Why Should You Care About OTC Hearing Aids?

Hearing aids have been taking Washington DC by storm of late. First was the President’s Council of Advisors on Science and Technology (PCAST) report entitled “Aging America & Hearing Loss: Imperative of Improved Technologies” in 2015, followed by the National Academy of Sciences (NAS) report “Hearing Health Care for Adults: Priorities for Improving Access and Affordability” last summer.

Both recommended a new category of hearing aids — one that could be sold over-the-counter (OTC) similar to how people buy aspirin or reading glasses. And just a few months ago, a bipartisan bill that authorizes a new category of OTC hearing aids for people with mild to moderate hearing was introduced in Congress.

The idea has been quite controversial, with proponents favoring the improved ease of access for these important devices and detractors worried that audiologists would be cut out of the process, increasing the risk that the aids would be used improperly or even dangerously.

Living With Hearing Loss | A Hearing Loss BlogMany of us have moderate or severe hearing loss, so these devices are not relevant for our immediate hearing needs. We require sophisticated devices and skilled audiologists to fine tune our settings. We need multiple programs and linked hearing assistance technologies that would not be available OTC, at least at first.

So why should we care? Here are my reasons. Please add yours in the comments.

1. Increased innovation: Innovation is a natural byproduct of competition. Large consumer electronic companies are eager to offer hearing related products, many of which may seamlessly integrate into existing smart phone applications. As the technology advances, it won’t be long before new features are incorporated into more traditional hearing aids and vice versa.

2. Reduced stigma: If more people are wearing hearing devices — and maybe some of them even look cool — stigma will fade. Increased access builds awareness and better understanding of the issues people with hearing loss face. Perhaps accommodations like hearing loops and closed captioning would become more standard fare too.

3. More service oriented audiologists: With devices available across multiple channels, the audiologist role will evolve into a provider of hearing services rather than primarily devices. Perhaps these services could even by covered by insurance over time.

4. Lower prices: With increased competition, prices have nowhere to go but down. Unbundling of audiologist services from devices will also allow patients to better understand what they are getting for the price they are paying. Increased clarity will allow consumers to make better choices for themselves and their families.

5. An emergency back-up pair: Do you ever worry what you would do if you lost your hearing aids or they needed to be sent out for a lengthy repair? While OTC aids might not be ideal for your particular hearing loss, they may be better than nothing in a pinch or as a back-up.

6. Safer options for those already buying over-the-counter: Unregulated OTC hearing aids already exist in the form of personal sound amplifiers or PSAPs. By law, PSAPs cannot be marketed to people with hearing loss, but that doesn’t prevent people from using them as hearing aid alternatives. While some PSAPs are safe and effective, many are not. An official OTC category would include strict quality standards enforced by the FDA and clear labeling explaining proper usage.

7. We don’t have to use them: Just because there is a new category of devices available does not mean we have to use them. We can continue to access high quality hearing aids from the manufacturers and audiologists we already know and trust.

Readers, do you care about the pending OTC hearing aid legislation?

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56 thoughts on “Why Should You Care About OTC Hearing Aids?

  1. I certainly care about this legislation but as you said this won’t affect moderate to severe loss. It’s fine as far as it goes and a good start. I just hope this awareness and accommodation progresses further. Shelling out thousands of dollars every few years is difficult at best and impossible for some at worst.

  2. I agree with most of your discussion. I am fearful that hearing aid companies will segment there products – one for the PSAP/moderate OTC market and others for those with moderate to profound hearing loss with no cost improvements to urge those to purchase the much needed products and increase the percentage of hearing loss patients who wlll take advantage of the the technology.
    Secondly, I disagree with the reclassification of PSAPs and their control under the FDA. They are readily available NOW. People can take advantage of them NOW. I find the argument for increased use after reclassification a complete failure of logic. Additionally some people with moderate to profound hearing loss will buy them without improvement. Those with moderate hearing loss can still hear most things. Those with more severe hearing loss who need them most need help in lowering costs of the more advanced hearing aids which the manufacturers will defend as “their propriety marketplace.”

