FDA Clears Lyric Hearing Aids for Self-Replacement: Impact on Patients and Professionals

Welcome to This Week in Hearing. I’m Shari Eberts, co author of Hear & Beyond: Live Skillfully with Hearing Loss. And today’s guest is Dr. Michelle Wiebke. She is the Lyric Audiology and Education Manager at Phonak. Michelle has supported Lyric since 2010, when she joined Insound Medical as a clinical trainer. And then when Sonova acquired the company, she transitioned to the Phonak team and has been with the company in various roles since. In her current role, she supports the clinical and audiological needs for Lyric across training, marketing, research and education. So thank you, Michelle, for being here today. Yeah, thanks for having me. Yes, and as a Lyric wearer myself, I’m very excited to be chatting with you and also excited about self replacement. But I’d say first things first, for those that might be less familiar with Lyric hearing aids, could you describe the product a little bit and what makes it so unique? Yeah, sure. So Lyric is definitely different than many other hearing aids that people might come to think of when they’re thinking of hearing aids. And one of the reasons is it’s invisible, but also because of its extended wear nature. So the Lyric is placed in the ear, and it can be worn for months at a time, up to four months. So you just live your life, go about your daily activities without being reminded that you have a hearing loss because you’re not having to put the device in or take the device out or change or recharge batteries on a daily basis. So that’s a really big distinction of a difference. I think the other big distinction goes along with that, which is that you get 24/7 hearings, so you don’t have this time without the hearing aids. And I think that’s really helpful in maintaining the feeling of safety and security, even with the hearing loss, because I think it’s important to hear at night whether you’re caring for someone or just want to feel safe, hearing things that are happening around your house as you’re sleeping. So in that way, I think it’s very different than the more traditional or commonly thought of hearing aids. Otherwise it’s placed deep in the ear by the hearing care professional. It’s sold on a subscription because once the device stops functioning in the ear, the device would be replaced by that hearing care professional in the office. It is all part of the subscription package that is purchased. That is a good explanation of it. One of my favorite things is the 24/7 because it really helps me with my tinnitus also. So if I don’t have the devices in. I have a lot of tinnitus. But when they’re in having that ambient sound, it’s definitely very helpful. Yeah, that’s a huge benefit of Lyric that a lot of people don’t think of. But if they’re suffering from tinnitus, often, hearing aids alone will help with that tinnitus. But most people with traditional hearing aids will take the hearing aids off at night. And that’s when many are really bothered by their tinnitus. And so with Lyric, you do have that 24/7 stimulation to help overcome that bothersomeness of the tinnitus at night. Absolutely. So, as you described it, it is kind of a niche product. How did your journey as an audiologist lead you to focus on Lyric? Because it’s been a while that you’ve been focused on this. Yeah, no, it’s a great question. So I started in a clinic that had lyric. And I was really hesitant to fit it at first because I was quite early in my career. But once I started fitting it, I fell in love with it. And I said, I’m going to work at this company. And since then, my grandpa, my dad have been, well, my grandpa passed, but my grandpa and my dad had been wearing lyric. And not even just the family that I have seen be successful with Lyric, but all the patients I’ve seen nationwide that it’s just, just made such a dramatic impact. And also I like the interaction that I get to have with the patients. When it comes to how to successfully get Lyric to work in an ear, it’s the positioning, it’s the placement. There’s a lot to do with me as the hearing care professional. Even as a side of programming, which you get a lot with more traditional hearing aids, there’s more things to do in that regard for traditional hearing aid, but with Lyric it’s really all about the positioning and the fit with some elements of programming. So I just really love to see how happy it makes people and how full of life they are when they’re able to wear it and just engage and live their life without even recognizing at times that they have their hearing loss anymore because they forget about it, because they’re not reminded on a daily basis. That sounds terrific. So let’s talk about the news. The big Lyric news that people can now independently replace their devices. And full disclosure, I’ve actually been doing that for a while now. I think during COVID it was pretty hard to get into the office to have my hearing care professionals swap things out for me. But I’m sure for many Lyric wearers, this is very exciting news. So why make this announcement now? Yeah, so it’s a great point. And your experience is probably not unique. So we had heard anecdotally that patients, even on their own, had just decided, you know, I might be able to do this on my own. And Covid certainly fueled that for us. So we wanted to explore and be able to bring it to the broader Lyric audience. So we engaged with the FDA to get the clearance for this. And I think I started by saying one of the unique differences with Lyric is that the hearing care professional would replace the device when it failed. So the new kind of announcement with self replacement is that that actually changes that. So with self replacement, the patient’s able to see the provider every other time, and then on that off time, they can actually replace the device themselves at home, or if they’re on