Risk of Bacterial Meningitis and Death in Children with Cochlear Implants

[Tousi]

It is well known in the clinical community, but no one (except perhaps the FDA or the AAO-HNS) can force a clinic to make changes in their procedural policy. Note that the poll only asked *families* if they knew/remembered whether or not the shots had been done, if you call 100 implant centers, I expect that all of them discuss the shots as part of the eval process, and most require them.

If I remember correctly, one newspaper article (posted in the original threat on this board about one of the girls that died) stated that the parents admitted they were told by the implant center to get the vaccine, but the pediatrician didn't have it in stock and the family didn't follow up. Working with as many HI people as I do, and with a child in college, I have demanded (and received) this shot for all of my children as well as myself, even though none of us have implants, I just don't believe in messing around with something this serious when a simple preventative measure is available.

Sheri

Thank you, Advocate; I just think/wish there be something stronger than company policy; that an implant procedure would not proceed unless and until there's proof that the vaccination has taken place.

 

[LTHFAdvocate]

My 5 year old just got 7 vaccines in June. I'm not sure I could name every one without pulling out her yellow card listing them, and it would probably take me half an hour to find the card So I'm one of the most educated moms I know on the topic, and even I'm "unaware" Though I know she got "a" meningitis vaccination, there are two different ones out there and I don't honestly remember which one she got.

Back to my hatred of insurance companies -- if the ENTs could give vaccinations related to their patients and know they/the families weren't going to get hassles from the insurance companies paying for it, that might solve the problem. But in the US, this is unfortunately not the case. Vaccinations are not considered part of regular ENT practice, and thus PCPs/Pediatricians have to give the shots. We went through this with the Prevnar shot several years ago (which reduces ear infections) our clinic WANTED to give it to all of our ear tube patients, but the families weren't getting reimbursed for it if they got it at our clinic, where if they got the shot from their regular pediatrician, they WERE getting reimbursed.

I doubt a poll of your students will be very meaningful. Unless they were implanted as adults and have a long memory, who knows if they will remember which shots they got when or what they were for. The only thing that would generate valid results is to have them bring in their vaccination cards.

I'm going to have to disagree on that one. If parents were getting the information, they wouldn't be "unaware". Surgeons are obviously implanting children without the vaccine having been completed. And what about follow up? Are these kids just being implanted with no medical follow up? I have already decided to poll my students that are implanted to see howamnyof them have been vaccinated, or were even aware of the need.

 

[LTHFAdvocate]

People who feel strongly about this should petition the FDA or AAO-HNS for such a requirement

Thank you, Advocate; I just think/wish there be something stronger than company policy; that an implant procedure would not proceed unless and until there's proof that the vaccination has taken place.

 

[Tousi]

People who feel strongly about this should petition the FDA or AAO-HNS for such a requirement

Point taken but I would think that if surgeons, implant companies, etc would be more vigorous in insisting on the proof before proceeding, it would be in their best interest to effect such a simple thing without having the government telling them they must. It would also be in their best interest, publicity-wise. They are "healers" with good intentions so putting in place such a policy I've suggested is a win-win all around not only for them but for their clientele.

 

[jillio]

Point taken but I would think that if surgeons, implant companies, etc would be more vigorous in insisting on the proof before proceeding, it would be in their best interest to effect such a simple thing without having the government telling them they must. It would also be in their best interest, publicity-wise. They are "healers" with good intentions so putting in place such a policy I've suggested is a win-win all around not only for them but for their clientele.

Well said. Perhaps the focus needs to go from not just getting the surgery done in a timely fashion, but insuring that the surgery is done is a safe a manner as is possible. I would also like to see programs for counseling and adjustment issues become mandatory prior to surgery and following surgery. In the case of children, of course, this would include the entire family.
Too many parents have not completely worked through their own issues at having a deaf child before they follow through with an implant. It is then assumed that the implant is the final stage in dealing with these issues, when, in reality, it is only the beginning. We are doing a disservice to both hearing parents and deaf children when we implant them, and then consider that the only follow up services needed are AVT. That attitude of
We've created sound perception, so our job is finished here!" is at the root of the problems that we are continuing to see.