  3. Thank you for laying out why OTCs make sense. It’s not a perfect solution as those that are against OTCs point out. But since only 20% of people with hearing loss have hearing aids, something needs to be done and I don’t see any other solutions on the horizon.

    I particularly love that it would help reduce the stigma of hearing loss as more people use devices. I dream that designers and hearing aid manufacturers will partner to give attractive hearing aids like there are designer eye glasses (and of course the best price/performance). But that will only happen when the stigma of hearing loss is gone.

    Thank you.

  4. I think making more assistance available to more people has to be a good thing. I’m not sure how you’d know which OTC hearing aid would be best for you without the assistance of an audiologist, but I guess that’s when you go out and do the research.

  5. The worst problem with hearing aids these days is cost. Mine cost $2000 each! Insurance doesn’t cover much. Have a profound hearing loss . OTC will only benefit moderate hearing losses, but it could create competition and maybe keep the cost down.

  6. Thank you for sharing your thoughts on this Shari. You are right on target. I hope that new OTC devices that are developed include the telecoil component with specific information on how to use it. While the OTC market will focus on mild to moderate hearing loss, it’s difficulty hearing speech when background noise is present, that usually starts a person on the journey towards hearing instruments. That clarity of speech in noise issue is prevalent across the spectrum of hearing loss. And it affects enjoyment and participation in venues like theaters and at meetings. If hearing assistive technology is present in those venues, being able to connect directly to the sound system breaks down barriers. No matter the degree of hearing loss, people who have it do want to hear as best they can. Telecoils add value. I hope the OTC devices will include them.

    • The chance for TELECOILS in OTC devices is probably next to nil. The current PSAPs do dot have telecoils. They will only be made available if the FDA requires them. The last time we hoped our government would do something to help disabled people, we were tragically let down.,

      • Hi Jedidiah;
        Please be aware that some PSAP’s do indeed have T-coils in them.

        All features in any device are driven by market demand; if we are demanding features, then the features will get added.

        Too many people are NOT demanding T-coils in their hearing aids and so audiologist and practitioner stopped adding T-coils.

        Speaking of market demand, many people wanted small tiny “can’t be seen” hearing aids, this leaves no room for a T-coil.

        Shari has made many wonderful points in her blog and all of them are 100% correct. Lets not be chicken little and fear the falling sky, instead lets see the silver lining in OTC program coming. I can without a shadow of a doubt tell you, that services will improve from your practitioner or audiologist, pricing structures will change and improve. Technology will improve and to achieve market share, companies will need to start listening again to their clients.

        Right now the whole industry is driven by a small select couple of hearing aid manufacturers and they are dictating to YOU what are supposed to want. But these changes will allow us the consumers and users to start taking back control.

        In optical, having OTC reading glasses and OTC vision glasses available has not destroyed the opticians nor destroyed their industry. OTC glasses have not stopped people from getting the vision help they need to an “specialist” eye centre, but OTC glasses have certainly helped lower the cost of lens and frames and have helped create a whole new market of fashion glasses. At one time there was just a handful of frames to choose from, look at pictures from the 1930’s, 40’s, 50’s everyone is where similar glasses. Now we have choice, selection, style and some of the best possible lenses available.

        Sorry for the long rant. Let me end this by saying the only thing we have to fear is fear itself.

    • Julia;
      There are some PSAP’s and OTC hearing assistive devices available which contain T-coils.

      We as the consumer need to take back control of our hearing loss and start demanding companies provide technology that we need….

      We can start to do this by supporting the companies who are putting T-coils in their devices, who are creating user friendly Bluetooth features.

      Also wee need to stand up to the companies who also are creating propriety features in their products forcing us the consumer to overspend on the assistive products supplied by that said manufacturer just to manage all aspects of our daily living when it comes to hearing loss.

      • I was never told about T-coil from my hearing aid fitter. It wasn’t until I switched fitters/companies that I was told about it. I am still bitter towards my first hearing aid fitter, my life has completely changed because of t-coil. I am STILL bitter towards the hearing aid fitter. That was over 10 year ago!

      • I am sorry you did not get the proper information from your first hearing health provider about telecoils. My first HLAA convention was in 1996. It was there I learned about telecoils and all the important programs that are available. I am so thankful for HLAA for the information and education they provide for people who are losing their hearing.