vacation or wherever they are. So they don’t have to have that visit to the hearing care professional every time they need a replacement, or if something comes up unexpectedly, then ideally they would have that replacement device with them. So I think it really changes some of the landscape of what used to be a very specific Lyric subscription model where you were seeing the provider every time, and now there’s just so much more flexibility for patients to, if they have another home that is quite a distance from where their Lyric provider is, they may not have to see another provider in that location. If they’re able to do self replacement, or there’s so many different reasons that I think it’s really great. In certain locales, you may have parking charges or other things that are an additional cost, having to see your hearing care professionals, so you can reduce that. And in other locations, you may naturally drive an hour to seek medical professionals just because of the geography there. And so I think it can be a huge benefit in time saving as well, just in not having to make those trips every time. Yeah, absolutely. I agree with all of that. And what research did you do, though, to make sure that self replacement was safe and that it would be effective for people to do this on their own? Yeah. So when we heard that there were some patients saying that they were able to do this, we wanted to make sure before we brought it to the masses, if you will, that we could ensure that it was as safe and effective as what would have been the gold standard hearing care professional placement. So we did do a large clinical study that was across eight clinical sites. It encompassed over 550 insertions by both the hearing care professional and the self replacement by the patient combined. Throughout that study, we looked at different variables to determine the safety and effectiveness. But the outcome of the study showed that there was very little difference from the hearing care professional to the self replaced device insertion depth. So we compared how deep the hearing care professional was able to place it versus what the patient did on their own. And the audiometric outcomes saw a very similar outcome as well, where the results were really, really quite similar to results for the hearing care professional. When we looked at those outcomes for those patients who had done self replacement, when it came to safety, we saw similar things as well. There were no unexpected issues that came up as a Lyric wearer, you know, at times there could be a little bit of an abrasion or some redness or things of that nature. And so we certainly saw those over the course of the study it was about 14 to 18 weeks for each participant. So we certainly saw some of that, which isn’t unexpected, but there was no increase in any safety concerns in the self replacement condition over the HCP replacement condition. So it really helped us feel very confident that we could offer this and that patients could still get the benefit that they know and love of lyric. And I would have to say that FDA agreed, since they did, it was the foundation for the FDA clearance. And so they were very thorough in looking through that study and giving feedback in early stages. And so we had overall a really great outcome, I think, with the study. That’s terrific. Did you discover any risks, if any, for the self replacement, or was that sort of a minor issue? No, there wasn’t really anything unexpected with it. I mean, even, I think one of the bigger risks is if you maybe don’t get it put in quite right, or if it’s backwards or something, and we didn’t see that. So through the study and through the actual procedure for self replacement, the hearing care professional would train the patient on how to place the device. During that training, the hearing care professional can observe how the patient’s inserting and if they seem to have certain struggles, help coach them how to address those. That certainly happened in the training, but through those insertions that the patients did in the study there wasn’t anything that came up that was unexpected. We even looked at, like, handedness. So for someone who’s right handed, would they have issues on the left ear? And there was no evidence of any impact of handedness. So that ears, the data worked out quite similarly. So yeah, there really wasn’t. All the indications were very positive, which I think is really great. That’s terrific. Yeah. So do you think this is sort of the start of a continuum where maybe Lyric becomes more fully safe self replacement at some point, or, you know, how are you thinking about the future of that? It’s a great question, and I don’t see it being fully self replaceable, if you will. I think one of the key elements in the self replacement process, as the FDA cleared it, is that the patient would see their provider every other time. An important part of that visit is that the hearing care professional is going to assess the ear canal health at that every other visit. As you are likely aware, it’s quite difficult to look in your own ear. Thats a really important step in ensuring that the Lyric hearing and the benefits, those audiological benefits can be maintained. I don’t expect that it will ever become something that can be done without the HCP at all. And we certainly pride ourselves in that. The way we built this self replacement procedure, it is built around the hearing care professional because they are a really strong partner in the patient’s success for Lyric and determining the placement and determining how to get Lyric to live happily in the ear canal, which is kind of the feet in and of itself, because it’s not the most welcoming environment. It’s actually rather hostile, being warm, dark, humid. So I think there’s still that really strong need for the hearing care professional. To be involved in that process. That