The Future of Cochlear Implants and Hearing Solutions

Can outdated criteria be holding back modern medical advancements? Join us as we sit down with Dr. Jace Wolfe, Senior Vice President of Innovation at the Oberkotter Foundation, to explore the revolutionary changes in cochlear implant technology and the urgent need to update the FDA criteria. Dr. Wolfe sheds light on how far we've come from the past two decades, emphasizing that with the right audiometric thresholds, cochlear implants can dramatically improve speech recognition compared to traditional hearing aids.

Discover the extraordinary impact of the Oberkotter Foundation and its subsidiary, Hearing First, in transforming pediatric audiology. We honor the groundbreaking work of Marion Downs and her relentless advocacy for early newborn hearing screening. Dr. Wolfe shares the inspiring mission of the foundation, dedicated to helping children with hearing loss achieve their full potential, while also pushing for more progressive cochlear implant candidacy guidelines to ensure the best outcomes for patients.

Finally, navigate through the complexities of different hearing technologies with Dr. Wolfe as your guide. From the life-changing benefits of bone-anchored hearing aids for patients with chronic ear conditions to the advances in frequency lowering technology for those with high-frequency hearing loss, this episode offers a comprehensive overview. We also discuss the powerful role of SoundField and personal remote microphone systems in educational settings, underscoring their value for both children and adults facing listening challenges. Tune in for a deep dive into the evolving landscape of audiology and technological innovation.

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Transcript

Speaker 1: 0:19

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Speaker 2: 0:40

Hi, you're listening to the Hearing Matters Podcast. This is Dr Douglas Beck and today's guest is Dr Jace Wolfe. Welcome, jace, glad to have you here.

Speaker 3: 0:48

Thank you so much, doug. It's a pleasure to be here. As you know, I've always been a huge fan of yours, so this is an honor to spend the day with you and chat a little bit, catch up.

Speaker 2: 0:57

Well, thank you, that's very kind. Let me read your bio sketch for folks who may not be as familiar. Dr Wolff is the Senior Vice President of Innovation at the Oberkotter Foundation. He is the author of the textbook entitled Cochlear Implants Audiologic Management and Considerations for Implantable Hearing Devices. He is the co-editor, along with my dear friends Carol Flexer and Jane Medell and Aaron Schaefer, of the textbooks Pediatric Audiology Diagnosis Technology and Management Schaefer of the textbooks Pediatric Audiology Diagnosis Technology and Management, third edition, and Pediatric Audiology Casebook, second edition. He's also a co-author of the textbook titled Programming Cochlear Implants, third edition, and he's published over 130 book chapters and articles in peer-reviewed and trade journals. His areas of interest are pediatric hearing healthcare, pediatric hearing aids and cochlear implantation, personal remote mic technology and signal processing for children. So that's quite a mouthful. Can I summarize it by saying you've been very involved in pediatric audiology for the first 20, 25 years of your career.

Speaker 3: 1:57

That's consumed my whole professional and whole life All right?

Speaker 2: 2:02

Well, I think pediatrics is probably just about the single most important thing we do, so the fact that it's consumed your life is a life well spent. Let me ask you some specific questions. Right now, in 2024, you know, we are just over 1 million cochlear implants globally. Of course, about 65% of that market goes to cochlear, and you have Advanced Bionics and Med-El, and so these three companies really dominate globally, and particularly in the US, because those are the three that are FDA approved and they do a great job. But each of the cochlear implants, my understanding, has a little bit different criteria and that's a little different than the FDA criteria. So I wonder can you address that for us, just to get everybody up to speed, what is the FDA criteria? And then let's look at some of the manufacturers.

Speaker 3: 2:49

Sure, sure. So there are a couple of things that are important, and one, as you mentioned, are the FDA indications for use. One thing I think that's important to point out about those for the most part they haven't been updated for like almost 20 years, if not longer, and that's especially true for most of the indications for use for children, and so they're really conservative because when they were written we didn't know as much about cochlear implants as we know now, and most people who were receiving cochlear implants were completely profoundly deaf. You know, early on there was a hope that they would be a good aid toward lip reading. You know, early on there was a hope that they would be a good aid toward lip reading, but I don't think anybody envisioned or dreamed that cochlear implants would provide the same amount of success as far as open set speech recognition is concerned as they do with modern technology now.

Speaker 3: 3:37

So the indications for use with adults that the most lacks are with cochlear. They define that you have to have a moderate to profound hearing loss, but that's kind of vaguely defined, which in some respects is probably a good thing. Does that mean that it could be moderate across the audiometric frequency range or moderate in the lows and profound in the highs. And if you have an 8,000 Hertz frequency at 90 and everything else is better than that, does that qualify as profound in the eyes?

Speaker 2: 4:06

I'm so glad you're addressing this. And it's not just cochlear. We don't mean to pick on them. This is the language used throughout all of these scenarios, and when I started with cochlear implants back at the House Heir Institute in the early 80s this is years before the FDA approved it In order to get a cochlear implant you had to have a complete psychological profile, you had to have 110 dB thresholds and you had to have no lip reading benefit from wearing hearing aids. Back in those days, right, we had the Mac battery, which was the minimal auditory's capability, and I think it was Dorcas Kessler and Elmer Owens I might have that wrong, but I think so and so we would spend hours and hours and hours really going through who is a candidate and who is not, but they all had to have 110 dB thresholds. And now you're saying down to a moderate level. So moderate, by common definition, would be a four frequency pure tone average of about 41 decibels or worse, right 41 to 70, I believe, is that category.

Speaker 3: 5:03

That's correct.

Speaker 3: 5:04

And one thing, doug, I think that would resonate the most, maybe, with your listening audience is that, in particular, if the audiometric frequency, if the thresholds, are 60 dBHL or above, then you should start asking the question of whether the patient might potentially do better with a cochlear implant than a hearing aid, which also seems to be a pretty liberal criterion audiometrically.

