FDA Expands Pediatric Cochlear Implant Candidacy: What’s Changed?

Welcome to This Week in Hearing. I’m Bob Traynor, your host for this interesting announcement to be made by one of our young colleagues at the University of North Carolina Chapel Hill. We’re going to talk significantly here about the new FDA criteria for pediatric cochlear implants. To discuss this is Samantha Scharf, the research assistant professor of otolaryngology head and neck surgery at the University of North Carolina Chapel Hill. Thanks for being with us today, Samantha, to tell us all about this very, very important modification of the FDA regulations. Yeah, thank you so much for having me.

Okay, well, you know, before we get going here, I always like to have my guests tell us a little bit about their journey to get to be, in your case, the research assistant professor at an ENT department. And did that kind of start— maybe take us from how did you get interested in cochlear implants as part of your training and so on? So tell us about your journey into where you are today. So my interest in cochlear implants is actually what led me to my career in audiology. I learned about them and, you know, thought they were incredible and how they worked and then how they were able to transform people’s lives.

And from a care provider standpoint, I was really attracted to the idea of working with patients long-term and getting to support them throughout their journey. So meeting someone when they really had difficulties communicating and being able to provide a treatment option in a cochlear implant when, when appropriate. And then getting to work with that individual over the course of a year and the years to follow and really seeing that transformation in their lives while also getting to work with really cool technology that really is challenging to work with and really is, requires a lot of critical thinking. to apply and make sure our patients are, are getting the care that they need.

So that is what initially attracted me to the field of audiology and to the University of North Carolina. So that is where I was able to do my audiology degree and where I’ve really started and been my whole career. So I graduated and joined the clinical cochlear implant team at UNC and worked for several years in that department. And in that role, I was primarily clinical, but I was able to work with our research department quite a bit. A lot of the research that’s being done at UNC is very clinically focused. And so I was interacting with our research colleagues, collaborating on projects, seeing research patients for their clinical appointments.

And then fortunately, a couple of years ago, a role opened up on the research team, and I was very excited to move over and be able to do research full-time. Wow, sounds like that’s just kind of this little notch, this little notch, and this little notch, and, and, and now we’re here. And you and your colleagues put together a fabulous article, by the way, audience, that’s in the current issue of Hearing Journal. So look for August 26th issue of Hearing Journal. Dr. Scharf and her colleagues have put together a very interesting article that kind of explains a little bit about what we’re going to talk about today.

So, you know, having been one of Marion Downs’ students over, you know, longer than I want to admit ago, she instilled in us that the earlier the better for working with children. Now, I still remember using some of her bullhorns and squeaky toys and so on to assess babies before we had ABR. That maybe dates me a little more than I want, but the idea is that you and your team have kind of published some things in Hearing Journal, and maybe you can give me an idea of what some of the modifications are for the criteria, and then we’ll get into maybe why they made those. So what happens?

And I know there’s a 1-3-6 and a 1-2-3 and those kinds of things. And I’m sure that a lot of clinical audiology people that are seeing adults most of the time, or maybe see a kid once in a while, might not necessarily understand some of that because they’re in different literature. So let’s Let’s look at what is the change that the FDA is proposing, and where are we today, and what does the new change offer? So the most recent round of changes went through in 2025 for the MED-EL system. So in 2000, the minimum age requirement for children to get a cochlear implant was 12 months.

And that really wasn’t updated for about 20 years until 2020 when cochlear system, the minimum age was brought down to 9 months. And then in the most recent change, now it’s 7 months for those children with a bilateral profound sensorineural hearing loss. So that’s kind of the first big change is just that minimum age requirement. And then the second component to the most recent round of changes was the audiometric profile or what thresholds can be considered for a cochlear implant. So again, we’re starting from a place where historically it was profound or severe to profound, and we’ve seen those expanded for children who are 1 to 6 years old. It’s now moderately severe to profound.

