by Leeanne Seaver, Hands & Voices ©2010, with contributions from experts at Advanced Bionics, Cochlear Americas, and the University of Colorado Hospital. ©2010 Hands & Voices Communicator, Summer 2010, Reprinted with Permission
The stories we hear the most are inspiring: the deaf girl who won the school spelling bee thanks, in part, to her cochlear implant (CI) that enabled her to participate for the first time in this thoroughly “hearing” event; the Princeton-educated attorney who loves both her CI-friendly iPod and her Deaf cultural lifestyle. There’s no question that cochlear implant technology has changed the landscape of the deaf world and opened up new possibilities for many, many users. But not for all users, all the time. When things aren’t going well, parents often worry that their child is the problem—maybe s/he is the kind of kid the audiologist was referring to when she said “not every kid will be successful with a cochlear implant.” How long does the frustration and anxiety over little-to-no progress go on before it’s determined whether the CI device itself is the problem? What are the red-flags for device failure?
Whether you’re the parent of a child with a cochlear implant or considering this technology for your son or daughter, you need to consider the fallibility of this technology. The good news: in general, it’s rare. The bad news: a CI malfunction known as “soft failure” is difficult to identify, and it can be a long, frustrating process to discover it. If you’ve already lost a lot of time before even beginning to explore this possibility, your kid could be at real risk for language deficits and related problems. Arming yourself with knowledge will help you make informed choices and take prompt action if you’re ever worried about this issue for your child. Hands & Voices (H&V) has invited two major cochlear implant manufacturers and an independent audiologist who works at a large, metropolitan university hospital with many CI patients to share their insights and expertise to help get you started.
H&V: What is “soft failure”? What causes it? How often does it occur? Is there such a thing as “hard failure”?
SHANNON BURNS, AuD, CCC-A: A cochlear implant soft failure is an uncommon occurrence in which a device malfunction is suspected but cannot be proven using currently available methods of assessment. A cochlear implant hard failure may be characterized as more of a sudden loss of function, such as no communication between the internal and external devices. This may be proven with an assessment (integrity test) by the manufacturer of the function/status of the internal device. The Consensus Statement from 10th Symposium on Cochlear Implantation in Children assessed that soft failure:
- Is an uncommon occurrence
- Is a working diagnosis. (Only confirmed by removal, examination and identification of failure mode)
- Diagnosis begins with awareness of common presentations. (Declining performance, aversive symptoms or intermittent function)
- Diagnosis can only be made with complete otological examination, CT scan, expert re- programming, exchange of all external hardware, and integrity testing by the manufacturer.
COCHLEAR AMERICAS: A “soft failure” is a term used by the cochlear implant industry to describe a situation where a patient’s hearing performance has noticeably decreased but the implant integrity testing shows that the implant is functioning as normal. In other words, the implant testing does not show a problem with the internal device, but the patient is not hearing as well as they used to.
There is a wide range of patient clinical situations where a “soft failure” occurs. Therefore we are not able to draw any specific conclusions about what causes “soft failures”. Indeed, quite often a change in a patient’s hearing performance will not be device related, but instead will be related to the patient’s general health or medication.
“Soft failures” do occur, and in one recent study it was reported that 2% of the implant recipients had their implant replaced due to a soft failure (Data was collected from two major cochlear implant centers in the US, and devices were represented from each manufacturer – Cullen et al. 2008). This report does show that the Nucleus Cochlear Implants had a significantly lower incidence of soft failures than the other manufacturers.
A “hard failure” a.k.a “a failed device” is much easier to identify. A hard failure will be identified by a combination of a noticeable drop in a patient’s hearing performance, and the implant integrity testing showing the device as malfunctioning (or not operating as designed).
ADVANCED BIONICS: Cochlear implant “soft failure” is an uncommon occurrence in which a device malfunction is suspected but cannot be confirmed using currently available tools to test the internal device once implanted (often referred to as “integrity testing”). A soft failure may be suspected when there is a lack of or decline in hearing performance, perceptions such as a popping sound or intermittent hearing with the cochlear implant. Re-implantation of another device with subsequent alleviation of symptoms strongly supports the diagnosis of a soft failure but cannot conclusively confirm a device malfunction. A suspected soft failure is confirmed when the device is explanted and a failure mode is identified upon further evaluation and inspection.
