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FDA Approval of Apple AirPods Pro 2: Dr. Keith Darrow on Competing with Prescription Hearing Aids

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Can Apple's AirPods Pro 2 truly compete with traditional prescription hearing aids? 

In this episode of the Hearing Matters Podcast, we offer an in-depth look into the FDA approved Apple AirPods Pro 2 as potential over-the-counter hearing aids. We address the technical differences, including latency issues, fit, battery life, costs and more.

Drs. Darrow and Beck discuss the social stigma traditionally associated with wearing hearing aids, and the potential for trendy alternatives like AirPods to shift public perception and make hearing aids more socially acceptable. This episode delivers a compelling discussion on affordability, accessibility, and much more!

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Dr. Keith Darrow:

I'm going to really geek out here for a second. Prescription hearing technology has a latency or a time delay from the time the sound gets to it to it gets presented into the ears. It has a time delay of about five milliseconds which is not detectable by humans. Basically, I'm going to just say there is no delay, there's no ability to perceive a delay when using prescription hearing technology. Well, these AirPods, while they're great AirPod Pro 2, at least the records indicate there's 126 millisecond delay. What does that mean? Anything over 40 milliseconds can give you the sense of an echo. It's not going to sync up with the lips. That echo in background noise is only going to keep compounding itself to a point where it might actually be better to go without the AirPod Pros in background noise than it would be to have them, because it can really confuse the brain, really mess with the processing. So right now there's really significant limitations to when and where you can use this over-the-counter technology.

Blaise M. Delfino, M.S. - HIS:

You're tuned in to the Hearing Matters podcast, the show that discusses hearing technology, best practices and a global epidemic hearing loss. Before we kick this episode off, a special thank you to our partners Redux: Faster, drier, smarter, verified. Sycle: Built for the entire hearing care practice. Fader Plugs: the world's first custom adjustable earplug. Welcome back to another episode of the Hearing Matters podcast. I'm your founder and host, blaise Delfino, and, as a friendly reminder, this podcast is separate from my work at Starkey.

Dr. Douglas L. Beck:

Good afternoon. This is Dr Douglas Beck with the Hearing Matters Podcast, and today I'm interviewing my very dear friend, dr Keith Darrow. Keith, how are you? Hey?

Dr. Keith Darrow:

Dr Beck, thank you so much for having me here. What an important and timely topic, so thanks for doing this.

Dr. Douglas L. Beck:

Yeah, you bet. Well, the topic of the day, by the way, is that the FDA has said that Apple AirPods 2 can become hearing aids. And it's interesting because, of course, we've had OTC now for two years, but this is the first time the agency the FDA has authorized over-the-counter hearing aid software. So the FDA began allowing OTC back in 2022, looking at affordability and accessibility, and now we're at this new level where Apple AirPods their software has been approved as a potential OTC device. Is that right? Am I encapsulating that correctly?

Dr. Keith Darrow:

No, I think you summarized it perfectly and I think that, look, we're still in the wild wild west when it comes to this over-the-counter category. But I genuinely appreciate what Apple has done, which is bring more awareness to hearing loss, as far as I'm concerned, bring more awareness to the fact that, as far as I'm concerned, bring more awareness to the fact that there is a separate category of technology that falls into the over-the-counter or, as I like to refer to it, as the DIY category. Right, do it at home, treat your own hearing loss type category. For us, it further elevates what we do, which is provide prescription hearing technology to medically treat hearing loss and tinnitus. So we're comparing apples and screwdrivers here.

Dr. Douglas L. Beck:

First of all, I think it's important to understand and please correct me I think this is only really applicable to the AirPods Pro 2. Is that right?

Dr. Keith Darrow:

Yes, it is. That is the way that they have put it out so far. We all know that there's going to be the AirPods 3 that comes out. I mean, to me, what they've done is basically drawn a line in the sand that this technology is capable. Nothing before it, but everything after it will be. That's typically how Apple works they introduce something new and then they continue to make it only better over time. But yes, apple AirPod Pro 2.

Dr. Douglas L. Beck:

Right, right, and I want to be clear this is mine for a couple of years now. I guess I got this when they first came out, the Pro 2. And they have ear tips on them, and this is a very, very important characteristic, because this ear tip comes off right, and then you have just the receiving end. The important thing here, I think, that so many of us have maintained, is that you have to have an excellent seal. If you just have a loose device in your ear without sealing the ear canal, you're not going to get these benefits.