Speaker 3: 5:29

But I think a couple of things are cool about that, and one is that there are a number of different studies, both in the pediatric and the adult realm, that show that if you refer patients for a cochlear implant evaluation when they have 60 dB HL audiometric thresholds, many of them will end up not only qualifying and being a candidate for a cochlear implant, but they'll score better, they'll understand speech better with cochlear implants than they do with hearing aids, and so we've got evidence to show that. That's, you know, not just something that cochlear implant audiologists dreamed up in their zeal to try to get more cochlear implants to people who might benefit, but that's an evidence-based recommendation from Terry Zwollin, who used to be at the University of Michigan and is with Cochlear now, based on a large number of speech recognition scores that she looked at with patients with hearing aids, who eventually got cochlear implants.

Speaker 2: 6:16

And why do you think it's at that level? I have a theory, but that was my second point.

Speaker 3: 6:21

You're ahead of me and you know, you and I, I know that you have a strong background in electrophysiology and just an interest in physiology as well and, as you know, you can explain a mild hearing loss. You can explain the hearing loss that's 50 or 55 dbHL or better just solely through outer hair cell loss. But once your thresholds start to exceed 55 or 60, it can't be explained any longer with just outer hair cell loss, absolutely. But once your thresholds start to exceed 55 or 60, it can't be explained any longer with just outer hair cell loss. You're going to have to have some inner hair cell involvement as well. And when you start to have some inner hair cell dysfunction or loss, then even if we provide audibility with hearing aids, we might be sending an impoverished signal to the cochlear nerve.

Speaker 2: 7:02

So, that's my theory.

Speaker 3: 7:04

I'm interested.

Speaker 2: 7:05

What's your theory? No, I was going to say very much the same thing that once you hit about 55, 60, 65, it varies across human beings you start to involve the inner hair cells and inner hair cells are the essence of the auditory synchrony that one needs in order to have interaural timing, interaural loudness and to truly listen, to assign meaning, to sound. Prior to that, when you're talking about just an outer hair cell loss perhaps 40, 50, 55, 60 in some people, that's just a matter of loudness. We can some more or less replace outer hair cells by giving appropriate loudness in the appropriate spectral range. But once you hit an inner hair cell loss which again is probably 55, 60, 65 in most people, that's when auditory synchrony goes away and that's when, no matter how loud it is, no matter how much audibility you have, you're not going to be able to hear clearly.

Speaker 3: 7:54

Yeah.

Speaker 2: 7:55

I think you're exactly right.

Speaker 3: 7:57

It's interesting. You mentioned doing work at house back in the 80s and 90s with cochlear implants, and in the 90s was when I started school, you know, same time. Did you say that to make me feel? Good, not kindergarten, but audiology school All right, all right.

Speaker 3: 8:15

Back at that point in time, like you said, people had to be completely deaf to get cochlear implants, and I was fascinated by the work of Chris Turner and Cynthia Hogan and Dennis Byrd and Harvey Dillon, larry Humes. They were some of the first that showed that. You know, even if we provided audibility, when thresholds are above 55 to 60, you start to see diminishing returns and, in some cases, no benefit. So back then I was asking myself the question well, hearing aids don't work as well, you know, with audiometric thresholds in that range, but you're not a cochlear implant candidate until you have 110 dB thresholds. Now what do we have to offer for all these people who are going to really struggle?

Speaker 2: 8:53

Yeah, and now in 2024, and as we have for the last five or 10 years, we have all sorts of different electrode options, because we understand that if you insert a standard cochlear implant electrode into the cochlea there's a potential to do some damage to the residual hearing. So now we have electrode options and we have technology options that help to maintain the residual hearing that the patient has prior to cochlear implantation. Can you talk about some of those options?

Speaker 3: 9:21

Yeah, it's changing so fast and there are so many advances that are being achieved in that space, and so you're exactly right. I mean we have shorter electrode arrays that are only inserted into the basal portion of the cochlea. They completely avoid, just physically, the apical regions, and of course that's to try to avoid damaging the delicate sensory and structural cells or structures in that part of the cochlea and hopefully preserve low frequency residual hearing. We also have softer, flexible electrode arrays and there are a lot of studies that show that with those softer, flexible, skinnier electrode arrays, even if you get a full insertion all the way toward the apex of the cochlea, if it stays in the scala tympani, you could still get almost full preservation of hearing, which is just remarkable. So you can kind of have your cake and eat it too.

Speaker 3: 10:10

I mean, eventually, if there's a progression in that low frequency hearing to the point where they don't benefit from amplification anymore, then you can enable those electrodes and start providing electrical stimulation, but also surgical techniques, softer surgical techniques, but also surgical techniques, softer surgical techniques, slower insertion, robotic-assisted insertion to really guide a slow insertion into the scala tympani. And then we have interoperative electrococleography as well, so as it's being inserted, you can read the response from the cochlea and you can get real-time feedback that you can provide to the surgeons to kind of guide them in a soft surgery to try to avoid damage. So you're exactly right. Sometimes we can electrically stimulate those high frequencies and leave the low frequencies alone.

Speaker 2: 10:53

Which is kind of brilliant when you think about it, because what happens over many decades of use is the technology changes dramatically. Is the technology changes dramatically and what we've seen from the early days when I was involved 16 kilohertz, karyotones, single ball electrodes, things like that you know, in an analog world many I don't want to say most because I don't really know this to be true but I think many patients who got cochlear implants in the late 60s, 70s, into the 80s did eventually get upgraded and it was nice that you could take a ball electrode out and insert a digital electrode, lead that had, you know, more hotspots on it, more channels, more electrodes, and you could do that without damaging the cochlear structures.

Speaker 3: 11:37

Yeah, it's amazing. I'm so jealous that you got to work with Dr House and you know he's obviously just a pioneer in that area and we owe so much to him just for his courage to explore that. I mean, he was ridiculed in the otology circles at different conferences for thinking that that would even work. That it was. I mean, people questioned his ethics for doing that, bill.

