Fully Implantable Hearing System (FIHS)

[jljones1]

Just read about a new fully implantable product from Otokinetics that looks very promising. It's not commercially available yet, but hopefully we'll see something from this company soon.

[glucas]

This looks very interesting. Thanks for the post.

[jljones1]

Since I'm a new member, I cannot include websites in my posts until I've enter 15 posts, but "googling" Otokinetics will take one to their website where a description of the product and company can be found.

It's interesting how they are referring to their product as "an entirely new product category" that will "eventually render the entire class of middle ear implants obsolete". We'll see what happens ...

[jljones1]

According to Otokinetics, clinical trials will hopefully start early 2013 and FDA approval will occur in 2015.

[kevels55]

Thank you for this info jljones1:D It does indeed sound very promising, if this does work as well as they imply via their website below, then many hearing aid manufacturers may have to kiss their "Gravy Train" goodbye? Tis early days though and any severe competition with that lot is,, most welcome :D............. But who knows, they may make a severe dent in that $11 Billion yearly world wide hearing market as per their website statement?

If this; Fully Implantable Hearing System (FIHS) works, then I for one would be more than willing to give it a go.............. I would imagine that after viewing their video, surgery should not be overly complicated?

Cheers Kev:D


http://www.otokinetics.com/index.html

[jljones1]

If everything the company says is true, then I can see FIHS by Otokinetics putting a dent in both the hearing aid and middle ear implant markets, especially since Otokinetics claims their device and surgical procedure will be cheaper than today's middle ear implants. But we'll always have a need for hearing aids.

Hoping FIHS will be everything Otokinetics claims!

[kevels55]

If everything the company says is true, then I can see FIHS by Otokinetics putting a dent in both the hearing aid and middle ear implant markets, especially since Otokinetics claims their device and surgical procedure will be cheaper than today's middle ear implants. But we'll always have a need for hearing aids.

Hoping FIHS will be everything Otokinetics claims!

Yeah jljones1, I am fully aware they will still require Hearing Aids and the FIHS will not be cheap! I am also very unsure how effective these would be for a severe/profound sensorineural hearing loss as opposed to a conductive loss........... I mean, I can easily see the strong potential for Otosclerosis etc. Perhaps one of the Pro's would come in and give their 2 cents worth.......... If any are still speaking to me?:p

Cheers Kev:D

[HIP_Matt]

Speaking of taking $$ away from the hearing aid industry I wonder what these devices will cost ? Surgical procedure included and follow ups included. I shudder to even think what the amount would be.....

[DocAudio]

The Esteem implant costs, device and surgical costs total, somewhere in the ballpark of around $35,000 - $40,000 as I understand it. Unlike a Cochlear implant or a BAHA it is considered a hearing aid and typically not covered at all by insurance so much of that is paid out-of-pocket.

[DocAudio]

Is the Otokinetics Fully Implantable Hearing System for middle ear implants or cochlear implant?

I think that there are already a lot of Totally Implantable middle ear implants out there like the Envoy, Carina, etc. If the Otokinetics is another Totally Implantable middle ear implant, I'm going to pull out my hair and lose my mind!! What is with the obsession with Totally Implantable middle ear implants and completely forgetting about Totally Implantable cochlear implant??????????:confused:

Again, an implantable middle ear hearing aid is completelydifferent from a CI. The parts are far smaller and they are doing something completely different. I don't think that the industry has "forgotten" about a completely implantable CI, I think it's just that the parts that comprise the CI are just too bigto be completely implanted.

[DocAudio]

I think your only way would be to find someone at the CI company that will talk with you about it...honestly my knowledge of CI"s is very limited aside from the fact that even the new ones are very large. With the miniaturization of hearing aids in recent years, I'd figure that if it was possible to do it for a CI, they would have.

[Um bongo]

If the Totally Implantable Cochlear Implant components size is the problem, there may be other solutions. I need honest opinions though, if possible. My idea is to take away the Totally Implantable microphone and Implantable battery away from the Totally Implantable cochlear implant, while leaving the Totally Implantable speech processor in the Totally Implantable cochlear implant. To compensate for this, a chip microphone communicates with the Totally Implantable T-coil. For example, if Totally Implanted cochlear implant users had a Totally Implantable/Invisible T-coil inside the head integrated with the Totally Implantable speech processor, then a neckloop (e.g. CLA 7) could communicate wirelessly with the Totally Implantable T-coil.

