MuteButton

[Heinrich_S7]

Still can't believe that this thing shall work ... I am so skeptical about it. Of course I wish it shall but it sounds like a dream for me ...

Thing is we have multiple reports (including from people on this forum) that bimodal stimulation either got rid of their tinnitus completely (Clare B), or significantly reduced severe/chronic tinnitus to an almost inaudible level (kelpiemsp).

It's just that tinnitus hasn't had a treatment ever, but as we're approaching the 2020s, I believe most conditions (including biological aging itself, as David Sinclair as stated) will be more or less cured in the next decade.

 

[Heinrich_S7]

I think we can safely assume that ain't happening sadly.

Probably, I'm still preparing for a 5 hour flight there and back. I'm ready.

 

[Paulmanlike]

Still can't believe that this thing shall work ... I am so skeptical about it. Of course I wish it shall but it sounds like a dream for me ...

Same here @EDDTEKK. After years of following tinnitus research and plenty of let downs, with conclusion that developers of products always seem to show efficacy, there is reason to be cautious.

I will remind people that as of yet; it is still not understood where tinnitus comes from; hence how do they know where exactly to aim, reverse, resolve with something nobody can see. Tinnitus has always been a great big mystery and as of yet there is only something called theory. Even big public companies like Otonomy have a shit tonne of patents on things and really what they are doing is looking for a nail to hit with their hammer full of patents.

I can't help but wonder about placebo effects of tinnitus studies. How good does it feel receiving a treatment that is somewhat thought to slow down your tinnitus perception?

Regardless, I live in faith this will be the next best thing to a cure, but it seems to me this product is so little known about to the vast majority, even professionals, that this thing may not be better than a placebo. If this fails the only hope is regeneration and if that fails I can't ever see there being a cure.

 

[Paulmanlike]

Probably, I'm still preparing for a 5 hour flight there and back. I'm ready.

We shall be watching you fellow Tinnitaniun.

Remember though the 2 people who got relief is equally matched to the handful of reports I've encountered on the net who went for this treatment and got nothing out of it. Even Clare B whose tinnitus resolved, met 2 wrinklies on the trial who said it didn't help them, also a person said she was on this trial in 2016 (or maybe 2017?) who claimed it did fuck all.

 

[dayma]

Probably, I'm still preparing for a 5 hour flight there and back. I'm ready.

You and I both

 

[Heinrich_S7]

a person said she was on this trial in 2016 (or maybe 2017?) who claimed it did fuck all.

I believe the 2016 model wasn't bimodal stimulation though?

 

[Paulmanlike]

I believe the 2016 model wasn't bimodal stimulation though?

It's been bimodal, meaning stimulating the tongue and auditory system, since its development in 2010.

 

[Heinrich_S7]

It's been bimodal, meaning stimulating the tongue and auditory system, since its development in 2010.

I wonder why it was pulled off the market then. I heard it wasn't effective in the first place.

 

[Markku]

I wonder why it was pulled off the market then. I heard it wasn't effective in the first place.

Please watch our Q&A video, this is question #1.

https://www.tinnitustalk.com/threads/q-a-tinnitus-hub-meets-neuromod-lenire.32369/

 

[Sam Bridge]

@Paulmanlike, unless you have spoken with Dr. Lim and others, how do you know how much they know about tinnitus?

 

[Paulmanlike]

@Paulmanlike, unless you have spoken with Dr. Lim and others, how do you know how much they know about tinnitus?

Dr. Lim left my bed this morning with those leopard skin thongs I mentioned earlier in the thread. @Bam, while we were having a nice cup of coffee in bed, we had a detailed discussion about it.

No, in all seriousness though, as stated by Ross O'Neill, they work on the assumption that tinnitus is caused by hearing loss (see how he talks about constructing supply to the water pump), which is generally accepted throughout tinnitus researchers, but none can accurately say where tinnitus is produced, how it is produced, it's all theory. Tinnitus at this moment is invisible meaning there is no objective way of determine where it is or even what it is. This is common knowledge amongst tinnitus researchers.

There's a thread somewhere with multiple tinnitus theories on how it is generated but not even Dr. Lim can say for sure - I do hope I am wrong though.

He's good but not that good.

 

[GamesB2]

they work on the assumption that tinnitus is caused by hearing loss (see how he talks about constructing supply to the water pump), which is generally accepted throughout tinnitus researchers

As someone with minimal hearing loss I always hate reading anything akin to this.

