open the peer review of the first study TENT-A1. I fear this can take several months.

All the audiologists must be trained and contracts must be negotiated. This will take time. The device is ready, but the environment is not.

This tells me they want everything above board before it's release. This is the right way to do it. By making sure everything is in place they are ensuring their patients and themselves will succeed.

 

[GlennS]

This kind of behavior is not inspiring confidence.

Speak for yourself. I don't care if they dropped the word "January" in the past and even if they did, you're probably misinterpreting what it meant in context anyway. While I haven't been waiting on this since 2011 I'm not seeing any evidence to suggest this thing isn't going to start rolling out in less than a year.

 

[PDodge]

Thanks Markku!

 

[AliceW]

@EDDTEKK,

Not before autumn? Oh no...

I hope it will be available in March or April...............

And I'm afraid they first only accept Irish or British people to buy the device in Ireland... to keep other patients as clients in their own respective countries once they release the device in those countries... so it will be again such a long wait...

What do you think about that?

 

[Agrajag364]

Sounds like the device will be available in autumn or later in 2019.

They are still in clinical study (TENT-A2) and didn't open the peer review of the first study TENT-A1. I fear this can take several months.

All the audiologists must be trained and contracts must be negotiated. This will take time. The device is ready, but the environment is not.

They do not necessarily have to publish the TENT studies before releasing the device onto the market, according to EU device regulation rules.

 

[EDDTEKK]

Hi AliceW,

this is only my personal expectation. If we are super lucky, they might be faster.

 

[dayma]

@EDDTEKK,

Not before autumn? Oh no...

I hope it will be available in March or April...............

And I'm afraid they first only accept Irish or British people to buy the device in Ireland... to keep other patients as clients in their own respective countries once they release the device in those countries... so it will be again such a long wait...

What do you think about that?

International health care is quite normal. Not really sure why an audiologist would pass up on pure cash up front. That's always preferred.

 

[spedgas]

I've garnered tons of information from this thread. It's kinda getting to the point where we are speculating on effectiveness, price, and availability.

Reading all these guessing posts are starting to stress me out. I'm going to try and take a break from this website until Neuromod posts something on Twitter saying this thing is available.

Then I'll be back to read user testimonials. Hopefully this can reduce my stress revolving around this device.