Electrical Stimulation of the Cochlea for Treatment of Chronic Disabling Tinnitus

That the trial would conclude in December 2023, like it says on the ClinicalTrials.gov page. A year from now means October 2024.
I posted on here a while ago how they were having a hard time recruiting. I contacted them about a year ago and they were still accepting but I was excluded due to the medication. People here need to be more proactive about signing up for the clinical trials.
 
I think this, or Dr. Hamid Djalilian's work is the most promising. He drew up a mock of a potential device.

@Markku, has anyone reached out to Dr. Hamid Djalilian regarding the status of his device?
 
I posted on here a while ago how they were having a hard time recruiting. I contacted them about a year ago and they were still accepting but I was excluded due to the medication. People here need to be more proactive about signing up for the clinical trials.
I almost did a clinical trial in Boston for tinnitus via intravenous Lidocaine but they were doing so many fMRIs before and after the infusion that it was a no go with my hyperacusis. But that will be an interesting one to see.
The study concludes in December 2024 with results published sometime after that, so mid to late 2025. They enrolled 9 participants in the end.

Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus
Mayo Clinic is supposed to be reputable. Do you have any knowledge of how this implant works or where it gets inserted? Is it a cochlear implant? The word 'implant' makes it seem more invasive than other things out there.
 
Do you have any knowledge of how this implant works or where it gets inserted? Is it a cochlear implant? The word 'implant' makes it seem more invasive than other things out there.
It's all in this thread. Basically it's a middle ear implant, that sits behind the mastoid bone and stimulates the cochlear. The patient has a remote and can switch the electrical stimulation on and off. The program contains multiple different waves like sine waves, square waves and so on.

It's much less invasive than a cochlear implant.
 
@Markku, has anyone reached out to Dr. Hamid Djalilian regarding the status of his device?
Latest from today:
Dr. Hamid Djalilian said:
Our device is in process. If all goes as planned it'll start to be placed experimentally in late 2025. I'm doing all I can to accelerate it but it also depends on the FDA and what all they require of us before placing it in humans experimentally.
 
Dr. Hamid Djalilian said:
Our device is in process. If all goes as planned it'll start to be placed experimentally in late 2025. I'm doing all I can to accelerate it but it also depends on the FDA and what all they require of us before placing it in humans experimentally.
Matthew Carlson has already placed a device, which I guess is very similar, in 9 patients.

My initial thoughts.
 
And don't forget the 'other' Auricle (https://auricle.com/) is developing an implant that stimulates the cochlea externally to treat hearing loss that falls in the gray zone of not bad enough to justify a true cochlear implant. If successful, this may also offer the possibility of tinnitus relief.
 
And don't forget the 'other' Auricle (https://auricle.com/) is developing an implant that stimulates the cochlea externally to treat hearing loss that falls in the gray zone of not bad enough to justify a true cochlear implant. If successful, this may also offer the possibility of tinnitus relief.
I was looking over this recently. It's a small startup of two people. From Twitter conversations, they are looking for investors. In November 2023, Dr. Francis Wong said they wanted to start a clinical trial in two years, with a view to market in five years.
 
Matthew Carlson has already placed a device, which I guess is very similar, in 9 patients.

My initial thoughts.
I asked a follow-up regarding this:
Dr. Hamid Djalilian said:
Our hope is that our device could be placed with a much smaller surgery that most ENTs can perform. Dr. Carlson's device has a similar idea, but requires a so-called cochlear implant approach which only ear surgeons are capable of doing well. There are very few ear surgeons compared to general ear, nose, and throat doctors. We don't have much detail about his device, but it may help us get FDA clearance for so-called investigational device exemption, which allows us to do human studies.
 
I had a consultation with Dr. Djalilian yesterday. He is such a nice doctor who seems to be vested in treating and curing tinnitus.

We talked about his migraine protocol and the middle ear implants. He said he is still working on manufacturing the devices and that they need to get FDA approval for clinical trials. He believes his device will likely eliminate tinnitus when used. He said it would be a few more years before it hits the market.

He is also developing a way to regenerate hearing.

I believe the middle ear implants are the way forward.
 
I believe the middle ear implants are the way forward.
I agree with you. I think middle ear implants are really promising; it seems that some patients (8 of 22, according to the paper) got their tinnitus totally eliminated.
Important when considering an implantable device, several pieces of evidence suggest that it is unlikely that long-term electrical stimulation of the cochlea by an extra-cochlear electrode that does not violate the tinnitus who do not have hearing loss of sufficient severity to qualify for cochlear implantation. Given the results of the present study, trans-tympanic cochlear promontory stimulation may facilitate patient selection for device implantation.
However, I am really confused about the last paragraph of the paper. Does that mean patients without hearing loss are unlikely to benefit from the trans-tympanic cochlear promontory stimulation?
 