I assume Neuromod started out with the same principle but hopefully have tapped into the actual 'brain problem'.

Otherwise those of us who have tinnitus from no identifiable cause may be left out to dry for even longer.

Still gonna try it on day 1 though.

 

[Paulmanlike]

Just going through the research papers, I will leave Saturday night to bring to you these facts:

- TENT-A1 study has demonstrated efficacy and safety of 362 patients a discussed in the Q&A

- TENT-A2 study which is enrolling 192 patients and pouring more money into proving their device works is focusing on 3 main objectives. These are:

1.) CONFIRM the EFFICACY, safety, and patient tolerant ability demonstrated in the TENT-A1 study. Let's hope this has good results supporting the 362 patients in the TENT-A1 study. If it doesn't, they're in deep doo doo, but so far, so good.

2.) Evaluate the therapeutic effects of adjusting stimulation parameters over time. You heard it right, playing about with parameters that can (hopefully) improve efficacy over a larger patient population. Dr. Ross O'Neill, has only discussed as far as I am aware results from the TENT-A1 study, who knows what this TENT-A2 data will achieve?

3.) Determine the contribution of different features of bimodal stimulation in improving tinnitus outcomes.

 

[Paulmanlike]

As someone with minimal hearing loss I always hate reading anything akin to this.

I assume Neuromod started out with the same principle but hopefully have tapped into the actual 'brain problem'.

Otherwise those of us who have tinnitus from no identifiable cause may be left out to dry for even longer.

Still gonna try it on day 1 though.

As Dr. Ross O'Neill stated they believe the cause of tinnitus to be hearing loss related in a majority of cases and this is backed up by research (something like 86-90% have measurable hearing loss in tinnitus patients). I like his explanation about the hose pipe.

But @GamesB2, I think you will have a better chance of achieving longer term if not permanent lasting results. This is because if you have close to normal hearing (I believe everyone with tinnitus has hearing loss even those not measurable) because you have the hearing input available. The hose pipe is not restricted so your brain won't reverse to compensating for the hearing loss. Clare B had no hearing loss and achieved complete elimination of her tinnitus. So there is no scientific way I can think off to why this would not work for you from how I understand it and I read a lot of papers.

 

[GregCA]

Otherwise those of us who have tinnitus from no identifiable cause may be left out to dry for even longer.

The good news for you is that "no identifiable cause" may still mean you have a broken hearing apparatus somewhere (albeit unidentified), and possibly a similar maladaptive neuroplasticity process that this device is set to reverse.

 

[spedgas]

The good news for you is that "no identifiable cause" may still mean you have a broken hearing apparatus somewhere (albeit unidentified), and possibly a similar maladaptive neuroplasticity process that this device is set to reverse.

I like this theory. I went to bed one night without tinnitus and woke up in the morning with it. I have no measured or perceived hearing loss. Figuring out the cause has been unproductive. Even if I have to use that thing an hour a day for the rest of my life I will.

 

[Drone Draper]

Gah, just release this thing already.

 

[Paulmanlike]

Neuromod are presenting today at 11:30 American time, I wonder if there will be any coverage/videos/or anything where we will learn anything new.

I believe our Susan Shore shall be there and the guys from Frequency Therapeutics...

We deserve some news as we're likely gonna be the first customers who engage with the tinnitus community to spread the word.

 

[Markku]

Neuromod are presenting today at 11:30 American time, I wonder if there will be any coverage/videos/or anything where we will learn anything new.

I believe our Susan Shore shall be there and the guys from Frequency Therapeutics...

We deserve some news as we're likely gonna be the first customers who engage with the tinnitus community to spread the word.

I know @David from the BTA is attending ARO, so hopefully he can share some updates with us if there's anything of interest.

 

[Heinrich_S7]

Neuromod are presenting today at 11:30 American time, I wonder if there will be any coverage/videos/or anything where we will learn anything new.

I believe our Susan Shore shall be there and the guys from Frequency Therapeutics...

We deserve some news as we're likely gonna be the first customers who engage with the tinnitus community to spread the word.

Silence here we come!

 

[Marko Nakovski]

@Paulmanlike,
when they say they believe that hearing loss is the primary cause for tinnitus do they refer to hearing loss visible on a standard audiogram (up to 8 kHz frequency), or hidden hearing loss too?

Which criteria is included for the term hearing loss?

 

[Paulmanlike]

@Paulmanlike,
when they say they believe that hearing loss is the primary cause for tinnitus do they refer to hearing loss visible on a standard audiogram (up to 8 kHz frequency), or hidden hearing loss too?