Dr. Keith Darrow:

Exactly, it's very temperamental, and I think anybody who's worn the AirPods too, I mean, I've got them in my ears right now, right, sure, but if I start walking around and I start having a conversation, I don't know about you and maybe it's my ears, but they definitely start to slip out, and I've had that conversation with several other people. Frankly, when I do I wear them at the gym I have this little lock feature, you know, that basically goes up and locks them in. Otherwise they're they're all over the place. Fit is definitely. While the tips give them a good fit, they help to block out background noise. That, once again, we're talking about people who have their own hearing loss and we're trying to do a one-size-fits-all, which is why there are significant limitations to this.

Dr. Douglas L. Beck:

Yeah, this is an important point. If you go to the chronology and you try to find well, what's AirPod Pro 1, 2, 3, and 4, and now they're coming out with AirPods 4, and that's kind of a one size fits most, so I'm not really that impressed with that. The most popular of all have been the AirPods Pro, and the ones we're talking about now are the AirPods Pro 2. Now are the AirPods Pro 2. Now the interesting thing to me is when you think about AirPods and I agree, it's a remarkably good product but battery life is somewhere between four and six hours. So if you're going to try to use them for a hearing aid, you might need two or three pairs.

Dr. Douglas L. Beck:

And I don't say that kidding around, I'm totally serious, because I used to wear my AirPods Pro 2. I'd wear them as you may recall this, from in the morning. I'm wearing them until about noon or so. I take them out, I put them in the charger, I put in pair number two and then I reverse it at dinnertime. So that might be a way to manage it. I have not seen that the AirPods Pro 2 will have much of a longer battery life. Moving forward, it looks like they're in the four to six hours. Now you have to be careful when you look at battery life, because they say up to 30 hours with the case. Well, yeah, because the case is its own battery charger as well. I think you have to take that into consideration.

Dr. Keith Darrow:

But even, doug and I think this is an important point for people to realize, especially if you're listening to this podcast and you're in the field of hearing healthcare you're trying to figure out how am I going to talk my patients through this?

Dr. Keith Darrow:

Yes, apple will tell you four to six hours, but if you have the noise reduction on, if they're probably more than a month old, I mean, look, I get about two to two and a half hours out of mine, and that's on a full charge, right, and so that battery does wear down over time. So, look, I think this is a deal breaker, right, when it comes to treating hearing loss. This over-the-counter product, this Apple AirPod Pro 2, realistically will get you about two and a half hours, even though they say four to six. That's without the noise reduction on, that's with volume turned down. I get a couple of hours out of mine, and it's really important that the brain is stimulated by sound all day, not just two to three hours, so that, right there, sort of, might it help you hear better in some limited situations for a limited amount of time. Sure, is it the proper tool to use to treat your hearing loss and tinnitus? I don't think so.

Dr. Douglas L. Beck:

Yeah, I think of it as an adjunct device. And here's the thing, though when you think about hearing aids in the USA generally, you know, if you include the big box stores and the VA, we sell between, I think, five, six, seven million units per year. Apple AirPods have already sold over 150 million pairs, so you know that's pretty substantial. People do like AirPods, pods, I like air pods. I think the directionality, the noise reduction very, very good. But I think your point is the overriding point that if you're going to use these as hearing aids, you're going to need two or three pairs or you're going to have a little bit of difficulty but let me.

Dr. Keith Darrow:

but let me say this, doug, let's peel back the layers a little bit there, because you just threw out a huge number 150 million AirPods have been sold. Hearing aids are not even. They're not in the same league, right? However, 94% last I checked the only data I could find 94% of the 150 million were sold to people under the age of 40. I have two pairs and you have three pairs, so we make up a lot of that. Other 6%. Right, yeah, we do, and so I think. But that's really important to say okay, why did Apple do this? Look, I'm sure they have great intentions and I'm not trying to say anything negative, but, truth be told, there are corporate bigwigs that are sitting around saying how do we sell more of these? Well, let's talk to the people that aren't buying them. And what do we talk to older adults about? Hey, this can help you hear better.

Dr. Douglas L. Beck:

I like that. I think that's insightful. Let me just underscore the numbers. I looked up the same paper. I think Most AirPod users 60% of them are between age 18 and 25, 34% between 26 and 35. So that, right there, that's 94, 95% under age 35. So you and I have just changed their statistics.

