New University of Michigan Tinnitus Discovery — Signal Timing

[dj_newark]

Where did you get the information about her working in further improvements to the treatment?

Pretty sure she'd said that in the Palm Springs Hearing Seminar. I've definitely heard that somewhere, I'm not sure I remember where exactly though.

I've had Bard provide the exact quote I believe I've read. However, he wasn't smart enough to find the link that it came from and frankly neither was I. Make of this what you will:

"The Michigan Tinnitus Device is still in the early stages of development, but it has shown promise in clinical trials. Dr. Shore and her team are continuing to work on improvements to the device, and they are also exploring ways to make it more affordable. They hope that the device will eventually be available to everyone who suffers from tinnitus."

 

[Jonno02]

Where are we on the question of what qualifies as somatic tinnitus? Dr. Shore's trials only recruited people with this pseudo-etiology, but she never actually tested the device on "non-somatic" tinnitus, did she?

Nobody knows the implication of somatic / non-somatic.

What I'm quite interested in is how are all of you with residual inhibition? Do you experience it quite easily? Or do you need to play near enough the exact frequency of tinnitus you have at a loud volume to get it to work?

I can't help but think Dr. Shore's device works on the same principle as residual inhibition, but the electrical stimulus helps to prolong/make semi-permanent the reduction in volume.

 

[Nick47]

What I'm quite interested in is how are all of you with residual inhibition? Do you experience it quite easily? Or do you need to play near enough the exact frequency of tinnitus you have at a loud volume to get it to work?

External sound increases my tinnitus, which then calms once the external sound is removed.

 

[chinup]

Nobody knows the implication of somatic / non-somatic.

What I'm quite interested in is how are all of you with residual inhibition? Do you experience it quite easily? Or do you need to play near enough the exact frequency of tinnitus you have at a loud volume to get it to work?

I can't help but think Dr. Shore's device works on the same principle as residual inhibition, but the electrical stimulus helps to prolong/make semi-permanent the reduction in volume.

That's my belief as well. It's possible that whatever happens when you match your tinnitus tone on your own is just being extended with Dr. Shore's device somehow. It's like you're "feeding" your brain the sound it's searching for with the tinnitus.

There's an app called TinnitusPlay and it has a tone matching feature. I have a lot of shifting tones but I just start it down at 1800 Hz and slowly slide up to 10 kHz. It knocks everything out as I get within about 50 Hz of a particular tone. Sadly by the time the upper level tones are being inhibited, the lower level tones are already back lol. It does provide a bit of relief though, thankfully.

I'm hoping this is the mechanism at play as there's a good chance it will benefit me.

For what it's worth, only one or two of my tinnitus tones are somatic, the remaining 10 or so tones can't be altered. Some of them are "brain" tones that seem to be coming from my head and some are the common ear tones. Some are crickets. So if the residual inhibition mechanism is how Dr. Shore's device works, somatic tones aren't necessary. Obviously that's pure speculation so we'll see...

Also as bad as it sounds to have so many tones, keep in mind my tinnitus volume has reduced by about 60-70% over the past 2 years. I would consider it on the lower end of moderate these days; my hyperacusis is the much bigger struggle.

 

[Josh59]

My chronic tinnitus is also somatosensory. I can modulate it with my jaw, neck and nape. According to Dr. Shore's theory, this comes from the cochlear nucleus in the brain stem and interactions with the trigeminal nerve and the dorsal nerve. We've already talked about this.

But why is there also tinnitus that reacts to emotions, nervousness and stress? I also have this type of reactive tinnitus. I've already read that it might come from other areas of the brain such as the amygdala (to be confirmed).

Could there be several areas of the brain affected that could cause tinnitus? If the cochlear nucleus (the first auditory relay) calms down, will tinnitus in other areas of the brain such as the amygdala be less intrusive?

Is this kind of exchange and debate between researchers taking place in order to better understand and target tinnitus?

I ask this question because, in any case, Dr. Shore's research work needs to be exploited by other doctors/researchers in order to make further (faster) progress on this condition.

 

[BobbieJay-1954]

My chronic tinnitus is also somatosensory. I can modulate it with my jaw, neck and nape. According to Dr. Shore's theory, this comes from the cochlear nucleus in the brain stem and interactions with the trigeminal nerve and the dorsal nerve. We've already talked about this.

But why is there also tinnitus that reacts to emotions, nervousness and stress? I also have this type of reactive tinnitus. I've already read that it might come from other areas of the brain such as the amygdala (to be confirmed).