A “hard” failure is typically defined when a device malfunction is suspected and indeed confirmed with the available assessment tools (the “integrity” testing).
Testing of the device can be conducted either in-situ (e.g. integrity testing in the ear) or upon return of the explanted device to the manufacturer. Once the device is explanted and returned to the manufacturer, a wide range of tests can be performed to assess the functionality of the device. If none of these tests fail, but the patient is performing better with the new device than with the explanted, then the conclusion is that the explanted device had a “soft failure”. Because the term “soft failure” has come to have a variety of meanings, Advanced Bionics does not actually use this term. Instead, Advanced Bionics uses the following classification scheme based on the testing that was performed on the device:
- Confirmed Device Failure – The explanted device failed a test when it was returned to Advanced Bionics for failure analysis.
- Clinical Failure of Unknown Origin – The device failed an integrity test when it was tested in-situ; however it has yet to fail a test upon return to the manufacturer. In some cases these devices have not yet been explanted and returned to Advanced Bionics.
- Clinically Device Tested OK – Other Reason for Explant – These are cases where the device did not fail any clinical integrity test however the device was explanted and upon return to Advanced Bionics, the device passed all tests. “Soft Failures” would fall into this category. Included in this category is the case where 1.) a patient perceived there was an issue with the device and 2.) integrity testing did not indicate a failure and 3.) upon explant the device was returned and passed all testing and 4.) the patient performed better with the new device than the explanted. The percentage of explanted devices that fall into this category is quite small (less than 2%).
- Medical Explant – Explants for non-device related reasons. These include infections, extrusions, electrode migrations, etc..
H&V: How can families recognize the signs or symptoms of a soft failure?
SHANNON BURNS, AuD, CCC-A: The suspicion of a soft failure begins with the awareness of common presentations including declining performance (decrease in speech perception scores or functional thresholds) and/or aversive symptoms (non-auditory sensations) such as popping or shocking sensation or intermittent function. The working diagnosis of a soft failure is arrived at after painstaking evaluations by the cochlear implant team, manufacturer and patient. A soft failure can only be confirmed by removal, examination of the suspect device, and identification of a failure mechanism.
COCHLEAR AMERICAS: A family would not necessarily recognize the signs or symptoms of a soft failure (as defined). Rather they should focus on the recipient’s hearing. If they notice significant changes in hearing performance they should contact the family member’s audiologist for a consultation. The audiologist would then determine whether programming changes are appropriate or if an integrity test should be performed on the internal device.
ADVANCED BIONICS: For older children who can tell parents about what they are (or are not) hearing, parents should watch for any changes in their child’s ability to hear, any reports of aversive sounds such as pops or changes in sound quality including static or buzzing, and any reports of discomfort, pain or tingling around the head or face.
For young children who cannot report what they hear, parents should watch for unwillingness to wear the device, a change in behaviors (more aggressive, frustrated), a change in attentiveness, and/or a regression or lack of expected development of communication skills.
H&V: What should a family do if they suspect there is a soft failure with their child’s CI?
SHANNON BURNS, AuD, CCC-A: Generally speaking, if there is any significant change in hearing ability, sound quality, or the presence of non-auditory stimulation the family should contact their cochlear implant audiologist immediately for further troubleshooting and assessment. The clinical specialist from the cochlear implant manufacturer may be called upon to perform an integrity test of the internal device, although this test is often “within normal limits” in case of soft failures.
They should have an excellent team of professionals that must including audiologist, speech therapist, physician, parents and educators who are closely connected and all collecting data on progress and benefit over time. This team together discusses progress and can explore the possibility of a “soft” failure as necessary. If these things aren’t in place from the time of implantation (or before) a soft failure may not be identified in a timely manner.
COCHLEAR AMERICAS: They should contact the child’s audiologist for an appointment.
ADVANCED BIONICS: If families note any of the symptoms of soft failure, or if they have any concerns about their child’s hearing performance for that matter, they should check all the external equipment to be certain it is functioning properly and immediately contact the cochlear implant center.
H&V: Are some kids at greater risk for soft failure?
SHANNON BURNS, AuD, CCC-A: No. However, kids who do not have a good team in place can have two problems. First they could have internal device issues or simply processor programming issues that could be overlooked because no one is actively managing/monitoring their hearing. Second, they could be thought to have a “soft” failure when the reason for lack of progress is actually lack of appropriate intervention and follow through.
