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FDA Approved OTC Hearing Aids: A Win for Hi-Fi Audio?

by September 06, 2022
Bose Hearing Aids

Bose Hearing Aids

If you're an audiophile suffering hearing loss, we've got some good news for you!

On Aug 16th, the FDA finally issued its long-awaited final rule that creates a new regulatory category for over-the-counter (OTC) hearing aids available without a prescription. The ruling is expected to open up market competition for new devices intended to help those with mild to moderate hearing impairments. It’s not so much a deregulation of hearing aids, but a new category of consumer hearing aids that must meet certain FDA requirements. These guidelines have been years in the making, and it should be a sound improvement for hearing in a country where many lack health insurance or have a health plan that lacks coverage for hearing aids. Surprisingly, Medicare and many private health insurance plans that may cover a visit to an audiologist, won’t cover hearing aids themselves.

As those of us old enough to remember Schoolhouse Rock know, the new ruling began as just a bill called the FDA Reauthorization Act. The bill received overwhelming bi-partisan support before being signed into law by President Trump back in 2017. The law proves that sometimes Congress overcomes gridlock just long enough to be effective. The new FDA rules will take effect in just 60 days, so we could start hearing about new products hitting the market by mid-October. This is a positive step for us GenXers because we're entering our years of potential hearing concerns. It should soon be cheaper and easier to extend youthful hearing levels with an injection of 21st Century technology, innovation and market competition.

Age Related Hearing Loss

The ruling has been widely embraced by audiologists and hearing health professionals because it removes barriers from accessing hearing aids. But support for OTC hearing aids isn’t universal. The American Speech-Language Hearing Association (ASHA) has expressed misgivings, saying that people with moderate to severe hearing loss may not be receiving the help they need with OTC hearing aids. Of course, ASHA recommends a visit to a professional as the only way to get real help. But I think anyone would agree that if it's an option to see a doctor about any perceived hearing loss, you should.

Hearing Loss: Worse Than it Sounds

Hearing loss are two words no audioholic wants to hear. For most of us aging audio enthusiasts it’s an easy problem to ignore. Barring illness or accident that compromises a lot of our hearing at once, we might not notice a gradual erosion of certain frequencies. But still, fans of hi-fi audio may be more in touch with their hearing than the average person, and as we get older, hearing the shimmer of the cymbals in one of our favorite recordings may require a bit of strategic EQing.

Still, these little details in our hearing should not be ignored, as the consequences could be worse than just losing a few sounds. According to the National Health and Nutrition Examination Survey from 2011–2012 that documented age-related hearing loss for males and females, our loss of perception in high frequencies can become noticeable in our 40s. But it’s not until we start to lose some of our speech-related frequencies that most people will really start to recognize there might be a problem.

The most common symptoms of high-end frequency hearing loss are included in the following graphic from HealthyHearing.com:

High Freq Hearing Loss

Bad news for men - understanding women gets no easier in middle-age

Dangers associated with hearing loss, especially in the speech-related frequencies, may be more serious than you think. Once you lose perception of certain words, it affects auditory-lingual pathways in our brain that atrophy like an unused muscle. Left unchecked, this problem can become compounded and lead to an overall cognitive decline. Fortunately, access to hearing aids is about to become a lot easier.

Hearing Hi-Fi Audio

Liberty 3ProNo doubt, we are about to see new “audiophile-grade” hearing aids aimed at those with mild to moderate hearing loss. They’re already available for the current prescription market by brands like Widex and even Bose. Higher-end hearing aids will be an inevitable part of the new market created by the FDA rules, and those targeting audiophiles will surely grow as a specialty market that may be ripe for new kinds of snake oil claims. Despite having to meet FDA guidelines, some OTC hearing aid manufacturers are likely find workarounds for marketing devices with unfounded or merely implied claims. It would be wise to sharpen your own Carl Sagan BS detector and be wary of claims with no evidence or scientific studies backing them up.

It’s no surprise that hi-fi audio enthusiasts are a largely aging market, with many of us well past 40 years old and maybe just starting our own hearing decline. But can hearing aids help extend our enjoyment of hi-fi audio? To be clear, I have no expertise in hearing aids or hearing. But there is plenty of anecdotal information online telling us that hearing aids are no barrier to enjoying good sound quality. So, you should never feel that you can’t hear good sound while wearing your hearing aid. Our brains are highly adaptable and even if things sound a little different through a hearing aid, our minds adapt to sound just as it adapts to vision aids. So, it is possible to perceive all those little details that make for a pleasurable listen. A simple Google search on hi-fi sound and hearing aids will result in plenty of stories from people enjoying good audio with hearing aids.