Speaker 2: 12:00

House. He was beat up so many times verbally and Bill always said when you find yourself within the company of the majority, it might be time to rethink your position. Bill also pointed out that it was the scouts and the leaders in the front of a posse back in the days, right, the people who were the leaders. They're the ones who got all the arrows. And I could tell you story upon story I think it was 60, 61, he did his first three cochlear implants in Los Angeles, so this goes back 65 years ago, and it wasn't approved until 86 by the FDA. So he had that 25-year period where he was being ridiculed.

Speaker 2: 12:42

Bill House also, in addition to being probably the world's foremost proponent of cochlear implants, he developed things like the trans-labyrinthian craniotomy, which is how we go post-auriculary to the skull base to remove acoustic neuromas. Now, bill, in those early days when he was working with Dr William Hitzelberger, who was a neurosurgeon, the nursing staff would hide Dr Bill House's surgical instruments and they would say we don't allow this ear doctor to be working on brains. The nursing staff did that, wow, oh yeah. And and Bill went through so much ridicule and he is I would say this lovingly Number one. I consider him a personal mentor because I worked with him for four or five years.

Speaker 2: 13:25

But number two, I hope to one day have one 10th of the fortitude that Bill had. That you know, this is what the science says and you could disagree, you could have your own opinion, but you don't get your own science. And Bill, because he was so amazing as a human being, he could persevere, he had the wherewithal and he had the gastrointestinal ability to just suck it up and move forward. So I could go on for two hours. But it's your interview. But you mentioned one of the most important people in my life, dr Bill House, and I'm so glad you did.

Speaker 3: 13:56

Thank you for that I could talk to you all day about this and it's funny just the timing of this conversation because you talk about getting out in front and taking the arrows and being a disruptor, and those are the people who facilitate change. And one of my colleagues here at the Oberkotter Foundation. I just had the pleasure of listening last week to her give a presentation on the history of pediatric audiology, especially as it relates to the Oberkotter Foundation, and she was enamored with the research that she had done on Marion Downs and she took a lot of criticism for her belief that number one it was better to go early, which just seems bizarre today that it was critical to do that, but that you could screen in the newborn period as well, and without her really pushing.

Speaker 3: 14:42

that it makes you wonder how long it would have taken to get to the point where we are now.

Speaker 2: 14:48

Tell us a little bit about the Oberkotter Foundation, because right now I do believe you are a vice president there. That's correct.

Speaker 3: 14:52

That's correct. Tell us a little bit about the Oberkotter Foundation, because right now I do believe you are a vice president there. That's correct. That's correct, and I'm so happy to be here and so excited about the work that we have planned for the future. You know the story of the kind of genesis of the Oberkotter Foundation. It's really almost a romanticized story. It's a really neat story. Mildy Oberkotter was born in the 1930s with significant hearing loss and so of course this is before newborn hearing screening, before digital hearing aids and probe mic and cochlear implants, all those things. Her father started out for a carrier service a little before her birth and he started as a stenographer and slowly worked his way up the ranks in the company.

Speaker 2: 15:32

And was that UPS? Right? Okay, that's what, yeah, which is just stunning.

Speaker 3: 15:37

So in 1985, he started the Overcutter Foundation in honor of his daughter, but it was really his daughter, mildy, who decided that the primary focus of the Overcutter Foundation really needed, and Mildy's unbelievably brilliant. She's been extremely successful. She learned through visual and tactile cues to learn to speak and to communicate orally and aurally and has really, by all levels at which she would measure success, she's had an incredible life. It was her decision to really invest that money to be able to give opportunities to children with hearing loss really that she didn't have, but for them to really reach their full potential in their listening and spoken language and literacy development.

Speaker 2: 16:21

So really a remarkable person, very selfless thing to do and Oberkotter to this day, I believe you can go to the website and you can take free CEU courses. Right that? Are AAA or ASHA eligible for CEUs? That's correct.

Speaker 3: 16:35

There's a subsidiary of Oberkotter called Hearing First, and Hearing First provides information for professionals who work with children with hearing loss and then families as well, and there are also digital communities where families can interact with one another and ask questions with one another or two professionals, and the same thing, too. There's a community like that for professionals as well. But we have short kind of crash learning courses on hot topics in audiology like genetics or auditory neuropathy. We're going to have a month where Jay Hall and Marlene Bogato and Renee Gifford and Ryan McCreary are going to talk about the literature the best audiology literature for 2023 in cochlear implants, hearing aids, diagnostics and then miscellaneous issues.

Speaker 3: 17:21

So if you're too busy to keep up with the journals. You can just weigh in, you know, just participate with that, but no charge at all to take any of these courses. They'll all be placed on demand as well, and you can get free continuing ed credits through AAA and ASHA for participation.

Speaker 2: 17:38

That's fantastic. So my hats off to the Overcollar Foundation. Thank you so much for all you do for people with hearing loss and, in particular, for children. Absolutely stellar. I wish we had more organizations like that in the US. So I hate to get us off topic because we're rolling and we haven't yet hit the outline, but some of the FDA criteria is very old, going back decades, and each of the manufacturers on their out-of-the-box regulations and guidelines for who is a candidate. They're all a little bit different. So can you discuss for us what would the differences be across different manufacturers? Are there any really obvious differences that jump out at you as to when somebody is a candidate for X versus Y versus Z?

Speaker 3: 18:22

Yeah, that's a great question. There's a common theme and all of the guidelines and the indications for use are super conservative because they were written and approved so long ago. Cochlear is the most lax. For adults. You can have no more than a 60% sentence recognition score in what's called the best aided condition and no more than 50% correct in the ear to be implanted For advanced bonics and MED-EL. It's close, it's 40% and 30%. So the speech recognition scores are pretty close and those are for sentence recognition tests.

