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Brian Lehrer: It's the Brian Lehrer show on WNYC. Good morning again, everyone. Let's talk about hearing aids. Did you know that the Food and Drug Administration has now moved to enable access to hearing aids over the counter? That is, without a prescription for people with mild to moderate hearing loss? That's a group that likely includes millions of Americans. Consumers have long been frustrated with the high cost of hearing devices and medical exams that precede them, while soon many will see these costs come down significantly because of this rule change.

We get to the specifics of the rule change now with Christina Jewett, New York Times Food and Drug Administration correspondent. Also joining us is Lauren Dragan, senior staff writer at The Times product review website Wirecutter, who's put together a really well-resourced guide to over-the-counter hearing aids and how to go pick out the right one. Hi, Christina, Lauren. Welcome to WNYC. So glad both of you could join us.

Lauren Dragan: Hi. Thanks for having us.

Christina Jewett: Yes. Hi, Brian. Thanks for having us on.

Brian Lehrer: Christina, first things first. What is the FDA's new rule, and when can people start buying hearing aids over the counter?

Christina Jewett: Well, essentially the rule changes the status quo, which was that you had to go to an audiologist for a couple of appointments to figure out what kind of hearing aid you need, select that, get a fitting, make sure everything's working. This is a process that could cost roughly $5,000. Now under this rule, people can go to a retail store or a website when these devices are ready, probably in October, and buy a hearing aid. These are going to be pretty high-tech devices that you can adjust using an app on your phone.

This is what's believed to be a really underserved population that's been pretty off-put by the cost and the process of getting a hearing aid that will hopefully be able to access this technology, but much more easily.

Brian Lehrer: Why did hearing aids need FDA approval in the first place, and why did they decide that they no longer do?

Christina Jewett: You can imagine if something is totally unregulated, really shoddy, it could be extremely loud and disruptive, and it could not work and make things worse for someone with a hearing problem. I think, overall, regulators like to have a handle on things that have such a deep impact on a person's life. The deregulation isn't quite as free-ranging as it sounds. There's actually quite a bit of fine print now on how those devices have to work, minimum standards, labeling. All those things were addressed by the FDA, but it sets a bar that these companies have to cross to market these devices. By and large, if they cross that bar, you can ideally go to the store and pick one up

Brian Lehrer: Listeners, we can take your questions about the FDA's decision to enable over-the-counter access to hearing aids for people with mild to moderate hearing loss, and your questions about how to go about shopping for one. 212-433-WNYC, 212-433-9692, or tweet @BrianLehrer, or if anyone has a story in this regard we'd love to hear it too.

Lauren from Wirecutter, let me go over to you. I see you put together a really helpful consumer guide about the best over-the-counter hearing aids and how to pick the right one, which we'll get to. You write in that article that the answer to the question, "What is an over-the-counter hearing aid?" just that simple direct question is trickier than maybe it should be. How come?

Lauren Dragan: [laughs] It is. Well, there were a lot of interested parties in the crafting of this law. There was a huge open commentary period, and like Christina mentioned, there's different people concerned for different reasons about how loud is too loud. What makes something safe? What sort of controls should someone have when they're getting their own fitting at home? That's the reason why it's a little bit more complicated, but also because there's a lot of gray area in terms that people use. People have been using what we might consider now an over-the-counter hearing aid as what was called a PSAP before, or a personal sound amplification product.

It's a really long word, that's why we call them PSAPs, but essentially they aren't supposed to be used for hearing augmentation for hearing loss. They're technically supposed to be used as like spying on your neighbors I guess, or bird watching. It wasn't a lot of regulation about it. Even though there were laws in the books saying that they weren't supposed to be used for that, the thing about this is that the FDA doesn't really have anyone checking up on any of this stuff. The laws are there, but it's really up to the community at large.

By that, I mean consumers, audiologists, people who are using these products to whistleblow and point out the products that don't meet these guidelines to the FDA to have something happen. Otherwise, it's a little bit of the Wild West. There's a lot of different things out there. There's things called hearables, which are more like-- I guess you can call them earbuds with some hearing augmentation built in, and there's the PSAPs I mentioned. Now we're going to have prescription hearing aids and over-the-counter hearing aids. There's a lot of jargon getting thrown around in this early stages.

Brian Lehrer: I've had the experience on a number of occasions as a radio interviewer where people with some degree of hearing loss come into the studio for an interview, and they put on the headphones and they're like, "Wow, this is great. I was afraid I might have trouble communicating with you because I have partial hearing loss." Then they put on the headphones and it's just headphones, but it puts the sound right in their ears. Are any of these over-the-counter products like that or are they all very small things that you try to put in your ear without it being seen much?

