OTC Hearing Glasses Hit the U.S. Market: Inside the Nuance Audio Launch

Hello everyone and welcome to This Week in Hearing live from the Nuance Audio US launch event. The US launch of Nuance Audio’s hearing aid glasses will come as no surprise to anyone reading HHTM or following this podcast channel. Even so, the launch event in New York was a great way to learn their future plans and share them with you. After an opening presentation, a nightclub atmosphere including live DJ set the scene for attendees to try the glasses in the real world. Let’s dive in. Okay. Hi Andrew, this is Davide D’Alena. I’m the head of global marketing for Nuance Audio and Essilor Luxottica and it’s. A pleasure to see you again. Congratulations on the US launch and in this spectacular event. Thank you very much. We are very excited. Finally, after a couple of years of hard work on the product on the go to market, we are finally on the market. And so we are collecting feedback from consumers. Very excited and looking forward to do more. Well, it really was quite a journey. I remember while it was summer two years ago, almost two years ago when I went to Milan to try the prototypes and now here you are. Very stylish, very nice looking. So first off, what have been the impressions of people who have tried it? I think it was most of the people here at the event were amazed about the product itself and the fact we are in a very noisy environment. Actually we are reproducing what you call as cocktail party effect is right in this room And so actually the people are experiencing the right culture context and they are really enjoying the product so working pretty well. I was just wearing it in the other room where the DJ is and I must say that it’s really helping to hear better even if you don’t have any hearing loss, honestly. Well, there’s always, as was pointed out in the main presentation, you may not think of yourself as having hearing loss, but one of the first things to go is your ability to understand people in noisy environments like this one. Absolutely, absolutely. The right context where you can really understand and experience if your hearing is like at the perfect spot or not. These are the typical contexts where you start to lose some words, where you start to say, okay, can you repeat so we reproduce it exactly the kind of use case of this product. And so the US rollout will begin in your optical channels like LensCrafters for example. And how do you envision the rollout expanding from there? Well, not only actually we already launched the product on US territory and so today you can find our product in our retail network naming LensCrafter, Target Optical, Pearlvision, but also in our optical partner, so ECP or National Key account and also already in some audiological partners. So already as of today the consumer has the choice across different kind of channels and doors where they can find the product and then this kind of distribution is going to increase. Since day one of our project and our proposition we told to the world this is going to be an open network model, meaning that if you want distributed product, happy welcome. And you know there is a very democratic approach. You can get the product and you can serve your patients in the best way. Okay. And then if somebody does not wear glasses today and they would order them say with the transition lenses, can they order them directly through the Internet or do they go into a shop even? So no, you can order on nuanceaudio.com so there is our website and through the website actually you can order your frames but also your lenses in the U.S. so basically you can get your pair of Nuance Audio with also optical glasses at your home. So it’s already live. Okay. And right now you have two very nice styles and you’ve got a couple of different colors and a couple of different sizes. Yes. And I’m sure you’ve done your homework on styles that will look, appeal to the demographic that they would be aimed at, which is rather like you and I mostly. Right? Absolutely, yeah. And will you expand, will you use any of the brands like Ray Ban for example? What are your plans style wise? So actually on the style we selected the two more the two most popular styling on US market, the round and the square. Yes. We selected the three most important caliber, so the frontal caliber, the frontal length which is 48, 54 and 56. And we select the two most sold colors, black and red, burgundy. Now we are already working to expand color style and so on and so forth and it will come in the next few months let’s say on top of that. Of course. I don’t know, let’s see. There is a possibility that we are going to collaborate with some brands. We just started this journey today with Nuance Audio. So we start with this brand and then we will see in the near future what’s going to happen and how. Will it expand in different countries. What will the rollout look like? Actually we already launched also in Italy. That launch started in Italy end of February. So we are at very beginning as well. Yesterday or last weekend was the first day of sales in France. So we started France and then in May we are going to roll out in Germany and UK and very soon in Spain as well. This is just for the first six months of the year. The second part of the year, there is already a big pipeline of countries that we are aiming to expand. Start from Asia Pacific to Latin America. More news will come. And how difficult was it from a regulatory point of view to expand into all these different countries? Yeah for sure that’s a challenge because every country has a different regulatory environment when it comes especially to medical device class two over the counter. So it’s a very specific low country by country. So we started this part in US where we got finally at the end of January the FDA. We started then also the part in Europe where at the end of January, well actually before the Christmas we got our CE mark. But anyway, every time that you need to open a new country, you need to assess regulatory environment which may be different country by country. So it’s a, let’s say time consuming process. And that’s why also we cannot roll out suddenly on all the countries around the world. Yeah, makes perfect sense. And my hat’s off to you because you’re globalizing over the counter hearing aids by expanding into these countries. As was pointed out, there’s over a billion people in the world with mild to moderate hearing loss. And for a significant percentage of those this could be a viable solution. Absolutely, that’s, I think our final aim Andrew, is to give access to millions of people to hearing care. You know today that there is a big barrier for people with mild to moderate hearing loss to approach hearing care because of the stigma, because of the comfort, because of the price, because of several reasons. And we really aim to break down those barriers and give access to millions of people which are in need. So to have a better hearing better vision and better quality of life. And I really like this. I presented at EUHA last year and I talked about stigma, the different facets of stigma. And with these I think of for example, a person who’s still working, who’s feeling either real or perceived ageism and how they might be at that moment in their life hesitant to wear something that looks like a classic hearing aid. And of course the worst thing is not to do anything at all. Right. And so in this demographic this is an exciting solution. Absolutely. And the work environment is one of, we think one of main use case. And so I’m sure that it’s going to help a lot of people in this environment too. Now, what are your plans, your feature roadmap going forward? You’ve got now functioning