In short, what I'm trying to say is, if the Totally Implantable cochlear implant canceled a Totally Implantable microphone- it would make it significantly smaller. All the while, a chip microphone that can communicate with the Totally Implantable/Invisible T-coil is surgically placed in the outer ear canal allowing complete invisibility. Or, a neckloop (such as CLA 7) is resorted to, and it communicates wirelessly with the Totally Implantable T-coil. Another huge advantage of a small external microphone communicating with the Totally Implantable T-coil (whether in the outer ear canal or in the form of a neck loop) is that it allows the Totally Implantable battery to be much smaller and last longer. The following reasons:

1) The Totally Implantable microphone is canceled.

2) Since the Totally Implantable microphone is cancelled, it's less work for the Totally Implantable battery.

3) An external microphone communicating with the Totally Implantable T-coil provides instant clean audio quality signals instantly. And, it does not take an ounce of energy away from the Implantable battery (just the CLA 7 neck loop's double-A batteries).

4) Totally Implantable microphones can be complicated, and the Totally Implantable speech processor may have to do much more calculations in order to compensate, such as cancelling body noises and et cetera. This drains the Totally Implantable battery, which makes it larger, and therefore more difficult to implant during surgery. But, a microphone from an outside source that communicates wirelessly with the Totally Implantable T-coil/Totally Implantable cochlear implant instantly provides perfect quality sounds without making the speech processor work harder.

If this could work, how do I get cochlear implant companies to pursue this technology?

Thanks.

If you speak to people like Cochlear, you'll find it's what they have on the table already.

But, you still have to power it, drive the transducers and receive a clean signal: all of which becomes several times more difficult when you need to make the device hermetically sealed and medically safe.

[jljones1]

Is the Otokinetics Fully Implantable Hearing System for middle ear implants or cochlear implant?

I think that there are already a lot of Totally Implantable middle ear implants out there like the Envoy, Carina, etc. If the Otokinetics is another Totally Implantable middle ear implant, I'm going to pull out my hair and lose my mind!! What is with the obsession with Totally Implantable middle ear implants and completely forgetting about Totally Implantable cochlear implant??????????:confused:
I have a little more information. As I understand it, the Otokinetics FIHS device, called the "Krescendo", is not considered a middle ear implant. Part of the device is attached on or near the cochlea. It will be intended for both sensorineural and conductive losses, moderate through profound ranges.

It is designed to restore high frequencies over 10 kHz, so should do well with ski-slope losses.

Safety studies are almost complete with good results. Human trials are expected to start in about a year. The company hopes to gain FDA approval in about 2 years.

(I got this info from the company. Their website has a "contact us" section. I sent them questions twice and both times, they were very quick to respond.)

[DocAudio]

I have a little more information. As I understand it, the Otokinetics FIHS device, called the "Krescendo", is not considered a middle ear implant. Part of the device is attached on or near the cochlea.

It is designed to restore high frequencies over 10 kHz, so should do well with ski-slope losses.


Since the cochlea is entirely encased in bone, except for the portion that is connected to the middle ear, I'm not sure how they plan to attach it on/near the cochlea if it's not in the middle ear. If the device is implanted in the middle ear to gain proximity to the cochlea...then doesn't that make it a middle ear implant???

Why are they working to "restore" hearing to frequencies over 10KHz when there is no valuable speech information at those frequencies? What's their projected benefit? One last thing, if the cochlea is damaged at/above 10KHz, you can't "restore" hearing. You can amplify all you want but it won't be "restoring" anything. I believe that is very misleading wording.

[corey]

It would be nice if they could come up with a way to tap in to the body bio-electric system of ours to power these aids. that would remove the toxic chemicals related to the battery.

This would also remove some balk hopefully.

[corey]

If the Totally Implantable Cochlear Implant components size is the problem, there may be other solutions. I need honest opinions though, if possible. My idea is to take away the Totally Implantable microphone and Implantable battery away from the Totally Implantable cochlear implant, while leaving the Totally Implantable speech processor in the Totally Implantable cochlear implant. To compensate for this, a chip microphone communicates with the Totally Implantable T-coil. For example, if Totally Implanted cochlear implant users had a Totally Implantable/Invisible T-coil inside the head integrated with the Totally Implantable speech processor, then a neckloop (e.g. CLA 7) could communicate wirelessly with the Totally Implantable T-coil.