Lauren Dragan: They're all very small things. You have to think about wearability. Let's be honest. Right now we have a society that still, for some reason, stigmafies-- if that's a word. There's a stigma around hearing aids, and so there's a lot of emotion wrapped up in this. When people go shopping there's feelings of-- Even the marketing, I should say - when I was doing research for these to see what was out there - has a very, as I put it, "Damn it, grandpa. You're deaf." It's very angry and very shaming, and it shouldn't be.

It is like any other thing, like glasses. I'm hoping that now that these products are out on the market we'll have more of that comfort level of, "Look, people wear earbuds," and some of these devices look very similar to earbuds. It'll hopefully blend in and encourage people to get the help they need because 86% of Americans over 50 who have hearing loss don't wear hearing aids. I think that's going to be a huge, huge deal.

Brian Lehrer: Yes. A lot of people who may be experiencing frustration personally, or experiencing frustration directed at them, as you were just describing, from family members or whoever may say, "Oh, now I can go out and try something." Christina, that leads me to another question. Is this deregulation, where you could now soon buy these things over the counter, really just for the kind of hearing aid that boosts volume? How many people really have that kind of hearing loss versus a more complicated hearing loss where the hearing aid might need to be programmed in some way?

Christina Jewett: This is targeted at adults and not children, and also for people with mild to moderate hearing loss. That's one of the flaws that critics of this pointed out, was this is sort of the ultimate bad breath problem. People who have hearing loss often don't necessarily realize it, and taking that a step further, they may not be in the best position to evaluate if they have moderate or more than moderate hearing loss. The people I talked to said that there's concern about the place of the audiologist in all of this. Do they become sort of a dodo bird?

What they're hoping is that this makes a larger market that's interested in hearing correction, that turns to the audiologist to really figure those things out, and to get help if they're struggling with calibrating their over-the-counter hearing aid.

Brian Lehrer: Here's a dodo, I mean an audiologist, calling in right now. Jane in Brooklyn, you're on WNYC. Hi, Jane.

Jane: Hi. Hello. Thank you very much. Can you hear me?

Brian Lehrer: Yes, I can hear you.

Jane: Okay. I just want to say that I'm hoping that more people will consider hearing aids who have not considered hearing aids before, but I think there's two cautions. One is obviously things can cause hearing loss that are medically correctable, and things can cause hearing loss which are very serious. You should see somebody who can check that you don't have either fluid in your ears or a tumor in your middle ear or in your inner ear that's causing the problem. My caution is that people who get these hearing aids, lots of people get a hearing aid and then if they don't like it they don't go back to get it readjusted.

Many, many people who use hearing aids do better once the hearing aid gets adjusted when they have learned to use it and learned to listen with it. Then they can say, "I can hear here, but I can't hear here," or, "I hear people with low voices. I don't hear people with high voices," and then the audiologist can do something to adjust it. My question is if you don't think you're hearing well don't give up, because you can do better if you get a professional who helps you.

Brian Lehrer: Jane, thank you so much for that call. Lauren from Wirecutter, how does this play into the choices that consumers may now be empowered to make, or we could say that consumers will now have the burden of starting to make on their own if they don't see an audiologist? Are the products that are now going to be on the market adjustable enough that if your loss, as Jane was just describing, is more in the high range you could set it one way, if it's more in the low range you could set it another way? How variably adjustable are these products?

Lauren Dragan: They're actually more adjustable than you might think. One thing I want to point out is that first of all there's a lot of things in our guide that we talk about as, just like Jane mentioned, that you definitely want to get checked to make sure that there isn't earwax or some other thing. Any time you have sudden hearing loss where it's like one day you're hearing fine and the next day it's significantly worse, that is definitely something you should get checked out.

For people where it's been a gradual thing where they're suddenly hearing people, they're starting to notice people less suddenly, saying things like, "Hey. I'm calling your name, you're not hearing me," or they're asking people to turn the TV up and things like that, that's really more who these things are for. One of the things that we talk about in the guide is that the majority of people who have that kind of hearing loss generally lose it in that upper range like she was mentioning.

There are guidelines as to how much gain there should be between the signal that's coming into the hearing aids and how much they're boosted. We tested and by and large most of these devices boost in that same range. The higher end that gets lost, that's where consonants are that really form the shape of words, so that's standard. Some of these do have various ways of adjusting it.

Some of these devices that we tested are more manual. You can go in and there's a little EQ slider like you'd have on a stereo system, and you can move it up and down and adjust it that way, all the way up to some of these products that have built-in appointments as part of the process. When you buy them, you have a call with someone that is going to help you as a hearing professional get the sound you want, and you can do over-the-air adjustments.

You call them, say, "Hey, listen. I'm at a cafe. It's kind of weird in here. I'm hearing too many other things like glasses clinking. Is there any way we can get a different setting and adjust it?" They can actually send over Wi-Fi an update to their sound profile so that the person can actually get exactly what they need in the right situations.

