Q&A: Tinnitus Hub Meets Neuromod (Lenire)

[spedgas]

Neuromod doesn't have another presentation until the end of the month. I'm guessing we don't hear anything new from them before that.

 

[F-u-T]

I wouldn't be surprised if they waited to release the device until after they have approval in the US. That will be the main market share they are targeting.

 

[R. David Case]

View attachment 24163

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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

Nice work @Markku!

Very interesting, I hope it helps many. I totally agree with his assertion of neurological pathways feeding off of each other in a circular manner. I call it a feedback loop but same thing.

 

[El BUZZ]

For a long time the mechanisms of tinnitus have been ignored.

It will be an eternity until we will realize the amount of effort behind this work you guys from Tinnitus Talk have done.

Thanks from the bottom of my heart!

 

[Hazel]

For a long time the mechanisms of tinnitus have been ignored.

It will be an eternity until we will realize the amount of effort behind this work you guys from Tinnitus Talk have done.

Thanks from the bottom of my heart!

Much appreciated! And welcome here!