makes sense. So, as we’ve kind of been talking about, I mean, Lyrics are not for everybody. So how can consumers and HCPs tell if a person is a good candidate for Lyric? Sure when it comes to being able to figure out if you’re a good candidate for Lyric for a patient I definitely encourage you just to ask the provider or ask the provider what they know about it. Lyric is only available in about 3% of clinics nationwide, so it is not as broadly available as other products. So if the provider that you’re already familiar with or seeing isn’t offering it, but you think it would be something that interests you, definitely go to the Phonak website and you can look for a lyric provider near you. But the main candidacy requirements are an intact eardrum as well as You cannot have a history of head or neck radiation just to ensure that the ear canal can remain healthy. Outside of that, it’s more for mild to moderate degrees of hearing loss. But otherwise, the rest of the candidacy will largely come with the assessment of the HCP in the shape and size of the ear canals to just determine if the Lyric would be able to fit in the ear and if they would be able to successfully wear it. And it’s also important to know within that subscription, there is that trial period. So anybody that’s interested in wearing Lyric would get a trial period where they can then wear it out, see how it feels, see how it fits, to really understand if it’s something that’s going to work in their lifestyle and in their daily life. Right. That makes a lot of sense. And any tips for practitioners that might be thinking about prescribing Lyrics? Yeah, so as I mentioned, there’s only about 3% of offices nationwide that offer it. And so if you’re someone who is not able to provide lyric right now or you don’t have it we’re happy to chat with you at Phonak to see if it would be a right fit for you. So we’re always looking for great partners for Lyric. When we think about a great partner, we’re looking for someone who is really comfortable working deep in the ear. So someone that’s already very comfortable with cerumen removal or with some IIC products and taking deep ear mold impressions, that really sets them up for great success with Lyric to start and then just a really great business partner. We know patients love Lyric. They love the invisibility that is generally what brings a lot of people in the door, but after they’re in the door and they’ve tried it, that’s not what they typically cite as the reason for keeping it. So they really love a lot of the other benefits. But with that in mind, we really like folks that are going to be able to market and really get the word out to their patients that they have this solution. Because it is quite unique, but for many, it is a real lifesaver. I know of a patient who’s a firefighter who says he wouldn’t be able to do his job without being able to wear Lyric. And I’ll probably butcher this. But he’s also, I think, on, like, the dive team or, you know, the water rescue portion of the fire service. And so he’s just he’s so happy that he can wear Lyric. He doesn’t know how he would be able to do those things with any other product. And so I think there’s a lot of different kind of professions that it speaks very directly to. Even physicians, veterinarians. Where you can just wear your stethoscope without needing something else or a Bluetooth connection for that. So there’s a lot of great benefits and reasons for people to seek out Lyric. So if you are not a Lyric provider, I definitely encourage you to reach out to us if you have interest. Because there are definitely patients who can benefit from the unique nature of Lyric. Oh, that makes a lot of sense. Are there any new features that are coming down the pipeline for Lyric? I know it’s been sort of a I don’t know if it’s the right word to say. It’s sort of pared back in terms of features. But I don’t know if there are any new ones that are in the pipeline. Yes, that’s a great question. So one of the benefits of wearing Lyric and being in the subscription is if there are updates, patients automatically get those. But as opposed to more traditional products. That will have sometimes a life cycle or an update cycle of six to twelve months. Lyric is not that rapid. Largely because patients who are already wearing Lyric love it. And we have to be very, very thoughtful with our innovations. Such that those patients aren’t going to then be have the rug pulled out from under them. That we’ve now changed it. And it just isn’t what they’re used to. Because we’re very, very conscious of that and want to protect that. But with that in mind, we are always making updates. I mean, self replacement is one of those updates to help in even the provider’s process. Right. And to help keep Lyric very sustainable for them in their practices by allowing patients to maybe not even have to come up to half as many times for replacement. So I think that was a great advancement in that way. So often our updates may not be felt by every patient. Because if you’re wearing a medium, when we added the extra extra small or extra extra large sizes, you didn’t know about that. So in the future, though, we continue to look for ways to maintain and keep Lyric very sustainable. And so sometimes that may mean updates in chips or updates in parts just to ensure that we’re able to reliably keep producing the product. And as far as new features in the pipeline, I’m not able to say, but I’m hopeful we’ll have some really great news soon. Excellent. Oh, I look forward to that. Awesome. Well, I thank you, Michelle, for being here today on the podcast and sharing your perspective on Lyric and this exciting announcement on self replacement. And if people want to learn more about Lyric, they can visit Lyric.phonak.com. so thanks again very much. Thank you very much, Shari. I appreciate you taking the time to have me here.