Electrical Stimulation of the Cochlea for Treatment of Chronic Disabling Tinnitus

[Nick47]

The Bionics Institute are going to make a huge difference to our cause once they get their system into clinical point of care.

@UKBloke, I agree. Dr. De Ridder said in a lecture in 2021 that an objective measure would be 2-3 years away. What worries me is how it's gone a bit silent in the last 18 months. I spoke to @DebInAustralia and we discussed the possibility that there may be a lack of funds. I think last I heard they could distinguish between controls 78% of the time and between mild and severe with 88% specificity. Numbers sound good but need much more accuracy for the clinic. I guess it's a case of using it on more participants so the AI learns to be smarter.

 

[Nick47]

I was encouraged to report an improvement

@Mentos, that does not go down well with me at all. In fact I feel physically sick.

 

[UKBloke]

@UKBloke, I agree. Dr. De Ridder said in a lecture in 2021 that an objective measure would be 2-3 years away. What worries me is how it's gone a bit silent in the last 18 months. I spoke to @DebInAustralia and we discussed the possibility that there may be a lack of funds. I think last I heard they could distinguish between controls 78% of the time and between mild and severe with 88% specificity. Numbers sound good but need much more accuracy for the clinic. I guess it's a case of using it on more participants so the AI learns to be smarter.

I do wonder whether the Bionics Institute could trial their system as is, in parallel with a current clinical trial of a tinnitus treatment to compare it to TFI. I suppose it depends how portable the set up is.

The most encouraging thing about 4-fold decreases in TFI though (absent @Mentos's comment - let's hope these trials overall are not skewing results) is that when a device really works, it'll smash TFI through the floor. There'll be none of that, 13 TFI points of clinical significance that require hyperbole to describe the effect - ala Lenire lol.

 

[@dam]

@UKBloke, I agree. Dr. De Ridder said in a lecture in 2021 that an objective measure would be 2-3 years away. What worries me is how it's gone a bit silent in the last 18 months. I spoke to @DebInAustralia and we discussed the possibility that there may be a lack of funds. I think last I heard they could distinguish between controls 78% of the time and between mild and severe with 88% specificity. Numbers sound good but need much more accuracy for the clinic. I guess it's a case of using it on more participants so the AI learns to be smarter.

The more money that gets into tinnitus research, the faster a cure will become available.

 

[Nick47]

(absent @Mentos's comment - let's hope these trials overall are not skewing results)

I think the Polish study is very different, using the ear canal rather than placement in the middle ear, which showed the very significant results.

 

[Gb3]

I think the Polish study is very different, using the ear canal rather than placement in the middle ear, which showed the very significant results.

Ya, I think it's different.

 

[just1morething]

I got this on my Mayo portal today:

Thank you for your interest in Dr. Carlson's tinnitus device study. Please look at the list below and let me know if you meet these initial inclusion criteria, AND if you would be willing and able to come to Mayo Clinic in Rochester MN for at least 26 visits, some of them weekly, over about 15 months' time.

• Age: 18 years of age or older
• Normal to mild/moderate hearing loss
• Tinnitus much worse in one ear (or only in one ear)
• Tinnitus bothersome for less than 12 years
• Tinnitus that is severe, disruptive and has not been relieved by conventional measures such as a hearing aid or masking (white noise machines)
• No history of major head trauma
• No history of major clinical depression or anxiety
• Not on an antidepressant or antianxiety medication

If you are still interested in participating in the tinnitus study and think that you meet these initial criteria or have any questions or concerns about this study, please reply to this message or call (507) 293-2445. We would need to do additional screening by phone as well as a consent form review and electronic signature, before proceeding further.

Sincerely,
Nicole Tombers
ENT Study Coordinator Supervisor
Mayo Clinic​

That's an awful lot of visits and I'm probably borderline on how long I had tinnitus, plus I may not meet other criteria.

 

[lapidus]

Tinnitus bothersome for less than 12 years

When I read it fast at first I interpreted it as not having had tinnitus for more than 12 years.

Looking at it again, I interpret it as there is no limit on how long you've had tinnitus as long as it hasn't been bothersome for more than 12 years.

For example, you could've had it for 30 years but it's been normal, stable and mild for 25 years and the last 5 years it's worsened to bothersome levels.

But why specifically 12 years?

 

[AfroSnowman]

I got this on my Mayo portal today:

Thank you for your interest in Dr. Carlson's tinnitus device study. Please look at the list below and let me know if you meet these initial inclusion criteria, AND if you would be willing and able to come to Mayo Clinic in Rochester MN for at least 26 visits, some of them weekly, over about 15 months' time.