In short, what I'm trying to say is, if the Totally Implantable cochlear implant canceled a Totally Implantable microphone- it would make it significantly smaller. All the while, a chip microphone that can communicate with the Totally Implantable/Invisible T-coil is surgically placed in the outer ear canal allowing complete invisibility. Or, a neckloop (such as CLA 7) is resorted to, and it communicates wirelessly with the Totally Implantable T-coil. Another huge advantage of a small external microphone communicating with the Totally Implantable T-coil (whether in the outer ear canal or in the form of a neck loop) is that it allows the Totally Implantable battery to be much smaller and last longer. The following reasons:

1) The Totally Implantable microphone is canceled.

2) Since the Totally Implantable microphone is cancelled, it's less work for the Totally Implantable battery.

3) An external microphone communicating with the Totally Implantable T-coil provides instant clean audio quality signals instantly. And, it does not take an ounce of energy away from the Implantable battery (just the CLA 7 neck loop's double-A batteries).

4) Totally Implantable microphones can be complicated, and the Totally Implantable speech processor may have to do much more calculations in order to compensate, such as cancelling body noises and et cetera. This drains the Totally Implantable battery, which makes it larger, and therefore more difficult to implant during surgery. But, a microphone from an outside source that communicates wirelessly with the Totally Implantable T-coil/Totally Implantable cochlear implant instantly provides perfect quality sounds without making the speech processor work harder.

If this could work, how do I get cochlear implant companies to pursue this technology?

Thanks.

If you wore the mic as a neck piece directly on your skin the radiation output over LONG periods could lead to cancer. The transmitter would need to be away from your body a certain distance especially if used long hours. Radiation is accumulative with a LONG half life.

it is not like back ground radiation because of its concentrated exposure right at the skin in the same location.

I Learned about radiation exposure and cumulative effect from the 7 1/2 hours , being continually exposed to x-ray during heart surgery. This allowed them to watch live what was going on inside.

so radiation exposure by transmitter is something to watch when in contact with skin.

even cell phones require certain distance from skin when in the on mode. It is in the warning section of the manual.

so try to come up with a way to transmit without radiation or try to come up with a way to suspend the transmitter a certain distance from the body. Not sure how you would suspend it without it being noticeable.

The manufacturer is going to say the radiation level is safe because they want to sell. The manufactures are not going to care if the radiation does slow harm because it will be hard to prove it was their device that did it. So as the user, of the device, you need to take steps to protect yourself when pursuing this.

so something to think about cyborg.... when pursuing the CI companies.

Just curious why so hell bent on getting CI instead of using HA?

Also why would you want an untried tech implanted that could risk your life. especially with anti-biotic resistant infection around now days and the risk of said tech breaking regularly due to limited testing? break downs means surgery, means more risk of infections.

anti-biotic resistant infection is a bigger issue than most people know.

I know about it because of my proximity to MAYO CLINIC.

MAYO stance on infection now is, don't do anything unless it is life threatening. I have had several infections, they did not give anti-biotic for. One blood, another throat. Blood infection was bed ridden for a week, throat for a month of painful swallowing.

So do you really want to risk it? Why get cut open, if its not necessity, especially so close to your brain?

Is it because you want to fit in to be "normal"?

What is truly normal? Who criteria is it?

If you were deaf or 90% loss, then I would understand taking the risk.

I had a fantasy when I was a kid to get robotic ears to replace my real ones because every part of my ear is bad except the ear drum. Then I got older and reality decided to slap me. I dreamed of this back in the 80's before CI was ever born.

reality was we are not perfect the tech we make isn't perfect either. Hearing is not an absolute necessity to survival, just makes it harder.

tech can't repair itself unlike tissue, so when the tech breaks, major surgery is required. Then there is the pain....

[prodigyplace]

I think you are looking for the legal experts forum. You must have typoed.

This is the hearing aids forum. There are very few (if any) legal experts here.

[woodchippz]

Cyborg, I am researching CIs and saw a provider who claims to participate in US clinical trials, and claims to have access to CIs not yet approved in the US. I do not know if this would include the fully implantable ones you reference from Australia...... I can not post links so please google the Koss Cochlear Implant Program. The main page under surgical procedures is where I read about this. I have a consut with them in late april. Maybe they have what you are looking for.

