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

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.

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 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.

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.

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.

Having 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.

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.