Profound high-frequency sensorineural hearing loss treatment

Profound high-frequency sensorineural hearing loss treatment with a totally implantable hearing system.
Jack A Shohet, Eric M Kraus, Peter J Catalano

OBJECTIVE This study seeks to assess the efficacy of the Envoy Esteem totally implantable hearing device in treating profound high-frequency sensorineural hearing loss. PATIENTS Five patients with profound high-frequency hearing loss participating in a prospective, multi-center, nonrandomized Food and Drug Administration clinical trial. INTERVENTION Implantation with Esteem totally implantable hearing device and comparison to baseline unaided and aided conditions. MAIN OUTCOME MEASURE Speech reception threshold and word recognition scores (WRS) at 50 dB HL presentation level. RESULTS Preoperative speech reception threshold improved from an unaided 65 dB and aided 48 dB average to 26 dB with the Esteem at 12 months. WRS at 50 dB scores improved from an unaided 10% and aided 23% average to 78% postoperatively. CONCLUSION The Esteem totally implantable middle ear hearing device provides appreciable functional gain and improvement in WRS to rehabilitate hearing in patients with a profound high-frequency sensorineural hearing loss.

This was published in 2011 December; 32.

Based on this article, will the Envoy Esteem help profound hearing loss?

I was told back in April that i was a candidate for esteem implants. I waited 4 months and all of a sudden the surgeon decided not to implant esteem because I have a profound high frequency loss (I did 52% in speech test though, requirement is 40% and above). I asked why change of decision now and not in April, the ear surgeon told me that new management of Envoy medical is following strict guidelines on who can be a candidate for esteem and if he still implant the esteem it would be classified as off label device means no support like testing and warranties from envoy medical. I called Envoy and they me that doctorss makes the final decisions and not Envoy on who should be the candidate esteem and here Dr. Marzo is saying he can do it but Envoy wont let him. I m really confused and frustrated.

0250.Hz L-15 R-20
0500.Hz L-25 R-25
1000.Hz L-70 R-80
2000.Hz L-105 R-100
3000.Hz L-110 R-110
4000.Hz L-90 R-100
6000.Hz L-90 R-95
8000.Hz L-95 R-100

Word Correction % is 40 in Right and 52 in Left.

I had a very similar experience with Envoy Medical. Funny, our audiograms are nearly identical.

I was ruled a candidate, and I had a surgery date set. Then I went in for additional testing and a technician at Envoy Medical decided I didn’t fit the criteria. Dr Shohet concurred that I’m not an ideal candidate because my low-pitch hearing is normal, and they simply cannot amplify the mid-high pitches to the levels I need without making the low pitches uncomfortably loud. Looking at your audiogram, they probably decided the same thing for you.

The Esteem is an analog device. With its current design, it can’t be adjusted with the same level of accuracy as a digital sound processor. Because of this, people like you and me with sharply-sloping ski-slope hearing loss are not ideal candidates. Maybe that will change in the future.

Thanks for the info. So Envoy folks are telling me the truth. BTW, do you wear any hearing aids? About a year ago I started wearing siemens nitro all in the ear aids, they are just ok to get by. Since I never wore HA all my life so I am looking for inputs and suggestions from peolple who have my type of hearing loss means profound high frequency loss. Thanks again!

No problem at all. That’s what these forums are for.

Again, my hearing is a lot like yours. We are both what audiologists call “hard to fit patients”. We have profound loss aka deafness in the mid-to-high pitches (2000 Hz and up), and no hearing aid on the market can change that. With patients with profound hearing loss, the plan is to try to block up the ear canal with a tightly-fitting mold (as opposed to an open-fit mold), which traps in all the sound and allows for higher gain. The problem with this for patients like us is that hearing is simply too far gone in the mid-to-highs to get much benefit from massive amplification in these pitches, and the processing of the sound results in distortion, like piping everything through a loudspeaker. The reality is that I’ve never worn a pair of hearing aids that I truly liked, although the pair that I have on trial is alright.

I’m currently on trial with a pair of Naida S CRT V’s with an extra large vent in the molds, per my request. I trialed the Naida S CRT IX’s (some of the most advanced hearing aids on the market), but I found I wasn’t getting anything extra from the bells and whistles on those ones. The Naidas have great feedback control mechanisms, which is the only reason I could get away with the large vent. With the large vent, the low pitches reach my ear without any processing, resulting in more natural sound. The hearing aids amplify the mids and highs without touching the lows, which is the way I want them to work. Also, the occlusion (which I hate) is greatly reduced. The only problem is that I don’t really know how much benefit I am getting from them. The Naidas provide a good amount of gain, but as I said above, there is simply no amount of amplification that will allow me to process sound at 2000 Hz where my loss is 110 dB+. Effectively, these aids attempt to target the pitches between 500-1500 Hz where I have hearing loss, but not nerve-cell death. If they provide improvement, it is marginal. I need to make a decision in the next 2 weeks on whether I want to keep them.