COCHLEAR AMERICAS: There is no clinical evidence that some kids have a greater risk for soft failure than others. There seems to be more importance around which cochlear implant manufacturer produced the device (as presented in the paper by Cullen et al).
ADVANCED BIONICS: In 2006, Advanced Bionics identified internal moisture problems in a significant number of implants manufactured with a component (called a feedthrough) built by one supplier (“Supplier B”) whereas no such problems occurred in components from another supplier (“Supplier A”). Accordingly, recipients of suspected devices and their cochlear implant teams were notified to monitor for any suspected changes in performance or sound quality. Since that time, AB has manufactured HiRes 90K devices with feedthroughs provided only by Supplier A which demonstrated very high reliability (99.6% 2 year CSR).
While the internal reliability of cochlear implants today is very high, over 99%, parents of children with cochlear implants regardless of type should monitor their child’s performance and discuss any concerns with their cochlear implant surgeon and audiologist.
H&V: What is the recommended protocol when there is a soft failure?
SHANNON BURNS, AuD, CCC-A: Otological examination, CT scan, close monitoring of performance over time, expert re-programming and hearing testing, exchange of all external hardware, and integrity testing by the manufacturer.
COCHLEAR AMERICAS: Any change in hearing performance must be managed by the patient’s audiologist based on the clinical symptoms. This may range from monitoring the patient to requesting an integrity test by the manufacturer. Hearing performance data and other clinical data with the cochlear implant should be continuously monitored, so that if a concern arises, there is baseline data to compare to. These measures, along with information about any medical concerns, can help the implant team and manufacturer make the best recommendation regarding whether or not to replace the device.
ADVANCED BIONICS: The appropriate management option for a child with a suspected soft failure is determined by the cochlear implant team (CI surgeon and audiologist and therapists) and the parents/ caregivers with input from other professionals actively involved with the implant user’s health care. Typically, the cochlear implant team first rules out the possibility of external equipment malfunction and may make programming adjustments and then request a comprehensive integrity test from the manufacturer. A consensus statement from a panel of cochlear implant experts outlined management options as follows: 1) prolonged observation if the device continues to provide substantial benefit and symptoms are tolerable; 2) removal and re-implantation; or 3) in rare cases, implantation of the opposite ear (if not also implanted) when hearing performance is the main concern.
H&V: If a child has to be re-implanted because of soft failure, does his/her family have to pay for the second surgery?
SHANNON BURNS, AuD, CCC-A: Generally the cochlear implant manufacturers support the decision of the surgeon and audiologist to explant/remove a device and will cover expenses not covered by insurance if the device is under warranty. The warranty for the internal devices is 10 years.
COCHLEAR AMERICAS: This does depend on whether the implant was still under warranty, and whether or not it was determined to be a failed device. It is unusual for a family to have to pay for revision surgery
ADVANCED BIONICS: Cochlear implants have a warranty and the center and family should work with the manufacturer on specific cases. Specifically, for Advanced Bionics devices, we make no distinction between “soft” and “hard” failures; rather, we follow the recommendations of the cochlear implant team and cases of suspected soft failure leading to explantation are therefore covered under the terms of the warranty.
H&V: If there has been a soft failure, are there any risks to the child’s brain or internal processes?
SHANNON BURNS, AuD, CCC-A: Generally, no.
COCHLEAR AMERICAS: A soft failure does not add any risks to the child’s brain or internal processes. The risk of surgery to replace the implant is not significantly riskier than the child’s first cochlear implant surgery.
ADVANCED BIONICS: We are aware of no studies or cases showing such risk.
H&V: How long does the CI’s internal device usually last? Should families plan on the need to re-implant their child due to the anticipated “lifespan” of the internal device?
SHANNON BURNS, AuD, CCC-A: The implant is designed to last a life time, but because they have not been in existence for a “life time”, there is no way to know how long they will really last. Also, technology changes/improvements lead people to electively replace internal devices when the benefits are substantial. For instance, some people who received single channel implants from the late 70s or early 80s are having theirs replaced. I would expect that most pediatric patients will have their implant replaced at least once in their life time.
COCHLEAR AMERICAS: Nucleus devices are designed for a lifetime. Cochlear’s implant reliability is the best in the industry and we do not think families should be required to plan on re-implanting their child every few years. For example, for our earliest generation products after 23 years there is a 93% cumulative survival.
