New University of Michigan Tinnitus Discovery — Signal Timing

[Jonno02]

After reading through all these pages, I still am not clear if Dr. Shore's device will help those with noise-induced tinnitus. Can any experts chime in?

This is pretty much the category it's most likely to help.

 

[AnthonyMcDonald]

After reading through all these pages, I still am not clear if Dr. Shore's device will help those with noise-induced tinnitus. Can any experts chime in?

Are you serious? Lol.

Apparently you didn't read my replies. Acoustic shock and hearing damage are the most common causes of tinnitus, so obviously the device will work for noise induced tinnitus.

unless I am mistaken, doesn't she believe that all tinnitus occurs in the DCN? But not all the tones that I have are somatic. Hence asking if only some of my tones would benefit from her device or if all of them would.

Tones do not matter. It's not like the device is only going to suppress one tone, that doesn't make any sense. Tinnitus is hyperactivity in the DCN, which the device aims to calm down. It's not like there's only 1 tone that has been caused by DCN hyperactivity and others elsewhere lol.

 

[eagerUser]

If the tinnitus comes from the hyperactivity in DCN and Dr. Shore's device calms it down, why doesn't it eliminate tinnitus?

Is it possible to make this part of the auditory system calmer and suppress tinnitus?

I mean let's say from 0-10, the hyperactivity is 10 before the treatment, then the device calms the cells and makes it 3 after ~12 weeks. Why can't it bring the number down to 0 with continued usage?

 

[OptimusPrimed]

Are you serious? Lol.

Apparently you didn't read my replies. Acoustic shock and hearing damage are the most common causes of tinnitus, so obviously the device will work for noise induced tinnitus.

Tones do not matter. It's not like the device is only going to suppress one tone, that doesn't make any sense. Tinnitus is hyperactivity in the DCN, which the device aims to calm down. It's not like there's only 1 tone that has been caused by DCN hyperactivity and others elsewhere lol.

I have subjective tinnitus caused by an acoustic trauma (17 years ago) and it has worsened in the last years because of new noise exposures, TMJ and Bruxism. I now have worsened chronic ringing and "hissing" that is in sync with my pulse and can be silenced with mandible protrusions and flexion of neck tendons. With some hearing distortion (dysacusis) of course. While I would love to be helped by this device, I am doubtful it will help.

While I am excited for the study and anxious to see how it translates into the real world, it is important that we don't get too invested in this device. It is dangerous to one's mental health to be fully invested in the device only for it to come back a failure. Those of us that have been around for a long time, we have seen this happen multiple times with multiple treatments. We just don't know if this is going to help a lot, or any of us at this time. Dr. Shore implies the DCN is at least partially responsible but we know there are multiple brain centres responsible for tinnitus (and likely hyperacusis, etc). For example, the auditory thalamus is also a suspected culprit. We don't know if it will help people with single tones, hyperacusis, multiple tones, we just don't know.

Dr. Shore's theory remains a theory at this time. And should be treated as such. I am sorry to inject some skepticism into this conversation but I see a lot of new tinnitus sufferers come on here and put all their hope into these experimental treatments and end up disappointed. As bad as it is we need to learn to be happy with the ailment because there may never be treatments.

 

[Utdmad89]

Are you serious? Lol.

Apparently you didn't read my replies. Acoustic shock and hearing damage are the most common causes of tinnitus, so obviously the device will work for noise induced tinnitus.

Tones do not matter. It's not like the device is only going to suppress one tone, that doesn't make any sense. Tinnitus is hyperactivity in the DCN, which the device aims to calm down. It's not like there's only 1 tone that has been caused by DCN hyperactivity and others elsewhere lol.

When you say calmed down, do you mean it is quieter, as in it won't give you silence?

 

[Nick47]

I see people getting too wrapped up in tones rather than the principle. The hyperactivity just causes a fcking tinnitus (tone, hiss, cicadas or whatever) that may be similar to where the hearing loss is. Like pain can be perceived differently, so can tinnitus. Obsessing over tones isn't much use.

 

[dj_newark]

If the tinnitus comes from the hyperactivity in DCN and Dr. Shore's device calms it down, why doesn't it eliminate tinnitus?

Is it possible to make this part of the auditory system calmer and suppress tinnitus?

I mean let's say from 0-10, the hyperactivity is 10 before the treatment, then the device calms the cells and makes it 3 after ~12 weeks. Why can't it bring the number down to 0 with continued usage?

I believe that we can! I think that with prolonged use the device will continue to dampen hyperactivity of the DCN, thus lowering the volume of tinnitus. But this hasn't been tested in a clinical trial setting, medical trials have to have an ending at some point, so that's the only reason that Dr. Shore and her team haven't committed to this. They will only commit to what they've tested in a trial and directly observed.