Which criteria is included for the term hearing loss?

They did not mention this in the Q&A, other than they believe hearing loss is the main cause for tinnitus. No mention of other higher frequency or hidden hearing loss.

However I wouldn't read too much into it, they only tailor their auditory stimulation through your audiogram so all the frequencies get sufficient stimulation. For example my last hearing test showed a small drop in the 6 kHz range, I would assume they would turn the volume up on the 6 kHz sounds over the others in my treatment. That's if I do have loss, I need to confirm it with a second audiogram.

I need to reiterate though, if you have no measurable hearing loss in a normal audiogram then there is no reason to believe that the treatment won't work for you.

As stated Clare B had a normal audiogram and achieved complete elimination of her tinnitus. The science, as @hans799 put it in layman's terms earlier in the thread, gives you a better understanding how this treatment is supposed to work.

@David please keep us posted on how today goes!!

 

[Piney]

Hearing loss without a doubt can cause tinnitus. I am severely deaf in one ear, the ringing was instant and never left for 11 months now. I went from 100% hearing to around 10% in a second. This is a big weekend - let's hope we get some new information from the ARO convention.

I'm close to giving a CI serious consideration, I'm praying for this new bio tech stuff.

 

[Drone Draper]

Holy hell, really?

 

[Paulmanlike]

I think Neuromod will discuss the 326-patient trial and the 192-patient ongoing trial, but I can't see them releasing the info to the public just yet as they said they don't want to undermine the peer review process.

But then again surely patients want to see the evidence even from their own data if they are going to release it in the first quarter (before the peer review will be published).

Just the way the timing is they're in a sticky situation.

From a business viewpoint what would you do?

 

[gorzakus]

Was anyone at this meeting from Tinnitus Talk?

 

[EDDTEKK]

Do you think the less hearing loss the better the outcome or result? What are your thoughts?

 

[Paulmanlike]

View attachment 26602

Was anyone at this meeting from Tinnitus Talk?

@HomeoHebbian is a director of a tinnitus research lab - he may have been there.

And of course, @David from the BTA is there as already mentioned.

Do you think the less hearing loss the better the outcome or result? What are your thoughts?

If you can't hear then how can you stimulate the frequencies if you have complete loss? However I think if this treatment becomes a thing for tinnitus treatment and indeed a breakthrough, who knows? A new product integrated into hearing aids?

Just as I thought though, they are discussing the TENT-A1 trial, which we received a lot of info from the Q&A, so if we were to learn anything new from this presentation it may be more accurate statistics, or any plans on a release date, or anything else not mentioned in the Q&A.

You never know this time next year tinnitus may be considered a treatable condition with this method... instead of the old learn to live with it line.

326 people, 80% reporting improvement, 2/3's of either all or the 80% statistically significant improvement, sounds too good to be true.

We can only hope the TENT-A2 shows similar or improved results with changed parameters to improve efficacy. I wonder if they discussed anything about the TENT-A2 trial.

Also, importantly, why the non-responders were non-responders - have they figured it out?

 

[PDodge]

So what exactly is going on? MuteButton is on tour? How much are the tickets?

 

[Marko Nakovski]

@Paulmanlike One thing that I don't understand is that Claire B case is just the opposite from the criteria of Neuromod team. As far as I understand Claire didn't have any hearing loss. I don't know if they tested her hearing on normal audiogram or if she was tested on all frequencies. I think it was on normal audiogram.

So in that case I'm wondering how would they set the device to stimulate the tongue... Maybe all the patients who had good hearing on frequencies up to 8 kHz are using the device based on some other principle or different kind of therapy, who knows. Maybe they tested her hearing frequency above 8 kHz because that will make the criteria more expanded but in case they didn't, I'm not sure how would they connect the device on patients with good hearing following the idea of treating tinnitus based on hearing loss.

Claire said her cause of tinnitus is unknown. She wasn't exposed to loud noises or events at all. Their idea or should I say criteria of matching the tinnitus based on hearing loss is totally the opposite to Claire's case.

And the part when they said that patients with tinnitus and hyperacusis had much better results but no improvement of hyperacusis itself is even more confusing.

Maybe patients with hyperacusis had a lot of spikes or some sort of reactive tinnitus so they benefited the most from the treatment. It's the only possibility that came on my mind after reading that. Maybe this device will help the most those who have reactive tinnitus and spikes.