ADVANCED BIONICS: The expectation for any cochlear implant is that it should have a minimal chance of failing within a 10 year period. This not to say that there is a zero chance of failing within 10 years, but rather that the probability is acceptably low (well less than 5%). Therefore, families should not have to plan on a re-implantation within the 10 year period. In fact, the reliability of Advanced Bionics current device is such that families have a good chance of not seeing a failure at the 15 or even 20 year mark.
Even so, our life spans are now 70 and 80 years, so the expectation should be that children implanted at two years old will have several cochlear implants over their lifetime. AB builds our implants with the technical capacity or headroom to be upgraded through software programming that requires no surgery. This gives children being implanted today as much access as possible to the breakthroughs of tomorrow with the hope that the device will function much beyond its warranty period. Nevertheless, while the advances of decades to come cannot be predicted today, it may be that some advances are so great they may warrant re-implantation to upgrade hearing performance.
H&V: What else should families know about this topic?
SHANNON BURNS, AuD, CCC-A: It may be important for families to be aware of the potential for electrostatic discharge (ESD) to compromise internal device function.
COCHLEAR AMERICAS: Soft failures are rare. Small fluctuations in a child’s hearing performance are normal. Significant changes in hearing performance may not be normal. Keep good records of your child’s hearing performance, pay attention to significant changes and see your child’s audiologist at yearly intervals or more frequently if required by the condition of the patient.
ADVANCED BIONICS: We are committed to making reliability of our product- both internal and external components- our number one goal. Our patients remain foremost as we demonstrate the importance of quality in all of our daily activities. We continue to invest substantial resources to improve the quality in all that we do.
H&V: What if everything seems to be going ok but no you’re worried?
H&V: Chances are everything is ok! Just be sure your cochlear implant audiologist does a “hearing performance test” with the implant to establish a baseline from which you can measure progress, lack of progress or digression. This is extremely important for every CI user so you know when something is going wrong, and can promptly identify a soft failure in the unlikely event that your child may have one.
Whether it’s a cochlear implant supporting listening and spoken English, or Cued Speech, S.E.E., or American Sign Language—whatever mode or method you’re using, make sure your child is developing language; expect him or her to make progress and achieve fluency that’s age-appropriate. Do all you can and should to ensure that you have the knowledge you need to help your child reach his/her fullest potential.
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I have a 25 year old Ineraid with a processor box from Med El. Approximately 10 years ago, I started having periods where the high frequencies would cut out for periods of several hours and gradually return. This intermitent problem grew worse and worse until the middle frequencies also cut out. I noticed if I fell asleep on the couch on my side with the implant in, I experienced this problem, but somehow it never happened if I fell asleep in that position with the implant out. At one point, the implant quit working except for a hum for a very long period of time. I remember it was at least 3 weeks, but might have been a month or more. I replaced all external equipment and the problem was not solved. One day however, it just came back to life. So, for about 8 years, I had intermitent, but ever increasing problems that were definitely very detrimental to my ability to function. The last two years, however, for some reason, I have had very few incidents of this happening. The Ineraid does not have an internal receiver in it so it is not clear why there was such a problem. I still find my old Ineraid superior to my newer Advanced Bionics device in the other ear. Not sure what the moral of the story is, but soft failures definitely exist.
My son recently experienced a change in his implanted device(Cochlear), he was implanted in his second ear July 25, 2011 and he had to increase the volume for the first time. He says, “that solved the problem”, but with a known failure rate of 1% I wonder if this is just the beginning. With my son I know when his attitude changes something is going on, I wonder if this will happen again.
My daughter was implanted at age 2 . She has had the implant for 2 years 3 months. She has never alerted to sound. We have had several mapping sessions,impedance checks, x-ray and c-scan to check placement and has gone to the brain institute in Boulder Colorado for brain mapping. Her brain waves never changed with the stimulation. She wears her device 4 to 6 hours a day without a problem…except she doesn’t hear from it. We are wondering if it’s a soft failure where everything else checks out from her nerve to the device. We are at our wits end. Please advise us with any ideas you may have. We are desperate to figure this out. We do understand that some people will not have success with the implant for various regions but we can’t seem to find the reason and wonder if we should still encourage her to use the device or have it or at least the magnet removed….she has other medical issues that require scans. We would rather not add doses or radiation from the c-scans if we could just use an MRI but due to the “failed” implant she has to have c-scans. Sheesh!