Brian Lehrer: If you're just joining us, we're talking about the FDA moving to enable access to hearing aids over the counter, that is without a prescription, with Christina Jewett, who covers the FDA for The New York Times, and Lauren Dragan, senior staff writer with The Times product review website, Wirecutter, where we're talking about some of these products that are now being offered or just about to be. Tina in Nassau County, you're on WNYC. Hi, Tina.

Tina: Hi. How are you?

Brian Lehrer: Good. You have a question.

Tina: I wear hearing aids and I have for a number of years. I went to an audiologist. The cost was astronomical but I had my own insurance through work and my husband's. They paid for the entire cost, but then my husband retired and whatever. I don't have his insurance anymore. I just got new hearing aids. I'm paying for half the cost, and I was rejected by the company that was going to help me pay based on some nonsense. I'm concerned about people who have already purchased hearing aids, but I'm more concerned about the ability to do what an audiologist does.

I love the idea that this whole thing was deregulated and the costs will be affordable, but I just know from my own experience that tuning a hearing aid is so-- it's complicated, and that's why we have audiologists. It seems to me that it would be great if we could lower the cost of the hearing aids but still have the expertise of somebody who understands the really fine points of tuning.

Brian Lehrer: Yes. Thank you, Tina. How will this work? Will people go to the pharmacy and work with somebody in the hearing aid section, Christina, and try on different products? Will you be able to try them on? I know there's a lot of restrictions on putting things in your ear, putting things on your body in over-the-counter products generally. Do you know?

Christina Jewett: I think it's a good question. As someone who grew up in the print newspaper industry, industries transform and respond to technological change and structural change. I think it's a really open question. Will Rite Aid carry these and have an audiologist who's there on Saturdays and Sundays or on contract or there full time? That's an important question. I don't think this is an industry that's going to disappear. I think it's a question of how does it-

Brian Lehrer: Interesting.

Christina Jewett: -adjust and conform to this--

Brian Lehrer: To be determined.

Christina Jewett: Right.

Brian Lehrer: One more call, and I think it's a product recommendation. Patrick in Wharton, New Jersey, you're on WNYC. Hi, Patrick.

Patrick: Hi, Brian. How are you?

Brian Lehrer: Good. What you got for us?

Patrick: Can you hear me?

Brian Lehrer: I do.

Patrick: I got a hearing aid through Medicare and it was like $1,100, and the audiologist could never get them to sound other than a cheap AM radio, and I was really disappointed. Then the Bose company came out with their alternative. It was $800 and they're amazing. You can dial in on your phone. You can set them for inside and outside. They have all different kinds of things, and they were a fair price and they work. I was so disappointed with the audiologist. He said, "Oh well, we could upsell you to ones that cost thousands and thousands of dollars," and I was like, "Oh my God." Anyway, there's my--

Brian Lehrer: All right. Interesting that it comes from Bose, which of course has a big reputation in consumer audio. Lauren, last question for you. His experience makes it sound like there are already over-the-counter hearing aids. Is that the case, and what changes? We have a minute left.

Lauren Dragan: Okay. To make it as quick as I can, Bose has actually pulled out of the market now. They're doing more consulting work, unfortunately. There were some states that essentially if a product was similar enough to a traditional hearing aid they could be sold in those states. A few places had Bose for sale, Jabra as well, that will now be nationwide; they'll be available. To say about the audiologist experience, I want to say also the technology has changed so much in the last five years. It was something that our panelists kept saying over and over.

That the ones that had experience with hearing aids said that the products that they could get now that were so inexpensive were vastly better than things that they had tried before. That's because of microchips getting smaller, and there being more capabilities with sound processing in these little tiny microchips.

If you've had hearing aids before and you have given up on them, I would say don't. Also, to speak to everyone's points here, I think that there isn't any one answer that's going to be right for everyone. The most important thing you can do is that with these devices, they'll be sold in places like Best Buy. They already announced they're going to be doing that in October, where you can go in and just buy something off the shelf. Look for something that has a long return policy. 45 days is the minimum, some of them have up to 100 days.

Take them home. Take the time. Allow yourself to adjust to them because one of the things that people say is that the initial process involves some brain adjustment that has to happen. Hearing is not just corrected like the way glasses are. You want to give your brain some time to adapt to the new sounds, and then you can actually see if these things are going to work for you. It's not an out-of-the-box instant fix.

Brian Lehrer: Lauren Dragan, senior staff writer at The Times product review website Wirecutter, who has put together a really well-resourced guide to over-the-counter hearing aids and how to go about picking out the right one, and Christina Jewett, who covers the Food and Drug Administration for The Times. Thank you both so much for joining us. This was incredibly informative.

Lauren Dragan: Thank you, Brian.

Christina Jewett: Thanks for having us.

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