• Age: 18 years of age or older
• Normal to mild/moderate hearing loss
• Tinnitus much worse in one ear (or only in one ear)
• Tinnitus bothersome for less than 12 years
• Tinnitus that is severe, disruptive and has not been relieved by conventional measures such as a hearing aid or masking (white noise machines)
• No history of major head trauma
• No history of major clinical depression or anxiety
• Not on an antidepressant or antianxiety medication

If you are still interested in participating in the tinnitus study and think that you meet these initial criteria or have any questions or concerns about this study, please reply to this message or call (507) 293-2445. We would need to do additional screening by phone as well as a consent form review and electronic signature, before proceeding further.

Sincerely,
Nicole Tombers
ENT Study Coordinator Supervisor
Mayo Clinic​

That's an awful lot of visits and I'm probably borderline on how long I had tinnitus, plus I may not meet other criteria.

Do you know if there is funding for travel?

 

[AnthonyMcDonald]

I think it's safe to say that the cochlea isn't the root cause of tinnitus, for the most part. What should be targeted is the brain stem (DCN), which has been shown in numerous studies, to be the epicenter of tinnitus generation (at least in noise-induced tinnitus cases), like in Susan Shore's papers.

 

[Nick47]

I think it's safe to say that the cochlea isn't the root cause of tinnitus

Do you still think that's the case with reactive tinnitus and hyperacusis? Even though it feels like it's in the ears?

 

[just1morething]

Do you know if there is funding for travel?

I just talked to Nicole and she said there is no travel funding for the first phase, but there may be funding for the second phase if it makes it that far. Unfortunately I did not meet their criteria to be a trial participant.

 

[AnthonyMcDonald]

Do you still think that's the case with reactive tinnitus and hyperacusis?

Yes, for the most part.

 

[Strawberryblonde]

I think it's safe to say that the cochlea isn't the root cause of tinnitus, for the most part. What should be targeted is the brain stem (DCN), which has been shown in numerous studies, to be the epicenter of tinnitus generation (at least in noise-induced tinnitus cases), like in Susan Shore's papers.

Will this device help sound distortions such as beeps heard with the likes of running taps and white noise? I'm not up to date or have a full understanding of how it works.

 

[EDDTEKK]

"Bothersome or Severe Tinnitus" with no impact on mood is ridiculous! Most patients need to take antidepression and sleep medication.

What do they expect at the Mayo Clinic? Happy tinnitus sufferers?

 

[just1morething]

What do they expect at the Mayo Clinic? Happy tinnitus sufferers?

When I talked to Nicole at Mayo Clinic earlier, she said the device was attached to the mastoid bone behind the ear. I was thinking it was in the ear canal.

 

[awake 44]

I think it's safe to say that the cochlea isn't the root cause of tinnitus, for the most part. What should be targeted is the brain stem (DCN), which has been shown in numerous studies, to be the epicenter of tinnitus generation (at least in noise-induced tinnitus cases), like in Susan Shore's papers.

I totally agree with you @AnthonyMcDonald (as usual to be honest). Your outcomes are aligned with my brainstorming. It is a very logical assumption that tinnitus is generated in DCN:

- If tinnitus was generated in cochlea, then all people with hearing loss should have tinnitus. We all know this is not the case. For example, my grandma is totally deaf, and she has no sign of tinnitus.

- According to the theory of Dr. Susan Shore, tinnitus is the brain's reaction to the hearing loss.

First thing is those phenomena are two separate issues. Second thing is the fact that you don't need to have major hearing loss to get tinnitus.

When you are analyzing the above statements, the logical conclusion is that the statement of tinnitus originating in the cochlea is totally wrong.

 

[Gb3]

"Bothersome or Severe Tinnitus" with no impact on mood is ridiculous! Most patients need to take antidepression and sleep medication.

What do they expect at the Mayo Clinic? Happy tinnitus sufferers?

That's what I said.

 

[AfroSnowman]

I just talked to Nicole and she said there is no travel funding for the first phase, but there may be funding for the second phase if it makes it that far. Unfortunately I did not meet their criteria to be a trial participant.

Yeah, I reached out as well. Nicole said you basically had to live there to take part in the study.

