Q&A: Tinnitus Hub Meets Neuromod (Lenire)

[Tinnitus Talk]

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Listed below are the individual questions.
These links are handy when you want to see a specific question answered.​

1. A few years ago the device was already on the market - what happened to it?
2. What have you learned from the past few years up until now?
3. Were you expecting those with hyperacusis to respond better to the treatment?
4. Is the treatment more effective on tinnitus, hyperacusis, or both?
5. Did you distinguish between pain hyperacusis and sound intolerance hyperacusis?
6. What is the safety profile for hyperacusis patients like?
7. How does the device work and is it individually calibrated?
8. Is there any need for re-calibration of the device, and if so, in what circumstances?
9. Can the device be used at home, and what initial steps are required?
10. What makes the device effective? Is it based on neuroplasticity?
11. Is the treatment personalized to the individual's tinnitus?
12. Does the tinnitus frequency or type of sound matter in terms of the treatment's efficacy?
13. How does it actually help tinnitus? Does it reduce the loudness of tinnitus?
14. Are you going to further follow up on the clinical trial participants?
15. Can the device be used for more than one treatment period? Can it help with future tinnitus spikes?
16. What was the level of improvement the trial participants experienced?
17. Are there any groups of people who might not respond well to the treatment?
18. Does the degree of hyperacusis matter in terms of benefiting from the treatment?
19. Are you going to look deeper into subtyping of tinnitus?
20. What is the timeline of the TENT-2 clinical trial?
21. Are there any instances of tinnitus getting worse or being cured from the treatment?
22. What is the general safety profile of the device?
23. Do you have to have a certain level of hearing to qualify for the treatment?
24. Is there any risk to using headphones for the duration of the treatment?
25. Could the sound part of the treatment be delivered via hearing aids or earbuds in the future?
26. Why did you choose TFI and THI as outcome measures in your clinical trials?
27. Was the group of people with severe tinnitus represented in the clinical trials?
28. Are you able to see how the treatment works? Do you have any brain imaging data?
29. What is the science behind stimulating the tongue?
30. Have you confirmed the safety of stimulating the tongue?
31. Why did you choose audio as a form of stimulation?
32. Have you gathered any data on how the treatment works on children?
33. When will the device be released and where will it be available?
34. Are there any estimations on how much the device will cost?
35. Will the device need to be fitted by an audiologist?
36. Are you training audiologists for the fitting of the device?
37. Can people from other countries travel to Ireland to buy and get set up with the device?
38. When will the device be available in the United States?
39. Will the device be available via public health care or insurance plans?
40. Outside of tongue stimulation, could the treatment be delivered on a smartphone?
41. Are you accepting new investors?
    
42. Does Neuromod have any financial relation to Tinnitus Talk?
43. How competitive is the market place for tinnitus treatments?
44. Who do you see as your competition in the market place?
45. BONUS! Steve tests a demo unit of the device
46. Parting thoughts and the value of Tinnitus Talk

 

[Markku]

Dear all,

I know many of you have been anxiously waiting for this moment, and here it is: the published video of our Q&A with Neuromod Devices!

It's an extensive Question & Answer session of over an hour. The discussion centres around their soon-to-be-launched device to treat tinnitus, a follow-up to the MuteButton device, which is based on the science of bi-modal neuromodulation. Topics covered include: the efficacy and safety of the device, the research behind it, how it works, for whom it works, and when, where and how it will be made available.

The questions are based on input we received from you guys. Although we could not ask all your questions, we believe the key ones have been addressed.

Please keep the following in mind when commenting in this thread:
- Any off-topic comments, i.e. not in direct response to the video, will be removed;
- Any disrespectful, abusive or slanderous comments will be removed;
- Do not comment if you have not watched the (whole) video.

Finally, I would like to take this opportunity to acknowledge what a huge collaborative project this has been. Please spare a thought for the countless unpaid hours that went into creating this informative resource!

- @Steve took time out of his busy schedule to travel to Dublin to meet Neuromod;
- @Hazel spent 8h curating and structuring the interview questions, another few hours advising on video production, and will spend probably about 10h on the – yet to be created – sub-titles (volunteers are welcome!);
- I myself spent about 30h on video editing and production. It's definitely the biggest video project we ever did!
- @Ed209, @Jack Straw and @TuxedoCat functioned as our review panel, providing valuable feedback.

We hope you find this video useful and informative. If you do, please share the video on your social media and help get it out to more tinnitus patients!

 

[Starthrower]

Excellent @Markku!!

 

[RODRIGO]

Amazing.

 

[JohnAdams]

Wow, I can see much work has gone into this. Can't wait to hear from users on this site about it.

 

[Jcb]

Guys thank you so much for this, I'm going to have to watch it in parts as concentration isn't great but you've all put so much work into this, huge respect my friends.

 

[AliceW]

Thanks a lot for your work @Markku and @Steve!

 

[Benoves]

Wow that's a nice piece of work you've done guys!

Can someone explain to me what he is saying from 29:30? Are people with high frequency tinnitus highly responsive?

For what kind of people the device works the best?

Sorry for my questions but English is not my native language.

 

[Krolo]

Wow that's a nice piece of work you've done guys!

Can someone explain to me what he is saying from 29:30? Are people with high frequency tinnitus highly responsive?

For what kind of people the device works the best?

Sorry for my questions but English is not my native language.

People with Tinnitus + Hyperacusis were super responders to lower their tinnitus. Not sure if that is what was said at 29:30 but that's my takeaway from the video.

 

[Autumnly]

The only thing that worried me is that the device needs to be fitted by an audiologist. Getting a new audiogram done shouldn't be a problem but I'm worried no audiologist or ENT near me will learn how to set up the device and I'm not sure that I can travel to a bigger city due to tinnitus/hyperacusis.