[Don]

3) Does anybody, including audiologists and experts here, HAVE any idea at all what the above article is talking about? Could it REALLY be that the article is implying an invisible cochlear implant as the next generation product?


Please keep me informed!

Thanks.

Maybe, except I would view it as "a" next generation device, not necessarily "the" next generation.

It will come out when they get the technology ready and there is a viable market at the price they would have to charge. Not a minute sooner but also, not a minute later. But for now there is no such device and the device you have is helping you hear whereas just a few years ago you would not have had so many options.

[Andrew]

I would like to hear more about the Otokinetics product, if possible.



From a published article, "OtoKinetics Inc. was formed in 2009 to develop and commercialize an extraordinary hearing device. Invented by otologist Dr. George Lesinski, the Fully Implantable Hearing System (“FIHS”) uses multiple patented, proprietary technologies to directly stimulate the cochlear fluid, bypassing the eardrum and the middle ear."


Do audiologists on the Hearing Aids Forum know if the Otokinetics product directly stimulating the cochlear fluid would work for those with profound ranges?

[IMBack]

Scale model prototype micro-actuators have been tested by two independent laboratories, with outstanding results. Surgical tools have been developed and patented, and surgical techniques have been developed, tested and refined on over 100 cadaver temporal bones

We believe the OtoKinetics Krescendo will be highly effective for a wide range of losses

OtoKinetics will commercialize Krescendo, a device that we believe

I don't think I would be holding my breath.. Their web site seems more about wishing and hoping then actual fact.

[IMBack]

if you go to their web site you can watch a video.. again they don't seem to have any facts posted just marketing hype.

IF they actually ever come to market they are going to be a every expensive option. Device, ENT, Hospital, etc.. $50K wouldn't surprise me.

[jljones1]

Hi Andrew. I sent a few questions to the Otokinetics company via their website (there's a "Contact Us" section). The CEO promptly responded both times. Try sending them any questions you have about the device. As far as the cost, per their website, their device is supposed to be less costly than current middle ear implants. Hopefully that'll be true.

The last I heard from them is that they are finishing up with animal safety studies which have gone well. Next will be human clinical trials due to start early next year.

Hope this helps.

[Ski-Slope]

But, isn't the Otokinetics implant starting clinical trials in early 2013?


I heard that it's not a middle ear implant. Instead, it directly moves the cochlear fluids in the cochlea. Does cochlear implants move the cochlear fluids in the cochlea? Does anybody know?


I'm very intrigued by these implants. Please pitch in, experts.

Middle Ear Implants bypass the eardrum and drive the ossicular chain (tiny bones connecting the eardrum to the cochlea) using either magnets or piezoelectric drivers. Cochlear implants insert a series of electrodes into the cochlea, sending electrical impulses directly to the eighth cranial nerve. As a side-effect, existing hair cells in the cochlea are usually destroyed during implantation.

The Krescendo appears to be something in between the 2. If the device is anchored to the wall of the cochlea, directly moving the cochlear fluids, it is still relying on the hair cells inside your cochlea. If you are profoundly deaf and these hair cells are functionally dead, no amount of movement of the cochlear fluids will register. Therefore, I am skeptical that this device will be able to address truly profound (100+ dB) hearing loss.

This product is a long way from the market. They *hope* to have phase 1 clinical trials in 2013. I fail to see how this surgery would be less invasive or less expensive than a middle ear implantation. At this point, you might be better off exploring products which are currently available, rather than holding out hope that this will be ready for you in a few years.

[edlawson]

I too have been on the Otokinetics website and emailed the company with a prompt response from the CEO. We are living in exciting times for the hearing impaired, with improvements in hearing aids, middle ear implant technology, the Krescendo product, and improving CI's. I am strongly considering the Esteem in 3-4 years if and only if some improvements are made in battery life and overall success rates (some have NOT had the satisfactory results which are generally 5-10 db improvement over hearing aids). Esteem is currently 35k. Would I pay this to have 5-10 db gain and totally implantable system....you bet. Would I pay more for something better, most definitely. I am concerned that the Otokinetics product may turn out to be less than we hope and I welcome more input from anyone more knowledgable on the concept of a transducer moving cochlear fluid. Ski Slope makes a good point re. the efficacy of moving fluid if the hair cells are damaged...don't know the answer to that.

[hearlink]

Cochlear Implants is an easy and useful hearing solution for adults and children