Dr. Douglas L. Beck:

But the thing we didn't talk about is price, and the thing is these are pretty cheap. I mean, these are 249 bucks. Maybe you can buy a rebuilt pair for 199. And this, to me, is very important because you know, the reason that we got into the FDA OTC rules and regs was access and affordability. Now I have a brand new paper coming out, I believe in the Hearing Review this week, and I pointed out I'm going to read you this little section here when we're talking about affordability and accessibility, which again was the motivating factors for the FDA, we observe today access appears to have been increased. Access is pretty good. You can get hearing aids almost anywhere.

Dr. Douglas L. Beck:

Now, however, the better OTC products often cost $1,000 to $29.50 per pair. Now that's, according to the National Council of Aging, placing the better OTCs beyond the reach of most people that OTC was created to help. Cber 2024 reports that at Best Buy OTC products range, per pair, $200 to $2,550. And Susie Orman we all know Susie Orman. She was publishing in NASDAQ that most Americans 60% do not have $500 for an emergency. As such, it seems pretty hard to imagine that most Americans are going to spend more than $500 on a pair of hearing aids. So this is a unique niche in the market. They're going for very, very inexpensive and very, very high quality. Now what would you say if the batteries on these AirPods? What if they lasted 16 hours?

Dr. Keith Darrow:

No, and here's why. So that's a great question, right, because right now I don't want hearing providers to just rely on the. Well, it doesn't last as long, because they can fix that. If you can get prescription hearing technology to last 12 to 15 hours, Apple can make it last 30 hours. If they really wanted to right, they could figure that out. They're much smarter than we give them credit for. Here's the issue as it stands today.

Dr. Keith Darrow:

Number one the biggest complaint of our patients is hearing in background noise. And while you might want to say, oh, but AirPods have noise reduction, they do. I love having my AirPod Pros in on an airplane because it does really well with that constant motor noise, sort of bringing that down. However, at least as of today, when it comes to using AirPod Pros in a restaurant setting, in a real life situation, hanging out with friends or colleagues, right now it does have noise reduction, but only in a very specific beam forming pattern, in that you can hear the person that's directly in front of you pretty well. It can separate speech and noise by about 7 dB, which is impressive.

Dr. Keith Darrow:

But only this. We don't live in that world, doug. Right? What hearing technology? What all the major manufacturers have done over the last few years is taken that beam and they've essentially made it almost 360, in that it picks up speech and reduces background noise, just like the brain does. It doesn't have this sort of beam forming technology, so right there, that's one real limitation, because you're still not going to hear great in background noise.

Blaise M. Delfino, M.S. - HIS:

I want to back up a second.

Dr. Keith Darrow:

You're talking about price, right, so let's talk about the affordability and access. I've been trying to tell people this for the longest time Hearing aids are not expensive. We have to get that thought out of our mind. That's part of the problem. Is we put up this barrier. We talk about cost. Frankly, the same stuff that I'm putting in people's ears you just said it you can get them over the counter for $2,500. You can get Oticon, Widex, Phonix. You can get them in big box stores, you can get them on Amazon. You can get them all for a pretty decent price. It might be somewhere between $1,500 and $2,500.

Dr. Keith Darrow:

Hearing aids are not expensive. What's expensive is us and I shouldn't even use the word expensive it's the value that we provide. It's the care, the customized prescription, the follow-up care. You know I've seen some studies that say audiologists, if you take into account a four-year treatment program and consider all the times you meet with your patients, the clean-in checks, the annuals, if everything's included, it boils down to like 20 bucks an hour. Right, Like it's something where the cost is in us and you have to be able to justify your cost, and I think that we absolutely do, because to date there's never been a study showing that a over-the-counter, a DIY hearing aid can provide true medical value. People might say OTC sounds good, but they've never been shown to reduce the risk of a fall, reduce the risk of cognitive decline, improve cognitive performance, increase quality of life, reduce tinnitus I mean, you can't even talk about tinnitus and these over-the-counter widgets, right?