Speaker 3: 18:59

But here's the thing with all of those indications of use. What the most important determinant is is what the criteria are for the payer. So if it's a commercial insurance company, each one typically has their own policies and oftentimes they mirror the indications of use, but sometimes they're a little different, like they might actually call for the use of CNC words instead of sentence testing. And then you have CMS and CMS. Recently it was 40% or less than the best-aided condition was CMS, but that recently was increased to 60% or less in the best data conditions with CMS, but that recently was increased to 60% or less in the best data condition. That was due to work from Terry Swollen and Craig Buckman at Washington University.

Speaker 2: 20:56

Yeah, and the percent correct scores on these, whether they're sentences or word recognition, scoring quiet. How confident do you feel with the test, retest of those scores? Because I think they're often they have a lot of latitude.

Speaker 3: 21:09

Yeah, you're exactly right. I mean there's been some great research. Margo Skinner, a long time ago, looked at the test, retest, reliability of C and C words and she showed that you know two things. Number one she recommended to do two full lists, so 100 words, to get a good measure of you know of how well people are able to understand those monosyllabic words. And she also identified list pairs that, when put together, were equivalent across the different lists within the full battery of CNC words, and the same thing with AZ bio sentences. That's kind of the standard that we use right now to evaluate speech recognition and cochlear implant recipients and there's a lot of variability across one list to the next. And so there's been some work that shows kind of what the more difficult lists are and the ones that are the easiest, with recommendations for what to use.

Speaker 3: 21:59

I'll tell you something really interesting that I think you'll find interesting. I've definitely had a ton of adult patients who can score near perfect on cnc words, you know. So there's no context there with auditory, visual stem, auditory only, auditory only. Wow, yeah, yeah, I mean you know really pretty routine, that I would have adult patients who would score in the 80s or 90s on cnc words, just auditory only now hold for a second.

Speaker 2: 22:23

For For those who don't know, cnc that's consonant, vowel consonant. So a pa, a ba, a ka, a ga, a sa, a sha, a fa, a va, a ra a la a ma, but these are actual words, so like cat and please and for and car and actual monosyllabic words. So you have the same format, but you're using words instead of phonemes, and virtually 100% with cochlear implants words instead of phonemes and virtually 100% with cochlear implants.

Speaker 3: 22:51

That's correct and I will say this in most clinical studies the mean score on the CNC word test for adults with cochlear implants is around 65% correct, and there are a couple of factors that are responsible for that. I mean sometimes you have adults who have been deaf for a really, really long time across the audiometric speech frequency range, and so their outcomes aren't as good. And then the other thing that can happen is that you know you have adults who they wait eight or 10 years before they get hearing aids. So you have some auditory deprivation that changes the auditory nervous system and then they get hearing aids and then they reach the point where hearing aids really are no longer that beneficial. They can still hear, but not understand as well.

Speaker 3: 23:25

So they don't have total deprivation but they wait another eight to 10 years before they get a cochlear implant and so those scores can sometimes kind of taper off and bring down the mean. If you have an adult who has a relatively shorter duration of deafness and the surgeon gets it in the scale of tympani, they're going to score 80% or above in most cases. And what's really remarkable, doug kids, when I was at Hearts for Hearing we had data and the group at NYU had data with kids. Shani Detman in Australia has data with kids. Kids typically when they get their implants early, almost always score 90% or above. You know, if they get them early and they wear them all the time because they have no deprivation and they have no wear or tear of their cochlea, you know kind of put them over time so they outscore adults. But the key is to get it early and to make sure they wear it during all waking hours.

Speaker 2: 24:18

So tell us, how do you use auditory only versus visual only versus a combined presentation?

Speaker 3: 24:24

Oh, great question and you're spot on. And you know, unfortunately today we don't use the visual assessment anymore and the reason is and we should probably kind of revisit and get back to that but the reason is is that most patients develop really great open set speech recognition so we can show the benefit and we can get a measure of how they're performing auditorily with the cochlear implant, with just the auditory only administration of those tests and yeah, it's really cool. It's really cool and the kind of standard of care tests that we use to evaluate just post-operative cochlear implant outcomes, especially in adults but older children. As well as the CNC test, which stands for consonant nucleus consonant it's a consonant, vowel, consonant, monosyllabic word test, really similar to the NU6 test and you know most of my patients that I served would score above 80% on that test in the auditory only condition, with many scoring, you know, in the nineties or near perfect on that test.

Speaker 2: 25:25

Incredible. And this is how, long after cochlear- implantation.

Speaker 3: 25:29

There's a lot of great research that looks at that. Renee Gifford in particular has shown that people kind of hit asymptotic levels as early as like three to six months. It doesn't take long.

Speaker 2: 25:40

Astounding, astounding. So if you were to counsel a patient today, so supposing you have a patient 85, 90 dB loss, so severe to profound loss, and their word recognition and quiet zero to 20% and recently deafened, let's say in the last 12 to 18 months, what do you feel comfortable saying to that patient as far as the long-term outcome for that individual with cochlear implants, and talk about also bilateral versus monolingual?

Speaker 3: 26:05

Yeah, gosh, all great questions.

Speaker 3: 26:07

So my expectation for that patient with only 12 to 18 months duration of deafness would be that they would develop excellent, open, set speech recognition.

Speaker 3: 26:16

And that's the kind of patient that I would definitely expect their CNC word scores to be in the 80s or 90s. I would expect that kind of patient to be able to communicate over the telephone very effectively, to be able to go back to restaurants and communicate noise, to be able to understand speech over the television maybe still keep the captions on, but to be able to really understand also the words and dialogue over a television. But counseling those kind of patients there's an art to it, because you want to manage expectations and you know I've always told the students that I've worked with or the new clinicians that what you want to do is that you want to try to set expectations as low as you can without chasing the patient away. If you think that a cochlear implant will benefit the patient, you want to set those expectations super low but make sure they still, you know, conclude that a cochlear implant is a good idea and then after the fact, you do everything you can to exceed expectations.