 

[LTHFAdvocate]

I really don't think this is the case Jillio. I've never met a CI surgeon with the attitude you describe below, and I've actually met more than half of the CI surgeons in the US in person, and probably communicated with another 1/3 of them by phone or e-mail. I can't remember any letter of medical necessity ever written by an implant clinic (and again, seen hundreds of these) that doesn't include a significant component on therapy and education following the CI surgery. A huge chunk of medical/audiological cochlear implant conferences is dedicated to the topics of "what else needs to go with the implant to optimize speech and language outcomes", including entire 1/2 and frequently full day sessions educational and psychological issues in addition to the always-present topics on therapy, which complement the issues on surgical techniques and timing. There were 1200 attendees at the last conference like this in April in Charlotte.

That attitude of
We've created sound perception, so our job is finished here!" is at the root of the problems that we are continuing to see.

 

[jillio]

I really don't think this is the case Jillio. I've never met a CI surgeon with the attitude you describe below, and I've actually met more than half of the CI surgeons in the US in person, and probably communicated with another 1/3 of them by phone or e-mail. I can't remember any letter of medical necessity ever written by an implant clinic (and again, seen hundreds of these) that doesn't include a significant component on therapy and education following the CI surgery. A huge chunk of medical/audiological cochlear implant conferences is dedicated to the topics of "what else needs to go with the implant to optimize speech and language outcomes", including entire 1/2 and frequently full day sessions educational and psychological issues in addition to the always-present topics on therapy, which complement the issues on surgical techniques and timing. There were 1200 attendees at the last conference like this in April in Charlotte.

That is what I am referring to: maximize speech and hearing outcomes. That is a very limited view. And let me ask, does your clinic also arrange for follow up counseling services for both parent and child and siblings following implantation? Do they have someone who does home visists? Do they offer advocacy for educaitonal services, or does advocacy end once the insurance company has been convinced to pay for the surgery? The problems that are being encountered are notthose that can be addressed through surgery or medicine. Butthey are still a very real part of the CI experience.

And what about pre-surgical services? Or are we in such a rush to complete the implantation in a timely manner, that we forget that CI surgery is life changing, not just for the recipient, for for the family, as well.

 

[Tousi]

I really don't think this is the case Jillio. I've never met a CI surgeon with the attitude you describe below, and I've actually met more than half of the CI surgeons in the US in person, and probably communicated with another 1/3 of them by phone or e-mail. I can't remember any letter of medical necessity ever written by an implant clinic (and again, seen hundreds of these) that doesn't include a significant component on therapy and education following the CI surgery. A huge chunk of medical/audiological cochlear implant conferences is dedicated to the topics of "what else needs to go with the implant to optimize speech and language outcomes", including entire 1/2 and frequently full day sessions educational and psychological issues in addition to the always-present topics on therapy, which complement the issues on surgical techniques and timing. There were 1200 attendees at the last conference like this in April in Charlotte.

Okay but my post is/was much more narrow and specific to resolving the issue of that vaccination.....I can handle only so much at a time....

 

[jillio]

Okay but my post is/was much more narrow and specific to resolving the issue of that vaccination.....I can handle only so much at a time....

Yep, we'll start at the beginning, okay?

 

[LTHFAdvocate]

You can have a goal (even a primary goal) of maximizing speech and hearing outcomes without abandoning other goals. Our clinic provides referrals for counseling services, and our non-profit does advocacy for IEPs (and NOT just for implanted patients, and NOT just for patients of the clinic). No, we don't do home visits, but honestly, outside of an IFSP, who does? It's just not feasible, especially not in California. Anyone at our clinic who downplayed the life-changing event of implantation wouldn't last here very long.

No one "rushes" families into decisions at our clinic, when the families are ready to schedule surgery, they schedule it. Our clinic has in-person support group meetings where they can meet other families at various stages of the implant evaluation (or post-implant) process, and we work very closely with both state early intervention programs and local schools who have hearing impaired students.

That is what I am referring to: maximize speech and hearing outcomes. That is a very limited view. And let me ask, does your clinic also arrange for follow up counseling services for both parent and child and siblings following implantation? Do they have someone who does home visists? Do they offer advocacy for educaitonal services, or does advocacy end once the insurance company has been convinced to pay for the surgery? The problems that are being encountered are notthose that can be addressed through surgery or medicine. Butthey are still a very real part of the CI experience.

