Electrical Stimulation of the Cochlea for Treatment of Chronic Disabling Tinnitus

Hmm, maybe. I feel like mine set into the brain a lot sooner than the two year mark. I do think Otonomy is going to work for some people, but I also suspect that a lot of these "cures" are going to be therapies that quiet it rather than banish it for good. I'd be very happy with that!

 

This study looks very promising based not just on the results but the fact it was based on data from cochlear implants. It seems a primary completion date is June 2023. I presume this is another trial?

 

Something popped up today about the most updated trial taking place with this. So it looks like the first study that was published this time last year was using a device that they temporarily put into the eardrum to conduct the study and then removed the device, which makes sense because it said in a 3 month follow up, most of the patients’ tinnitus scores returned to baseline. The trial taking place now through Mayo Clinic sounds like an actual permanent device placement, pretty much taking it to the step of true implementation for clinical use. And yes, it says study completion date of June 2023, but not sure if that’s what they are on target for still.

Here is the link to the latest that I saw through Mayo Clinic:

Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

 

I think this is one of the more exciting potential treatments for tinnitus. Based on cochlear implants having a direct effect on reducing tinnitus in 80%+ of users, this is building a device off that basis. It is also only minimally invasive compared to a cochlear implant.

Interesting that they only exclude on the basis of greater than moderately severe hearing loss in the 500 Hz - 2000 Hz range. Is that because they are stimulating the lower-middle frequencies?

 

Is this like a Phase 2 trial? So it could be out in a year or so?

 

Errrrrr, NO.

 

I feel like they are drawing that line because if you have greater than moderately severe hearing loss in those ranges, that would also most likely mean your higher frequencies are lost, therefore you may be more suited for a cochlear implant? I feel like this is made for those who are nowhere near needing a cochlear implant based on hearing loss/damage, but also have found no relief/improvement with tinnitus given a hearing aid, or, aren’t even “severe” enough for a hearing aid but still suffer from tinnitus due to hearing loss/damage.

I would love to think that, but I think it is separate from what the first trial was since it wasn’t the same people, but I could be wrong. I think the sample size for this was 16 people so I’m wondering, if it shows significant results, might they do another phase with greater sample size. And I’m not sure how you have a control group in something like this, if it’s even possible. I’m also wondering if their device has a patent yet.

I agree this is a no, BUT, given that they are modeled/based off of cochlear implants, and those have been approved for medical use for quite some time now, just MAYBE we wouldn’t be waiting forever for this to get FDA approval, if/when it gets there, because of its “predecessor”.

 

Just thought to add from ClinicalTrials.gov:

“Researchers are gathering information on the safety and effectiveness of a novel device called the Tinnitus Implant System for the treatment of tinnitus. This study requires one year of participation with at least 21 visits to Mayo Clinic in Rochester MN for device programming and audiometric testing. The device is implanted during an outpatient surgery. Participants may keep the study device after participation is complete.”​

The part where they say participants may keep the study device after participation is complete is a winner and speaks for its safety efficacy. Imagine being part of the study, it actually working for your tinnitus, then being set with it in your much improved quality of life.

What is confusing to me is in the exclusion criteria, it states “normal temporal bone CT” and “normal contrast-enhanced MRI of the head”, as in they want to see something “not normal” in these areas for participation?

 

I live less than a 2 hour drive from there. Thanks for the link @ErikaS.

 

Research developing in such different directions? That might be a sign that they have gone "back to the drawing board". They began by concentrating their observations on the ear... It seems plausible that this mystery sound might also be amenable or observable in the brain.

Now if those Australians (The Bionics Institute) can manage to streamline their objective way of detecting and measuring tinnitus (hyperacusis too please), that might cut out one helluva lot of trial phases and placebo samples and such-like. It could be a modest but important step that our generation brings to this centuries-old problem.

But of course detecting and measuring tinnitus ain't exactly curing or removing anything.

 

You should definitely follow this then, because if success is seen in this first trial, I’d only assume a second would be held with larger sample size. It would be very cool to be selected for this, however it says as an inclusion factor, you should have had tinnitus longer than 6 months but less than 3 years.

 

I wouldn't say they've gone back to the drawing board, more that they have established 2 ways to tackle it:

1) Increase electrical activity running through the auditory nerve.
2) Decrease activity in the DCN.

Performing 1) seems to also cause 2).

Obviously other areas become involved in the brain too.

I agree about the objective measure. I think it's crucial, because once that becomes established and reliable, then researchers and companies will flock to the field.

It's just to rule out obvious things like tumours or bone dehiscence.