Speaker 2: 27:09

I think that's a great way to go, you know, is to under-promise, over-delivery, right? That's the yeah, okay, yeah, that's it. So you and I had a discussion a while back about bone-anchored hearing aids, and I'm not opposed to bone-anchored hearing aids. In many populations, the one that comes to mind for me personally is people with chronic ear disease. You know, they might've had two or three mastoidectomies, they might've had a tympanoplasty along the way, and they're just not, you know, surgical candidates any longer. They have a maximal conductive loss or substantial conductive loss, and in that case bone-anchored hearing aids always made sense to me. I remember when we did our first one back at house gosh mid 80s with a company called Zomed Trees. Back then, tell me your criteria. What do you think about bone anchored hearing aids and who's the ideal candidate for it? I've seen some people get bone anchored hearing aids that, frankly, as an audiologist, it didn't make much sense to me.

Speaker 3: 28:04

I think we're on the same page on this. I think these devices can be life-changing for people who have especially maximum conductive hearing losses that are inoperable, especially if they have a draining ear, that they can't wear hearing aids because of a draining ear. I've seen these be life-changing, obviously, for children who are born orally atretic, where there's not an article even to put a hearing aid or a way to deliver sound to the ear canal, and I think these devices are great for that kind of niche population that we serve. There's research that shows that if the air bone gap is greater than 30 decibels that a bone conduction device is supposed to provide better audiometric outcomes than hearing aids. But when you go back and look at those research studies they're not particularly well designed and they're old and, as we know, hearing aid technology has improved so much over the last several decades that maximum output without distortion is so much better. Gain before feedback is so much better that I'm not necessarily certain that 30 BB is a good evidence-based cutoff for an airbone gap, you know, for determining candidacy. But I'm with you.

Speaker 3: 29:13

I think significant conductive hearing losses that are inoperable are the best patient population for that device. You know it's also approved indication of use with single-sided deafness. But I'm not a huge fan of that. I mean, I've seen patients wear it when they have single-sided deafness, but it essentially just serves as a cross device. It's not aiding that ear, it's just delivering it over to the opposite ear. It doesn't improve localization, it doesn't improve speech recognition and noise when speech comes from the front Most of the things that we associate with single-sided deafness. Those are still going to be challenges.

Speaker 2: 29:49

And wasn't there a time I want to say 15 years ago when the FDA approved bone-anchored hearing aids for single-sided deafness, or am I confused on that?

Speaker 3: 29:57

It is approved by the FDA and I'm not for sure the exact time period, I'm thinking maybe 18 or 20 years ago.

Speaker 2: 30:03

But my point on that is that you have the Weber effect. So if this ear is dead which would be my right ear and I put a device here, the sound will be perceived in the better cochlea or the more conductive ear. And so you're exactly right. I know that I had read a few papers where very few patients would get some sort of localization ability and maybe it was a tonal thing that they would pick up on. But in order to localize, you know you need interaural loudness differences, interaural timing differences, head shadow effect. You know you need these things, that sort of mandate. You have to have two inputs right, kind of like directional hearing localization.

Speaker 2: 30:45

Some people, you know, do remarkably well with one device that breaks all the rules. But I wouldn't think of that as my go-to. And I do like the idea. If I had a substantial sudden sensory neural loss 60, 70, 80 dB I'd vastly prefer a cochlear implant because then I'd be able to use the worst ear as an ear and still get signals in there. So now I can compare and contrast my left and right ear, now I can localize, now I can get independent word recognition in my worse ear.

Speaker 3: 31:13

Yeah, you're spot on. I mean, we're exactly on the same page. I believe that for individuals with single-sided deafness, cochlear implantation should be the standard of care, without a doubt. That's the only way to stimulate that ear again and get sound to that ear, and that's the only way that you can start to kind of approach binaural hearing again. It's not going to be perfect because you can't restore those low frequency timing cues with a cochlear implant.

Speaker 3: 31:37

But you certainly can capitalize on the high frequency interaural level differences and there's a wealth of studies that show better localization with single-sided deafness when you get an implant on that side. And there are a wealth of studies that show better localization with single-sided deafness when you get an implant on that side. And there are wealth of studies that show improvement in speech recognition and noise as well. Another biggie is that a lot of patients with single-sided deafness have really bothersome tinnitus in that poor ear as well. And in many cases when you restore stimulation to that ear too, that tinnitus will go away, or it's at least the very bothersome. And you don't get that with the bone conduction device either.

Speaker 2: 32:12

Yeah, I think you're exactly right. I think you're exactly right. I wanted to just get your thoughts as well on frequency lowering when would you recommend it or would you recommend it, and who are the best candidates?

Speaker 3: 32:22

I think there are again kind of niche candidates for this. I don't know if you remember or not, doug, but probably back in like 2012 I was at the halseer institute. There was a workshop being done like a weekend workshop being done for dispensing audiologists, and you and dave fabry and gus muller were there, and so we were the four presenters and you were so kind to me I was just getting started you know, well, I didn't know you publishing and it was.

Speaker 1: 32:47

You were so nice, I mean you, I was just getting started, you know, publishing.

Speaker 3: 32:48

You were so nice.

Speaker 3: 32:49

I mean, you treated me like an equal when I'm in the room with these gods of audiology who are the others giving the presentations.

Speaker 3: 32:55

But ironically enough, my presentation that weekend was on frequency lowering technology, and back in 2012, 12 years ago, everybody was interested in it. It was kind of, you know, still kind of the new kid on the block in a way, and I think it still was a pretty relevant technology back then, because receiver technology was so much more limited back then. You know, I mean hearing aids would roll off, especially power hearing aids, at around 4,000 Hertz, so you couldn't gain access to those higher frequency sounds. And also, to kind of go in full circle to our earlier conversation, we didn't have the shorter hybrid cochlear implant electrode arrays at that time as well, and so I think, even though it was far from a perfect technology, it tried to provide some benefit for people for whom there was no other option. But you know, today, for people with moderate hearing losses, before I think we needed frequency lowering technology to help those patients hear the highs. Now I think hearing aid bandwidth is sufficient to amplify those sounds. That's very interesting.

