Electrical Stimulation of the Cochlea for Treatment of Chronic Disabling Tinnitus

[Freerunner]

Another interesting study has been completed. What do you guys think?

"All 22 (100%) subjects experienced clinically significant improvement in the THI during the study period with a mean decrease in scores of − 31 (95% CI − 38 to − 25) from a baseline of 48. Twenty (91%) experienced clinically significant improvement detectable on at least two of the three tinnitus survey instruments and 17 (77%) experienced clinically significant improvement detectable on all three survey instruments (i.e., THI, TFI, and VAS). Eight (36%) subjects reported either complete (THI of 0; n = 3) or near-complete (THI 1–4; n = 5) suppression of their tinnitus following a stimulation session. Thirteen (59%) subjects reported a nadir following stimulation at or below the threshold for "no or slight handicap" on the THI (≤ 16). No adverse events were observed.

Conclusions:
These findings establish the foundation for the development of an extra-cochlear implantable device that delivers electrical stimulation to the cochlea for the treatment of disabling tinnitus. For patients considering device implantation, trans-tympanic cochlear promontory stimulation can facilitate patient selection."​

Links to the study details:

Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open‑label trial towards the development of an implantable device

Link to Clinical Trials page:

Cochlear Promontory Stimulation for Treatment of Tinnitus

 

[DocTors_94]

I find this good honestly, all the patients had improvements. I bet there is definitely some NON-placebo effect.

 

[Don Tinny]

I wonder why research is developing in such different directions. Seems like there are 10 possible treatments but we have nothing today. So frustrating.

 

[AfroSnowman]

Wow this looks really promising. Can we get this done?

 

[DocTors_94]

I wonder why research is developing in such different directions. Seems like there are 10 possible treatments but we have nothing today. So frustrating.

It's true. But I also have to say the more options avaliable, the more chances to shut the tinnitus up with multiple treatments. I am still waiting for Prof. Thanos Tzounopoulos to move ASAP. We need that drug.

 

[DimLeb]

@DocTors_94, sorry to say, but Thanos Tzounopoulos's drug still is so far behind. I believe it is at least 8-10 years away, given it hasn't even started Phase 1...

 

[David S]

I always liked this approach. Interesting that 18% had a permanent reduction. They only had simulations 3 times.

With more stimulation more people might get permanent effect? Must be a lot to fine tune with the stimulation algorithm.

Why not a semi-permanent solution based on a microwick?

https://www.earsinus.com/silverstein-microwick

And then a fine sliver cable aiming for the cochlea.

The electronics could be an open in-ear unit. It is not much that is needed.

 

[Padraigh Griffin]

It's true. But I also have to say the more options avaliable, the more chances to shut the tinnitus up with multiple treatments. I am still waiting for Prof. Thanos Tzounopoulos to move ASAP. We need that drug.

He's never going to get to market with that drug. It is 7/8 years away. Tinnitus will be cured by then. There is already a potassium channel modulator XEN-1101 due in 18-24 months. I can't see why the Professor is bothering. I've emailed him for comment on XEN-1101 a few times but it has fallen on deaf ears.

 

[ploughna]

It'd be great to find out where they plan to go next with this. Follow on with a bigger trial? The fact that it used available, proven technology and methods is a big positive from a potential availability standpoint.

 

[Mathew Gould]

He's never going to get to market with that drug. It is 7/8 years away. Tinnitus will be cured by then. There is already a potassium channel modulator XEN-1101 due in 18-24 months. I can't see why the Professor is bothering. I've emailed him for comment on XEN-1101 a few times but it has fallen on deaf ears.

All tinnitus will be cured, or tinnitus from loud noises, or tinnitus from neck/jaw, etc?

 

[Matchbox]

Wow this looks really promising. Can we get this done?

I think there's a clinical trial ongoing.

I don't see how this wouldn't be done at an audiologist's office to treat tinnitus. it's so obvious and low threshold invasive.

 

[Don Tinny]

I think there's a clinical trial ongoing.

I don't see how this wouldn't be done at an audiologist's office to treat tinnitus. it's so obvious and low threshold invasive.

Maybe severe tinnitus is not as profitable a market as we think. Most people have it in a mild form and there is a lack of interest.

 

[Gb3]

Recruitment Status: Suspended (Enrollment for study is currently on hold pending additional funding and resources.)

First Posted: November 30, 2018

Last Update Posted: January 21, 2022

 

[hopes]

It is 7/8 years away. Tinnitus will be cured by then.

If only...

 

[AfroSnowman]

I think there's a clinical trial ongoing.

I don't see how this wouldn't be done at an audiologist's office to treat tinnitus. it's so obvious and low threshold invasive.

Takes an implant, right? So maybe an ENT.

 

[Gb3]

If I read this correctly, this is used in combination with a cochlear implant.

"Extra"

 

[Matchbox]

You could put the electrode on the eardrum, some people don't need that much invasive voltage, if they get an effect but the voltage gets too high to help further, that'd make them an implant candidate on the bony cochlea (not a CI).

 

[Athens]

He's never going to get to market with that drug. It is 7/8 years away. Tinnitus will be cured by then. There is already a potassium channel modulator XEN-1101 due in 18-24 months. I can't see why the Professor is bothering. I've emailed him for comment on XEN-1101 a few times but it has fallen on deaf ears.

I like your optimism. What are your thoughts about whether a successful treatment for hyperacusis will be developed in the next few years?

 

[DocTors_94]

If I read this correctly, this is used in combination with a cochlear implant.

"Extra"

Where did you read that? An inclusion criteria of the study was to have maximum moderate hearing loss (that would exclude them from having a cochlear implant). Furthermore, in exclusion criteria, cochlear implants are not MRI compatible. So actually, this device wasn't used in combination with a cochlear implant.

