New University of Michigan Tinnitus Discovery — Signal Timing

[ajc]

I certainly do not hope we in Europe miss out on a possible treatment due to the lack of EMA submission...

Surely you understand it's not just about EMA submission. Auricle will need to bring their infrastructure to Europe too, otherwise the EMA submission is pointless, if there's no device available to be bought.

It's 100% sure the US will come first and EU will come later, maybe even many years later...

I'm not even sure if a medical device needs EMA submission? Isn't it for drugs only? Probably a CE Mark is enough for a medical device... Lenire has the CE Mark too.

 

[Jason Ranovik]

For everyone looking at the Phase I data, I cannot stress this enough: the Phase I trial had far too small of a sample size for it to mean anything reliable. The purpose of a Phase I trial is to:

1. Quickly detect if there are any major or common adverse effects, so the study can be stopped before it harms a larger number of people, and
2. To determine if it's worth investigating further, with a trial that is large enough to produce reliable results.

Not only was the Phase I trial too small to be extrapolating those results to the general population, but many things may have changed between the Phase I and Phase II trials. I'm not saying any of these are true, but it's possible and we won't know until we see the paper:

• Different eligibility criteria (I know the Phase II trial was very specific with a preference for onset within the past 6 - 12 months, unilateral tinnitus, somatic tinnitus, etc.)
• Slight variations of the treatment (duration, intensity, frequency, etc.)
• Different metrics for evaluation

My point being, the Phase II results could very well be completely different than the Phase I results.

 

[Bambam0]

You're right and we should all continue to expect the best and prepare for the worst.

Optimism should come from the fact Susan Shore has been at it for 20 years and we have a forum member who reported improvement in the Phase I trial.

Pessimism should come from the fact that this is a terribly difficult issue to solve with many causes and NO one has solved it yet.

That said if she cures me personally, I will get a tattoo of her face on my bawd. Or at minimum wear a necklace with a pendent of her face daily until I go back to the earth.

 

[Toby1972]

I've seen the picture of the device with the earbud and the two electrodes (cheek / neck). Can someone briefly explain how the process works? What sounds are played, where exactly are the electrodes attached? What program do the electrodes play? (TENS, EMS, massage?)

(I returned Neuromod's Lenire, after 6 weeks without any effect, so I'm familiar with the device that is most similar to the Dr. Shore's device).

 

[IntotheBlue03]

Just adding this for reference within the thread as I was concerned about the pitch matching of the device only going up to 12 kHz. I had recently seen in a post made by @linearb that he has tinnitus in the range of 14 kHz and as is known widely here, the device was effective for him during the first trial. Hoping that means frequency or tone for the rest of us will be a non-issue.

 

[Jonathan Gormsen]

Really excited to see how Dr. Shore's device will perform. Not really getting my hopes up to be honest.

 

[Uklawyer]

IT WILL WORK.

 

[Reed19]

Really excited to see how Dr. Shore's device will perform. Not really getting my hopes up to be honest.

I know what you mean. I have trouble wrapping my head around the concept of a device working for some but not others.

 

[IntotheBlue03]

Really excited to see how Dr. Shore's device will perform. Not really getting my hopes up to be honest.

Why do you have doubts? I know we are all eagerly awaiting the trial results, but just curious about your opinion.

 

[IntotheBlue03]

I know what you mean. I have trouble wrapping my head around the concept of a device working for some but not others.

Are you basing this on the people who didn't respond from the first trial?

We know the parameters were changed for the 2nd trial so here's to hoping those participants were affected by the short duration of treatment as opposed to the device not working for them at all.

 

[IntotheBlue03]

IT WILL WORK.

Say it again @Uklawyer, I'm hoping it works for everyone and if not, at least for most. I forget where the stat comes from but I believe up to 80% of tinnitus sufferers are somatic.

Really hoping, as other posters have mentioned, that the participants who didn't respond in the first trial may have been affected by factors like a shorter duration of treatment, etc. There's no data on them unfortunately.

 

[GlennS]

IT WILL WORK.

If only posting pronouncements in ALL CAPS made it so.

 

[Uklawyer]

If only posting pronouncements in ALL CAPS made it so.

IT DOES.

IT WILL HAPPEN.

 

[Don Tinny]

Does it make sense to try this device when your tinnitus is non-somatic?

 

[IntotheBlue03]

That said if she cures me personally, I will get a tattoo of her face on my bawd. Or at minimum wear a necklace with a pendent of her face daily until I go back to the earth.

Personally I think you should commit to doing both.

 

[Padraigh Griffin]

Does it make sense to try this device when your tinnitus is non-somatic?

Only time will tell. I think they have tried it on such tinnitus. Would be fairly unlikely that they haven't in all these years.

Personally I think it's worth a go.

 

[DebInAustralia]

Does it make sense to try this device when your tinnitus is non-somatic?

Why wouldn't you?

After all, although the trial hasn't included non-somatic participants, I don't think the researchers know if it will or won't work on other subsets of tinnitus.

 

[AfroSnowman]

Does it make sense to try this device when your tinnitus is non-somatic?

I think Dr. Shore has said that in theory it should work. Of course there is a reason she is limiting her study to somatic tinnitus.

 

[IntotheBlue03]

Does anyone have any theories on why they preferred unilateral tinnitus instead of bilateral in the second trial? Again I know the poster @linearb has a similar centralized high frequency (14 kHz) tinnitus as I do and he still had results.

