Electrical Stimulation of the Cochlea for Treatment of Chronic Disabling Tinnitus

[Bhaveen]

Given that we recently learned that Dr. Shore's device won't be on the market for years, the new hype seems to be focused on this subject.

Seriously, guys, are you really ready to have a device implanted in your ears to alleviate tinnitus?

Honestly, it would freak me out. I'm more interested in a non-invasive device.

Of course, it's good to see that some researchers are working hard to find something useful.

For me, it feels like this device has the potential to silence tinnitus for some and deliver great results for others. Dr. Djalilian seems willing to engage with us as a group of sufferers, while Dr. Shore's device can reduce symptoms, but there's no communication from her. If only Dr. Djalilian had the Auricle device, I dare say we would get it sooner. And I would absolutely get implants if it meant some peace and quiet.

 

[Nick47]

I spoke with someone about patents, as I would be pissed if Dr. Djalilian had patented his device. The outcome of the conversation was:

Whether you should patent a device developed with funds from gifts and donations depends on various factors, including the terms under which those funds were provided, ethical considerations, and the potential benefits or drawbacks of patenting.

1. Funding Agreements: Check if the gifts or donations came with any stipulations regarding intellectual property (IP). Sometimes, donors might have conditions about how the resulting work can be used, or they might expect that the work remains in the public domain.

2. Institutional Policies: If the work was done under the auspices of a university or research institution, there might be specific policies governing the ownership and patenting of inventions. Many institutions encourage or even require patenting to protect and potentially commercialize innovations, which can then be used to further fund research.

3. Ethical Considerations: Consider the ethical implications of patenting an invention developed with donated funds. If the donors expected their contributions to support public good rather than private gain, it might be more appropriate to keep the invention open-source or accessible.

4. Public Benefit: Patenting does not necessarily prevent public benefit. Patents can provide a way to control the quality and distribution of a technology. They can also help secure funding for further development and ensure that the invention is used responsibly.

5. Costs: Patent filing and maintenance can be expensive, which might be a concern if the funds were intended for direct research rather than IP protection.

 

[UKBloke]

Seriously, guys, are you really ready to have a device implanted in your ears to alleviate tinnitus?

If the procedure to install the proposed tech was as invasive as having a cochlear implant, I would think very seriously about it before trying, even with my severe tinnitus and loudness hyperacusis. However, my understanding is that they are working towards a device that could be fitted in audiology clinics. I'd willingly go for that.

Yes, I nearly vomited when I saw that. WTF?

WTF indeed. The situation is ludicrous.

 

[Gb3]

Dr. Djalilian seems willing to engage with us as a group of sufferers, while Dr. Shore's device can reduce symptoms, but there's no communication from her.

I would like to say that Dr. Shore did communicate with us. She did a whole Q&A with us!

→ Q&A with Dr. Shore

She just won't comment on the FDA process.

 

[ErikaS]

The data for this is probably already out there.

When first learning about an electrical tinnitus implant, one of my initial concerns was the long-term effect of applying current to the hearing system. A feasibility paper (I can't remember which, I'm afraid) mentioned exactly this, but in the context of cochlear implant patients. It concluded that tests on CI users > 5 years post-op showed no negative effects on residual hearing, alleviating my concerns.

I'm pretty sure that among the cohort of CI users who also experience tinnitus, there must be some with hyperacusis. Parsing that data to learn about their experience would likely be difficult but not impossible. Perhaps this is where projects like Tinnitus Quest can help.

I agree with you that someone must have experienced reactivity and/or hyperacusis before getting a cochlear implant. I read about a woman who considered getting a cochlear implant for a while due to single-sided deafness. I know she struggled with severe tinnitus, but I'm fairly certain she also mentioned having hyperacusis. She eventually decided to get the cochlear implant, and I believe she said it significantly reduced both her tinnitus and hyperacusis.

I suppose it depends on the location of the hyper-excitatory nerves, synapses, and other factors that contribute to someone's sound sensitivity or reactivity. Suppose those misfiring/excitatory factors are in the inner ear. Would they need to be "eliminated," as happens with a cochlear implant, before the device begins sending electrical signals through the electrodes in the cochlea?