 

[AnthonyMcDonald]

If the tinnitus comes from the hyperactivity in DCN and Dr. Shore's device calms it down, why doesn't it eliminate tinnitus?

Is it possible to make this part of the auditory system calmer and suppress tinnitus?

I mean let's say from 0-10, the hyperactivity is 10 before the treatment, then the device calms the cells and makes it 3 after ~12 weeks. Why can't it bring the number down to 0 with continued usage?

Who said it can't? The trial finished after a certain amount of time, after which the subjects continued improving. Who said it's impossible to keep using it? I don't see why that would be impossible.

Either way, I myself wouldn't mind a mild quiet room squeak or hiss, that would be nothing to me.

 

[Utdmad89]

Who said it can't? The trial finished after a certain amount of time, after which the subjects continued improving. Who said it's impossible to keep using it? I don't see why that would be impossible.

Either way, I myself wouldn't mind a mild quiet room squeak or hiss, that would be nothing to me.

I'm hoping, if this is true, that we can go back to using headphones at a reasonable level. And go to loud places with ear protection without the tinnitus spiking!

 

[Jonno02]

If the tinnitus comes from the hyperactivity in DCN and Dr. Shore's device calms it down, why doesn't it eliminate tinnitus?

Is it possible to make this part of the auditory system calmer and suppress tinnitus?

I mean let's say from 0-10, the hyperactivity is 10 before the treatment, then the device calms the cells and makes it 3 after ~12 weeks. Why can't it bring the number down to 0 with continued usage?

In the patent it said 2 patients during a study were completely cured IIRC.

 

[Monkee Man]

If Dr. Shore's device would somehow calm the hyperactivity in my brain enough to mitigate hyperacusis and make me less prone to reacting or spiking from louder sounds/events, but had no real effect on my baseline tinnitus level, I'd be over the moon. I mostly habituated to tinnitus within 2 months of onset, it's the limitations it brought me that have truly affected my life negatively, as annoying as the tinnitus can get.

I will not get my hopes up whatsoever, but it's nice to dream.

 

[Nick47]

Dr. Shore's theory remains a theory at this time. And should be treated as such. I am sorry to inject some skepticism into this conversation but I see a lot of new tinnitus sufferers come on here and put all their hope into these experimental treatments and end up disappointed. As bad as it is we need to learn to be happy with the ailment because there may never be treatments.

Being sceptical is fine and we all should be a little. After all there has been so much bullshit out there for decades in terms of alleged treatments. However, Dr. Shore's theory is a bit more than just theory. Her team have objectively seen the activity in the DCN in animals and developed a treatment that has worked in 2 human studies. People have to understand that by 'it works' means it will treat a percentage of people with tinnitus. Mirtazapine works on depression, but does it work for everyone? If the answer is no, do we conclude it's ineffective against depression?

 

[eagerUser]

Wow!

Guys, it is the middle of 2024, we are all rid of tinnitus. Not only tinnitus, Dr.Shore's device did some magic and cured our hyperacusis and noxacusis. All Tinnitus Talk members are invited to my dinner party with music played through quality speakers at 60 dB. I'm playing "say something, I'm giving up on you" because tinnitus doesn't say anything anymore.

What a beautiful night we all have. Cheers

 

[eagerUser]

As bad as it is we need to learn to be happy with the ailment because there may never be treatments.

We have to be happy with the ailment because other ones may hit us later. IMHO, no matter how hard you are hit by life, you have to get up and continue with a smile on your face. I confess that I myself cannot stay positive at times.

But, we shouldn't spread negativity. We are all alive by our dreams, no matter if they come true or not.

We have some real results that the device works. It is backed by 20 years of research. Being negative makes everything harder.

Let's be realistic, the device will improve the condition for lots of people. I would love to say all the people are cured by it but that's not realistic.

 

[Athens]

In the patent it said 2 patients during a study were completely cured IIRC.

I recall that the two patients being cured were in the initial human trial/study, not in the second larger group, but it probably does not make any difference.

 

[Jonno02]

I recall that the two patients being cured were in the initial human trial/study, not in the second larger group, but it probably does not make any difference.

I would say that's even more encouraging.

 

[InNeedOfHelp]

I'm afraid that, because Auricle took the De Novo route at FDA, things are unfortunately delayed as the device is no longer De Novo because Neuromod completed the route with Lenire. Auricle will be a Class II device:

FDA: Product Classification - Combined acoustic and electrical external stimulation device for the relief of tinnitus

Knowing the FDA, Auricle will need to reapply again, because different department, different people involved, bureaucracy...

And on top, unfortunately Neuromod got funding from the European Investment Bank. I'm assuming this will make it more difficult for Auricle to attract such funds to expand their treatment.