Going forward, you and I are in a tough position. Sharp ski-slope hearing losses aren’t getting any easier to treat, and our hearing bottoms out in the profound category. Middle-ear-implants show some promise because they can provide more gain and more “natural” sound than hearing aids, but ultimately we have to come to grips with the fact that with 100+ dB of loss at 2000-4000 Hz, these are cochlear “dead zones” and no hearing aid or middle-ear-implant will result in us comprehending speech in those pitches. Recently, my audiologist said that looking at my audiogram and history, I was trending towards getting a cochlear implant sometime within the next decade. In the past, I had rejected that idea, but I can see myself going down that path if my hearing continues to deteriorate. My audi said that bimodal patients (with a cochlear implant in one ear and a hearing aid in the other) can regularly achieve word recognition and speech discrimination scores well above what I’m getting now with hearing aids. Another thing to look at is short electrode cochlear implants, which attempt to use “soft surgery” methods and a shorter electrode in order to preserve low-pitch hearing in cochlear implantees. The problem with any cochlear implant is amount of rehab required, retraining your brain to associate electrical impulses with various sounds. It is a very difficult process and it’ll never sound truly “natural”.

I would recommend that you find a really good audiologist in your area who works with all kinds of patients, from hearing aid patients to cochlear implant recipients and even middle-ear-implantees if possible. Unfortunately, as I mentioned above, there is no “fix” for our kind of hearing loss, but you should give some of the better hearing aids a trial in order to find your best fit. In terms of middle-ear-implants, there is also a product out there called the Ototronix Maxum, which is similar to the Esteem but cheaper. It’s worth a look, although it is tough to find a whole lot of information about it.

Let me know if you have any more questions.

Thanks for your detailed response. I have also trailed phonak naida in the past and didnt like it…maybe because i never wore HAs for longer period of time. I constantly look for something in the ear type and i know it wont help me much but some (maybe) and thats what i am after. If i get the high end brand like you are trailing right now and i know they are way better than my nitro but i know for a fact that they will end up in my drawers so why bother. I was very excited about esteem but seems like that wont work either per your experience with them. I did check the Ototronix Maxum site and that looks promising…something I would definitely give it a try if qualified. Thanks for providing the product name.

I didn’t like the Naidas I first tried, either. Now I am trialing a pair of Naida CRT’s, which have the receiver in the ear canal. They are very discreet (thin wire instead of a tube) and sound more natural than the BTE versions. Add in the large venting on these aids, and they are much better and more comfortable than any other pair I’ve tried in the past. I actually look forward to wearing them sometimes, which is more than I can say for any other pair of hearing aids I’ve ever worn.

That said, I know exactly how you feel about new hearing aids, having gone most of my life without wearing them. I have been extremely skeptical about buying new aids because they never really “work”. You and I simply don’t get much benefit from hearing aids, and the high-end ones aren’t worth the cost. I was quoted $5,000 for the pair of these Naida S CRT V’s, which is not bad compared to the top-of-the-line aids out there. I have to make a decision on these by this weekend, not sure which way I’m leaning yet.

Many things related to Esteem are not real.

They even lied when showed that lady in a video saying she was hearing her voice for the first time in life. What a big lie. She can’t beneift from Esteem Implant if she is completely deaf that she nevr heard her voice.

Now here they didn’t indicate what do they mean by hight frequencies. Maybe they only mean 6000 and 8000 where no much speech is there. The main proeblem for us is the mid frequncies where there is much speech.

They should have put audiogram before and after implant if are really confident this implant works for profound loss.

The audiologist surgeon who said that Esteem is not right for me recently told me that I can be candidate for a maxum device. He just completed the training on maxum and is ready to implant device in his patients and I am one of them. One part of maxum is semi implanted and other one is like a long tube hearing aid goes in the outer ear. The cost is $10,000 per ear includes surgery and device with warranties, that is much cheaper than Esteem but am not sure yet to move forward with it. There is no trail period and no refunds if I dont like it. Its reversible though unlike the cochlear implants. Also I was told that maxum is good for people with severe high frequency loss. Anyone has any experience with it so far? Thanks!

$10k to him per ear or $10k total per ear including all the hospital cost? an hour in a surgery suite around here will set you back in excess of $10k and I’m guessing around Chicago more.

$10k total but again no returns, exchange or refund even portion of it. I did talk to one maxum patient in TX, this person is very happy with it and he had tried all kinds of HAs.

The Maxum is approximately $10,000 per ear, including surgery. I believe I was quoted $12,000.

The procedure is pretty simple. They go in through the ear canal and attach a small magnet to the ossicular chain. Takes about a half an hour.

The problem is that only a few hundred people have received the Maxum, so there is very little documentation or clinical results on the device. Also, there is no guarantee that Ototronix will continue to develop new receivers / processors if they aren’t making money on the technology.

Cyborg, you say you have one Nucleus 5 implanted. How do you feel about it regarding perception of speech and your ability to understand on the telephone with it. I have just undergone an implant in my left ear and will not have it programmed for probably another 3 weeks or so. Just curious about your experiences.

Hey Cyborg, I now have an implant in my left ear, activated March 14th. It’s been good and getting close to being great. I now hear one on one conversations great and with a Clearsound CLA7v2 Adapter to my phone I hear conversations better than I have in 15 years or more. Good Luck on yours.

Not sure if the right place to post… I have profound high frequency loss, with my drop beginning at about 1k. Going for evaluation on Friday for clinical trials for med el EAS hybrid, and hoping to find others that have looked into CI hybrids. My residual hearing may make me not a candidate (72% on a suspect testing methodology).

anyone else researching hybrids?

Cramer, I’m interested in how your evaluation came out. I may be getting the Cochlear America hybrid as soon as this fall in my other ear. I’m not familiar with the Mde El’s though.

Maybe this person has moderate hearing loss and not profound loss like yours.