Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults with Chronic Tinnitus and Varying Levels of Hearing Loss (TINIS)

[IYIiKe]

Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults with Chronic Tinnitus and Varying Levels of Hearing Loss

This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software.The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone.It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve.The sound processor is worn behind the ear and powers the implant via the coil.The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear.The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance, and self-reported questionnaires on their tinnitus and general health.

It looks like this clinical trial was posted 2 weeks ago.

The study mentions cochlear implants, but I'm not sure if there's a specific placement for this device that makes it similar to the one Dr. Hamid Djalilian discussed in the Tinnitus Quest Q&A.

 

[Gb3]

Finally, a large company is evaluating cochlear implants.

 

[Nick47]

The study mentions cochlear implants, but I'm not sure if there's a specific placement for this device that makes it similar to the one Dr. Hamid Djalilian discussed in the Tinnitus Quest Q&A.

@IYIiKe, this is a very good spot! While the method isn't entirely clear, the hearing profiles listed in the inclusion criteria aren't typically those indicated for a cochlear implant.

The clinical trials begin soon, so if you're in the trial areas, reach out and get in touch.

What's also intriguing is that Kelly Assouly is the investigator, and Cochlear Ltd. finally seems to be backing this initiative.

It wouldn't surprise me if Cochlear Ltd. or Med-El beat both Matthew Carlson and Hamid Djalilian to market with some kind of prototype!

 

[IYIiKe]

Competition is beneficial. Ideally, we'd see multiple devices undergoing concurrent studies, rather than the current trend where one device fails and all similar variants disappear. I was encouraged to see a major player taking interest. If the research yields positive results, it could attract internal investment rather than relying solely on grants. This might also motivate competitors to expand their efforts, so even if the research doesn't succeed, the increase in knowledge is a net positive.

It's promising to see that they're seriously considering chronic tinnitus sufferers by excluding cases under six months, something I hope Tinnitus Quest also considers for their grants.

I'm curious what the device is. An actual cochlear device? Have they found a way to stimulate the cochlea without destroying it like a traditional cochlear implant? That would be huge.

 

[Nick47]

I was interested in this trial since it's only a two-hour train ride from London. Unfortunately, it's only open to local residents.

 

[HighleyTall]

In Kelly Assouly's thesis, tinnitus pitch matching was performed, so this approach likely only works for tonal tinnitus—similar to bimodal neurostimulation, as promoted by Brai3n for Lenire in Ghent.

 

[IYIiKe]

If any Dutch speakers could help inquire, I'd be very grateful—I'm extremely curious whether the implant destroys residual hearing. The criteria for joining the study suggest it might not, but my attempt with Google Translate in Dutch seems to have been ignored.

 

[LBE]

It appears that the electrode never enters the cochlea, which would prevent any residual hearing loss.

The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve.

It seems similar to the stimulation method that Dr. Carlson used in his initial trial here:

Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open-label trial towards the development of an implantable device - Journal of Translational Medicine

Background Chronic tinnitus affects millions of people globally and constitutes the most commonly compensated disability among military service members in the United States. Existing treatment options largely surround helping patients cope with their disease as opposed to directly suppressing...

translational-medicine.biomedcentral.com

 

[Nick47]

In Kelly Assouly's thesis, tinnitus pitch matching was performed, so this approach likely only works for tonal tinnitus—similar to bimodal neurostimulation, as promoted by Brai3n for Lenire in Ghent.

Completely different. Tone matching is just an outcome. This directly stimulates the auditory nerve using only electrical stimulation. No sound is involved.

It seems similar to the stimulation method that Dr. Carlson used in his initial trial here:

Yes, I thought so, too.

 

[Fields]

If any Dutch speakers could help inquire, I'd be very grateful—I'm extremely curious whether the implant destroys residual hearing. The criteria for joining the study suggest it might not, but my attempt with Google Translate in Dutch seems to have been ignored.

I'm a native Dutch speaker. Are you talking about the Brai3n clinic, or something else?

What would you like to know, exactly?

 

[Tim Moore]

It appears that this clinical trial builds on previous studies they've conducted involving an implant and electrical stimulation. I did a search on Google Scholar under the name Kelly Assouly, and there are quite a few studies. One published in 2024 showed particularly good results! So, this approach may be quite effective, and the clinical trial might be aimed at expanding its application to a larger group of participants.