Ireland: Neuromod Devices Closes €30 Million Financing to Expand Availability of Tinnitus Treatment Device Lenire®

I was happy with Neuromod making proper turnover as this might help releasing an upgraded version of Lenire, but not so happy with them attracting governmental funds.

 

[Jonno02]

I'm afraid that, because Auricle took the De Novo route at FDA, things are unfortunately delayed as the device is no longer De Novo because Neuromod completed the route with Lenire. Auricle will be a Class II device

I'm unsure about that.

The devices, at a very high level, are similar. Acoustic and nerve stimulation.

The FDA don't work at a high level though, there are substantial differences between the devices.

If correct though, Auricle could change their submission to a 510k which is still a pretty accelerated route compared to PMA etc.

The FDA would have been aware of Lenire's submission when they accepted the review of Auricle, so who knows.

 

[Tomas80]

I'm afraid that, because Auricle took the De Novo route at FDA, things are unfortunately delayed as the device is no longer De Novo because Neuromod completed the route with Lenire. Auricle will be a Class II device:

FDA: Product Classification - Combined acoustic and electrical external stimulation device for the relief of tinnitus

Knowing the FDA, Auricle will need to reapply again, because different department, different people involved, bureaucracy...

And on top, unfortunately Neuromod got funding from the European Investment Bank. I'm assuming this will make it more difficult for Auricle to attract such funds to expand their treatment.

Ireland: Neuromod Devices Closes €30 Million Financing to Expand Availability of Tinnitus Treatment Device Lenire®

I was happy with Neuromod making proper turnover as this might help releasing an upgraded version of Lenire, but not so happy with them attracting governmental funds.

Please excuse me, I don't understand your post at all. What exactly does this mean for Auricle's FDA process? Does the judging start from scratch? In a stricter mode? Thank you.

 

[InNeedOfHelp]

I'm unsure about that.

The devices, at a very high level, are similar. Acoustic and nerve stimulation.

The FDA don't work at a high level though, there are substantial differences between the devices.

If correct though, Auricle could change their submission to a 510k which is still a pretty accelerated route compared to PMA etc.

The FDA would have been aware of Lenire's submission when they accepted the review of Auricle, so who knows.

Please excuse me, I don't understand your post at all. What exactly does this mean for Auricle's FDA process? Does the judging start from scratch? In a stricter mode? Thank you.

What I'm saying is that the De Novo route is a different route then a normal 510k with different requirements, different forms and a different process.

FDA does not disclosure current submissions/applications due to competitor sensitivity. I don't think they would inform Auricle on this matter: "Yes, your competitor is almost to market. 3 more months. You can just submit a normal 510k." seems extremely unlikely. So, it would be very unlucky if Auricle started a De Novo procedure but this seems very likely as there was no other approved device on the market.

If, and that is speculation, Auricle started a De Novo procedure, while the device is not De Novo anymore, as you can see above - a clear categorization was created due to Neuromod's application - Auricle will follow the normal 510k process. Yes, 510k is faster indeed but it requires a different submission, most probably to a different department too.

In short, what I am stating is that the requirement and procedure for 510k is obviously different from De Novo procedure. I'm hoping that Auricle does not have to do a ton of changes / resubmission in a different category due to that. The FDA is obviously not a flexible organization.

Again it is speculation like 99% of this topic and I will go into hibernation again until something tangible pops up, but bimodal stimulation for tinnitus is now formally a Class II treatment method.

 

[Jonno02]

And what I said is that how do we know the FDA classifies them in the same category? One stimulates the tongue, the other the neck. The FDA may have decided that the devices are therefore not the same.

510k requires a like for like comparison with an already marketed device. The devices have different modalities and I don't think the FDA will treat them as equivalent.

In all of my years dealing with Class III medical devices, I have never heard of an already in process submission being rejected due to a competitor making market. That is not a good use of the FDA's limited resources. They will have an internal process for this eventuality.

 

[InNeedOfHelp]

And what I said is that how do we know the FDA classifies them in the same category? One stimulates the tongue, the other the neck. The FDA may have decided that the devices are therefore not the same.

510k requires a like for like comparison with an already marketed device. The devices have different modalities and I don't think the FDA will treat them as equivalent.

In all of my years dealing with Class III medical devices, I have never heard of an already in process submission being rejected due to a competitor making market. That is not a good use of the FDA's limited resources. They will have an internal process for this eventuality.

See here the classification again for ear, tongue or skin stimulation together with acoustic stimulation for treatment of tinnitus. They are clearly grouping skin stimulation with tongue stimulation in the same class.

FDA: Product Classification - Combined acoustic and electrical external stimulation device for the relief of tinnitus

I never said they will reject the device. They will reject a De Novo request as bimodal stimulation is already classed. I think it will end up being 510k for that but time will tell. Indeed they don't waste resources but, with your experience, you know very well how strict the FDA is on their procedures.