  7. Shari, thank you for sharing your thoughts. As invited, here are my reasons in response to the points you make:

    Why Should You Be Concerned About OTC Hearing Aids?

    1. Innovation in the HA market already exists. There are Lyric hearing aids that are completely invisible to the eye, there are CICs, and pink sparkly purple ear molds, bling for tubes, and a large variety of colors to blend in or stand out. Every few years HA technology takes a big leap. Remember body aids and huge batteries? Now we have small BTE HAs with Bluetooth technology wirelessly streaming from our smartphones. Innovation in PSAPs also exists and is increasing, without the OTC bill becoming law. Just google “hearables”.

    2. Stigma: Hearing people wear BT devices in their ears and I do think this has helped reduce the stigma of people wearing something in their ear. A big PSAP earbud like the Bragi being renamed as a HA might decrease stigma. But then again, it might not. Who knows?

    3. Divorcing the device from the service: It will be very challenging for an audiologist or hearing aid dispenser to service dozens and dozens of different devices, some with or without proprietary software, and in many cases there will be no way to customize the “PSAP renamed HA”…so where’s the service in that? You state “Perhaps these services could even by covered by insurance over time.” If they aren’t covered by insurance, how is the audiologist to make money? Will consumers pay out of pocket for service on top of the price they’ve already paid out of pocket for a device? (The experiment in unbundling so far is yielding mixed results.)

    4. Lower Prices? Bose has a lot of competition, yet tightly controls their prices, just as Brooks athletic shoes have lots of competition, yet ferociously controls their prices. Apple has competition, yet controls their device prices. Those 3 companies haven’t lowered their prices in years. Why would the big 6 HA companies lower their prices on HA? They aren’t yet competing with “PSAP renamed HA”. Will they? Starkey is floating a trial balloon with the Bragi Dash to see if people want a custom earmold fit ($500). Unbundling is something I fervently support and many audiologists are trying it now.

    5. Back-Up: A high-quality PSAP (think the Roger Pen, the FM system, even a Williams Pocketalker with t-coil) will also do in a pinch. I keep my old pair of HA as a backup and have never been without a HA (my audiologist will also give me a loaner).

    6. Safety: PSAPs should be regulated by the FDA to ensure safety. PSAPs should not be called HA because they aren’t HA. It is not necessary to create an OTC HA category to create regulation for existing or new PSAPs. PSAPs are marketed as hearing enhancement, and people know exactly what that means (they aren’t hearing aids but will help me hear).

    7. We may be required by our insurance companies to first try a “PSAP renamed HA” before they approve a true HA for us. We may have to fight for insurance coverage of our HAs if HAs go OTC. When prescription medicines go OTC, insurance no longer covers them.

    • Thanks for adding to the dialogue on this topic. I do agree insurance coverage is a concern, but there is precedent for insurance coverage based on severity of illness. Change is messy, but I believe change is coming and will benefit us all over time.

  8. All the arguments for a delineation in hearing aid devices between OTC and non-OTC is becoming a technological anachronism, along with the entire business model for audiology in general.

    There is a convergence occurring in PSAPs and traditional programmed hearing aids due to tech innovation.

    Examples: Eargo provides superb OTC aids for around $2000 a pair. They are rechargeable and completely invisible. NO programming required. No audiologist. Currently only works for moderate to low hearing loss, but that will eventually change.

    Phonak’s Lyrics are excellent invisible hearing aids, though analog. They do not require programming. I believe they require an audiologist only because of FDA rules. They are very expensive, but I think with relaxed FDA rules competitors will come out with comparable products that will reduce the cost.

    Phonak’s Silk has a completely in the canal hearing aid that does not require a custom mold. Right not an audiologist is required because they are considered a traditional hearing aid. Effortless to insert in the ear and very comfortable. They require an audiologist now to program, but I’m convinced that technology software solutions will emerge that will permit do-it-yourself programming that will be situationally interactive, thus being superior to one-time audiologist programming; and essentially free.