It's saying insurance won't pay for a cochlear implant for someone who has tinnitus but mild/moderate hearing loss. Maybe more studies like this will change that.
 
In the interview, they mentioned testing electrical stimulation of the cochlear using a probe, mainly on patients with no usable hearing, to ensure that it did not cause hearing loss.
 
I never thought about it before, but is this first generation of implants being developed as fully internal?

I'm guessing semi-implanted with an external portion (usually the audio processor, right?) wouldn't make much sense for someone with tinnitus but otherwise good hearing.

But that makes me wonder if they would be able to combine this technology with existing implants as well.
 
The device is fully implanted in the middle ear space. The patient has a remote control to switch it on and off.
Thanks for pointing me towards this thread. I look forward to seeing the Dr. Hamid Djalilian Q&A in August.

I hope I'm not off-topic, but from what I gather, cochlear implants themselves have a decent chance of reducing tinnitus, so why are they not being used in very severe tinnitus cases?
 
I hope I'm not off-topic, but from what I gather, cochlear implants themselves have a decent chance of reducing tinnitus, so why are they not being used in very severe tinnitus cases?
It's not off-topic, as this research was inspired by cochlear implants. Although the implant is not in the cochlea, it is placed in the middle ear through a small surgical procedure.

You need to be very deaf to get a cochlear implant. Although it does not guarantee that it will reduce tinnitus, it often does. Also, the surgery damages residual hearing, although drugs like SENS-401 are in clinical trials to preserve some hearing.
 
A new study with 30 participants (15 in the intervention group and 15 in the placebo group) has been published.
Results said:
In the intervention group, 9/15 participants (60%) had total suppression, 4/15 (26.6%) had partial suppression, and 2/15 (13.3%) had no suppression. In the control group, 2/15 participants (13.3%) had partial suppression and 13/15 (86.6%) had no suppression.

In the intervention group, mean (±SD) VAS scores were 9.1 (±0.6) points at T0, 2.0 (±2.7) points at T1, and 6.7 (±1.6) points at T2 (Figure 1A). The mean reduction in VAS scores between T0 and T1 was 7.1 (±3.1) points. This reduction was statistically significant (Wilcoxon signed-rank, z = 3.40, p = 0.0006). The mean reduction in VAS scores between T0 and T2 was 2.4 (±1.8) points. This reduction was statistically significant (Wilcoxon signed-rank, z=2.93, p = 0.0034). Seven participants in the intervention group achieved VAS of 0 points at the T1 timepoint.
Suppression of Severe Tinnitus Via Acute Electrical Stimulation of The Round Window Niche: A Randomized Controlled Trial
 
A new study with 30 participants (15 in the intervention group and 15 in the placebo group) has been published.

Suppression of Severe Tinnitus Via Acute Electrical Stimulation of The Round Window Niche: A Randomized Controlled Trial
Nice! I see hope that a market-ready solution will exist by 2030. The approach seems similar to what Dr. Djalilian and the Mayo Clinic are doing, and the results have been consistently good to very good.

Dr. Djalilian mentions that it works in 60-70% of cases, and it worked here as well, achieving complete suppression. In fact, it was even reduced by another 20%. These are promising prospects.

Hopefully, the belief that "there will never be anything" will gradually come to an end, and we will have a chance at a happier life in the foreseeable future.
 
A new study with 30 participants (15 in the intervention group and 15 in the placebo group) has been published.

Suppression of Severe Tinnitus Via Acute Electrical Stimulation of The Round Window Niche: A Randomized Controlled Trial
I want to ensure I'm reading this correctly—this sounds like a great result! I'm crossing my fingers that Dr. Djalilian's work on middle ear implants will likely achieve similar success.

Do we know what will be done with these findings? Are they moving forward with a plan to commercialize this treatment for tinnitus sufferers?
 
This is unbelievable—86.7% of participants experienced total or partial tinnitus suppression. That's better than most treatments for many conditions. The fact that they didn't continue working on this since the 1970s is outrageous. We could have had a treatment decades ago.

Governments should support Dr. Djalilian so we can develop something like this as soon as possible, with emergency approval and use!
 

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