As for what the broader consumer electronics market could bring to hearing aids: I’m presently testing some IEMs that have a built-in hearing test that creates a personalized frequency curve tailored to your hearing. In our present highly regulated hearing-device market, devices that perform any kind-of hearing “test” are strictly for entertainment purposes and aren’t intended to be a medical diagnosis. It's likely that new over-counter hearing aids will have similar built-in tests with corresponding apps to let you set preferences. The IEMs I’m testing provide an optional DSP based on your custom “HearID” curve that I believe just increases the volume on those frequencies it surmises are gaps in your hearing. I know for me it’s trying to fill in some of the higher frequencies, perhaps giving me more in frequencies I do hear. The effect though, is a mess to my ears, so I don’t use that DSP setting. I prefer the default EQ because my customized “HearID” sounds far too tinny. Perhaps I’ve grown so accustomed to not hearing some higher frequencies that I've developed a revulsion to them. Or maybe my ear-brain mechanism is smarter than the DSP powered microphone.

Will Popular Audio Brands Get Into Hearing Aids?

As we look forward to new innovations and relatively inexpensive hearing aids, it will be interesting to see if more familiar audio or consumer electronics brands jump into the market. When Sound United was acquired by Masimo earlier this year, we speculated on its development of new wearable sound devices. Getting into hearing aids seems like a no-brainer for Masimo now. Although Masimo is known for wearable, non-invasive monitoring devices, is it possible there might be some overlap with hearing aids in the near future? With Sound United, Masimo now has brand options. After all, who wouldn’t trust an audiophile-grade hearing aid from brands like Denon or Marantz? I can easily envision the possibility of a premium flagship Marantz hearing aid coming out next year. Which will be followed up of course, by a slightly less expensive Denon using much the same technology.

My Own Noticeable Hearing Loss

Bateman StackHaving already crossed into my 50s, I know I’ve lost some perception of higher frequencies. For at least the last couple of decades I’ve taken great care not to abuse my ears and never attend a live performance without earplugs. Since I spend a lot of time listening to headphones and IEMs, I use a technique where I’ll find a volume I like for a particular song first, then volume-down two notches, reducing at least 2-dB of loudness. Although it doesn’t seem like an optimal volume right away, some songs just NEED to be loud! But the mind adjusts my perception within a minute or so and I no longer notice that I’ve turned it down.

But I wasn’t always so cautious about protecting my hearing. I probably lost some of it going to punk rock and metal shows through my teens and 20s. Seeing GWAR every Devil’s Night in Detroit was a ritual. The shows were so loud that every Halloween I had the audible sensation of being behind a pane of glass with the rest of the world on the outside. However, the effect would dissolve by the end of the day so I was never really concerned. Today, I shudder to think of what I was doing to my hearing. If anything contributed to the loss of some of my higher frequencies, it's evenings with GWAR.

One result of higher-frequency loss may be found in my current-day choice of headphone. As a frequent hi-fi headphone listener, I count Audeze's LCD-line among my favorite. My LCD-3 planar magnetic headphones are notable for many strengths, but performance in high-frequency sound is not among them. It's their warm, intimate midrange I find near-perfection. I assume the reason I don’t notice its weakness in the upper-end is that I probably don’t hear a lot of it. But I've never cared for sonic brightness or any sound that emphasizes the upper-end of the freq spectrum.

Monkey CookiesIn my early days of hi-fi indoctrination, I had a good friend who was just a few years older with an established career so he could afford a real hi-fi system, circa late 1980s. He had what’s now referred to as the Bateman Stack - Harman-Kardon separates & EQ like the one demonstrated by Patrick Bateman (Christian Bale) in American Psycho. Although, American Psycho was still over a decade away from release at the time, so to us it was just an amazing sound system. My Bateman Stack friend liked to EQ his sound in such a way that emphasized more highs than I would have preferred. I think people associate emphasis on upper frequencies with more detailed sound. I always assumed I was just more sensitive to hearing higher frequencies than others, which may have been true back then. These days, in (non-professional) self-tests involving a frequency sweep, my ears seem to provide a significant roll-off above 15-kHz and I hear nothing beyond 17-kHz. But I don't think that's uncommon for my age. In fact, Gene DellaSala praised that result as being much better than typical for my age and I believe he's somewhat envious too.

I don’t think my hearing has a significant problem with human voice frequencies, commonly considered those between 85-Hz and 255-Hz. However, I have experienced the cartoonish hard of hearing old man trope where I’ll hear my wife or child say something and because I don't understand what the they're talking about, I'll reflexively repeat back a confused, imperfect rendition of what they just said. Sometimes with comedic results. My 9-year-old daughter finds one incident involving asking me a question so amusing she'll relay it to anyone who will listen:

Daughter: “Do you think we should bake cookies for our new neighbors?”