I apologize if my thoughts seem unclear or don't align with the studies. I've done much less reading and research for a while now for the sake of my mental health. Ultimately, we know that many people who suffer from tinnitus severe enough to affect their quality of life—those who would be candidates for these types of implants—are also troubled by reactivity and/or hyperacusis. As I mentioned before, it's the severe sound-reactive component that prevents me from fully living the life I once did.

 

[MiaVIL]

I agree with you that someone must have experienced reactivity and/or hyperacusis before getting a cochlear implant. I read about a woman who considered getting a cochlear implant for a while due to single-sided deafness. I know she struggled with severe tinnitus, but I'm fairly certain she also mentioned having hyperacusis. She eventually decided to get the cochlear implant, and I believe she said it significantly reduced both her tinnitus and hyperacusis.

I suppose it depends on the location of the hyper-excitatory nerves, synapses, and other factors that contribute to someone's sound sensitivity or reactivity. Suppose those misfiring/excitatory factors are in the inner ear. Would they need to be "eliminated," as happens with a cochlear implant, before the device begins sending electrical signals through the electrodes in the cochlea?

I apologize if my thoughts seem unclear or don't align with the studies. I've done much less reading and research for a while now for the sake of my mental health. Ultimately, we know that many people who suffer from tinnitus severe enough to affect their quality of life—those who would be candidates for these types of implants—are also troubled by reactivity and/or hyperacusis. As I mentioned before, it's the severe sound-reactive component that prevents me from fully living the life I once did.

Hopefully, Dr. Djalilian will touch upon this during his live Q&A. I've helped Tinnitus Quest by compiling a list of questions for him to prepare. Many have wondered if the middle ear implants will help reactive tinnitus, hyperacusis, noxacusis, and multiple tones.

 

[IYIiKe]

Does anyone else get Billy Mays vibes from Dr. De Ridder and Dr. Djalilian? They seem to have so many products: Neuromed "migraine therapy," UCI CBT, and now a middle ear implant? Dr. De Ridder announces a neuromodulation device at the same conference where he states that only a third of people are helped by treatment.

I've seen some of Dr. De Ridder's drug "cocktails" shared here, and they border on experimental—like throwing mud on the wall and seeing what sticks, with a lot of narcotic use involved. If the middle ear implants work, then great! But I am a bit wary when these names are involved.

 

[UKBloke]

3. Ethical Considerations:

I'm trying to understand the ethical standpoint of research that, on one hand, cites a 40-year-old experiment that produced results many of us dream of, yet, on the other hand, is still conducting feasibility studies today to determine if that same technology actually works. Someone from the research community will have to help me because I can't, for the life of me, reconcile these two positions.

 

[MiaVIL]

Does anyone else get Billy Mays vibes from Dr. De Ridder and Dr. Djalilian? They seem to have so many products: Neuromed "migraine therapy," UCI CBT, and now a middle ear implant? Dr. De Ridder announces a neuromodulation device at the same conference where he states that only a third of people are helped by treatment.

I've seen some of Dr. De Ridder's drug "cocktails" shared here, and they border on experimental—like throwing mud on the wall and seeing what sticks, with a lot of narcotic use involved. If the middle ear implants work, then great! But I am a bit wary when these names are involved.

At least they are taking action and being transparent about it. Dr. Djalilian has conducted clinical trials on his migraine treatment protocol, and in my opinion, his research on middle ear implants is very promising. Electrical stimulation has been around since the 1970s, so it's not exactly a far-fetched concept. We'll learn more once the Q&A happens on August 30th.

 

[Nick47]

I'm trying to understand the ethical standpoint of research that, on one hand, cites a 40-year-old experiment that produced results many of us dream of, yet, on the other hand, is still conducting feasibility studies today to determine if that same technology actually works. Someone from the research community will have to help me because I can't, for the life of me, reconcile these two positions.

"Electrical stimulation as a treatment for tinnitus is not new. Electrical stimulation of the hearing system in humans was first been reported by Volta in 1790. Grappengeiser discovered in 1802 that positive DC voltage applied to the external ear canal can effectively suppress tinnitus."

 

[Muggumbo]

"Electrical stimulation as a treatment for tinnitus is not new. Electrical stimulation of the hearing system in humans was first been reported by Volta in 1790. Grappengeiser discovered in 1802 that positive DC voltage applied to the external ear canal can effectively suppress tinnitus."

Better late than never I suppose...