And what about pre-surgical services? Or are we in such a rush to complete the implantation in a timely manner, that we forget that CI surgery is life changing, not just for the recipient, for for the family, as well.

 

[jillio]

You can have a goal (even a primary goal) of maximizing speech and hearing outcomes without abandoning other goals. Our clinic provides referrals for counseling services, and our non-profit does advocacy for IEPs (and NOT just for implanted patients, and NOT just for patients of the clinic). No, we don't do home visits, but honestly, outside of an IFSP, who does? It's just not feasible, especially not in California. Anyone at our clinic who downplayed the life-changing event of implantation wouldn't last here very long.

No one "rushes" families into decisions at our clinic, when the families are ready to schedule surgery, they schedule it. Our clinic has in-person support group meetings where they can meet other families at various stages of the implant evaluation (or post-implant) process, and we work very closely with both state early intervention programs and local schools who have hearing impaired students.

Then you are doing more than most. I see that you refer for counseling services....pre or post-implantation?

The point is, there are still individuals who are not receiving comprehensive services such as the ones that you have outlined that are provided by your clinic. And there seem to be more individuals who are not receiving services such as this than are.

Perhaps the rushing is subtle. Do you, in fact, present the view that time is of the essence in receiving maximum benefit in the area of speech and hearing? That has the proensity to coney to a parent of a newly diagnosed child that it is necessary that the implant be done ASAP, and then we'll deal withthe other issues at a later date. It also has the propensity to communicate to a parent of a newly diagnosed child that CI, and creation of sound perception, is the most important variable in learning to deal with their child's deafness. It can very well be a part of the picture, but it is by no means, the biggest part of the picture. If it were, we would not still be experiencing the magnitude of educational and social difficulties that we continue to see in CI recipients.

 

[jillio]

My 5 year old just got 7 vaccines in June. I'm not sure I could name every one without pulling out her yellow card listing them, and it would probably take me half an hour to find the card So I'm one of the most educated moms I know on the topic, and even I'm "unaware" Though I know she got "a" meningitis vaccination, there are two different ones out there and I don't honestly remember which one she got.

Back to my hatred of insurance companies -- if the ENTs could give vaccinations related to their patients and know they/the families weren't going to get hassles from the insurance companies paying for it, that might solve the problem. But in the US, this is unfortunately not the case. Vaccinations are not considered part of regular ENT practice, and thus PCPs/Pediatricians have to give the shots. We went through this with the Prevnar shot several years ago (which reduces ear infections) our clinic WANTED to give it to all of our ear tube patients, but the families weren't getting reimbursed for it if they got it at our clinic, where if they got the shot from their regular pediatrician, they WERE getting reimbursed.

I doubt a poll of your students will be very meaningful. Unless they were implanted as adults and have a long memory, who knows if they will remember which shots they got when or what they were for. The only thing that would generate valid results is to have them bring in their vaccination cards.

I find it meaningful that not a single of my students spoken with thus far had even been informed that the vaccine was reccomended, nor were they aware of the increased risk for bacterial meningitis. And yes, these are adults, but all were implanted as children. However, as adults,t hey need to be ware of the implications, should they ever have to make a decisonregarding one of their own children. And adults can contract bacterial meningitis,as well.

What is meaningful, is the indication that the information is not being supplied to candidates or to their parents. And surgeons are continuing toperform surgery without proof that the vaccine has been given, and thus, are increasing the risk. That is very meaningful.

 

[LTHFAdvocate]

No, Jillio, what that means is the information isn't being remembered by implanted children in their adulthood. That doesn't mean it wasn't given to them, that doesn't mean it wasn't given to their families.

Tracking people down 10 years after surgery (or even less than 2 years after surgery, as I just did for one retrospective review) is no easy task. The people most likely to have up-to-date contact information is the manufacturers, they are the places people with implants will continue to have consistent contact as the order upgrades/supplies.

What is meaningful, is the indication that the information is not being supplied to candidates or to their parents.

 

[jillio]

No, Jillio, what that means is the information isn't being remembered by implanted children in their adulthood. That doesn't mean it wasn't given to them, that doesn't mean it wasn't given to their families.

Tracking people down 10 years after surgery (or even less than 2 years after surgery, as I just did for one retrospective review) is no easy task. The people most likely to have up-to-date contact information is the manufacturers, they are the places people with implants will continue to have consistent contact as the order upgrades/supplies.