Speaker 2: 33:55

Yeah.

Speaker 3: 33:55

Yeah, yeah, still stimulate the cochlear nerve, avoid auditory deprivation and get a good outcome.

Speaker 3: 34:01

And then, when you know you have really significant high frequency hearing loss, maybe a cochlear implant should be considered and would provide a better outcome. But I think for patients, for children, if they do really well with hearing aids, if they're not a cochlear implant candidate but you can't provide full audibility of all those high frequency sounds and you know Pat Stomachowitz and others have shown that you really need to hear out to seven or 8,000 Hertz at least if you're a child to be able to hear a female S. You know you can exactly use contacts to surmise that there's an s there, and so I think using that to try to make that available for children and there's evidence that shows that it works, um, and we we did a lot of that research with kids almost a decade ago, if not longer, and then for adults, I think you have to be more careful because it is a form of distortion and it might be hard for them to adapt to and they might not think it sounds good.

Speaker 3: 34:50

But if you have an adult who they can't hear from 4000 hertz and beyond, again, that information can still be important for adults. And using some mild compression to squeeze at least a portion of that part of the speech frequency range to make it at least partially audible, I think could be helpful. I think it's critical to use Probe Mic to look at the audible bandwidth without frequency compression, determine what they're missing and then turn it on and see what kind of settings need to be provided to restore some audibility for like an S sound.

Speaker 2: 35:22

Yeah, that's very interesting.

Speaker 2: 35:24

I thought you would be a larger proponent, to be honest, because you know there were quite a few papers 90s and early 2000s showing really interesting and good results on different pediatric applications.

Speaker 2: 35:37

But I think you're right. You know, I remember in 2005, I wrote a paper with Jess Olson and we're talking about bandwidth at that point that had, at that point, 2005, which is not long ago just started to go out to eight to 10,000 Hertz on commercially available hearing aids and now some of them go out to 12,000 Hertz and admittedly, you don't have as much audibility there as you might like on many fittings, but on some fittings, you know, if you're particularly focused on giving children sound between 4,000 and 8,000,. You know we have different ear mold plumbing things we can do. We have different types of filters. Now we have much better transducers in the microphone and the receiver. So it's interesting. So what I'm hearing you say is it seems like it's a good idea sometimes here and there, now and then, but probably the go-to is to use the hearing aid if you can, because your hearing aids in 2024 can do an awful lot more than they could in 2012.

Speaker 3: 36:27

I think so exactly, and you know well, before all the major hearing aid manufacturers had this technology, there was the Israeli company ADR that produced a device with frequency transposition and it was really kind of tailored for people who have what now we would consider to be cochlear implant hearing losses, and they kind of had corner audiograms precipitously sloping, and you know a lot of those. You're right, those devices were beneficial but typically, like especially for monosyllabic words, people might improve 10 to 15 percent. And now individuals with those kind of hearing losses when they get a cochlear implant, oftentimes they improve 50 to 60 percentage points, if not better.

Speaker 2: 37:09

Sure, and that's a very, very pragmatic approach. I appreciate that and I know we're over time. But I've got one or two more questions for you. I know you've written a bit about sound field amplification and there was that brilliant book goes back gosh 20, 25 years ago. 20, 25 years ago it was back in the day when it was plural, singular publishing and it was Carol Flexer, joe Smaldino and I want to say Carl Randall Roadbook on sound field applications for classrooms.

Speaker 2: 37:37

So for those not familiar, sound field amplification is when the teacher might have a microphone right here in some sort of an FM or digital remote mic configuration, but in the corners of the room perhaps you would have excellent sound field speakers so the teacher could speak at a normal volume but it would be amplified through the speech frequencies. For the children with hearing loss in the classroom. Turns out most people really benefited from that, whether they had hearing loss or not. Okay. So the question If you have children in 2024 with, let's say, add, adhd, auditory processing disorders, things like that, so their hearing is relatively normal, threshold hearing, but their listening ability is not as good as the other children might have, would you recommend SoundField or perhaps low-gain hearing aids in 2024?

Speaker 3: 38:30

That's a great question, you know. I think all children in the classroom would benefit from a SoundField system and I think you know the improvement that it provides in the signal-to-noise ratio would particularly benefit children who would have some listening difficulties, especially if you can. You know you have some test results that you're certain are valid that show that they struggle some in noise. I think those children probably benefit even more so from a personal remote mic system. You know there are low gain or transparent devices that keep the ear open and the signal that's captured by the remote microphone that the teacher wears or that's passed around to the other students can be delivered directly to the ear.

Speaker 3: 39:11

And a sound field system, even a dynamic sound field system, that increases its gain as the ambient classroom noise levels increase. You know at most you probably expect like a five to eight dB increase in the SNR with those types of systems SNR with those types of systems, whereas with a personal system you can get upwards to 15 to 20 dB increases. With a dynamic personal system that would also increase its output as the ambient noise levels increase. So that would, if a child was really struggling with a listening difficulty in noise, that would probably be my first recommendation. You know the question about low gain hearing aids for children with normal hearing sensitivity and listening difficulties. I kind of feel the same way, but a little different than I do with adults.

Speaker 3: 39:54

I mean, I think there's so much more to learn there you know, and if that's due to some kind of a synchrony type condition, could a higher output kind of synchronize those auditory neurons a little better? Maybe, so, you know, could they benefit from a directional microphone or some of the noise management technologies in current hearing aids? Maybe so I think. Without a doubt we want to avoid occluding the ear, because I think that could potentially make things worse, at least in some situations. But I don't feel entirely comfortable climbing out on that limb and saying I would recommend doing that routinely with children with normal hearing thresholds, just because I feel like there's a need for more work and research in that area.