Inclusion Criteria:

1. Normal to moderate sensorineural hearing loss (based on pure tone audiometry (PTA) of 500, 1000 and 2000 Hz) and a word recognition score greater than 75%
2. Asymmetric subjective tonal tinnitus
3. Tinnitus that is disruptive
   1. Determined by THI score (in the severe range i.e. >56/100)
   2. TFI (in the severe range i.e. >52/100)
   3. VAS (> 5/10 )
4. Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking
5. Normal contrast-enhanced MRI of the head

Exclusion Criteria:

1. Tinnitus present less than 6 months or longer than 3 years
2. History of brain or major ear surgery
3. Prior major head trauma
4. History of depression or anxiety
   1. Determined by screening using the GAD 7, PHQ8, and HAI-S
      • GAD7 > 9 (indicates clinically significant anxiety)
      • PHQ > 9 (indicates clinically significant depression)
      • HAI-S > 25 (hypochondriacal level illness anxiety)
   2. Inability to assess, continue or complete trial
5. Currently on antidepressants, anxiolytics or antipsychotics
6. Active use of other tinnitus treatments
7. MRI Incompatible Devices
8. Known pregnancy

 

[PeterPan]

So many trials with positive results. So few available treatments that work…!

 

[InNeedOfHelp]

If I read this correctly, this is used in combination with a cochlear implant.

"Extra"

It doesn't say a cochlear implant is a requirement in the exclusion criteria. It seems like a standalone middle ear implant.

Something implanted in the middle ear seems scary to me.

 

[koffee_monster]

Another interesting study has been completed. What do you guys think?

"All 22 (100%) subjects experienced clinically significant improvement in the THI during the study period with a mean decrease in scores of − 31 (95% CI − 38 to − 25) from a baseline of 48. Twenty (91%) experienced clinically significant improvement detectable on at least two of the three tinnitus survey instruments and 17 (77%) experienced clinically significant improvement detectable on all three survey instruments (i.e., THI, TFI, and VAS). Eight (36%) subjects reported either complete (THI of 0; n = 3) or near-complete (THI 1–4; n = 5) suppression of their tinnitus following a stimulation session. Thirteen (59%) subjects reported a nadir following stimulation at or below the threshold for "no or slight handicap" on the THI (≤ 16). No adverse events were observed.

Conclusions:
These findings establish the foundation for the development of an extra-cochlear implantable device that delivers electrical stimulation to the cochlea for the treatment of disabling tinnitus. For patients considering device implantation, trans-tympanic cochlear promontory stimulation can facilitate patient selection."​

Links to the study details:

Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open‑label trial towards the development of an implantable device

Link to Clinical Trials page:

Cochlear Promontory Stimulation for Treatment of Tinnitus

Looks like they are waiting for further funding. Does anyone know if Mayo Clinic intends to continue this research?

 

[BuzzyBee]

I wonder why they exclude people who have had tinnitus for over 3 years? What's magical about the 3 year mark?

 

[Reed19]

I wonder why they exclude people who have had tinnitus for over 3 years? What's magical about the 3 year mark?

A lot of studies like to exclude chronic tinnitus to make results look better. There is a theory that chronic tinnitus sets in the brain and is thus harder to get rid of.

I think two years is the max amount of years I've heard for tinnitus spontaneously getting better.

 

[star-affinity]

A lot of studies like to exclude chronic tinnitus to make results look better. There is a theory that chronic tinnitus sets in the brain and is thus harder to get rid of.

I think two years is the max amount of years I've heard for tinnitus spontaneously getting better.

I really hate that "chronic tinnitus sets in the brain" theory. If that is the case, how the heck will we cure it?



But let's stay positive!

 

[Reed19]

I really hate that "chronic tinnitus sets in the brain" theory. If that is the case, how the heck will we cure it?



But let's stay positive!

I don't like it either. It sets in the brain and yet you can increase but not decrease the volume dramatically many years later.

I think researchers just want to inflate their studies with people who heal naturally without their treatment.

 

[Don Tinny]

I really hate that "chronic tinnitus sets in the brain" theory. If that is the case, how the heck will we cure it?



But let's stay positive!

I think those theories are BS. Chronic tinnitus usually fluctuates and we have moderate and severe days, so it can change.

 

[Reed19]

I think those theories are BS. Chronic tinnitus usually fluctuates and we have moderate and severe days, so it can change.

As far as being able to change, I would agree.

The ingrained in the brain part I believe is also about how in one study where they cut the connection between the ear and the brain. Only 50 percent of people had their tinnitus eliminated. It certainly is strange to say the least.

I believe if it started with the ear, it can end through the ear.

 

[Padraigh Griffin]

The ingrained in the brain part I believe is also about how in one study where they cut the connection between the ear and the brain. Only 50 percent of people had their tinnitus eliminated. It certainly is strange to say the least.

Be great to have a link to that study if you have it please. Really like to read it.

 

[star-affinity]

As far as being able to change, I would agree.

The ingrained in the brain part I believe is also about how in one study where they cut the connection between the ear and the brain. Only 50 percent of people had their tinnitus eliminated. It certainly is strange to say the least.

I believe if it started with the ear, it can end through the ear.

I think so too. At least it sounds reasonable that it is so. Otherwise I don't think for example Otonomy would keep working on their OTO-313 drug:

OTO-313 is a sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine. Otonomy believes that gacyclidine can reduce the severity of tinnitus symptoms following cochlear injury by decreasing the over-activation of damaged auditory nerve fibers in the cochlea.

Otonomy Completes Enrollment in Phase 2 Clinical Trial of OTO-313 in Tinnitus