Just curious from a research standpoint if anyone can speculate.

 

[Don Tinny]

I think Dr. Shore has said that in theory it should work. Of course there is a reason she is limiting her study to somatic tinnitus.

So I should put the device in my neck, even when I can´t modulate the ringing with neck movements

 

[GlennS]

IT DOES.

IT WILL HAPPEN.

I appreciate your optimism but this kind of commentary doesn't really add anything.

 

[IntotheBlue03]

So I should put the device in my neck, even when I can´t modulate the ringing with neck movements

Being optimistic but I'm going to say when this is released to market that the plan is to roll this out to clinics/audiologists to program for patients. Post trial results, hopefully Susan will be able to speak to non-somatic sufferers so that the audiologist/ENT programming your device can decide what would be more effective.

That's my best guess.

 

[Uklawyer]

I appreciate your optimism but this kind of commentary doesn't really add anything.

It adds hope. Whereas your commentary refuting such optimism does not bring much to the table.

 

[AfroSnowman]

So I should put the device in my neck, even when I can´t modulate the ringing with neck movements

Time will tell of course but I think the current status quo is there is no reason to exclude that as a real possibility. Remember though she only studied humans with somatic tinnitus, her animal studies obviously didn't filter for that. Maybe only the somatic guinea pigs responded.

 

[Gb3]

I think Dr. Shore has said that in theory it should work. Of course there is a reason she is limiting her study to somatic tinnitus.

I think with tinnitus being somatic there is a stronger indication that it is occurring in the dorsal cochlear nucleus.

 

[AfroSnowman]

It adds hope. Whereas your commentary refuting such optimism does not bring much to the table.

Well yes, but having ridden the emotional rollercoasters of the forums on Lenire and FX-322, it is good to keep in mind that the next time there is an effective treatment for tinnitus that goes to market, it will be the first time an effective treatment has gone to market.

Folks including yours truly had become so invested in the belief endlessly reinforced in the FX-322 thread that the trials were going to be positive that it was emotionally devastating when the results came in as a dud.

We should be optimistic, be positive, get excited, but still remember that every single chronic tinnitus treatment in the history of science has been a failure, so withholding a shadow of a doubt is probably healthy.

 

[Uklawyer]

We should be optimistic, be positive, get excited, but still remember that every single chronic tinnitus treatment in the history of science has been a failure, so withholding a shadow of a doubt is probably healthy.

So you are urging cautious optimism, @AfroSnowman. I dare say that many will be of your opinion. I do believe, however, that this one is not comparable, based on the 20 years of research coming out of an academic institution. Bimodal stimulation does look like an exact science, and your reserve is, indeed, justified. I, however, am bored and slightly crazy, owing to my years of anxiety and other health problems. The result is an occasional impulsivity, where I say "fuck it" and make prophetic statements such as this. I half believe it. The other half says "whatever will be will be" - which, I guess, puts me half-in-agreement with you.

 

[IntotheBlue03]

I hope that they will go for FDA/EMA approval at the same time.

Lenire applied for FDA last July/August and still no update, while being available in Europe for two years now. Not a fan of Lenire but I certainly hope that worldwide commercialisation goes smoother for Auricle. I certainly do not hope we in Europe miss out on a possible treatment due to the lack of EMA submission...

Hoping @Jason Ranovik can chime in on the FDA process. I'm not concerned with Lenire but wondering why the FDA has delayed this so long. I believe someone else mentioned Dr. Shore potentially initiating a fast tracking process through the FDA? Hopefully because Auricle is domestic it wouldn't face as many hurdles? Just curious.

 

[BuzzyBee]

Being optimistic but I'm going to say when this is released to market that the plan is to roll this out to clinics/audiologists to program for patients. Post trial results, hopefully Susan will be able to speak to non-somatic sufferers so that the audiologist/ENT programming your device can decide what would be more effective.

That's my best guess.

That's my guess too, but I don't understand why most of the audiologists (and doctors) I've met have never heard of Dr. Shore or her device or signal timing. Maybe they have seen so many tinnitus devices that they don't want patients to get their hopes up? But like @AfroSnowman, I'm still cautiously optimistic.

The good news is there are at least 8 tinnitus treatments in the pipeline all at various stages. My money is on OTO-313 based on some positive things I've heard from people in the know.

 

[IntotheBlue03]

That's my guess too, but I don't understand why most of the audiologists (and doctors) I've met have never heard of Dr. Shore or her device or signal timing. Maybe they have seen so many tinnitus devices that they don't want patients to get their hopes up? But like @AfroSnowman, I'm still cautiously optimistic.

The good news is there are at least 8 tinnitus treatments in the pipeline all at various stages. My money is on OTO-313 based on some positive things I've heard from people in the know.

If you don't mind me saying because I am quite cynical and jaded when it comes the medical community, their ignorance does not surprise me at all. Every single ENT or audiologist I have encountered except for 2 who happen to be involved in tinnitus research had no idea what I was talking about when I walked into their office and explained both my case and bimodal stimulation. They were absolutely clueless and sometimes extremely rude especially when I was interrupting their "patient blaming" mantra. I had one ENT get so frustrated that I knew more than him that he told me my proactiveness as a patient was a sign of my "high anxiety" which was "causing my TFI distress". Just idiots, the majority of them.

Are there any in the pipeline expected to come out soon or are they all a few years out? Curious what I may be missing, @BuzzyBee.