But I'll try to get a device as soon as they're available in my country.

Huge thank you to everyone that worked on this interview!

 

[Benoves]

People with Tinnitus + Hyperacusis were super responders that they identified from the subgroups. Not sure if that is what was said at 29:30 but that's my takeaway from the video.

I think that's what he said. Thank you.

 

[MBH]

Thank you, nice work!

 

[TuxedoCat]

For what kind of people the device works the best?

Hi Benoves, Use of the device seems to work best for people who have both tinnitus and hyperacusis. However, the effect is on their tinnitus and not on their hyperacusis. -TC

 

[PDodge]

Amazing! Thank you!

 

[Krolo]

Great job @Markku and @Steve! Finally watched the whole thing.

Must say that by the Q&A I am positively surprised and will now sell all my things to be able to live in Ireland from now on to be close to where the action is.

Only thing I am missing is when will it be out

@Autumnly,
I have the same issue but I really would take the pain to get my hands on this unit.

 

[Agrajag364]

Well done to all involved.

 

[TuxedoCat]

People with Tinnitus + Hyperacusis were super responders that they identified from the subgroups. Not sure if that is what was said at 29:30 but that's my takeaway from the video.

That is correct Krolo, please keep in mind the effect was measured on their tinnitus and not on hyperacusis. -TC

 

[Krolo]

That is correct Krolo, please keep in mind the effect was measured on their tinnitus and not on hyperacusis. -TC

Yes. The reply was of course not proper since it didn't do anything with the hyperacusis, only with the tinnitus. But still,

One hellish thing less to worry about is better then two I would say

@RCP1 Be ready for a Guinness as soon as this shit hits the market. I'll be over.

 

[Benoves]

Hi Benoves, Use of the device seems to work best for people who have both tinnitus and hyperacusis. However, the effect is on their tinnitus and not on their hyperacusis. -TC

Thank you TC.

I have multiple tone tinnitus and 40 dB hearing loss. I have no hyperacusis but some reactiveness. Can the treatment still work for me? On which patients did it not work?

Should it be worth it for me to try the treatment?

Sorry for all my questions. I can't wait for the subs. Reading is better than listening for me.

 

[WaqasVic]

Excellent, watching the video right now.

 

[Jack Straw]

That is correct Krolo, please keep in mind the effect was measured on their tinnitus and not on hyperacusis. -TC

I thought I remember him saying there was an improvement in hyperacusis as well. Maybe I am not remembering it right.

 

[Jcb]

So will you be renting this and then have to return it after the 12 weeks or once you buy it's yours?

 

[Jcb]

Also sorry for asking silly questions but my concentration is messed up, did I hear right when they said if it's catastrophic tinnitus it's not recommended?

 

[Krolo]

So will you be renting this and then have to return it after the 12 weeks or once you buy it's yours?

Pay up and ghost them so you can treat yourself for eternity

It did sound that they are not really decided on that yet since they didn't say a price. Maybe their pricing model will be more Netflixy.

 

[Sam Bridge]

Thank you TC.

I have multiple tone tinnitus and 40 dB hearing loss. I have no hyperacusis but some reactiveness. Can the treatment still work for me? On which patients did it not work?

Should it be worth it for me to try the treatment?

Sorry for all my questions. I can't wait for the subs. Reading is better than listening for me.

40 dB loss is fine. As long as you are not profoundly deaf (90 dB loss) you can use the device.

 

[Jcb]

Pay up and ghost them so you can treat yourself for eternity
It did sound that they not really decided on that yet since they didn´t say a price maybe their pricing model will be more Netflixy

Yeah I wasn't too sure if I had missed something but it sounded like you may rent it and then once the 12 weeks is up you return it.

Yeah I'll be going in ninja mode man, nobody will find me, I'll be sat somewhere deserted with the device.

 

[RCP1]

Yes, The reply was of course not proper since it didn´t do anything with the Hyperacusis just with the T. But still,
One hellish thing less to worry about is better then 2 I would say

@RCP1 Be ready for a Guinness as soon as this shit hits the market. I´ll be over.

Not a problem man - I think for all who have watched the Q&A from start to finish that Ross O'Neill and Neuromod are more than legitimate/well meaning/professional & scientific.

67% chance of meaningful reduction - They're good odds people.

Will be getting one in the new year - although January wasn't mentioned @Steve.

Is January the month it's coming out?

 

[Hazel]

did I hear right when they said if it's catastrophic tinnitus it's not recommended?

My understanding is that patients with very mild or very severe tinnitus were excluded from the trials, because it's hard to measure outcomes in these patients and attribute them to the device.

But that does not mean these patients could not benefit from the device! They just weren't included in the trials, so the data isn't there.

 

[RCP1]

Also sorry for asking silly questions but my concentration is messed up, did I hear right when they said if it's catastrophic tinnitus it's not recommended?

No they didn't say that - What they said was Catastrophic Tinnitus was not included in the trial as it would skew the results as people with Catastrophic Tinnitus are on meds + the effect would not be purely due to the device perhaps... Also people who have Catastrophic Tinnitus would be unlikely to get worse, only better, so it would again skew the results...

It's purely statistical and doesn't affect eligibility to use the device.

 

[Jcb]

My understanding is that patients with very mild or very severe tinnitus were excluded from the trials, because it's hard to measure outcomes in these patients and attribute them to the device.

But that does not mean these patients could not benefit from the device! They just weren't included in the trials, so the data isn't there.

Ah ok, cheers for clarification Hazel, that's good to know. Thanks for your hard work in this as well.