Thanks for any input u may have.
Tammy Edwards
My son got his second implant in 2006. He always acts like its shocking him when we put it on. He says all he can hear is a buzzing noise and refuses to wear it saying that it hurts. They have already turned off 7 electrodes. We are going for more testing soon.
Our daughter has been implanted since she was 2 1/2 with her 1st and had her second at five. She is very successful. She has been mapped many times and continues to changes because her hearing has gotten better in the last 12 years and is completely normal. She has had very good audiologist and auditory verbal therapist that worked with her. She started school at 16 months and the teachers were coming to the house before that. She is very outgoing with lots of friends and plays all sports. Just getting the implant does not give you hearing. The right audiologists, auditory verbal therapist, teachers and patience do.
False Sense of Hope
The corporation shows on their website the false sense of hope they give prospective patients. The corporation states that the cochlear implant “is the only medical technology able to functionally restore a human sense – Hearing.”
This is not true. The cochlear implant cannot actually restore hearing. A cochlear implant, as stated on the website, “captures sound from the environment,” “processes sound into digital information,” “transmits to the implant over a transmitting antenna,” “converts digital information into electrical signals,” “sends signals down tiny wires to the electrode array in the inner ear,” “delivers electrical signals through tiny contacts, or electrodes, to the hearing nerve,” then “the hearing nerve carries the sound information to the brain, where it is heard.”
An ear does not normally work in that fashion. For that reason, people with these implants cannot hear the actual sounds. The sounds are digital, and the hearing is not normal. The false sense people get about these implants actually bringing back the ability to hear is nonsense. Children cannot actually regain their hearing with a cochlear implant. It is a synthetic sound–it does not fix a broken sense.
There are also biological and technical issues that need to be taken into consideration. The corporation actually states that depending on the age of hearing loss, the age of implantation, the status of the inner ear, and other medical conditions, there is not a guaranteed level of benefit from the cochlear implant. Though these precautions are posted on the website, and each patient is evaluated individually, there is always a chance that the cochlear implant will not work as well as expected.
With a cochlear implant usually being one of the first options given to hearing parents of a deaf child, risks are usually taken and children may be stuck with the implant even though the desired result was not met.
A frequently asked question on the website is “Why do people get a Cochlear Implant?” One of the answers was, “They want to be included instead of left out.”
This is another false sense of hope. Children with the implants are not easily accepted and included. There is still a visible implant on the child’s head which will be an easy target for teasing in mainstreamed schools. The child will more likely be included without a cochlear implant in a deaf school than with a cochlear implant in a hearing one.
Children are cruel and will seek out anything to put another child down. A bionic ear will be an easy target for low self esteem. False hope of a cochlear implant’s success is an issue that needs to be more thought out and assessed. This false hope can lead to a child’s disadvantage.
Larry,
I am an adult. I was born hearing, lost my hearing in my mid 30’s while a single parent of 3 young children. The years I spent without sound were the worst years of my life. To not hear my children’s voices, not be able to make their doctors appointments, school calls, hear them at school plays/functions, etc was a nightmare. Yes, the implant is artificial hearing, but I would take that over any day then the struggle of when I could I was in a sound of complete silence. I now have a failed implant, after 14 years. This is my worst nightmare. I do hope to get a resolution soon as the world without any sound, real or artificial is not a world I want to belong in. Already my speech has dropped, just in a matter of days since the implant has failed. Speech patterns are a huge benefit of a cochlear implant. I do not see an implant as a false sense of hope, but I am living proof that is is life changing. Yes, children are cruel, but believe me, I have experienced MANY more cruel adults while without any sound and with the working implant, than children. In fact a lot children, if you just explain why my “ears” are broken, GET IT and adapt. I can’t tell you how many cruel adults DON’T GET IT. Anyway like I stated, I am now recently back in the world without any sound and it’s a very dark world. One way I explain the implant is that is an artificial limb, just as artificial legs help a person walk. I do not see this as a sense of false hope or a childs/person’s disadvantage, but as a new lease on life.