Speaker 2: 40:36

So let's talk about adults for a minute. So for adults who super threshold listening disorders, or they might have subclinical hearing loss, or they might have central auditory processing or auditory processing disorders, but they have relatively normal acoustic thresholds, what are your thoughts then on the adult population wearing a low gain hearing aid despite relatively normal thresholds?

Speaker 3: 40:59

You know one thing about adults is that they're their own boss and so they can kind of make their decisions. You know about. You know number one, the investment in that kind of technology. And then number two, on the backside, does the benefit justify the investment?

Speaker 3: 41:13

And I haven't recently done a lot of clinical work with adults who are hard of hearing or, you know, who have listening difficulties with normal hearing sensitivity and use hearing aids.

Speaker 3: 41:23

But when I oversaw a large clinic that had a team of audiologists that did that fairly routinely, they would have people who were coming in and they were struggling mightily. They had normal hearing thresholds. They would do the quick SYN test with those individuals and oftentimes their quick SYN score was really elevated. And if the patient was game they would do a trial with hearing aids. And you know the good thing about the trial is they can bring it back if it didn't benefit. But many of those patients would keep the hearing aids and they swore that it provided considerable improvement. So I think there's a place for it. I just think that you have to work with each individual patient because I think there's so much variability on what the underlying physiological cause might be and then just behavioral, subjective characteristics from one person to the next about the motivation of using it, what kind of environment they're in, that sort of thing.

Speaker 2: 42:13

Yeah, it's still a hot area for us. Going back to Jeff Danhauer, he and I wrote a paper in 2019. It was peer-reviewed, I think, at the Journal of Laryngology EMT Research and we had said at that point that there's about 38 million americans with hearing loss on an audiogram and we said there's another 26 million adult americans who have subclinical hearing loss. They have difficulty hearing, they have terrible difficulty in speech and noise and we were advocating that we we need to have firm strategies for them and beneficial protocols, because telling them their hearing is normal for their age doesn't help anybody. Telling them that, oh, your hearing is normal, you don't need hearing aids not helping them. So what we were advocating back then is kind of the same idea that a trial with speech spectrum enhancing gain maybe 5 or 10 dB would be beneficial for many people, most of the time Now will everybody jump on that bandwagon?

Speaker 2: 43:10

Absolutely not. About two-thirds of the patients, typically, I would expect, would find it interesting or beneficial and about one-third would say it's not worth the problems. I don't want to stick this in my ear, I don't want to pay for it, you know, whatever it is, but I do think that there are these 26 million people in the USA who have hearing difficulty, have speech and noise disorders. They're adults and they might benefit from somebody trying this, and it gets us into areas that are a little uncomfortable because some people would say, oh, you have normal hearing, you don't need hearing aids or amplification. Well, that's just not true. I mean, you can have normal thresholds and have tinnitus. You can have normal thresholds and have subclinical hearing loss. You can have normal thresholds and you can benefit from an enhanced signal to noise ratio. That's the goal and I like your approach With adults. You know you can let them try it. If it doesn't work, they can take them out of their ears, they can return them. They've got 30, 60, 90 days, whatever. But I think the key here is that we're seeing more and more people across the board.

Speaker 2: 44:09

There was a brilliant paper came out in 2023 in ASHA where the authors said that there was 23 to 25 million people in that situation, where Jeff and I had said 26,. But either is fine. The point is that these were mostly veterans and what they said is that these are folks who had extensive noise exposure maybe explosive, maybe noise trauma, things like that and their hearing thresholds were normal, but their ability to understand speech, and particularly noise, was terrible. So they were getting trials with hearing aids and the vast majority of them chose to get the amplification after giving it a try for a month or two and they found in certain situations it was really very, very useful. So I don't think we have good guidelines of this, one of the questions that comes up all the time when I lecture on this and when I write on this. People say, well, okay, normal thresholds, cool, and the guy's got trouble understanding speech and noise, cool, so you're improving.

Speaker 2: 45:00

The signal to noise ratio Makes sense, got it? How do you know how much gain to give them? And this is a big issue, right? Because a speech and noise test I wrote with Lauren Benitez. We included some of these folks, so we put in about 30 dB thresholds at 250, maybe at 1k. We use 25, 2k, 25, 3k, 30, 2k25, 3k30, 4k40, just to give appropriate sort of starting points of gain. And that worked out okay. But the more important thing we said is there are no guidelines for how much gain you're going to give these people. But what you really have to do is make sure that you're doing real ear measures so that when you're giving quiet, medium and loud input you're sure that you're not causing damage to the auditory system by over-amplifying Because you want the lowest possible MPO. As far as I can figure with, 15 dB of functional gain would be just grand. I think. More realistically, it's going to be closer to 5 to 10 dB of functional gain through the speech frequencies. How would you sit here in that situation?

Speaker 3: 46:00

I agree with you, and I don't know that there's enough research out there to make an evidence-based recommendation on how to do that. But here's my prevailing thought on this is and it's something that kind of concerns me a little bit about our profession is that I think we need a better diagnostic test battery to really identify the site of lesion and the underlying cause for these issues.

Speaker 3: 46:24

Because, as you know, there's research that shows that people who have extended high frequency hearing loss beyond the conventional audiometric test frequencies, that that might be a harbinger of damage. That's happened in the auditory system that you know might in a subclinical way be affecting outer hair cells within the audiometric speech frequency range. And some people who have hearing loss outside of the audiometric speech frequency range they have more trouble in noise. And so if that's the case, if it's subclinical outer hair cell damage, maybe the boost from hearing aids would help. But if it's because the outer hair cells, they're the cochlear amplifier but they also help with spectral resolution as well.