 

[Jonno02]

See here the classification again for ear, tongue or skin stimulation together with acoustic stimulation for treatment of tinnitus. They are clearly grouping skin stimulation with tongue stimulation in the same class.

FDA: Product Classification - Combined acoustic and electrical external stimulation device for the relief of tinnitus

I never said they will reject the device. They will reject a De Novo request as bimodal stimulation is already classed. I think it will end up being 510k for that but time will tell. Indeed they don't waste resources but, with your experience, you know very well how strict the FDA is on their procedures.

That link isn't what they're classing as equivalent. It's a general overview of what's been approved and what the target area of active treatment is, it's not the FDA saying what can now go under a 510k.

I couldn't submit a device that has stimulation of the brain through the skull and some headphones and say 'it's the same as the Lenire one that has a little electrode on your tongue and some headphones.' Entirely different, it's stimulating a completely different part of the head.

If the FDA refuse their submission based on it being De Novo, that does indeed count as rejection. Nothing to stop them resubmitting but I'd be absolutely gobsmacked if that happened.

With the amount of clinical data Dr. Shore has generated, they're in a very good position to have to do minimal, if any, rejigging of their submission either way. If they had prepared a 510k submission and were told it's actually De Novo, they'd be in trouble.

All conjecture anyway so you may be right, but let's hope we'll maybe see the device early 2024.

 

[Nick47]

They've been working with the FDA for a while so I don't foresee any issues.

 

[Jim Vasilakis]

It would be amazing if Dr. Shore's device could help fix hyperacusis. I imagine if it works, it would be more effective for treating loudness hyperacusis given that it seems to be caused by similar mechanisms as tinnitus, but I really hope pain hyperacusis can be helped by it as well.

Sorry to digress, I just wanted to ask a quick question regarding this. So loudness hyperacusis is caused by noise damage?

Also, a question regarding the device. Does anyone know if the loudness reduction remained permanently? We know subjects kept improving but do we know if anyone returned to baseline a year later?

 

[Utdmad89]

Also, a question regarding the device. Does anyone know if the loudness reduction remained permanently? We know subjects kept improving but do we know if anyone returned to baseline a year later?

We will have to wait till the results are published.

 

[Brody11]

Sorry to digress, I just wanted to ask a quick question regarding this. So loudness hyperacusis is caused by noise damage?

Also, a question regarding the device. Does anyone know if the loudness reduction remained permanently? We know subjects kept improving but do we know if anyone returned to baseline a year later?

Yes absolutely. Acoustic trauma seems to be the largest cause of hyperacusis along with others, like ototoxic medications, head injury, etc. It's not surprising that around 85% of those with hyperacusis also have tinnitus, both of which were likely caused by noise damage in most cases.

Additionally, I was just reading a statistic that said over 50% of people with pain hyperacusis can attribute it to a single noise exposure that they previously received, so yes noise damage is definitely a primary cause, although how similar the type of damage is is a little difficult to say.

From my understanding (maybe others with more knowledge can chime in), loudness hyperacusis is caused by issues with auditory gain, just like tinnitus, while pain hyperacusis seems to be caused by issues with the Type II nerves and/or middle ear muscles. So I assume Susan Shore's device could have some success with loudness hyperacusis since it's very similar to tinnitus, but I really don't know if it will do anything to help pain hyperacusis.

 

[awake 44]

They've been working with the FDA for a while so I don't foresee any issues.

Valid point stated by a knowledgeable member. That brings hope.

 

[eagerUser]

Yes absolutely. Acoustic trauma seems to be the largest cause of hyperacusis along with others, like ototoxic medications, head injury, etc. It's not surprising that around 85% of those with hyperacusis also have tinnitus, both of which were likely caused by noise damage in most cases.

Additionally, I was just reading a statistic that said over 50% of people with pain hyperacusis can attribute it to a single noise exposure that they previously received, so yes noise damage is definitely a primary cause, although how similar the type of damage is is a little difficult to say.

From my understanding (maybe others with more knowledge can chime in), loudness hyperacusis is caused by issues with auditory gain, just like tinnitus, while pain hyperacusis seems to be caused by issues with the Type II nerves and/or middle ear muscles. So I assume Susan Shore's device could have some success with loudness hyperacusis since it's very similar to tinnitus, but I really don't know if it will do anything to help pain hyperacusis.

No one, even scientists, knows the exact mechanism of noxacusis (pain hyperacusis). The Type II neurons theory is, after all, just a theory and needs further investigation.

We don't know if Dr. Shore's device helps pain hyperacusis but let's hope calming DCN also regulates Type II neurons firing.

 

[eagerUser]

For the name of God, don't spread negativity here. Some of us are suffering from noxacusis and this is the light at the end of the tunnel for us. I prefer to think that it resolves noxacusis even if it doesn't because it gives me hope to stay strong!