Me (confused): “You think we should be monkeys for our new neighbors?”

To be fair, I justified not immediately seeing a hearing specialist just yet due to mitigating circumstances - at the time my daughter was in an adjoining room while I was running water in the kitchen. But I do notice more susceptibility to voices being drowned out by nearby low-level background noise. This could be a speech perception problem involving TFS, or "temporal fine structures" as it pertains to hearing, another subtle hearing loss cue that may get worse over time.

Although I’m protective of my current hearing level, I’m still quite happy with it, but I hate to think my ability to enjoy my favorite hobby is liable to become compromised over time. That’s all the more reason that us aging audiophiles should have our hearing checked out from time to time. But it's nice to know that, with this new FDA ruling, when the time comes that I have to admit I’d benefit from a hearing aid, the options should be significantly multiplied.

 

About the author:
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Wayde is a tech-writer and content marketing consultant in Canada s tech hub Waterloo, Ontario and Editorialist for Audioholics.com. He's a big hockey fan as you'd expect from a Canadian. Wayde is also US Army veteran, but his favorite title is just "Dad".

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Recent Forum Posts:

Stanton posts on September 26, 2022 14:35
As someone who used to write CD reviews for Audioholics (see sig), hearing loss in my 50's finally led me to wearing (professionally) fitted hearing aids to compensate. I don't wear them all the time, but desperately need them for things like watching TV and hearing in public/meeting settings. I have been able to enjoy music without H/A's, but am painfully aware of what I'm missing on the high-end. I have been following H/A tech advancements closely, and welcome the prospect of “audiophile H/A's”. Since they are geared toward voice/speech, most H/A's have poor dynamic range (especially on the bottom end). Having said all of that, I am impressed with the Bluetooth/iPhone compatible H/A's I wear, and am lucky I found an audiologist that tweaked my settings to better enjoy music (they make a decent pair of wireless headphones).
Wayde Robson posts on September 11, 2022 07:59
lovinthehd, post: 1572035, member: 61636
While I don't like wearing headphones or IEMs…

I'm with you there. I hated them for so long. I never understood how people enduring that kind of violation of an orifice for stock earbuds. But they have improved dramatically in the last decade or so. I recall the old stock earbuds that came with smartphones all had solid, hard plastic earpieces & metal speaker grilles. There were no removable ear-tips, the part that plugged into your head was effectively a wide circular speaker, and I guess we were expected to lodge that hard chunk of plastic into our ear-flesh somehow. Discomfort and pain was required for a snug fit. They sounded like crap and I sometimes used to get little zaps in my ear from the metal grille, possibly the result of moisture and being plugged into the phone.

I've warmed to them in recent years, even if not necessarily for music. They've come a long way since then with silicone ear-tips and aftermarket memory foam cushioned eartips from sources like Comply. When doing work around the house I'll usually wear a single ear-bud and listen to a podcast or audiobook. For music I prefer a full sound system or over-ear headphones.
highfigh posts on September 07, 2022 08:49
I can see a few ways that these could be a big winner:

- If they're capable of being tuned via Bluetooth
- If the tuning is done by an audiologist
- If audiologists start to care about frequencies above 4KHz- they typically don't because 4KHz is the upper limit needed for speech intelligibility and their main purpose is to make sure people can understand speech.
- If people CAN'T mess with the settings unless they're well-instructed on how to do it correctly.

I can't wait for someone to come up with ‘high-end’ hearing aids or audiophile hearing aid batteries.

For those who don't know who he was or what he did, Les Paul did a lot to improve hearing aid technology in his later years and continued until he passed. Even if someone doesn't know who he was, they have heard the results of his invention and the technology he developed.
lovinthehd posts on September 06, 2022 20:45
While I don't like wearing headphones or IEMs, I suppose one of these days a product like this could be interesting as long as it comes with some decent setup capabilities…..hopefully that's still a bit off time-wise
Hobbit posts on September 06, 2022 19:43
Curious to where the technology goes? I could easily see these coming with a set of buds or headphones that connect to your phone and an app on your phone that gives you a hearing test and appropriately programs the hearing aids.

What will be interesting is to see how far OTC's takes technology. My guess is the first generations will be just amplifiers. If I had a pair, I could play the TV and Music at a volume to not drive my GF crazy as well as hear her from another room. However, they won't have all the room canceling/directional capabilities like the good ones making them not so good for loud restaurants. BTW, one good part of working from home is people speak into a microphone and I can turn the volume up on my speaker. Which is better than trying to hear soft speakers in a big conference room.
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