 

[UKBloke]

"Electrical stimulation as a treatment for tinnitus is not new. Electrical stimulation of the hearing system in humans was first been reported by Volta in 1790. Grappengeiser discovered in 1802 that positive DC voltage applied to the external ear canal can effectively suppress tinnitus."

We're living in clown-world, mate.

 

[Joeseph Stope]

We're living in clown-world, mate.

Ahem... I take it that your statement implies skepticism

"Electrical stimulation as a treatment for tinnitus is not new. Electrical stimulation of the hearing system in humans was first been reported by Volta in 1790. Grappengeiser discovered in 1802 that positive DC voltage applied to the external ear canal can effectively suppress tinnitus."

That is a very impressive scholarship, @Nick47.

How long did the tinnitus suppression last? Was there a control group and a placebo group in the study? What were the success and failure rates? Was the tinnitus chronic or early onset? Has this study been lost or hidden behind the couch for the last 220 years?

 

[Muggumbo]

We're living in clown-world, mate.

Next, we're going to find cave paintings that show cavemen cured tinnitus.

 

[UKBloke]

Next, we're going to find cave paintings that show cavemen cured tinnitus.

 

[LBE]

→ Non-penetrating round window electrode stimulation for tinnitus therapy followed by cochlear implantation

Whatever happened with this? They had a functional device that seemed safe and effective, one that could be implanted with a CI and that worked in a similar way to the device that Dr. Carlson is developing at the Mayo Clinic.

The present study is the first report on a long-term follow-up on tinnitus patients implanted with Tinnelec. Further clinical studies to implant tinnitus patients with residual or normal hearing on the affected ear are on the way.

This was in 2016.

 

[ErikaS]

→ Non-penetrating round window electrode stimulation for tinnitus therapy followed by cochlear implantation

Whatever happened with this? They had a functional device that seemed safe and effective, one that could be implanted with a CI and that worked in a similar way to the device that Dr. Carlson is developing at the Mayo Clinic.

This was in 2016.

This is the first time I'm seeing this study, and I'm asking the same frustrating question you are. In the abstract, they specifically state:

The main advantage of the Tinnelec implant would be the option to treat patients with normal and usable hearing, stimulating the affected ear with the cochlear non-penetrating stimulation electrode of the device. It also extends the treatment in cases of progressive hearing loss by explantation and reimplantation with a penetrating electrode, addressing both tinnitus and hearing impairment.

Then, at the end of the abstract, they go further to say:

The present study is the first report on a long-term follow-up of tinnitus patients implanted with Tinnelec. Further clinical studies to implant tinnitus patients with residual or normal hearing in the affected ear are underway.

So much for those further clinical studies that many of us would join in a heartbeat!

 

[LBE]

I've sent an email to each of the seven authors of this paper to see what progress, if any, has been made since then and if they're planning any further trials. I'll post if/when I receive responses from any of them.

 

[Nick47]

They had a functional device that seemed safe and effective,

It seems this was connected to a cochlear implant.

 

[LBE]

It seems this was connected to a cochlear implant.

That's right; in all three cases, it was paired with a cochlear implant. The part that seems relevant to our community is this:

The main advantage of the Tinnelec implant would be the option to treat patients with normal and usable hearing, stimulating the affected ear with the cochlear non-penetrating stimulation electrode of the device.

It seems from this that they had some plan to implant a cochlear implant that only provides extra-cochlear stimulation. I'm curious to see what, if anything, comes of my letters. (I've just found out that one of them has retired since the survey was published. One down, six to go...)

 

[Nick47]

This probably deserves its own thread, as this wasn't extracochlear stimulation but rather what could be called tympanic/ear canal stimulation. It's less invasive and is proposed specifically for ear tinnitus, not central tinnitus.

Patients who complained of head tinnitus were excluded.

The study is interesting and references similar studies in the discussion section. It involved a fairly large cohort, with reductions in symptoms for 75% of patients and complete resolution in 22%.

Frontiers | Excitation of the Auditory System as a Result of Non-invasive Extra-Cochlear Stimulation in Normal Subjects and Tinnitus Patients

One of possible approach that may suppress tinnitus is electrical stimulation of the ear. At first invasive techniques were used (promontory or round window ...

www.frontiersin.org

 

[UKBloke]

This probably deserves its own thread, as this wasn't extracochlear stimulation but rather what could be called tympanic/ear canal stimulation. It's less invasive and is proposed specifically for ear tinnitus, not central tinnitus.

