Electrical Ear Canal Stimulation as a Therapeutic Approach for Tinnitus — A Proof of Concept Study

Nick47

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Jun 16, 2022
2,202
UK
Tinnitus Since
2015
Cause of Tinnitus
Viral/noise
There were 66 patients, with just under 50% improving. Women and those with bilateral tinnitus fared best. The number reporting worsening was not clinically significant, i.e., just by chance/variations.
Results: After three days of electrical stimulation, tinnitus loudness decreased in 47% of patients, 45.5% reported no change, and 7.6% reported worsening. Tinnitus severity decreased in 36.4% of cases, 59.1% of patients reported no change, and 4.5% reported worsening. Women responded positively to therapy earlier than men. In addition, tinnitus distress decreased in patients with compensated tinnitus but not in those with uncompensated tinnitus. Finally, patients with bilateral tinnitus improved earlier than those with unilateral tinnitus, and the age of the patients did not influence the stimulation results.
Electrical Ear Canal Stimulation as a Therapeutic Approach for Tinnitus — A Proof of Concept Study
 
What is compensated tinnitus?
From my reading of the study, I found the following: "habituated/compensated (below 47 points) and unhabituated/decompensated."

This indicates to me that the researchers are using habituation and compensation as equivalent terms. And in contrast, those who have not habituated to tinnitus are considered decompensated.

It's a bit late for me to take a deep dive into the entire study, but it looks interesting. I don't see mention of which nerve or nerves they were targeting (vestibular, cochlear, or perhaps trigeminal which is further afield). Or perhaps the mechanism related to electrical stimulation is not directly targeting those nerves?

In any case, I'll read it more thoroughly. Thanks for the original post, @Nick47.
 
From my reading of the study, I found the following: "habituated/compensated (below 47 points) and unhabituated/decompensated."

This indicates to me that the researchers are using habituation and compensation as equivalent terms. And in contrast, those who have not habituated to tinnitus are considered decompensated.

It's a bit late for me to take a deep dive into the entire study, but it looks interesting. I don't see mention of which nerve or nerves they were targeting (vestibular, cochlear, or perhaps trigeminal which is further afield). Or perhaps the mechanism related to electrical stimulation is not directly targeting those nerves?

In any case, I'll read it more thoroughly. Thanks for the original post, @Nick47.
This is part of the preparation work for the INTAKT study, where they look to develop an implant. It is the third such company I know of doing this.

Their aims were to reduce tinnitus and experiment with different electrical waves to see what worked best. Broadly speaking, it targets the cochlea, with the implant designed to stimulate through the round window.
 
This sounds amazing! How do we get someone actually to do this in practice, or is this something that would require FDA approval, etc.?
It's experimental, so not publicly available. Only if you got a good contact with a researcher.
Only 3 days and 10 minutes each session? These are really good results.
I would say they are, although weren't the results taken straight after the session? It was only the ear canal, so it was even better. To me, this seems the best future treatment. I would be fighting to get into a clinical trial.
 
To me, this seems the best future treatment. I would be fighting to get into a clinical trial.
I agree 100%. This appears to be the most effective, realistic, and practical treatment on the horizon.
What is compensated tinnitus?
Compensated tinnitus is when tinnitus is not particularly intrusive.
 
If there ever were a clinic trial, do you think they'd accept participants from outside of Germany?
No, but if you live in America, I would follow Matthew Carlson and Hamid Djalilian and contact them to participate in their clinical trials.
 
Nice find, @Nick47.

I'm glad Heidi Olze et al. are back on the scene, especially as they're referencing the Feng, Djalilian et al. feasibility study from 2019 for a similar intervention—the more, the merrier.
 
Is this similar to what Dr. Djalilian is doing? Isn't his implant in clinical trials right now?
Yes, a similar approach is the final intended outcome. In this Olze et al. proof of concept study, they only stimulated via the ear canal to get the right types of electrical stimulation. The actual implant is intended to be placed nearer the cochlear, in the middle ear.

I think Heidi Olze is 7-8 years away from street deployment. Dr. Djalilian has claimed to have implanted a few humans, so the device is ready. However, he officially does not intend to start a human trial until late 2025. How did he get permission to implant anyone yet? Who knows?

Matthew Carlson has implanted nine patients, with a trial end date of December 2024. His surgical approach has been more invasive. He is 2-4 years from street deployment.
 
Yes, a similar approach is the final intended outcome. In this Olze et al. proof of concept study, they only stimulated via the ear canal to get the right types of electrical stimulation. The actual implant is intended to be placed nearer the cochlear, in the middle ear.

I think Heidi Olze is 7-8 years away from street deployment. Dr. Djalilian has claimed to have implanted a few humans, so the device is ready. However, he officially does not intend to start a human trial until late 2025. How did he get permission to implant anyone yet? Who knows?

Matthew Carlson has implanted nine patients, with a trial end date of December 2024. His surgical approach has been more invasive. He is 2-4 years from street deployment.
Thank you for this information. It looks very promising.
 
I wanted to get on with Dr. Djalilian's clinical trial, but he emailed me back saying that the trial is on hold while they create the device (maybe they are modifying it or getting a new generation). He advised me to take a look at his medicine treatment protocol, but I don't have migraines, and I don't want TRT & CBT; what are your thoughts on it? I got mine from infection/fluid, and I don't suffer any other illnesses or symptoms.
 
Yes, a similar approach is the final intended outcome. In this Olze et al. proof of concept study, they only stimulated via the ear canal to get the right types of electrical stimulation. The actual implant is intended to be placed nearer the cochlear, in the middle ear.

I think Heidi Olze is 7-8 years away from street deployment. Dr. Djalilian has claimed to have implanted a few humans, so the device is ready. However, he officially does not intend to start a human trial until late 2025. How did he get permission to implant anyone yet? Who knows?

Matthew Carlson has implanted nine patients, with a trial end date of December 2024. His surgical approach has been more invasive. He is 2-4 years from street deployment.
Are any of these in the UK?
 
what are your thoughts on it? I got mine from infection/fluid, and I don't suffer any other illnesses or symptoms.
I think Dr. Djalilian's protocol is worth a try. He's experienced and sees real-world results. A new thread under treatments is apparently being started by a member here. Similar to Retigabine and Lenire, real-world data can be gathered. This thread is for electrical stimulation of the ear, though.
Are any of these in the UK?
Not that I know of.
 
He advised me to take a look at his medicine treatment protocol, but I don't have migraines
I've also been inquiring about this. The way they explained it to me, and I don't quite understand it fully, is that you don't need to suffer from migraines for it to work but that tinnitus involves some of the same pathways in the brain as migraines. Therefore, migraine drug treatments can alleviate tinnitus.
 

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