Electrical Stimulation of the Cochlea for Treatment of Chronic Disabling Tinnitus

It may have been looked at in the 70s but the results appear to be positive AND I am fairly certain that they did not have the semiconductor technology in the 70s to produce the chips needed for small implantable devices to be used in this treatment. I personally believe this electrical stimulation of the cochlea is going to alleviate a lot of suffering and be the most impactful treatment of the next decade.

 

Unless you can get in a clinical trial and the trials are successful, I reckon you're looking at 5-7 years.

 

There was no placebo control group in this study, so this is worthless data. Plus, @Mentos, who took part in one of the trials was strongly encouraged to state that the treatment helped him, despite the fact that it did not. I have one more friend who used this method, and she was not happy either.

 

That doesn't seem like that bad of a wait even though it's a long time.

 

The lack of placebo control does not mean that the data is worthless. Dr. Djajilian and Mayo have both shown its effectiveness, which makes sense given the success that cochlear implants sometimes have.

You know of two people who have had their cochleas directly stimulated in a surgical setting? Not intratympanically, not subcutaneously, but directly?

 

I think the trial @Mentos was in was not extracochlear. It wasn't even on the tympanic membrane, just in the outer ear canal.

 

If you are in America, Hamid Djalilian is recruiting. They want about 100 patients.

Acoustic and Electrical Stimulation for the Treatment of Tinnitus

 

Game on. Nice find.

 

Ooh, I am in California. Looks like Irvine is 6 hours and 17 minutes from me. I also believe I meet all of the qualifications, although I am on Amitriptyline for sleep as of right now.

I am not understanding 100%. This doesn't seem too invasive, right? Besides the needle in the eardrum part.

Is anyone able to give a shorter answer as to what the study entails?

 

I’ve applied for this like 3 times. Never got a response.

 

If this was in the UK "I WOULD BE THERE LIKE A SHOT."

It is either non-invasive (ear canal) or minimally invasive (through the eardrum into the middle ear). I would absolutely love to be involved in a trial like this. Results from pilot studies have been very promising and Dr. Djalilian is a high profile ENT. It looks about as invasive as having a simple intratympanic injection, only this will use a small probe to electrically stimulate the cochlear and hopefully 'switch off' your tinnitus.

It could be they were not recruiting at the time. I noticed this was updated a few weeks ago to recruiting. It's great they are looking to recruit a decent sized cohort too.

For me this area of research looks to hold the most promise, along with brain implants, unless potassium channel modulators has a large off-label benefit.

They are looking to wrap the trial up in the summer of 2026.

 

Same. It looks like a well-balanced study technique and I'm all for this technology.

Interesting too that they've invited cochlear implant patients to participate and appear to be using the cochlear implant as an alternative stimulation pathway.

Also by including cochlear implant patients in these studies, we already have >5 year safety data on whether or not electrical stimulation around the cochlear destroys what natural hearing is left. From the paper I read on this (can't find the damn thing now) it appears that it doesn't, so that's very good news for tinnitus sufferers.

 

As I understand it, they will not be using implantable devices of any kind in the study? It's electrical stimulation using some sort of a probe, but on a larger scale to see the response rates in a larger cohort. We know smaller samples had good results. It seems they want to see if it works well in patients with cochlear implants too.

On the Tinnitus Talk Podcast Dr. Hamid Djalilian said they first have to manufacture the devices and then test them pre-clinically. To that effect they would start implanting humans in ~ 2026. I have listened to the podcast episode a couple of times and the idea is to give the patient a remote control that has a multitude of (square wave, narrow etc) electrical stimulation parameters on. This allows it to be used as needed if the tinnitus returns or becomes too bothersome.

So this seems to be a run up to that.

 

When I went back to the clinical trials website I saw:



I must admit I've hit 'peak research syndrome' so was quite surprised and may have overlooked something. But unless that's old methodology and they've moved the criteria forward during this current submission's tweaks, they appear to be exploring the cochlear implant angle for delivery.

 

Could also be like a control group of sorts, right?

 

So I guess I’m a little confused. On the Tinnitus Talk Podcast episode from May 2022, Dr. Djalilian discusses a specific device delivering stimulation right to the inner ear. Do they have a prototype for that device yet? Or are they exploring each of these stimulation avenues in the recent trial to build the device from what appears most effective?