And then for children 6 and up, it’s now moderate to profound. And a lot of these audiometric profiles are— will be quite familiar to most audiologists. We’ve got better hearing in the low frequencies, sloping down to that more severe to profound hearing loss in the mid and high frequencies. And so this expansion really just acknowledges what we already know about, you know, speech understanding, especially in English, and the importance of those mid and high frequency sounds for the development and also for spoken language.

So now with, with the most recent expansions, children who have better low frequency hearing but are lacking in the hearing in the mid and high frequencies are now considered eligible for a cochlear implant under the FDA criteria. You know, as one that used headbands and hearing aids on one side and a bone conduction oscillator, all these kind of things with single-sided deafness kids, I understand there’s some changes that have been going on with the use of cochlear implants, and now that’s part of the new FDA designation as well, correct? Yes.

So in 2019, when the FDA approved cochlear implants for single-sided deafness for adults and children down to 5 years of age, that was huge for that patient population. Children are particularly affected by single-sided deafness. If you think about a classroom, it’s noisy, there’s people all around, and there’s, there’s data to show that those kids struggle without any sort of appropriate technology to help them in the classroom. And even some of the technology that was available, it wasn’t promoting any bilateral hearing abilities that are so important for spatial hearing, for listening in noise.

And so with the change in 2019, children as young as 5 with single-sided deafness can have access to a cochlear implant to start promoting the development of those bilateral cues and bilateral hearing. Okay, great. Now, can you tell us a little about— I mean, I have an idea still. I mean, I think I might still remember that far back to look at the research that has gone into this early intervention and this modification for early intervention. Seems like I recall people saying years ago that the earlier the better. And at that time, we were hoping to get it down to under 3 years of age.

So now we’re looking at, we have it at a year, and now we’re looking at going less than that. And I think it’s maybe even 9 months, if I remember right. 7 months is the current. You can help us through that. So why would the research support modification of the current regulation? I guess that’s a good question. So there have been a lot of children who have been able to get a cochlear implant younger than 12 months, but for a long time through off-label use. So there are a lot of surgeons and centers who were willing to implant these children.

And then from a research standpoint, we’re able to look at their outcomes long-term and compare them to outcomes of children who received their cochlear implant in aligned with the previous FDA labeling. And what we found consistent with kind of all of the literature across pediatric audiology is the better that you’re able to give these kids consistent and quality access to sound, the better their listening and spoken language outcomes are going to be. This is true for children with hearing whose hearing loss can be fit with a hearing aid, and it’s certainly true for children who have much more severe auditory needs and who go on to get a cochlear implant.

For some studies have even showed that children receiving a cochlear implant as young as 7 months are pretty much able to catch up or be on par with their normal typically hearing peers, which is quite incredible when you think about where their auditory and listening and spoken language journey started. Whereas those kids even implanted a couple months later at, you know, 10 to 12 months of age, you know, they show great progress and go on to have really good outcomes, but they never are quite able to catch up. to those typically hearing peers. You know, in the world of pediatric audiology, it’s very well established to try and meet the 1-3-6 guidelines.

So screening by 1 month, a full diagnostic evaluation by 3 months, and then initiation of appropriate services or intervention by 6 months. And so for, you know, that need is still there for children who are born with a bilateral profound hearing loss, but they were having to wait until 12 months of age before they had any meaningful access to sound. So now that the minimum age has been brought down to 7 months, we’re not quite at the 6-month mark for getting these kids appropriate intervention, but we’re certainly a lot closer than where we were even just a couple of years ago.

And certainly a big component of this reducing the age has to do with safety and making sure that, you know, we’re doing what’s in the best interest of the kid, but also making sure we’re doing it in a safe way. And so recently at UNC, we were able to participate in a multicenter trial looking to expand the FDA labeling. And we had a prospective arm of about 38 ears and then a much larger, larger retrospective arm looking at the safety of children receiving a cochlear implant younger than 12 months. And in our study, there was really no difference in the safety of the device younger than 12 months compared to the older cohort.