 

[ErikaS]

This is the feedback I got back from Nicole after I sent some general questions surrounding the current trial and future trials:

"The current trial is still ongoing and won't be completed in June, no. Yes, more studies will be needed before commercialization (best case scenario, at least two more separate studies). I can't guess the date that all the research will be concluded, but it will be years from now. As far as staying up to date with following trials, ClinicalTrials.gov is definitely the best place to get that information because study teams are required to update that website regularly with results, and also post new studies before a single participant is enrolled."​

Just an FYI.

I just talked to Nicole and she said there is no travel funding for the first phase, but there may be funding for the second phase if it makes it that far. Unfortunately I did not meet their criteria to be a trial participant.

I am confused, are they still gathering participants for Phase 1?

Yes, for the most part.

I think you know your stuff after all of the research on your end, and therefore I really hope you're right with the Michigan device! My tinnitus was not noise induced, it was inner ear infection induced causing damage. However, I'd like to think that hair cell damage is damage, whether noise or infection, and hopefully how that damage came about doesn't determine your response.

I also do appreciate the research of a cochlear device because, as we know, not everyone is going to respond the same to one treatment. At the end of the day, you just don't know what will be your intervention to really improve your tinnitus, reactivity, hyperacusis, and overall QoL.

 

[just1morething]

I am confused, are they still gathering participants for Phase 1?

I think so. I think she said they have 10 participants so far. I had tinnitus too long and also had TMJ disorder, so I didn't qualify. I would have traveled the 1.5 hours for potential relief. Living with ear(s)/head noise is sure unpleasant for me. Nothing seems to give me relief lately except for of course sleep.

 

[UKBloke]

Reading through the various studies, I've still not happened upon a method of action for this technology, so just want to share a couple of thoughts.

Ever since I heard the theory about tinnitus being a symptom of malfunctioning neural 'gating,' I've tried to visualise tinnitus (and the associated neural pathways) as an electrical circuit.

A malfunctioning gate within an electrical circuit will allow errant signals to 'bleed though' to where they shouldn't be, so the hypothesis of tinnitus bleeding through to the conscious mind from the sub-conscious certainly makes sense to my barn door of a brain.

Anyhow, this thinking led me to research the works of Nikola Tesla, and subsequently, Georges Lakhovsky who utilised Tesla's work in his own electrical medical devices in the middle of the last century.

Lakhovsky (and others) believed that human cells become 'diseased' because their electrical resonant frequencies have lowered. He aimed to address this scenario by having his machines rejuvenate those cells via broadband EMF, which conversely would also correct their operating voltages (transmembrane potential).

If, for whatever underlying reason, the cells in our tinnitus neural gates are operating at lowered voltages/frequencies to the ones of people who don't suffer from tinnitus then an attempt to re-energise those cells in order that they perform the task for which they were designed makes sense.

Whether we did that with a Lakhovsky Multiwave Oscillator or a Mayo Clinic hardwire onto the cochlear, would it make a difference? Wouldn't the main thing be to ensure the re-charging energy gets in and upstream to the gated filters? Well, that's the hypothesis at least.

 

[Nick47]

Reading through the various studies, I've still not happened upon a method of action for this technology, so just want to share a couple of thoughts.

Ever since I heard the theory about tinnitus being a symptom of malfunctioning neural 'gating,' I've tried to visualise tinnitus (and the associated neural pathways) as an electrical circuit.

A malfunctioning gate within an electrical circuit will allow errant signals to 'bleed though' to where they shouldn't be, so the hypothesis of tinnitus bleeding through to the conscious mind from the sub-conscious certainly makes sense to my barn door of a brain.

Anyhow, this thinking led me to research the works of Nikola Tesla, and subsequently, Georges Lakhovsky who utilised Tesla's work in his own electrical medical devices in the middle of the last century.

Lakhovsky (and others) believed that human cells become 'diseased' because their electrical resonant frequencies have lowered. He aimed to address this scenario by having his machines rejuvenate those cells via broadband EMF, which conversely would also correct their operating voltages (transmembrane potential).

If, for whatever underlying reason, the cells in our tinnitus neural gates are operating at lowered voltages/frequencies to the ones of people who don't suffer from tinnitus then an attempt to re-energise those cells in order that they perform the task for which they were designed makes sense.

Whether we did that with a Lakhovsky Multiwave Oscillator or a Mayo Clinic hardwire onto the cochlear, would it make a difference? Wouldn't the main thing be to ensure the re-charging energy gets in and upstream to the gated filters? Well, that's the hypothesis at least.