    We are at the cusp of profound disruption in the hearing aid industry comparable to UBER disrupting the taxi industry. Regulators and special interest groups (such as the audiology trade organizations) will continue to fight to retain oversight of this industry, contrary to the best interests of the consumer. We need to get all of them out of the way to allow for true competition. This new bill is a good start, but is meek by comparison to disruption that is already occurring at a grass roots level.

    • I agree that disruption is coming. It can be messy, but it is usually better for the consumer on the other side. Thanks for adding to the discussion with these interesting points.

  9. Hello Shari
    I wish I could be sure that these OTC devices would actually help the person with mild hearing loss to hear better, but I’m sceptical. People buy OTC reading glasses very successfully but hearing loss is a more complicated thing.
    Which brings me to my main point. Before I retired I worked for over 15 years with people living in retirement housing complexes. I met dozens and dozens of people who had hearing aids but didn’t wear them – not because of the stigma but because “they didn’t help”. I would try to encourage the person to go back to their audiologist and get adjustments/different hearing aids/whatever but very often that one bad experience seemed to have closed their mind to the very idea of hearing aids. “It’s not worth bothering”. “I’m too old now”. “They hurt my ears”. It was absolutely tragic. People need good advice and expert fitting by an audiologist, which I don’t think they’ll get from an OTC sales team.
    Thanks, though, for a very interesting and thought-provoking post.

    • Vera;
      An expression used in Australia is: There is horses for courses. IE some horses are best for straight tracks, some best for short sprints, some best for long distance endurance.

      This is very true for H/A’s and PSAP’s. Just because “something” did not work in the past does not mean that something new in the the present or the future will not work.

      What works for some, might not work for others, so should we be limiting the industry as a whole just because something did notwork for a handful of people at one time in the past?

      I have a set of OTC PSAP’s with Bluetooth and the ability to make custom adjustments via my smart phone to volume, treble base and tone. These devices are considered only for people with mild to moderate hearing loss. My father has a very EXPENSIVE pair of hearing aids from one of the big three hearing aid manufacturers. These H/A’s are meant to be set up for his hearing loss. He is in the high profound category of hearing loss and is considered a power user. (IE his batteries don’t last long at all due to volume required)

      His H/A’s cost thousands of dollars more than my simple OTC-PSAP’s, which are less than $1K for the pair.
      When my father tried my aids, he was surprised that they were actually a usable item even for him.

      Yes the volume was not quite what he needed even at max volume, but he could “get by” using them especially if there is a financial issue and he was not able to afford his H/A’s from the well know manufacturer.

      I have seen people who others claimed were deaf in a care home start to cry when they were given a Pocketalker to use for the first and they could HEAR loved ones again.

      For people in the mild to moderate range of hearing loss, it is not as complicated an issue as “some” people in the hearing industry actually make it out to be. In fact I would say that our eyes are a lot more complicated yet as you have stated, people have been using OTC-reading glasses for years. But the wrong pair of glasses can actually damage your vision even more. Where as for someone with mild to moderate hearing loss, using a poor quality low end OTC-H/A or PSAP just might mean they wont hear as well as getting a higher quality device and or a properly fitted H/A from a hearing specialist.

    • Thanks for adding your thoughts to the discussion. It always saddens me to know that people have a hard time with their devices. Hearing is complicated, but that is no reason to give up. I believe competition can do nothing but improve quality and usability of all the devices, but people still need to make the effort to try. Thanks again for sharing your perspective.

  10. WOW – OTC’s are getting to be as controversial as Republican and Democratic.

    Truthfully I see it as a gamble but well, I’m a gambling girl! Even if it doesn’t work perfectly, it will bring the issue out in the open and that in itself is good.

    Thanks Shari.


  11. Shari, these are truly insightful, good reasons to “care”. The OTC issue blossomed when somebody stated that there is some huge number of Americans who need hearing assistance and yet only a third (roughly estimated) get help. We are already on a slippery slope with the numbers when someone leapt to the conclusion that the biggest guilty party for non-adoption has to be “cost”.

    As a manufacturer of a specialty hearing aid accessory that enables people to dye their transmission tubes, (Vanish -www.hearingaidsvanish.com) we avidly support any effort that will help more people improve their hearing. We also think we need to be very thorough and clear when we suggest potential ways to increase hearing aid use.