So this hopefully just helps reassure providers and families that it is safe to implant these children at the younger age, as young as 7 months old. And certainly there’s a huge performance benefit when we look at the outcomes for these children. Fabulous kinds of research that’s going on these days. And so basically the kids that had been implanted kind of off-label, you know, off outside of the criteria. Those were compared against those that were kind of treated on the label, and the kids did better that were off the label than were on the label.

So how— Yes, and it follows our common sense of what we know about early intervention for children, is that the earlier you’re able to intervene and provide sound for these kids, the better they’re going to do across their lifetime. It sets a really good foundation for their auditory and listening skills the earlier you’re able to provide a quality sound. Now, this was done with a— you guys were using a MED-EL implant to do this. Correct. Will then— will these data apply across other manufacturers’ implants as well? So the data was on the safety and efficacy was just with the MED-EL device. Cochlears was brought down to 9 months of age based on previous work.

So I have to imagine that across the field everyone moves in a similar direction. And so we’ll see this with other devices as well. But currently when we look strictly at just the FDA labeling, the MED-EL device is indicated for 7 months and older and the cochlear device is indicated for 9 months and older. And now the single-sided deafness kids, what kinds of modifications in the criteria are being made for them? So as I mentioned earlier, the current minimum age for children with single-sided deafness is 5 years. That is what came through with the FDA approval back in 2019.

But as we’ve been saying, the earlier we can get an ear access to sound, the better. And we know that Really, 0 to 5 is that critical period of development for language and for the auditory pathway. So there we are working to look at the safety and efficacy of cochlear implants in children younger than 5. So that’s a project we’re working on now, and we’ll hope that— we have to wait for those kids to grow up a little bit to see how they do when they’re a little bit older. But that is something we’re actively looking at to bring that criteria in line with the idea of earlier intervention and providing sound earlier.

So I’m a clinical audiologist in my clinic, and so what should I do to kind of apply the things that you outline in your Hearing Journal paper to my patient population? And maybe something about if I have a pediatric clientele or if I have a mixed clientele or if maybe if I see a kid, you know, once every month or so in my adult practice? Our goal for this paper was to really spread awareness for people to know and really make a concise document of what are the new indications because So many things have changed in the past 5 years, and it could be hard to, to keep up with it.

And so for someone working in pediatrics, especially as soon as you get that diagnosis of a profound sensorineural hearing loss, even if it’s a very young infant, to start the process then and make those referrals for a cochlear implant evaluation rather than waiting until they are 6 or 7 months to start the referral process, because just As anyone who works in a cochlear implant center knows, it takes time to move through the system and get all of the appointments with the surgeon and the necessary imaging. So the earlier that those referrals can be made is going to help these children reach that goal of implantation as early as 7 months.

Because that is, you know, even though that’s the criteria, that’s a little bit of a logistical hurdle for a lot of centers and a lot of patients to meet. And so the important component of that is an early referral as soon as that child is identified. And then for someone who works maybe with children who are a little bit older, seeing them a little bit later when they’ve been fit with hearing aids, but they might be struggling, to know that even if someone has good residual hearing, especially good low-frequency hearing, to still consider and keep an open mind that they might be better served with a cochlear implant.

So one thing that I would recommend people look at as well is the referral guidelines for a cochlear implant candidacy evaluation. Mm-hmm. As have the criteria changed, so has the criteria for who should even be referred for further evaluation. And so there’s a great organization called Cochlear Implant Patient Access to Hearing, or CI-PAF, and they just set new guidelines that are more in line with the current criteria. So on the adult side, we have 60/60 guidelines of when to refer. So for children, we have CI-360 ’cause there are 3 components.

So for children who you’re seeing in your clinic who have a 4-frequency pure tone average, of 60 dB or greater, they should be referred for a CI evaluation. If their aided word recognition score is 60% or less, they should be referred. And then if they have a hearing aid that their speech intelligibility index with the hearing aid is 0.6 or less, they should also be referred for an evaluation. And so if any kid is meeting any one of those 3 criteria, they should be referred for a cochlear implant evaluation.