I’m just trying to understand where exactly he is and comparing to other work like the ongoing study at Mayo in Minnesota with a specific cochlear stimulation device that is implanted via the mastoid bone that all participants got, and if the device works for them, they get to keep that device implanted.

Just trying to understand who is in the lead of actually getting something to market the fastest, assuming their device intervention works.

 

Definitely. And as mentioned before, even if they're not considering CI for delivery during this phase, we know we already have a related CI safety/control group of sorts due to the studies done on CI patients' natural hearing >5 years post implant.

I just hope Dr. Djalilian's team can sort out the various negative effects some patients experienced during treatment; I recall previous reports of visual disturbances and even pain, although I'm not clear on the numbers.

 

I wasn't aware of the visual disturbances, let's hope he can get that finely tuned.

 

Got a sudden a brainwave. Would it not be a great business plan for major companies like Cochlear UK, Cochlear US, Advanced Bionics, MED-EL etc. to develop extracochlear implants?

They have the market shares on intracochlear implants, but it's a limited percentage of the population who are eligible.

It makes sense as feasibility studies for extracochlear implants show good results and they have advantages over the intracochlear implants:

+ it's a much much bigger market
+ devices cost less to manufacture
+ less invasive surgery required
+ less training of professionals required
+ more ENTs will be able to carry it out
+ less complications from surgery compared to intracochlear implants
+ easier to access for upgrades

Could we draft a proposal to these companies?

EDIT:

I sent the information above + studies and preliminary data from pilot studies to these companies.

I've so far had a reply from MED-EL.

I know this is something Kelly Assouly has been trying to do, getting big players involved in device manufacturing for tinnitus.

 

There's a startup looking to develop just that (coincidentally sharing the same name with Susan Shore's enterprise):

• Website: Auricle
• YCombinator: Auricle
• LinkedIn: Francis Wong (CEO of Auricle)

 

I think you shared this a few weeks back.

This thread is not about that. This thread is about a device that does not restore hearing, but like in the studies, electrically stimulates the cochlea to reduce tinnitus. → Listen to Dr. Hamid Djalilian's Tinnitus Talk Podcast episode!

Having a couple of ENTs working away in their office is not the same as a global player on board, with a lot more resources to get things moving.

 

Got it - thanks.

 

Estimated study completion date for Dr. Carlson's novel tinnitus implant system is still 12/2023. I may email Nichole to follow up on this just because I will be SO interested in the results of this study due to the previous studies' results, and the fact that it is an actual implanted device into the mastoid area. Not just ear canal placement or right at eardrum electrical stimulation. This could potentially be the real deal. And, if it has promising results, that hopefully means a Phase 3 clinical trial follows soon after.

 

I've looked at this again. It seems they want to find out what types/frequencies of electrical stimulation are needed to suppress a large cohort of tinnitus patients. For instance, square waves, narrow waves, sine waves etc.

They are finding this out by using cochlear implants in those with severe-profound hearing loss, using the ear canal and also with a probe that goes through the ear drum to the middle ear to stimulate the cochlear.

The device itself will then be manufactured with different stimulation parameters that the patient can choose.

Once manufactured, they will need to implant on a 'model' and then into animal models before moving to implanting humans in 2026.

I think Dr. Carlson is slightly ahead as they have been directly implanting 9 patients with a device already manufactured.

→ Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

@ErikaS, I will be interested in the results!

 

Nicole's response to my email is not at all what I wanted to hear regarding study completion, and I don't even know how to take "we might do another tinnitus device study in the future" other than just simply that.

 

This is interesting. I remember seeing this a few years back when my tinnitus began and I totally forgot about it. It's like noise-cancelling for your brain! Hopefully the study results are positive.

 

I'm still really intrigued by this line of research for a number of reasons; the channels (potassium) and gating being the central ones though because of their equivalent in electronics. I need to do a proper post on it at some point - still trying to remember a load of stuff from way back when in college.

 

What were you expecting to hear? That sounds pretty good to me. They have all the people enrolled and they will complete the trial. If the results are good, they may not have to do another trial.

 

On ClinicalTrials.gov it states the the estimated study completion was December 2023, as in 2 months away. So I was just bummed to hear that the information wasn't up to date and that it won't be completed until a year from now.

She had mentioned to me in a previous email months back that if this trial was successful, they would most likely have to do at least 1 more trial of larger sample size due to the current sample size being 9 I believe. We will see!

 

That the trial would conclude in December 2023, like it says on the ClinicalTrials.gov page. A year from now means October 2024.