 

I think it says "but less than 12 years". I’m not sure I would qualify, but I will call them and look into it.

 

This is who you reach out to:

Tombers.Nicole@mayo.edu

I reached out to her last year when they were recruiting for this study. The exclusion criteria includes antidepressant use, so I couldn’t participate. I asked if she could share information about the device and she told me she couldn’t because of all the patents.

@Nick47, I’ve read through the study and they believe the electrical stimulation might do something to potassium channels just like Trobalt did.

 

In the current clinical trial, the mean effect size of subjects’ nadir tinnitus level post-treatment exceeded the threshold for clinically significant decreases on the THI by over four-fold.​

If the above is true, then those original results were stunning.

Prof. Heidi Olze and her team have been researching this technique too. If I'm not mistaken, it's also a chunk of Hamid Djalilian's work that Brian Fargo is financing.

That's in the inclusion criteria.

 

Yes, but there is XEN1101, which is basically the same drug, and could be used off-label soon.

 

I don’t understand how this device is “implanted” or “powered”? Can some explain?

 

There seems to be 3-4 different teams carrying out “ongoing” research on some type of cochlear electrical stimulation device specifically for tinnitus.

There was this study done at a university in Poland completed this past June that used a prototype device that gave both electrical and magnetic stimulation to the ear. It was non-invasive, with the electrode being placed in the external ear canal. 100 patients, showing a 79% improvement rate in tinnitus symptoms post treatment.

Then there is this team in Shanghai that used a four-electrode implant to produce extracochlear electrical stimulation on guinea pigs. Results showed that it did significantly decrease “multiple measurements” of tinnitus by changing the misfiring auditory-somatosensory system without affecting hearing or the hair cells in the inner ear.

Along with these two, you have Mayo Clinic team in Minnesota, USA and then INTAKT project in Germany with their tinnitus implant. I am happy this area is being focused on by more than one group/team for research and competition purposes. I would just like something to move faster, but don’t we all.

 

The Bionics Institute are going to make a huge difference to our cause once they get their system into clinical point of care. Having said that, what is incredibly encouraging about the Mayo Clinic's early results is the four-fold decrease on standard THI. I reckon with figures like that there can be no mistake that the device is really doing something.

 

What made you look into cochlear electrical stimulation, when you just had your treatments done at Advanced Rejuvenation? Also what URL shortener do you use? I was just wondering which one was the easiest to use. Is it Bitly?

 

It'll be very interesting to see how this develops. For example, if the Mayo Clinic trial is successful, is it something they may be allowed to offer patients as a treatment, or will it need to go through further trials, FDA approval, etc. In many ways, it's a new application for existing technology. Definitely encouraging to see multiple researchers honing in on a similar approach.

 

@Gb3, do you think stimulating the cochlea opens up the potassium channels?

 

As we both know, there is no guarantee to what I had done. So, still growing my knowledge base as long as I have debilitating tinnitus! Also, I randomly came across the study I posted above the other day and it really intrigued me, and I agree with others that this could really be an answer for tinnitus, especially tinnitus that is of cochlear origin.

All I did was highlight the word “this” after typing it, then already had my URL “copied,” so I pressed the link above to include URL and it goes into the word that I have highlighted.

 

You all are referencing the work of Dr. Matthew Carlson, with whom I have spoken on a few occasions.

Net, net: Dr. Carlson is in Phase 2 trials this year with about 12 people. He then wants to do a third trial at several locations in the USA, including military bases due to the huge veteran need for tinnitus mitigation.

He was 3-6 years away from street deployment as of September 2022.

Dr. Carlson has also spoken with Dr. Djalillian and they are a good 7 years away.

So this is promising, but it's going to be a while. I'm awaiting Dr. Susan Shore's device, in the interim...

 

Unfortunately, I think they would need a much larger sample size next. It would be a dream if they could say that it essentially models already existing technology, therefore could be expedited. But anything being implanted into someone is probably going to go through the tedious steps. Wish they offered “compassionate use” on this!

 

Yep, implantables are almost always Class 3 for the FDA. A much more rigorous approval process.

 

Thank you for this information! Those in the USA can keep an eye out for the Phase 3 trial locations if the Phase 2 shows significant results to support a Phase 3.

 

A bit curious about this Polish study. Since it isn't invasive (you just put a thingy into the ear canal, just like you'd do with an earplug) and the results were quite impressive, wouldn't this be pretty easy to get to market?

 

@Mentos took part in the Polish study years ago, with no improvement. It wasn't blinded. Results look impressive but there seems to be a lot of detail missing. The Polish study is non-invasive and stimulates via the ear canal.