 

[Nick47]

showed particularly good results! So, this approach may be quite effective, and the clinical trial might be aimed at expanding its application to a larger group of participants.

@Tim Moore, the study you linked focused on cochlear implants. From my understanding, this intervention does not actually go into the cochlea itself.

 

[Gb3]

@Tim Moore, the study you linked focused on cochlear implants. From my understanding, this intervention does not actually go into the cochlea itself.

That's my understanding as well.

 

[Nick47]

@UKBloke, hello PAL,

I wanted to get your thoughts on this. It seems that the surgical approach is similar to that of a cochlear implant, but I'm having trouble understanding where exactly the electrode is placed. It mentions the promontory bone, but when I look at the anatomy of the inner ear, it's not entirely clear to me.

I'm also puzzled by the external sound component that sits over the implant. I assume it will resemble a cochlear implant and still rely on external sound in some way, but I'm not sure how that works.

I don't think I'm the only one who has more questions than answers.

 

[UKBloke]

@UKBloke, hello PAL,

I wanted to get your thoughts on this. It seems that the surgical approach is similar to that of a cochlear implant, but I'm having trouble understanding where exactly the electrode is placed. It mentions the promontory bone, but when I look at the anatomy of the inner ear, it's not entirely clear to me.

I'm also puzzled by the external sound component that sits over the implant. I assume it will resemble a cochlear implant and still rely on external sound in some way, but I'm not sure how that works.

I don't think I'm the only one who has more questions than answers.

Hello, mate. Sorry I didn't reply earlier—I'm still not receiving alerts when tagged.

I was also a bit confused when researching these latest updates because I've seen references to both "on the promontory" and "in the promontory," which suggest two very clinically different setups. However, I haven't seen any mention of "through the promontory."

As I understand it, the Cochlear device would adapt aspects of cochlear implant technology (understandable) but without an electrical array running into the actual cochlea. Moreover, there wouldn't be a surgically implanted transmitter or receiver—my assumption is the sound processor would be the hearing-aid-like thing.

The access route would be similar to that of a cochlear implant (i.e., through the mastoid), with an electrode positioned on the promontory in a surface-mounted way. The idea is to transfer a therapeutic electrical charge across the cochlear structure to stimulate the auditory nerve.

While the installation procedure differs from what Hamid would offer, I don't see much difference in the treatment protocol. The primary distinction seems to be the different access routes, with one requiring general anesthesia. This might make the intra-tympanic route more desirable in the end. Still, I think it's fantastic news that Cochlear is now involved in this space.

 

[Nick47]

@UKBloke, would you take part in this trial if it were in the UK?

 

[UKBloke]

@UKBloke, would you take part in this trial if it were in the UK?

I've not seen a diagram referencing the Cochlear device, and on a technical level, the information they've supplied to date lacks the relevant detail, so there's some presumption on my part. My belief is that a sound processor sits over the ear (in the same position as a hearing aid) and that this is physically connected through the mastoid to a wire attached to the promontory.

At this point, I take it that the sound processor isn't actually processing hearing in any way (so normal hearing versus non-normal would appear largely irrelevant in this setup). Instead, it looks as though the processor is generating the current required (probably from a battery), presumably at the particular timing intervals necessary for the amelioration of the tinnitus percept upstream, i.e., somewhere beyond the auditory nerve. This "charged" aspect, i.e., the presence of a current (or not) at and around the cochlea, would tie in with the reports from cochlear implant recipients with tinnitus who have voluntarily offered their observation that their tinnitus reduces when their cochlear implant is switched on.

For now, I would have to think very seriously about participating in a trial requiring a general anesthetic if it were in the UK. On the other hand, if delivered intra-tympanically requiring a local, yes, I would participate. Here's hoping.

 

[IYIiKe]

I'm a native Dutch speaker. Are you talking about the Brai3n clinic, or something else?

What would you like to know, exactly?

I'd like to know if, since the clinical trial includes participants with normal hearing, the implant is expected to affect any residual hearing. I wouldn't want to participate if it might destroy residual hearing, and it's unclear whether this is a cochlear implant or another type that isn't expected to impact residual hearing like typical cochlear implants do.

I think the POC would be rarts@cochlear.com, but not sure to be honest.

Thank you very much!