Dr. Douglas L. Beck:

Yeah, these are all good points and these are things that help separate OTC or DIY from prescriptive hearing aids. Right, when you're looking at the literature on cognition, when you're looking at the literature on cognition, when you're looking at the literature on satisfaction, those things are basically done based on prescriptive hearing aids. And the other thing that we haven't talked about at all, which I think is worthy of a few minutes here, is the issue of stigma, because when you're wearing your AirPods, these are considered to be somewhat cool and trendy and great, but stigma of traditional hearing aids is very real. I'll give you four quotes from 2024.

Dr. Douglas L. Beck:

Forbes 2024, reports people with hearing loss avoid hearing aids for many reasons and social stigma plays a significant role. In their survey, 48% of respondents believe there is a stigma associated with hearing aids and they report 63% of millennials, 47% of Gen Xers and 41% of boomers agree there's a stigma. Now that's Forbes 2024. Webmd 2024 says the same thing 62% of Americans wear visible corrective eyewear and 45 million wear contact lenses, which is kind of incredible. Yet only 15% of people with hearing loss wear hearing aids. This is Beadle Genstead et al 2024.

Dr. Douglas L. Beck:

Younger and older adults might hold negative, implicit attitudes towards older and younger people who wear hearing aids. And finally, I'll give you Nick Bach, ekberg and Waite 2024, explored how and when a stigma-induced identity threat is experienced by adults with hearing loss and their family members. All participants in their study believed hearing loss and hearing aids were associated with stigma. So I wonder, when we're talking about something like Apple AirPods which are admittedly cool and trendy and maybe sexy and maybe much more acceptable is that a factor? When you talk to patients, do you consider stigma? Do you talk to them about that?

Dr. Keith Darrow:

Look absolutely Well, and I'll tell you what I would challenge you, because my bet is, if you go back to some of those publications I don't know, 50 years ago, 40 years ago they'd probably say the same thing about glasses. Remember glasses? You were four eyes, you were teased by people. Something was wrong with you, you were blind. So, look, I almost think it's a good thing. The fact that you can read these in major publications says we're talking about it more. The fact that Apple's talking about hearing loss and hearing aids means we're talking about it more. It means our society is on the path to acceptance. But you're right, doug, the stigma is real. Here's what I can tell you In the month of September 2024, I'm going to travel to, I'll be in Waycross, georgia, little Rock, arkansas, madison, Wisconsin, new Jersey.

Dr. Keith Darrow:

I do these symposiums all the time, these patient-facing symposiums, and I always start with the question of hey, 90% of people with hearing loss do nothing about it, right? You guys are a great group for me to ask this question why Tell me what's going on? Now, admittedly, it's a bit of a plant, because I know the answer and undoubtedly, there's always several people who raise their hand and say stigma. So the stigma is real, but the only way to fight back against the stigma is to talk about it more Podcast articles. You know Apple having the shining star of technology and software to talk about hearing loss and hearing aids. Thank you, thank you, apple.

Dr. Douglas L. Beck:

In my new article coming out in October in the Hearing Review. That's all about custom-made products and the reason that I write about that is because I wear a set of IICs invisible in the canal hearing aids when even I'm lecturing at your events, at audiology experts and things. Nobody's ever noticed them and I think this is. It makes me more comfortable to have that in my ear and to give me that security blanket that I'm hearing much better and I can attend much better to what's being said.

Dr. Douglas L. Beck:

I like that a lot, but I don't want to have a giant hearing aid or a BTE or a Rick or a right. This is my own personal preference and I know that maybe that's a vanity issue, but you know I don't have that much that I can hold onto there, so I'll take what I can get. But you know this is very real when people don't discuss the stigma of hearing aids, it's the 800 pound gorilla in the room for most patients. You know, when we talk about access and affordability, that's cool and those are important things. But I think the third thing that impacts who gets hearing aids and who doesn't is stigma and cosmetic issues.

Dr. Keith Darrow:

It is absolutely a real issue. As I sit here today in the clinic, I just saw a patient this morning and I had this discussion and I just I always have to be real and I always have to say, look, I respect that, I understand it, and here's the way I approach it. Number one I'm going to recommend the best prescription technology that meets your hearing needs and, if I can, I will make it as invisible as possible. I certainly understand and I respect your concerns of vanity and stigma, but hearing is the single most important thing I do and we can't compromise that. And then you've probably heard me say this too. I'll often joke with patients and say, look, I understand you don't want to walk around with a beige banana behind your ear. Thankfully, those days are mostly gone. But think about it this way. People might say, oh, what's that thing behind your ear? And then they just okay, they go about their day and they don't think about it.

