"We can rebuild him...we have the technology. We have the capability to make the worlds first Bionic man. Steve Austin will be that man. Better than he was before. Better. Stronger. Faster."
Then came along the Bionic Woman. She received amplified hearing in her right ear, a strengthened right arm and could run at 60 mph, just like the Six Million Dollar Man.
It didn't matter that they could run 60 mph, or that his left eye had a 20:1 zoom or that she could throw an object farther than any human being. What intrigued me the most was her hearing. I wanted was to hear better. Hear more clearly.
Do we have that technology? It appears that we do. There are implants available for the blind, laser surgeries for contact wearer and cochlear implants for deaf or profoundly hearing impaired. But what about those of us in the middle? Those of us whose hearing is not severe enough for a cochlear implant?
Again, feeling caught in the middle, between the hearing/deaf worlds, I see a glimmer of light. There is now a hearing implant made just for those who have moderate to severe sensorineural hearing loss. The FDA approved this device a little over 18 months ago and is known as the Esteem, manufactured by Envoy.
This implant garnered even more attention when this emotional video aired in late September, generating over 8 million hits.
Okay, time to dig in a do some research, before I get my hopes up. My thoughts/reactions are italicized below each question.
What is the Esteem hearing implant?
It is a fully implantable prosthetic hearing device that uses no microphones to process the sound. Instead, it uses your eardrum to process the sound. It is surgically placed under the skin, so it is invisible. This frees up your ear canal, minimizing background noise, feedback and the hollow/echo-y sounds you would hear with a traditional hearing aid. You can switch the Esteem on and off with a remote control device.
Invisible? Cool. That also means waterproof ~ I would be able to hear in the pool or in the shower. Background noise? I could do with less of that. Switch it on and off? I'm not sure if I'd want to turn it off ~ I'd like to be able to hear my alarm clock without sleeping on an uncomfortable hearing aid.
A stable, bilateral, moderate to severe hearing loss. From my understanding, it can be a loss from several sources: genetic, damage from external sources, viral infections or aging. The key is that the loss must be stable, (not progressively becoming worse) and be in both ears.
Normally functioning eustachian tube, middle ear anatomy and tympanic membrane.
Ability to understand speech with traditional hearing aids, equal to or greater than 40%
Minimum 30 days experience with properly fitted hearing aids.
You must be 18 years or older.
As far as I know, I would qualify!
Anything that would possibly disqualify me from the Esteem?
Yes. Chronic ear infections, inner ear disorders, recurring vertigo, mastoiditis, hydrops, Meniere's disease, disabling tinnitus, swimmer's ear, scar tissue, excessive sensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold.
Nothing applies to me; looking good so far.
Will you reach "normal hearing" with the Esteem?
93% of the patients implanted with the Esteem scored equal to or better than hearing with their hearing aids on a speech intelligibility test ~ 56% scored better, while 7% scored less. 78% responded with clarity being somewhat or much better and ability to understand speech with background noise was 69% or better.
It appears that the device achieves a level similar or better than a traditional hearing aid would. I guess it depends on the individual and their severity of hearing loss. Is it "normal" hearing? I'm not sure.
What are the risks?
As with any surgery, there are risks. 42% experienced "taste disturbance," 7% experienced facial paralysis, while 18% experienced tinnitus. One year later, 14% had taste disturbances, 1% had facial paralysis, and 5% still had tinnitus.
The facial paralysis is one side effect that scares me. I experienced a short (thank goodness) and terrifying bout of Bell's Palsy, which paralyzed the left side of my face.
Future studies?
As a condition of FDA approval, Envoy must follow 181 implanted subjects for five years and provide a report. Safety, effectiveness, and any other side effects will be noted.
I think this report will be available in 2014. That's only two years away....
How much does it cost?
The cost can vary throughout the country, depending on the surgeon, facility, and if you require an overnight stay. Envoy estimates that it is approximately $30,000. Per ear. Ouch.
The Esteem has a maintenance-free, non-charging battery based on pacemaker technology that lasts anywhere from 4-9 years, depending if you keep it turned on at night. To replace the battery/processor, you would need to undergo a minor outpatient surgery at the tune of about $7,000, although the cost could go down over time...the life span of a new battery in 5 years is expected to be 14+ years.
This is a deal-breaker for many people, and would be for me, as it would wipe out any retirement savings for us. Our son is planning to attend medical school and we need to be saving for that.
Is the Esteem covered by insurance?
At this point, it appears that it is not covered (or fully covered) by insurance. Some patients have had success in getting their insurance company to pay for part of the implant. Study your insurance documents, understand them and if it covers a cochlear implant, prosthetic other semi-implantable devices, it may cover an Esteem implant or portions of it. Make sure you have the correct procedure codes and any pre-authorization needed before undergoing the surgery.
Will I get the Esteem Implant?
This device looks promising as a whole, although the price tag is enough to scare anyone away. I've submitted my audiogram to Envoy, just to see if I even qualify.
It looks like I will wait at least two years before embarking on this journey. That will give the company time to do their follow-up, work out any bugs, and perhaps tweak the performance of the device. Perhaps by then, our insurance company will include covering the device and/or procedure.
I'm not looking to be the next Bionic Woman. I just want to hear better, without all the fuss and muss of a hearing aid.
What are YOUR thoughts? Would you consider having this implant? I would love to hear from you.
Sources: FDA Press Announcement 3-17-10, FDA Approval, updated 6-11-10, FaceBook Envoy Esteem Patients Group
My ENT doctor said I'm a candidate for this but told me it wasn't covered by insurance. I have been snooping around in my policy and it covers cochlear implants and all prosthetics. Now I'm thinking it would be covered. I have hereditary nerve deafness (cookie bite) and it slopes down to nearly 90db loss. As you understand, I'm desperate to find a better solution. What do you think?
ReplyDeleteLisa, I would contact some people who have had the implant. I joined a closed FaceBook group and there was a lot of mixed reviews. Each individual had different results based upon their expectations. Many had scar tissue issues, which required another surgery. Others experienced frustration in learning to hear all over again.
DeleteYour doctor may say you are a candidate, but you would also need to submit your info (hearing test results) to Envoy to see if they think you are a candidate. When I contacted my insurance company, they wanted the IDC9 codes from Envoy before they would tell me if it is covered. IF Envoy says it is a prosthetic, your insurance may cover it. If they say it is an implant, they may not, as it is not a cochlear implant. Insurance is tricky.
Once you feel that you have as much information as you can, you will then be able to make a decision that is right for you. Good luck and let me know what you find out!
Thanks Frieda
ReplyDelete