Speaker 3: 47:04

So if it's a spectral resolution, issue is that going to be helpful to give more gain, you know, because you're going to get more spread of excitation.

Speaker 3: 47:11

Even I'm not for sure, you know, and if it's type 2 auditory nerve fibers, the nerve fibers that code higher level inputs, the more gain we provide, the higher the output level for the signal, you know, maybe the more difficult it is to code those signals. And so I, in my opinion, I feel like we need more tests, we need more tools, we need more research to develop those tools and help us understand how to use those tests. The spatial processing disorder, which presumably might be more in the cerebrum than it is in the nerve, you know, or in the cochlea, you know. I just think we need that. And what worries me about this, doug, is that I feel like there's still a lot of good audiology research in the technology realm, because there's a dollar to be made there and so there's funding available, you know, with hearing aid and cochlear implant research. But some of you know us old guys and I call myself an old guy because I'm going to be 50 in the summertime- I have shirts that are older than me, but OK.

Speaker 3: 48:09

But you know, as old guys you know, some of us are starting to retire, get long in the tooth and aren't doing as much research as in the past. And I just hope, like the AUD has been great, hope like the AUD has been great but I hope that our profession doesn't get away from that good clinical research, especially in the diagnostic arena, because I think we have a ways to go to be able to truly understand what's happening with those types of patients, so then we can make the best decision from an intervention standpoint.

Speaker 2: 48:37

Yeah, I have to agree. I think we need honestly to just get away the whole term and I know this is going to annoy people, so let me preface it this way I absolutely 100% endorse universal newborn screenings. Critically important, brilliant. Every child born should have a universal newborn hearing screening at birth 100%. After that I don't think we should ever do a screening. I seriously don't. I think anybody with auditory concerns complaints should have a comprehensive audiometric evaluation when you're seeing people get screenings.

Speaker 2: 49:12

Number one because it was a screening they don't take it seriously. Number two screenings always miss mild cognitive impairments not always, but often miss that. They always miss auditory neuropathy and auditory, but often miss that. They always miss auditory neuropathy and auditory neuropathy spectrum disorders. They always miss hidden hearing loss. They always miss kids with dyslexia. They always miss ADD. They always miss ADHD. They miss mild cognitive impairment.

Speaker 2: 49:37

Because it only takes 20% of the auditory fibers for you to perceive a sound so you can press the button or raise your hand. The fact that you can pass a watch tick test means absolutely nothing clinically. You could have 20 percent of those auditory fibers. Oh, your hair is normal. No, he doesn't. No, but it'll never be discovered because it was a dumb screening, same with whisper tests, you know. So these things still exist out there in the real world and people still give them credence and I think we are so much smarter now than we were in World War II and to be using any of these technologies. I use test meaning 0 to 25 dB as normal.

Speaker 2: 50:25

Another 26 million have listening disorders. Those people with supra threshold listening disorders, also called subclinical hearing loss, also called auditory processing disorders. Those people will never be found on a hearing screening. The vast majority of adults and children with auditory processing disorders, totally normal thresholds. So so my point is, I think part of doing a better job clinically, part of really doing a better job diagnostically, is to stop doing screenings because I don't find them to be useful at all and they don't dig enough so that you or I you know you at almost age 50, me pretty damn close to age 70.

Speaker 2: 50:59

If I have the screening results of a patient looking at pure tones with a 30 or 40 dB pass threshold, I have no idea what to tell the patient. You know you've passed the test. That has no meaning. So I think as professionals we have to get away from that. Dr Wolfe, it's been a joy working with you. I'm so glad we had this time. Tell me your final closing thoughts what do you think about screenings versus diagnostic examinations in 2024. What do you recommend? What do you advocate?

Speaker 3: 51:25

I agree with everything that you've said. I would say this just as a pediatric guy the incidence, the prevalence, excuse me of hearing loss probably doubles between birth and kindergarten. So I still think there's a room for conventional screeners, whether it's pure tone screening or OEs and middle ear measures to catch those kids who have later onset or progressive hearing loss. But your comment in our earlier conversation that we need a elevator up our game with our diagnostic tools to be able to catch people with listening difficulties even though they have a normal audiogram, I think that applies to screening as well. And what you're saying about screening, I think that's true for pure tone screening. But why can't we up our game and use smartphones and engage people with their smartphones to do cognitive screeners or speech and noise tests or to evaluate their phonological processing and sensitivity skills, and then we can start catching children or adults who have dyslexia or people who have listening problems and noise. I don't know that it's necessarily that we shouldn't do screenings, that we probably should just be doing a different type of screening.

Speaker 2: 52:33

Yeah, and I want to back up a little bit and totally agree with you. I've been a huge advocate of speech and noise screenings. I'm not so big on hearing numbers. I know that'll annoy people too, because if it's just one number, I don't care if it's a four frequency average. Three frequency, that's a measure of loudness and very important, very important.

Speaker 2: 52:53

But I think if we're going to establish a screening system, we should screen for loudness and for clarity, because these are the two major issues and if we're only doing one well, maybe we can argue that that's a screening and it's better to have some information than none. But I would say it's the idea of 20-20 in vision and it's the idea of knowing your good cholesterol and bad cholesterol. I think people can handle two numbers if they're done well. So I wouldn't mind a screening number on a pure tone average. That's fine, a four frequency pure tone average. But I think that has to be complemented with the clarity number, determined perhaps by a triple digit test, by a calibrated speech and noise test that you could do on a phone. I have no issue with that at all. So I think you're right and I appreciate you bringing that to light, because it's not just a matter of screening or not screening, but it's a matter of whatever you're doing, doing it correctly.

Speaker 3: 53:42

This has been so much fun. Like I said, I have a ton of respect for you. I've always been a huge fan of you as a person and your work, and this has been an honor just to share some time with you just chatting about the work that we love.

Speaker 2: 53:54

Thank you so much, my friend. It's a joy and I hope that we get to do this again sometime soon.