Dr. Keith Darrow:

If you're a mom or dad and you're sitting at the dinner table with your family and you're not interacting, if you're starting to isolate yourself, if you're inappropriately laughing at jokes that weren't a joke while somebody's telling a story, if you're trying to fudge your way through a conversation. You know what happens. The second you get up, everybody starts talking about you. Everybody starts talking about the stigma of mom's getting old. What are we going to do with her? Is it dementia? What's going on here, when in reality, you could just be hearing so you know? Yeah, maybe wearing a tiny piece of prescription hearing technology. If it gets you hearing better and interacting more, I'm all for it.

Dr. Douglas L. Beck:

Yeah, that's great, all right. So the bottom line, you know, I think we're both agreeing that the new application of the Apple AirPods 2 Pro is very appropriate for some people. Some of the time it doesn't replace prescription hearing aids. It has assets, it has liabilities, it has pros and cons, and I want to also encourage people to take their online hearing test associated with this. I did that today, the Mimi M-I-M-I. I thought it was pretty good, to be honest, and it's kind of a von Beckeshe sort of a test. If you haven't taken it before, you press the button or you hold the button in while you're hearing the beep. When you can no longer hear it, you let go, which is kind of what we used to do with Beckeshe back in the 30s, 40s, 50s and 60s, and I can tell you my test was pretty darn accurate.

Dr. Keith Darrow:

So I would encourage that and I think and I, but I let me tag, let me just jump onto this. I would encourage you you anybody out there to acknowledge that, while that test may be pretty good and it might actually align pretty well with the beeps we do in the clinic, yeah.

Dr. Keith Darrow:

The beeps. Is this much of the hearing test right? Absolutely, the beeps tells us your ability to perceive beeps. Yes, I don't know about you, Doug. I've been doing this for over 20 years. No patients ever come in and said I can't hear beeps. Can you help me with that Right? So there's a lot more to it and I think if you use that as a, dare I say, a cursory test to say, hmm, is my hearing normal or not, and then I would also encourage you to say look, if you're not hearing as well as you used to in background noise, even though your hearing still seems normal, undergo a full evaluation so that you understand exactly how your brain is processing.

Dr. Douglas L. Beck:

Yeah, and this is so important right, hearing tests online. They can do beeps online. They're fairly accurate. Again, the Mimi test I took that I thought it was pretty close to my actual hearing test. However, an actual comprehensive audiometric evaluation is not just about beeps. As Dr Darrell was saying, we need to do speech and noise tests, we need to do listening and communication assessments and we need to do bone conduction testing and we need to check your eardrum through tympanometry and we also need to do reflexes ipsilateral and contralateral and otoacoustic emissions. That tells us what's going on with your auditory system.

Dr. Keith Darrow:

Exactly the beeps are in my practice in the hearing and brain centers. The beeps are one-seventh. I don't know what that is percentage-wise, but it's a very small percentage.

Dr. Douglas L. Beck:

It's one-seventh yeah, I'm going to give it about 18%, 17%, there you go.

Dr. Keith Darrow:

It's one-seventh of the overall cognitive screening and diagnostic evaluation process.

Dr. Douglas L. Beck:

The other thing is that these AirPods are meant for people with mild or moderate loss and they would not be sufficient for anybody with moderately severe, severe or profound loss. Dr Darrow, I want to thank you for your time and I want to thank you for your knowledge on this topic. I think this is so important. Consumers obviously are going to be looking at this as well. Professionals and they should. It's a very, very clever technology. It has some very good assets and it has some liabilities as well. Not a panacea. It doesn't replace any professional care at all. I always want to urge people if you have hearing loss or you have listening difficulty, particularly in noise, a pure tone hearing test isn't going to tell us what we need to know. We need to get you into the office for comprehensive audiometric evaluation, including listening and communication assessments, speech and noise, bone conduction, hearing tympanograms, otoacoustic emissions reflexes, ipsy and contra. Then we know what's going on and it's the same thing we do in medicine it's diagnosis first, treatment second. Dr Darrell, thank you so much. Have a wonderful day.

Dr. Keith Darrow:

Thank you.

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Blaise M. Delfino, M.S. - HIS

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Dr. Keith Darrow

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