Doesn’t mean that they are necessarily a candidate, that they will choose or go on to pursue a cochlear implant, but those referral guidelines are more in line with the current FDA criteria for children. So now I’m going to put on a parent hat here. And so I have a newborn, and I’m— and And I’m now concerned about their hearing because I was told by their audiologist that did an ABR or ASSR or some sort of an evaluation that told me they indeed have a profound hearing loss. What kinds of things should parents do and think about when they are moving toward the implant process for an infant?

So I think for parents, it obviously can be big news and sometimes difficult for some parents to get that news of their child having a profound hearing loss, especially if it’s not something that runs in the family. So they could not have familiarity with the device or with the technology beforehand. I would encourage parents to as much as possible keep up with those referrals and to try to move through the process as early as possible. So appreciating that there was a lot of work put in through the field to reduce the minimum age from 12 to 7 months, because that showed such a meaningful improvement for these kids.

And so for families who are wanting to pursue listening and spoken language for their children, to know that there is a little bit of a time— it is more of a time-sensitive issue. And so as much as there is going on when they have a newborn, and I’m sure there’s a lot of other competing demands for their time, but to— Absolutely. To try to keep up with those referrals and to know that these devices are safe and effective for this patient population.

And there’s, you know, 30-plus years of evidence to show how much they could do for children born with a profound hearing loss and how the devices And our understanding of how to program them have only gotten better in recent years. You know, not a long time ago, there was a lot of resistance for cochlear implants among the hearing-impaired community. And so have you seen any changes toward that, or do you have significant resistance sometimes for cochlear implants for infants of hearing-impaired individuals? Yeah.

So the tricky part is that if a family, for whatever reason, doesn’t show up to their evaluation or cancels the surgery, we don’t always have a good— we don’t always— are not always able to contact them to say and ask, you know, what their decision was and why and what factors led to them canceling an appointment or canceling a surgery. There has been a lot, especially on social media, uptick in people who are less, not as big of a fan of promoting cochlear implants for young children.

And I do think that a lot of families can be affected by that, especially, you know, once you start seeing something on social media, you just keep seeing that and it kind of becomes this endless loop that’s hard to break out of. But one of the things that we hope that families can take away from this article if they do stumble upon it is that importance of early intervention and knowing that if a child, if the goal for a child is to develop listening and spoken language, they need that access to sound early.

It’s not something that you can wait until perhaps the child is old enough to understand because at that point, that critical window for language development has far passed and the outcomes with the cochlear implants are going to be a lot poorer than they would’ve been had the child received intervention a lot earlier. You know, and these data that you’re referring to, kind of an overview, of course, because that’s all the time we have, but, you know, we should realize that these data that you’re referring to that talk about the early intervention and the earlier the better, Those data go back 50, 60 years. Mm-hmm.

And we’ve now found more refinement of the data based on current studies with the kinds of evaluation techniques we have, the kind of assessment of the data that we have. Plus, we have a lot of experienced patients that have grown up now with a lot of these things, and they’re even— they even testify that they have done so much better with an implant or early amplification and those kinds of things. So, were there some things that you wanted to add to our discussion here, Samantha, that we didn’t get to yet? I think we’ve covered it all.

I think just the big summary is that Early intervention, as we’ve known for a long time, is really important for kids, especially those with more severe hearing loss, and that we are continuing to learn and expand. So hopefully in a couple years you can come back and see— say that we’ve learned even more about pediatric audiology and cochlear implants to provide better outcomes for these kids. Well, To those of you out there today my guest has been Dr. Samantha Scharf, research assistant professor within the Department of Otolaryngology, Head and Neck Surgery at the University of North Carolina Chapel Hill.

Thanks so much for being with us today and giving us a very nice overview of the new FDA regulations for pediatric cochlear implants. Thank you so much for having me. You bet. So now, those of you out there as well, be with me next time when we provide another important audiological orientation to a topic at This Week in Hearing.