Lenire — Bimodal Stimulation Treatment by Neuromod

Everything seems very promising. The only thing I'm afraid for is that they only tested the device on people who have had tinnitus less than 5 years. Time since tinnitus onset is a very important parameter in my opinion and they didn't include it.
They measured the improvement against THI and TFI scores. I think these scores will become lower when people habituate, and habitation can cost years.

As I speak for myself, my THI and TFI scores are much lower nowadays then 5 years ago. Not because the tinnitus is less, but overtime you learn to live with it more and more. It still bothers me (a lot), but I can sleep without masking and am living an active live again and am not so afraid of the tones in my head anymore.
So if all the people they tested the device on are less than five years into tinnitus I expect they would have had some natural improvement in their THI and TFI scores.
 
Can anyone explain in detail these inclusion bullet points for the trial?
  • Maximum AC pure-tone audiometry hearing loss of 80 dB HL in any test frequency in the set {2,3,4,6,8}kHz or 40 dB HL in the set {250,500,1000}Hz either unilaterally or bilaterally
  • Baseline Minimum Masking Level (MML) between 20 and 80 dB HL
  • Tonal tinnitus
 
@kelpiemsp before this trial made you better, did food, salt, alcohol, marijuana make your tinnitus worse? And after the trial did any of the above still affect your tinnitus?
These things only affected my tinnitus perception temporarily. Salt and diet would only impact pulsatile, which I don't have. Anything that alters your mood will of course have an impact on your tinnitus perception. So yes.
 
Can anyone explain in detail these inclusion bullet points for the trial?

  • Maximum AC pure-tone audiometry hearing loss of 80 dB HL in any test frequency in the set {2,3,4,6,8}kHz or 40 dB HL in the set {250,500,1000}Hz either unilaterally or bilaterally
  • Baseline Minimum Masking Level (MML) between 20 and 80 dB HL
  • Tonal tinnitus
Easy:
  • To be part of the experiment you must not have more than 80 dB hearing loss in the frequency range from 250 Hz-8 kHz, and not more than 40 dB hearing loss in the frequency range of 250 Hz-1 kHz, otherwise you can't be part of it.
  • Your tinnitus must be maskable in the frequency range of 250 Hz-8 kHz by a sound level of 80 dB or lower, otherwise you're out.
  • If you have atonal tinnitus (for example 8 kHz-16kHz buzzing sound, you can't be a test person either! So "TV static buzzers" are doomed!
 
I am confused. I thought it works for every type of tinnitus sound. No...?
It is. What was said by @ageoflove is incorrect. Tonal tinnitus is a constant streamline sound. I would say static TV buzzing is that. Atonal would be multiple at once. HOWEVER, it was said tonal and atonal are ok. Atonal was just an exclusion at first.
 
Ross O'Neill said tonality did not matter in his Q & A... unless they have since discovered it does... the lady on the testimonial said she got rid of shhh sound which is atonal, right?
 
Easy:
  • To be part of the experiment you must not have more than 80 dB hearing loss in the frequency range from 250 Hz-8 kHz, and not more than 40 dB hearing loss in the frequency range of 250 Hz-1 kHz, otherwise you can't be part of it.
  • Your tinnitus must be maskable in the frequency range of 250 Hz-8 kHz by a sound level of 80 dB or lower, otherwise you're out.
  • If you have atonal tinnitus (for example 8 kHz-16kHz buzzing sound, you can't be a test person either! So "TV static buzzers" are doomed!
So for someone who wouldn't have qualified for the trial any chance of this working on them?

For example I wouldn't have qualified as I have a 50 db dip at 1000 Hz and a 40 dB dip at 500 Hz. My tinnitus is barely maskable at 80 decibels of masking so hopefully it doesn't get worse before it gets released.
 
A few reasons I can think of, if I understood the research correctly:
  1. the timing is critical (that's the secret sauce): adding a variable such as the distance between your speakers and your ear would most likely destroy the secret sauce. Sound propagates at about 1 foot per millisecond, and we do know from studies that getting the right timing requires millisecond accuracy. Using headphones reduces this variability greatly.
  2. the volume is important (which is why it is corrected with regards to your PTA data) and would also be affected if you were using speakers
  3. the PTA data can be different for left and right ears, which can be corrected with a different band equalizer for each ear in a headphone delivery mechanism, but not with speakers
  4. it is not clear that the signal is the same for both ears: perhaps the left and right sound channels are different, which also requires headphones
That makes sense. Thanks.

I really like that word "secret sauce" :D Good one!
 
Easy:
  • To be part of the experiment you must not have more than 80 dB hearing loss in the frequency range from 250 Hz-8 kHz, and not more than 40 dB hearing loss in the frequency range of 250 Hz-1 kHz, otherwise you can't be part of it.
  • Your tinnitus must be maskable in the frequency range of 250 Hz-8 kHz by a sound level of 80 dB or lower, otherwise you're out.
  • If you have atonal tinnitus (for example 8 kHz-16kHz buzzing sound, you can't be a test person either! So "TV static buzzers" are doomed!
Regarding bullet point 2. Will that be the same for the finished product? How can you measure that without blaring 80 dB of noise in your ears?
 
I am confused. I thought it works for every type of tinnitus sound. No...?
Yeah, what is with these conflicting messages??

They said tone/pitch of tinnitus didn't matter, now they say hissing 8-16 kHz is OUT?! (I have mainly hissing tinnitus at 14-15kHz :()
 
  • If you have atonal tinnitus (for example 8 kHz-16kHz buzzing sound, you can't be a test person either! So "TV static buzzers" are doomed!
There was literally a woman in the testimonial videos who had a "hiss" or "tv buzz" who said that this device made that noise go away completely...
 
Very encouraging - the actual data seems to be even better than the data mentioned in the Q&A!

Also, there are two separate lines of improvement over time - first, the device itself will get better as they find new parameters; second, individual symptoms seem to improve over time as the device is used.

This just made my day! :)
 
@annV is the hero we need, but don't deserve!
 
@TheDanishGirl; but that is just for the trial.

@ageoflove also said that TV static buzzer are doomed, but that is incorrect. Ross O'Neill said in the Q&A that the treatment works irrespective of tonality/atonality.

So cheer up, there's hope :)
But I don't understand why there should be a difference between the trial and real life. If they thought it would work on all kinds of tinnitus, why exclude people with 8+kHz tinnitus from trial... I just don't understand that.
 
@ageoflove's post on this page.
I just explained the posted criteria 1:1!

Of course I also hope that atonal tinnitus is also treatable by Lenire.

BUT nearly every sound therapy defines that noises (knocking, scratching, buzzing, whooshing...) and high pitched sounds (like in two-digit kHz frequencies) are not typical "tonal sounds".

Of course from scientific view high pitch is the same sound wave but with higher frequency, and "noises" are a combination/superposition of different wave length sound waves...

Let's just hope this machine (with the right settings) kickstarts neuroplasticity in the auditory cortex and desynchronizes the hyperactive brain structures!
 
But I don't understand why there should be a difference between the trial and real life. If they thought it would work on all kinds of tinnitus, why exclude people with 8+kHz tinnitus from trial... I just don't understand that.
IMHO, there really should be a TENT-A3 trial where they open it up to everyone else but instead early adopters will find out as they use it.
 

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