Well, that's a very deep hypothesis. I just think in simpler terms sound is turned into electrical activity which is transmitted through the auditory nerve. A cochlear implant will do this, but often the tinnitus is reduced even when the wearer is in a quiet room. So it's not the sound masking it? Sending electrical charge bypasses the sound component but is still the same result, electrical activity to the auditory nerve. This then activates the neurons that were firing spontaneously in the absence of that charge and causes them to calm down and return to default

But then the question is why does a person with a switched-on cochlear implant get tinnitus suppression when they are in a soundproofed room? There is no external sound to start the process.

I'm a believer in the bottom up approach where the misfiring in the DCN spreads through the inferior colliculus to the MGB/thalamus and is perceived in the auditory cortex.

So if possible, it's best to address tinnitus at a cochlear level if you can, or at least the DCN. That is more akin to turning the stop tap off, rather than running upstairs to stop the leak in the pipe, which seems to be the approach of treatments like tDCS.

 

[UKBloke]

I'm a believer in the bottom up approach where the misfiring

Thing is, I'm yet to see a cogent explanation as to why misfiring occurs. In that sense, dysfunctional gating leading to neural noise, is the simpler hypothesis.

 

[DimLeb]

Thing is, I'm yet to see a cogent explanation as to why misfiring occurs. In that sense, dysfunctional gating leading to neural noise, is the simpler hypothesis.

Not an expert on this of course (no one on this earth really is), but to answer this, I believe we need to also research what and how it happens in other diseases which have a forced tinnitus as their symptom (otosclerosis, Meniere's etc). It would make sense that some people (out of all) with those kinds of diseases would not develop tinnitus, assuming some people have a "good" gating brain system that stops the misfiring at its roots according to the gating system theory.

 

[Nick47]

dysfunctional gating leading to neural noise, is the simpler hypothesis.

I've understood the potassium channels don't recover in those who get chronic tinnitus. Are these Kv7.2/3 channels the key to gating?

 

[JimmyStrong]

So if possible, it's best to address tinnitus at a cochlear level if you can, or at least the DCN. That is more akin to turning the stop tap off, rather than running upstairs to stop the leak in the pipe, which seems to be the approach of treatments like tDCS.

So is turning off the tap more effective/efficient, or is fixing the leak better? I'm confused.

 

[UKBloke]

I believe we need to also research what and how it happens in other diseases which have a forced tinnitus as their symptom (otosclerosis, Meniere's etc).

Agreed. Again, just hypothesising, but if those diseases cause a symptomatic increase in subconscious neural activity, say as a result of inflammation or various misfirings, then these raised levels of activity leaking across the faulty gate to be perceived as tinnitus sounds plausible. This is the thing I like about the gating theory; it doesn't really care much for where the signals originate, just that they reach the gate and leak over it.

Regarding other non-related conditions as an example, this is where I could believe something like schizophrenia originates. I get a sense that there we have 'satellite' personalities, or fragments thereof, orbiting our central-self that for a healthy person cause no issue because of a functioning related gating system. However, if that system were to fail then it seems plausible that just like tinnitus, aspects of 'other' self/personalities could leak over into our main one and cause those horrible symptoms.

Ultimately, if this gating thing holds up, I do believe there'll be a biomarker for it.

I've understood the potassium channels don't recover in those who get chronic tinnitus. Are these Kv7.2/3 channels the key to gating?

They've evidently been indicated in various tinnitus research so it seemed like a good place to start. Whether they hold the key or not, your guess is as good as mine. Regarding this current research, they actually mention Calcium Channels. That was a new one on me.

 

[Nick47]

So is turning off the tap more effective/efficient, or is fixing the leak better? I'm confused.

I'd prefer to run to the stop tap and turn it off rather than deal with the upstream effects of holding buckets under the leaking pipes.

As in "my fucking auditory cortex has sprung a leak and I want to jump off a very high bridge, and I can't turn the stop tap off".

 

[UKBloke]

So is turning off the tap more effective/efficient, or is fixing the leak better? I'm confused.

Sorry to butt-in here but here's a plumbing example lol.

I don't know where you are but in the UK we have single domestic fresh water systems that feed both drinking water and things like central heating. In order that the 'dirty' water that builds up in a central heating system doesn't back up into the drinking supply (apologies for that dodgy looking tap), regulations require one-way valves to be fitted in the system at various points.

In many respects these valves function as a gate by keeping the two water systems separated. In our tinnitus model it's the valve that would partially fail, and we'd end up drinking dirty water.