Cochlear Implants can make they become totally deaf after they realize that CI is not working for them at all. It is too late for any person who went through that experience and lost all of their residual hearing. It is not necessary to put Deaf children into this bad situation. Deaf children need better and to be treated better. Deaf children are innocent. A person with CI CAN’T “hear” like a non-deaf person. The reason is We are saying this because there are many failure people with CI in this society that many people never been heard. CI is full of risk that parent is willing to do their Deaf children which it makes me sick. We feel bad for those Deaf children who have no choice to make. The parents are actually destroy their true soul from the beginning which it is a totally WRONG. We have the right to learn what we want to learn not what we’re told to learn.
Hearing aid device is better than nothing because there is unnecessary to have surgeries on Deaf children’s healthy. Give them a choice that they like or not like it anytime without being stuck with CI in their heads. As far as We know there is too risk to remove it by CI doctors who refused to do this removal at all. We know it is not safe to remove but why do Deaf people have to deal with CI devices as they cannot or do not wear it anymore. That’s very outrageous situation.
NO one care but we deeply CARE for these Deaf children as well. Deaf children is so innocent and deserve to accept the positive reinforcement for their being deaf from the beginning. We do not need anyone to put them into a very negative reinforcement that Deaf or Deafness is bad negative word. Deaf people is not allowed to be Deaf if they are happy with which it is a totally wrong. All I’m seeing these people who loves to degrade people whoever disagree, as they believe Deaf children need CI. We have the right to learn what we want to learn not what we’re told to learn. Even though, people have a very negative emotions or feelings, here is the question, Do you think it is appropriate for people’s their negative emotions or feelings who have the right to implant on Deaf children? We think not because it is still carrying on the old behavior pattern cycles from these people’s own negative feelings toward Deafness issue. It need to be stop to have a very unhealthy behaviors and attitudes toward Deaf children from the beginning by these people who have a very low self esteem themselves and very negative view into a word “Deaf or Deafness.”
Deaf children can learn anything but hear. They do not need to hear at all which it is none of anyone’s business since they born with it or becoming deaf as is. Just give them hearing aid if they like it or not before Cochlear Implant device because it is totally unfair. You can assume that they will hear everything as you are expecting them to have a better life in their future because of CI. What a joke! They degrade Deaf children into believing they NEED a CI NO one can cure or fix it.
I hope someday you’ll understand what my meanings is all about. Think twice before you will give more damage Deaf children’s true soul and mind works. People creates more damage toward Deaf children’s self esteem and self acceptance. CI is the full concept of trashy evil medical as is. Medical Code of Ethics says “DO NOT HARM” including deafness. You do not tell them everything in a very honest approachment at first place.
American Sign Language is the one true language as well as English is the one true language not spoken language as well as we can combine into Bi-Bi language. It is very equal communication for both Hearing and Deaf people altogether. It works very well.
Who said we must hear and speak only? We can learn how to speak but it does not have the effective of successful to have our oral method only without sign language or hear the whole comprehension words with any devices. It does not make any sense because we do still miss out a lot in many ways as how can you expect us to hear everything while we learn with/without sign language. There is no sense to me at all. It is all about MONEY and DESTROY on everything what we are capable to do anything but hear. That’s turns me off. It leads more damage toward Deaf children’s true identity of their self esteem and self acceptance. Deaf children need to be accepted as we are and not be told we “need” something. Deaf children feel negative about themselves because they aren’t appreciated for who and what we are. That’s DISRESPECTFUL attitude from CI company as well as we have prejudice, oppression and discrimination that we are still dealing with it every day even nowadays. What a very discouragement behaviors that people have to act this way? It’s discouraging, selfish, controlling, and trying to grab power over Deaf community or Deaf children ‘s non-choice.
We have the right to accept and be happy for who or what we are. We have the right to learn anything without hear because the importance of reading and the concept of language to understand are the answer. It has nothing to do with CI or HA or HEAR or SPEAK itself alone. Where is the respect of cultural diversity for American Sign Language and True identity Deaf children and people who does not want to have CI?
My daughter has experienced soft failures. It is an extremely challenging time for families and even harder for the CI user. This is an excellent source of accurate and valuable information. Thank you for providing unbiased parent support. Hands & Voices folks take on those difficult subjects. I would love to see another article about infections of implant devices and treatment protocols. My daughter also had both devices become infected and have to be removed. This was even more difficult and having no hearing for approaching one year is very very hard for all involved.