    Although only approximately a third of the hard-of-hearing in the U.S. choose to fix a hearing problem, in European countries where they give hearing aids away (through socialized medicine), still only 40% choose this no-cost solution. What could possibly explain why the other 60% remain aidless? The answer is quite obvious and one that exists with our friends or relatives. It’s Aunt Ethel or Uncle Jim or Grandpa that can’t hear most of what goes on, but insists that they hear well enough to get along and don’t need help. It’s called stigma.

    It’s o.k. to wear glasses, walk with a cane and get gray hair. However, there is still a perception (yes, called stigma) that hearing aids tell the world that you are disabled, or old, over the hill, maybe losing your mind and most of your marbles. The unfortunate reality is, until we get over this unfair negative image, even inexpensive hearing aids won’t move the adoption needle very much. Even so, it is a step in right direction and hopefully, over time, stigma will vanish.

    If nothing else, this legislation will force the hearing aid industry to clarify various needs, products, and treatments – from slight hearing loss up to severe loss – with better definitions of what is available at what cost.

  12. I am not sure OTC aids will help reduce stigma. The target audience is likely to be the elderly with age related mild to moderate loss. I can imagine many thinking “why can’t you hear me with your fancy hearing aids when grandpa picked up a cheap pair at Walmart and they have helped him immensely.” Obviously that’s a selfish statement since grandpa in this case would be getting the help he needs, but has otherwise not gotten. My other point is that I completely agree that audis need to be more service oriented. I would gladly pay for a lip reading class or honestly any hearing loss related class, but there are none that I am aware of. Car dealer lobbyist groups fought vehemently against Tesla directly selling to consumers..

  13. Shari, great article and nice discussion. Like so many others mentioned, I feel stigma plays a huge part here. Even in countries where hearing aids are free, the adoption rate is still relatively low. We need to get to a point where people view all assistive technology in a different way – and I don’t think it’s too far off.

  14. Stigma is definitely a big problem. And it’s fueled by manufacturers and providers that constantly advertise small, invisible, can hardly be seen, no one will notice, etc. Why don’t these same entities share information about hearing aid ‘add ons’; assistive technology that makes a difference, and even promote the pretty colored BTE aids, earmolds, etc.? Stigma is promoted by the industry. It’s up to people who use hearing aids successfully to wear them proudly; to let them show, and to be ready to answer questions when someone notices them. I’m ‘old’ now, but I wasn’t when my hearing loss was diagnosed at age 22. Still, the diagnosticians made me feel old. Audiology practices would do themselves well to hire people with hearing loss who cope well and who use and understand technology as hearing loss support specialists. These people could facilitate discussion groups, work with people on speech reading, and help in myriad ways. Finding support from other people with hearing loss who were willing to sit down and talk about “IT”, was the single most important factor in my learning to cope well. And, while my hearing loss was/is progressive, it was mild at the time of diagnosis. I waited 13 years after diagnosis before I sought further help. I hope that OTC hearing aids will encourage people to take action much sooner than I did. I believe it’s worth a try, and I encourage others to be supportive of those who are struggling with stigma. Talk about “IT” from a personal perspective.

    • Spot on, Julia! Your comment – “Stigma is definitely a big problem. And it’s fueled by manufacturers and providers that constantly advertise small, invisible, can hardly be seen, no one will notice, etc.” – plays into the hands of the industry that makes big bucks on the technology of miniaturization and the vanity with which many of us are plagued. All you have to do is look at the slick magazines aimed at older people and you see super active people with lots of white hair, white perfect teeth and apparent perfect health. Most of my friends don’t look like that! And ALL of us are dealing with some physical issue that includes hearing loss.

      My implant is just over a year old. I worried that I”d look like some Cyborg creature to my friends and others but then the benefit was so profound that I began to even stop covering it up with a cap or hat. It’s a great conversation starter and talking is one of my best things. And listening is improving 🙂

    • OTC hearing aids won’t be appropriate for everyone but hopefully new entrants into the market will force improvements in products and services for all hearing aid users. Thanks for your comment.