hearing aid glasses that really work. Right. I’ve tried them on multiple occasions. You can see I’m working. Yes. And I could even refer back to the original report I did from Milan where even though my own hearing loss is out of bounds for these glasses, the improvement was substantial. But you have a feature roadmap beyond today. Absolutely. What does that look like? We are already working to the next generation of the product. This launch is a launch not only of a new product, not only of a new category, but this is going to be an innovation platform. So it’s the first kind of a number of products that we are going to launch in the near future. So we are already working on the next release which are going to be of course additional style and additional colors to expand the offer and assortment. But I’m going to integrate also additional future hearing test integrated in the glasses, hearing improvement in speech and noise improvement through AI. We are going to integrate some additional let me say health sensor to improve tracking of your quality of life, let’s say overall. So you know, there are a number of things on which we are working and will come very soon. And do you see the hearing feature merging into smart glasses as well or will those remain distinct in your mind? We don’t know actually. The products are quite different because one is a bit more, let me say, as an entertainment product. So you can of course get picture the video, you can do a lot of things including the AI support. But in our case today the product is more focused as a medical device which is going to solve a functional needs. Then if down the road those two categories are getting together. We don’t know. We will see. Yeah, I understand the difficulty because you don’t necessarily want to take a pair of smart glasses in for regulatory approval. Exactly. And yet at the same time you could see the use case. I wear them. Right. I’m shooting videos and I go into a nightclub. Exactly, exactly. So let’s see. We will see. And we will see also how consumer will react to this new category and then we will decide. Well, I’m optimistic for the future of these glasses and hopeful that people who are hesitant to get hearing care will see these as an option to get them started on their journey. So congratulations for that. Thank you very much. I really hope that with this launch we are going to help a lot of people to approaching the hearing care. Its something new. It’s something that you must experience. It’s something that you need to get used to because hearing care requires some time to get used, but then the benefits are just over there. So I really hope that this is gonna convince a lot of people to approach the hearing care and have a better quality of life. Well, I’ll be watching with more than a little interest as it rolls out and see how it goes, how the acceptance goes, and then the global expansion. So thank you very much. Thank you for spending some time with me. Thank you very much. Hi, I’m John Luna and I’m with superaudio. I’ve been with the company since the end of 2023. Congratulations on the launch. This is an exciting event. Thank you. Very exciting event. You’re wearing the burgundy ones too. I really like that color. Looks great. I took my wife when I shopped for them, so I do like the burgundy. Everybody wears black, but I think they look good. And so you led the FDA process for the glasses? I did. I worked with the company, the regulatory and quality research team, and we brought them through the FDA process, which was a 510k process. Okay, so yeah, tell me about it. You had to do the full 510k and what was the timeline for doing that? Well, your standard 510k is 90 days. But we, you know, we, we had a predicate that we were working against and so we had to prove that the product was as effective as the predicate substantially equivalent. So we’re able to do that through the normal timeline with no delays and you know, culminated in a clearance decision at the end of January 2025. Okay, so these are not self fitting and yet you still had to do a 510k process. Yeah, because it’s the first open fit product. We had to prove that it was substantially equivalent to the self fitting predicate. So we had to show using a audiology, best standards, best practices, real ear speech, understanding, the presence of background noise, standardized questionnaires. Exactly. That the product can do what other products could do in the market that were self fitting or even prescriptive. Okay. But now the pathway is open for future models because you won’t have to go through this process. That’s right, yeah, for our product. Yeah, for your product. So we’re software as a medical device, air conduction hearing aid software. Okay. And then where were the clinical studies run? Were they run here in the US or were they run somewhere else? No, actually they were all overseas Some of them were in Tel Aviv, some of them were in Italy. Okay, and how was that process? Were there difficulties? Because this is a unique product. I mean, what was the relationship between the development of the clinical trials and the development of the glasses? Like, what did that look like? Yeah, so the development of the glasses has been ongoing since the acquisition in July of 2023. And so when we got to the final version of the product and the final version of the software, both hardware and software, then that’s when we brought them into our clinical work and we compared that to a prototype clinical work. But once we realized we had the product that was going to meet the needs to get through the fda, that’s when we submitted. And what then are the next steps for you in the regulatory process? Are you already looking forward to next generation models? Well, ye, as you saw today’s presentation, we have a lot of future iterations of the product and things we can bring to the product. But right now my focus is commercializing the product in the US in both the vision industry as well as the audiology space. Okay, so what does it look like in the audiology space? In the presentation you talked about mostly the vision space and the vision channels. And how’s it going to roll out in the audiology space? So we’re currently rolling out in the audiology space. We have practices that are owned in private practice and franchise practices that are offering the product to their patients and to their clients on a daily basis for the mild to moderate hearing loss. Now in audiology or hearing aid practice, that person has already had a hearing test. Most likely it’s not a perceived mild to moderate hearing loss. It might be they came in wanting to find out what their hearing loss was, but they’re actually finding out that they are a candidate for this. And if they’re not going to choose another product in the store, this is something that is being offered to them as an option. Okay. So yeah, you have a bit of a pre screening going on there and if somebody’s out of bounds, they won’t necessarily recommend the glasses to them. That’s right. Yeah. It’s always up to the consumer as perceived mild to moderate if they choose to buy it. But it’s really for that mild to moderate hearing loss consumer. Yeah, which really goes to the point that even if you decide to go with an OTC product, it absolutely is helpful to have a professional assessment. Yeah, it is, it is. It’s great to know because you know your candidacy. You know what your baseline is, what your hearing loss is that day when you have it tested. And so that’s how it’s working in the audiology channel. It’s more of an assisted sale model or assisted dispensing model. Okay. Well, thanks. I really appreciate you laying that all out for me. I appreciate it. Thanks. You’re welcome.