Could there be several areas of the brain affected that could cause tinnitus? If the cochlear nucleus (the first auditory relay) calms down, will tinnitus in other areas of the brain such as the amygdala be less intrusive?

Is this kind of exchange and debate between researchers taking place in order to better understand and target tinnitus?

I ask this question because, in any case, Dr. Shore's research work needs to be exploited by other doctors/researchers in order to make further (faster) progress on this condition.

I feel personally that if this device is able to relax or potentially eliminate our tinnitus, the anxiety and stress we feel in regards to it would also reduce substantially. I know that the psychological response to tinnitus plays a very big part in the habituation process and how loud we perceive it but just knowing that something finally works could make us feel a lot more calm and, in turn, maybe reduce the emotionally induced tinnitus?

I agree with your last statement and hope that once Dr. Shore's device is finally available, it can be further improved for all types of tinnitus. I have faith that even though somatosensory tinnitus was used for the clinical trials, it could help those who can't modulate their tinnitus.

 

[Markku]

Update on Dr. Shore interview

We had the privilege to speak with Dr. Shore earlier today. She came across as someone very passionate about her work, and it's obvious she profoundly values the integrity of the research process.

Her preference is to do a written interview first, followed by a video interview at a later date. We hope the written interview is going to help with any misunderstandings, misconceptions, and difficulties or questions arising around the science and the latest study.

I would also plead our community to try and avoid sending her emails. Her time is now much needed elsewhere, and responding to questions from individual patients is not the best use of her time.

You can submit your questions by pressing the below button. We will keep the form open until Sunday, July 16th, 6 pm GMT. The answers are expected in the coming weeks.

Please note that, as is normal practice, she is not going to respond to questions about other treatments or companies, and in general will not respond to questions that are not strictly tied to her work/science and her device.

For background, please → read her latest study first.

Send Your Questions​

 

[Gb3]

Remember not to ask questions that she won't be able to back up with evidence from the clinical trials. She will not speculate in my opinion.

@Markku, did you get any info if the FDA process has begun?

 

[BobbieJay-1954]

Each day becomes more and more hopeful through these updates. With the tidal waves of questions she's about to be asked, I hope that her answers help to clear any misconceptions and settles our fears.

Thank you for this.

 

[UKBloke]

I'm presuming someone is going to ask Dr. Shore the question about perceived volume reduction in tinnitus measured in decibels.

A couple of pages ago here there was some debate about how a -6 dB measurement might translate in real world perception. I've been over the study paper so many times now I can't tell my a*rse from my elbow. Can someone clarify, did the study results imply a -6 dB reduction after the first treatment cycle and then no or minimal benefit after the second treatment and relatively short washout period?

 

[Hazel]

I'm presuming someone is going to ask Dr. Shore the question about perceived volume reduction in tinnitus measured in decibels.

A couple of pages ago here there was some debate about how a -6 dB measurement might translate in real world perception. I've been over the study paper so many times now I can't tell my a*rse from my elbow. Can someone clarify, did the study results imply a -6 dB reduction after the first treatment cycle and then no or minimal benefit after the second treatment and relatively short washout period?

Hi @UKBloke!

It's a good idea to submit your question regardless if you think it's already been asked. It gives us a signal what questions are considered more important by our community.

Have a great weekend and thanks for all your contributions here

Cheers,
Hazel

 

[Alberte]

@Hazel and @Markku, thank you so much to give us this opportunity!

 

[Jonno02]

I was having a think about this device earlier and it really is a bugger that COVID-19 cut the numbers down so much. With a bigger data pool, the amount of parameters that could have been tested would be huge. They probably have data on these anyway, so probably just a thought experiment.

• Does using left or right ear with the earbud produce better results?
• Any difference in time of day of use, i.e. right before sleeping (greater neuroplasticity)?
• Short frequent sessions or longer once a day session?
• Do low response users have better luck with a frequency change and/or volume change?
• Do low response users have better luck with retraining in electrode placement?

 

[Nick47]

I heard years ago Dr. Shore was also looking to develop a medication for tinnitus. I know she thought it was less preferred due to possible side effects they 'can have', however I cannot see her going off topic in the interview.

I would like to hear her views on pharmacology, and targeting specific neurotransmitters she's seen altered in tinnitus/hyperacusis.

If she doesn't stray away from the findings that led to the treatment, trial results etc, then are we going to learn anything new?

I would be interested in future avenues for exploration and why.

 

[dj_newark]

I heard years ago Dr. Shore was also looking to develop a medication for tinnitus. I know she thought it was less preferred due to possible side effects they 'can have', however I cannot see her going off topic in the interview.