Patients who complained of head tinnitus were excluded.

The study is interesting and references similar studies in the discussion section. It involved a fairly large cohort, with reductions in symptoms for 75% of patients and complete resolution in 22%.

Frontiers | Excitation of the Auditory System as a Result of Non-invasive Extra-Cochlear Stimulation in Normal Subjects and Tinnitus Patients

One of possible approach that may suppress tinnitus is electrical stimulation of the ear. At first invasive techniques were used (promontory or round window ...

www.frontiersin.org

I think this is extra-cochlear stimulation? Probe + saline solution inside the ear canal. Anyhow, regardless of that, the more of these study papers I see, the more bewildered I get. We're literally staring at an open goal. I even wonder about the point of Tinnitus Quest in this regard. The literature, pages and pages of it, is openly telling us that a treatment that works is already out there.

 

[Nick47]

I think this is extra-cochlear stimulation? Probe + saline solution inside the ear canal. Anyhow, regardless of that, the more of these study papers I see, the more bewildered I get. We're literally staring at an open goal. I even wonder about the point of Tinnitus Quest in this regard. The literature, pages and pages of it, is openly telling us that a treatment that works is already out there.

@UKBloke:

The external ear canal was filled with saline solution. The active silver probe was immersed inside external ear canal, avoiding contact with the skin of the canal. The passive electrode was placed on the forehead (in the midline) after skin abrasion with a suitable sterile abrasive electrode paste and clean gauze. The two electrodes were placed in such a way as to allow current transmission throughout the hypothetical plane (longitudinal axis) of the cochlea.

Now I'm not sure. How did they access the middle ear space? There's no mention of a tympanic route. Did they stimulate from the ear canal, or did they enter the middle ear directly, like Dr. Hamid Djalilian, to provide stimulation?

I'm absolutely bewildered as well. However, it's not a complete solution; it seems to be only about 60-70% effective. Given this, I would support the rapid advancement of any institution interested in developing or exploring this approach. Tinnitus research is incredibly important. Many patients may not benefit from this, and, frankly, it's likely to be costly. Can you imagine the NHS pushing for this when we have effective treatments like the OTO app?

It's a bit surreal to think of visiting the ENT and requesting a middle ear implant or a soft, implantable brain interface electrode.

 

[UKBloke]

How did they access the middle ear space?

They didn't appear to. They used a "hydrotransmissive" method requiring filling the external ear canal with a saline solution then setting an electrical probe (that didn't touch the walls of the canal) into it. Goodness knows how they managed to keep the saline from trickling out.

I think it's quite a complicated paper; there's a lot of cross-reference (going back to 1930), and the language seems a bit vague at times, but maybe this is because English isn't the authors' first language.

My main critique is that it isn't immediately clear how the effects of auditory percept (AP), i.e. a subjective noise resulting from the electrical stimulation, actually played out in the trial. They talk at length about AP but seem to flip-flop on that point quite a bit.

With that said, effective in 75% of tinnitus ears with a 22% score of tinnitus disappearance seems very promising to me, especially given the fact they're only working in the external ear canal.

 

[Nick47]

My main critique is that it isn't immediately clear how the effects of auditory percept (AP), i.e. a subjective noise resulting from the electrical stimulation, actually played out in the trial. They talk at length about AP but seem to flip-flop on that point quite a bit.

@UKBloke, yes, the authors seemed quite focused on the AP, specifically wanting to know which frequencies of electrical stimulation were perceived as sound. In retrospect, I understand this focus, as these frequencies could obviously induce tinnitus and should be avoided.

From what I gather, the patients likely lay on their side while saline was placed in the ear canal. They appeared to use a combination of electrodes to achieve the correct angle for transduction onto the round window.

 

[Nick47]

The trial at Mayo Clinic has been amended.

Patient enrollment 21 (previously 9).
The end date has been brought forward from 12/2026 to 06/2025.
The trial was suspended due to financial and resource issues.

➡ ClinicalTrials.gov: Cochlear Promontory Stimulation for Treatment of Tinnitus

 

[Nick47]

The trial at Mayo Clinic has been amended.

Patient enrollment 21 (previously 9).
The end date has been brought forward from 12/2026 to 06/2025.
The trial was suspended due to financial and resource issues.

This is incorrect. It appears that this refers not to the ongoing trial but rather to a previous one focused on preclinical aspects.