You don't engage in any longitudinal research regarding implanted indiviuals?

Don't youthink soemthing as important as receiving the vaccine and being made aware of the risks is important enought to stress to the point that it will be remembered? It would appear that it not ionly is not being stressed, but that the ball is being dropped by the medical community in insuring that the vaccination has been completed prior to surgery.

You know, my son has several life threatening allergies to antibiotics. One dose has the potential to put him into anaphylactic shock and end his life. While I might have had to look the names of the offending medications up (there are 5 of them), I always had ready access to that information in the case of an emergency. Now that he is an adult, he has access to that information, as well as his vaccination records, and any other pertinent medical information.

My point being.....why do so may people seem to be unaware of medical information that is crucial and important?

 

[LTHFAdvocate]

Then you are doing more than most. I see that you refer for counseling services....pre or post-implantation?

Either, it entirely depends on the family. Some people clearly need/want this, others don't

Perhaps the rushing is subtle. Do you, in fact, present the view that time is of the essence in receiving maximum benefit in the area of speech and hearing?

Certainly we present the concept of neural plasticity and language acquisition windows. That is well documented, and it would be foolish to ignore. More often than not, the families want to rush us rather than the other way around.

If it were, we would not still be experiencing the magnitude of educational and social difficulties that we continue to see in CI recipients.

The "magnitude" at our clinic is pretty much zero. When we have a patient who has a significant educational or social difficulty post-implantation there is always reason for it, and the reason generally has to do with either late implantation, failure to do appropriate follow-up audiology and/or therapy, or some concurrent medical problem unconnected with the implant

 

[Tousi]

Either, it entirely depends on the family. Some people clearly need/want this, others don't



Certainly we present the concept of neural plasticity and language acquisition windows. That is well documented, and it would be foolish to ignore. More often than not, the families want to rush us rather than the other way around.



The "magnitude" at our clinic is pretty much zero. When we have a patient who has a significant educational or social difficulty post-implantation there is always reason for it, and the reason generally has to do with either late implantation, failure to do appropriate follow-up audiology and/or therapy, or some concurrent medical problem unconnected with the implant

If you know you have patient "who has a significant educational or social difficulty post implantation, what would you feel/do if you knew this pre implantation?

 

[LTHFAdvocate]

20/20 hindsight would be a wonderful thing. Of course, nobody has it.

If you know you have patient "who has a significant educational or social difficulty post implantation, what would you feel/do if you knew this pre implantation?

 

[jillio]

If you know you have patient "who has a significant educational or social difficulty post implantation, what would you feel/do if you knew this pre implantation?

Exactly. The comprehensive services are simply not being offered. The CI is being presented as the sloution to all of the pproblems associated with deafness, when in reality, it assists only with the auditory aspect. If clinics and manufacturers are goingto promote and engage in implantation surgeries, then they also need to abide by the ethical guidelines that assist those patients in fucntioning optimally once the surgery has been performed.

 

[Tousi]

20/20 hindsight would be a wonderful thing. Of course, nobody has it.

I didn't mean that sarcastically; I was just wondering out loud if what I was talking about was (or should be for the sake of safety) the domain of the people manufacturing these devices all the way to whomever is involved with the patient pre-implant. Surely, somewhere along the line somebody can make sure the vaccination has been given before allowing the implantation without running to the government to make sure this happens. Am I being too simplistic?

 

[R2D2]

Perhaps the rushing is subtle. Do you, in fact, present the view that time is of the essence in receiving maximum benefit in the area of speech and hearing? That has the proensity to coney to a parent of a newly diagnosed child that it is necessary that the implant be done ASAP, and then we'll deal withthe other issues at a later date. .

In some cases such as meninigitis where ossification of the ear bones can take place, which would make it difficult and sometimes impossible for the electrodes to be inserted, there are good reasons to have prompt CI surgery.

Also as LTHAdvocate mentions the window of speech development is in the first three years of life and this is a well established observation. After that it closes and those who are implanted in later years struggle much more, although of course there are always exceptions to the rule. I'm not sure how I feel about older children being implanted if they have never heard sound before or haven't developed spoken language already - I wonder if its just setting them up for more struggle especially if the goal is to develop spoken language. I think it's better for them to remain dedicated to ASL if they have already started that.