I would like to hear her views on pharmacology, and targeting specific neurotransmitters she's seen altered in tinnitus/hyperacusis.

If she doesn't stray away from the findings that led to the treatment, trial results etc, then are we going to learn anything new?

I would be interested in future avenues for exploration and why.

I wonder if she was thinking about using potassium channel activators to treat tinnitus with this medicinal approach she was considering? That could be a powerful solution. I was never aware she'd considered a medicinal approach to tinnitus. I wonder if this is something she'd still consider doing. If I knew about this when the Q&A form was still open, I would have loved to ask about this!

 

[Hazel]

If I knew about this when the Q/A form was still open, I would have loved to ask about this!

We extended the deadline to 16 July, because we're sending out a newsletter today, which will give many more people who might not visit Tinnitus Talk frequently the chance to submit their questions. Let's see, we might have to curate a deluge of questions next week, haha!

This means you can now submit more questions if you want. The form allows for multiple submissions.

 

[dj_newark]

We extended the deadline to 16 July, because we're sending out a newsletter today, which will give many more people who might not visit Tinnitus Talk frequently the chance to submit their questions. Let's see, we might have to curate a deluge of questions next week, haha!

This means you can now submit more questions if you want. The form allows for multiple submissions.

Great, thanks! It's good to know we can submit some more questions. I appreciate you letting me know!

 

[Federico7878]

Update on Dr. Shore interview

We had the privilege to speak with Dr. Shore earlier today. She came across as someone very passionate about her work, and it's obvious she profoundly values the integrity of the research process.

Her preference is to do a written interview first, followed by a video interview at a later date. We hope the written interview is going to help with any misunderstandings, misconceptions, and difficulties or questions arising around the science and the latest study.

I would also plead our community to try and avoid sending her emails. Her time is now much needed elsewhere, and responding to questions from individual patients is not the best use of her time.

You can submit your questions by pressing the below button. We will keep the form open until Sunday, July 16th, 6 pm GMT. The answers are expected in the coming weeks.

Please note that, as is normal practice, she is not going to respond to questions about other treatments or companies, and in general will not respond to questions that are not strictly tied to her work/science and her device.

Such a great initiative. Thank you so much for this!

 

[Flowergirl]

Dear @Hazel & @Markku, thank you for all you do to keep us all informed. Reading this today tells me someone still cares. Thanks for giving us the opportunity to send questions to Dr. Shore.

But why is there also tinnitus that reacts to emotions, nervousness and stress? I also have this type of reactive tinnitus. I've already read that it might come from other areas of the brain such as the amygdala (to be confirmed).

Could there be several areas of the brain affected that could cause tinnitus? If the cochlear nucleus (the first auditory relay) calms down, will tinnitus in other areas of the brain such as the amygdala be less intrusive?

Weather and stress are my triggers.

 

[_Patrick_]

Dr. Shore's device is the one that has given me the most hope, but also the one that has frustrated me the most, because it feels like I have been hearing about it for decades and have been waiting impatiently for it, without seeing anything on the horizon.

It's a great opportunity to have her interviewed, thank you guys for making this happen.

Maybe she could tell us more about the industrialisation process and the extent of her involvement, and also if she has any idea if this will be available in Europe anytime soon?

Thanks again.

 

[dipp]

Dr. Shore's device is the one that has given me the most hope, but also the one that has frustrated me the most, because it feels like I have been hearing about it for decades and have been waiting impatiently for it, without seeing anything on the horizon.

It's a great opportunity to have her interviewed, thank you guys for making this happen.

Maybe she could tell us more about the industrialisation process and the extent of her involvement, and also if she has any idea if this will be available in Europe anytime soon?

Thanks again.

Kindly place your questions below. I also asked about European availability. I wouldn't mind to travel to the USA to get the device, but I don't travel by airplane since my onset because I have a lot of trouble with pressure on airplanes.

Send Your Questions​

 

[AmePerdue]

Kindly place your questions below. I also asked about European availability. I wouldn't mind to travel to the USA to get the device, but I don't travel by airplane since my onset because I have a lot of trouble with pressure on airplanes.

I don't mind flying to the USA to buy the device either but I'm concerned multiple trips per year might be needed for follow-ups and adjusting the settings and that kind of stuff.

 

[AnthonyMcDonald]

I don't mind flying to the USA to buy the device either but I'm concerned multiple trips per year might be needed for follow-ups and adjusting the settings and that kind of stuff.