  15. Hi Shari, Thank you for your great blog. may we use it to help those in need. We have a web site and Facebook page at Ears4Me.org Hope you take a look at it and let us know what you think. Fred McClory CEO

  16. Hi Shari. It was great talking to you last week at the convention and making me aware of your blog and advocacy work. I’ve spent all week reading past blogs and articles and you provide a great service to the HOH community. You’ve also motivated me to get involved somehow with the HOH community, I just don’t know what it will be yet.

    Maybe I am in the minority, but I believe this new OTC hearing aid law would benefit hearing aid manufacturers because the aids that are currently being sold will not go away as many of the current purchasers I would bet are in the moderate and higher category. They can’t function in a job or socially without the powerful, high priced aids. But manufacturers will be now able to manufacture a ‘low-cost’ model for the mild to moderate category that can be much cheaper to the consumer because they don’t have to go through the audiologist. And hopefully it will cause new manufacturers to enter the market and spark some competition and innovation.

    I also believe audiologists will still keep the current market for moderate to severe hearing loss, and might get some incremental business if they market themselves right to provide some limited assistance to those buying the new OTC category.

    As far as stigma is concerned, I think the newer generations are less conscious of things sticking out of their ears – just look at all of the business people running around NYC with those bluetooth devices in their ears! I admit it took me a few years to move from the CIC aids to my BTE aids because I taught high school and I was embarrassed to be seen with them. But I ultimately needed the power of the BTE’s and switched. And guess what – the students didn’t care. I explained what they were on the first day of school and everything was fine. Hopefully lower cost will help those who’ve been avoiding getting aids because of stigma.

    I am anxiously awaiting the vote in Washington DC. I hope common sense prevails.

    Have a great 4th everyone.

  17. I must tell you, again…that OTC hearing aids might be good for folks with mild-moderate hearing loss. But, they are useless for me (severe-profound hearing loss). We really need to fight for the monopolistic hearing aid manufacturers (there are only a handful of them!) to bring down the cost of those HA’s. These HA’s must be fitted by a licensed audiologist…no way around that. But, advocacy should consist of pushing for the exhorbitant prices of HA’s to come down. My hearing aids (purchased in 2012) cost almost $7.000! Plus, my audiologist did NOT install the telecoil; thus, I had to then buy the bluetooth streamer and microphone (another $500). I, too, am angry at my audiologist, for NOT giving me HA’s with telecoils. She SHOULD have done that, but she failed to do that. She gave me some lame excuse, when I found out about telecoils from my HLAA friends. Outrageous. So…bottom line..we MUSt fight to perhaps get some kind of compensation from insurance for HA’s; we also must fight to get the manufacturers to lower the prices of HA’s!!! Thank you.

  18. When I moved to Israel (where I live now), the one good thing about socialized medicine, is that the health agency paid for much of the cost of my new hearing aids. They are far better than the HA’s I bought in 2012. But, again, they are NOT perfect. ON top of that, making the HA’s almost invisible is BAD, because people just don’t “get it”, when I tell them I have hearing loss, because my hearing aids are almost invisible. The stigma about hearing loss ain’t going away very soon. It’s so sad..people either scream at me, or they say, “forget it”. That is so insulting and frustrating. I’m doing everything I can to do advocacy work,here in Israel. But, it’s an uphill battle. Yes, the new HA’s cost much less, out of my pocket. But, there is NO support for HOH/deaf people here (especially, late-deafened adults). There are hospitals and public agencies with the hearing loss logo/icon posted and a dummy microphone on plexiglass screens, though which clerks speak with the public. The government net mandated that ALL public places should have the microphones in working condition. These people never even hooked up the microphones, in the first place. I’m in the process of lodging complaints with agencies. I’ll probably NEVER see results, in my lifetime. It’s sad…very sad. Disabled people are not treated with dignity or respect. Breaks my heart. I’m also handicapped, because I can’t learn Hebrew (due to the hearing loss0. So, medical and government clerks are rude to me. They see me struggle to communicate and they do nothing to help me understand them. They “pretend” to not speak English. But, many of them can speak English. VERY VERY sad.

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