I don't see why it wouldn't be possible to do online.

 

[Luman]

Scientific American, July 13, 2023:

New Tinnitus Therapy Can Quiet Torturous Ringing in the Ears

 

[Josh59]

Hello,

In Dr. Susan Shore's many studies on the activation of somatosensory tinnitus by the trigeminal nerve, dorsal nerve, etc., it is often mentioned that neurotransmitters and glutamatergic effects play an important role in the excitation of neurons in the DCN.

In this study bt Dr. Shore, it mentions:

Another mechanism that could contribute to these effects is activation of GABAB receptors in the DCN that regulate dendritic excitability and excitatory inputs. GABAB receptors in CN are indeed strategically placed to modulate glutamatergic neurotransmission between the granule cells and their targets, the fusiform, cartwheel, and stellate cells in the superficial layers. The sources of GABAergic inputs to these regions could be vertical cells or superficial stellate cells, which cocontain GABA as well as glycine

I'd like your opinion on this.

Does this mean that the effect of GABA B could play a role in excitatory reduction and reduce somatosensory tinnitus?

I see that the only drug that can activate GABAb is Baclofen, which is a muscle relaxant.

 

[Nick47]

Do we know what pathway Dr. Shore's device is going through, 510(K) or De Novo, and if it changed after Lenire was approved? I saw the Lenire FDA approval document. They submitted for approval in August 2021, with it being granted in March 2023. 19 months seems very, very slow.

Is CE approval being run simultaneously to FDA? I see they have patents in Europe, however there has been no discussion on wider approval.

 

[ErikaS]

Do we know what pathway Dr. Shore's device is going through, 510(K) or De Novo, and if it changed after Lenire was approved? I saw the Lenire FDA approval document. They submitted for approval in August 2021, with it being granted in March 2023. 19 months seems very, very slow.

Is CE approval being run simultaneously to FDA? I see they have patents in Europe, however there has been no discussion on wider approval.

I thought we were told somewhere on this thread that she resubmitted for 510(K) after Lenire approval, but I don't know how factual that was. I am hoping if that's the case, and given Lenire is already approved and her device is USA university made with a published, peer reviewed study, it will move much faster to approval.

 

[InNeedOfHelp]

Do we know what pathway Dr. Shore's device is going through, 510(K) or De Novo, and if it changed after Lenire was approved? I saw the Lenire FDA approval document. They submitted for approval in August 2021, with it being granted in March 2023. 19 months seems very, very slow.

Is CE approval being run simultaneously to FDA? I see they have patents in Europe, however there has been no discussion on wider approval.

19 months was including launching the new study as per requirement of the FDA if I'm not mistaken.

I'd say it's very likely that they started as De Novo and had to reapply as I said earlier. There are different criteria for 510(K) and De Novo pathways. And Lenire created the De Novo for bimodal stimulation.

Every Monday around 11:00 CET the new batch of 510(K) approvals is published here:

FDA: 501(K) Pre-Market Notification

Just click on search and they pop up. I've been checking every week but after 7 months (since December...?), I'm starting to worry a little bit about additional requirements or an extra trial, as in total fewer than 120 people participated in 2 trials. I sincerely hope this is not the case, especially as they were pre-aligned with the FDA before.

 

[Jonno02]

Do we know what pathway Dr. Shore's device is going through, 510(K) or De Novo, and if it changed after Lenire was approved? I saw the Lenire FDA approval document. They submitted for approval in August 2021, with it being granted in March 2023. 19 months seems very, very slow.

Is CE approval being run simultaneously to FDA? I see they have patents in Europe, however there has been no discussion on wider approval.

FDA may have asked for additional information / corrective actions that took Lenire a long time. Nearly 2 years for approval from submission is laughable for implantable devices, never mind much 'lower risk' devices like these.

 

[Nick47]

19 months was including launching the new study as per requirement of the FDA if I'm not mistaken.

I'd say it's very likely that they started as De Novo and had to reapply as I said earlier. There are different criteria for 510(K) and De Novo pathways. And Lenire created the De Novo for bimodal stimulation.

Every Monday around 11:00 CET the new batch of 510(K) approvals is published here:

FDA: 501(K) Pre-Market Notification

Just click on search and they pop up. I've been checking every week but after 7 months (since December...?), I'm starting to worry a little bit about additional requirements or an extra trial, as in total fewer than 120 people participated in 2 trials. I sincerely hope this is not the case, especially as they were pre-aligned with the FDA before.

510(K) clearance is around 90 days from what I'm reading.