With FDA’s Blessing, New Over-The-Counter Hearing Aids And Personal Sound Amplifiers Promise To Disrupt Global Hearing Industry

FDA Hearing Aid Guidance for Consumers
The FDA Defines A New Class Of Over-The-Counter Sound Amplifiers

Improvements in technology and performance have enabled a new class of over-the-counter hearing aids and personal sound amplifiers to gather momentum in the global hearing-aid market. A new breed of manufacturers is bypassing traditional distribution channels with products that have the potential to dramatically change the price/performance equation and disrupt the traditional ways hearing-aid manufacturers have done business around the world.

In the U.S., the powerful Food and Drug Administration (FDA), which regulates hearing aids, has given this new class of of devices its blessing with a new name–Personal Sound Amplifier Products (PSAPs)–and a new set of guidelines for consumers who may want to buy and use them. It has also opened the door for a new class of over-the-counter hearing aids, sold directly to the consumer without the assistance of an audiologist.

The new products cost hundreds of dollars, versus the thousands of dollars that most name-brand hearing aids cost today. They are easy to acquire over the internet or through the mail. And they have the potential to start meeting the entry-level requirements of the largest market of consumers who need hearing assistance–the swelling ranks of fifty- and sixty-something baby boomers who are gradually losing some hearing and in need of mild-to-moderate hearing assistance.

Everyone has seen ads for low cost hearing assistance devices on late-night TV or in the back of the Sunday newspaper, but until recently they had little impact on the hearing-aid industry and even less on customers in need of true hearing assistance. Simple amplification doesn’t do the trick for most people who need to hear better in various situations, especially in challenging listening environments such as restaurants and at work. So while these low-cost sound amplifiers promise to solve your hearing problems, they often fail to perform as promised.

Until recently, there was no mistaking personal sound amplifiers for true hearing aids–sophisticated devices that often cost thousands of dollars, but which provide finely tuned correction to hearing impairments. True hearing aids provide digital sound processing tuned to the user’s hearing-loss profile along with features such as directional microphones, feedback cancellation and noise suppression. But as digital signal processors and other components have gotten more powerful and less expensive, it’s become easier to come up with alternatives to traditional hearing aids that do many of the same things just as well at a fraction of the cost.

Now a few manufacturers are taking the plunge with a new class of devices, sold over the counter rather than through audiologists, that look and feel just like the newest open-fit digital hearing aids from established hearing-aid manufacturers. These higher-end sound amplifiers cost several hundred dollars each, versus the cheaper sound amplifiers that often cost well under $100. But they are fully functional digital hearing aids with many features previously found only in high-end hearing aids costing thousands of dollars each.

Walker's Game Ear
Walker’s Game Ear Personal Sound Amplifier Enhances And Protects Hearing

The FDA spent a long time struggling with how to regulate hearing aids and sound amplifiers. There is no doubt some level of medical oversight is warranted, because if you over-amplify the sound going into your ears, you can damage your hearing. Just ask any physician dealing with a 20-something patient coping with self-inflicted hearing loss from extended iPod over-amplification. For years the FDA has required manufacturers to get its approval for hearing aids designed to rectify hearing loss in patients, to ensure the devices work without doing additional harm. Therefore it classified hearing aids as medical devices that audiologists would need to prescribed and fit for patients with medically diagnosed hearing problems.

But problems arose in accurately defining what kind of hearing assistance device would be a “hearing aid,” and what other kinds of devices could be sold over the counter without a prescription. Because the foundation technology of a hearing aid is so simple–basically a speaker and a microphone–you could call any amplification device a hearing aid. Radio Shack, for instance, for years has sold a two-by-three-inch microphone with amplifier that you can use with a set of cheap plug-in ear buds and hear much better than you could before. It’s the same technology as the body-worn hearing aids worn fifty years ago. But today you would be hard-pressed to define it as a hearing aid subject to regulation by the FDA.

The FDA finally settled on a definition of hearing aids as any devices whose specific purpose is to rectify medically diagnosed hearing impairments, whereas PSAPs, or personal sound amplification products, are devices used to amplify hard-to-hear environmental sounds for people with perfectly normal hearing:

PSAPs are intended to amplify environmental sound for non-hearing impaired consumers. They are not intended to compensate for hearing impairment. Examples of situations in which PSAPs typically are used include hunting (listening for prey), bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear (e.g., distant conversations, performances). Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the Food, Drug and Cosmetic Act. As such, there is no regulatory classification, product code, or definition for these products. Furthermore, there are no requirements for registration of manufacturers and listing of these products with FDA. (From Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, Feb. 25, 2009)

Clarifying the definition of hearing-aid devices meeting users’ needs for hearing enhancement rather than hearing correction opens the floodgates for technology and market innovators. For instance, Cabela’s, the hunting and outdoor supply store, sells behind-the-ear and in-the-ear devices developed by Walker’s Game Ear which integrate sophisticated hearing aid technology that enhances as well as protects the hunter’s hearing. It amplifies the slightest sounds of the forest to help the hunter listen for prey, but instantaneously shuts down when a shotgun fires, protecting the hunter from the noise of the blast, which otherwise can seriously damage hearing. Prices for the Walker’s Game Ear products range from under $200 to more than $600.

The FDA has also clarified regulations on the fitting and distribution of hearing aids it has approved for sale. While it very strongly recommends that consumers get a medical evaluation and hearing test before purchasing either a hearing aid or a personal sound amplification product, it allows them to purchase hearing aids without a medical consult if they sign a simple waiver form:

A prospective hearing aid user must provide to the hearing aid dispenser a written statement from a licensed physician that the prospective user has been medically evaluated and is a candidate for a hearing aid. This evaluation must occur within 6 months prior to the date of purchase of the hearing aid. If 18 years of age or older, the prospective user may waive this requirement for medical evaluation provided that the prospective user signs a waiver statement under the conditions outlined in this regulation. (From Guidance for Industry and FDA Staff…)

Credible manufacturers are emerging who offer fully functional digital hearing aids directly to consumers costing hundreds, not thousands, of dollars. Songbird Hearing, utilizing digital signal processing technology originally developed at the famed Sarnoff Labs in New Jersey, has a line of hearing aids available over the internet. Its Flexfit ($179.90) and Ultra ($269.90) hearing aids offer people with mild to moderate hearing loss good sound processing and enough amplification to help hear the TV and get along better at a noisy dinner table, with the Ultra offering high-end features such as feedback cancellation, noise reduction and a button for four “Sound Boost” settings. Its Flexfit Disposable offers 400 hours of hearing for $79.90, at which point you just order another; it’s good for occasional users who will get many months of use out of the device and don’t want to bother replacing batteries. (We’ve just acquired an Ultra and will be reviewing its performance in Hearing Mojo in the near future).

For higher-end users, America Hears offers premium-performance hearing aids at less than half the cost of hearing aids from the leading manufacturers. America Hears hearing aids use top-end digital signal processors, advanced sound processing software, and include all the advanced features high-end hearing-aid users expect. We’ve written about America Hears before and have tested their products, and found them to be as good as the leading name-brand manufacturers. America Hears requires a recent audiogram that’s been administered by an audiologist or certified fitter, but programs the hearing aids at the factory to your unique specifications. It then ships them directly to you along with a programming kit that you can use to fine-tune the aids yourself, or download changes you want from the America Hears audiologists who will make the programming adjustments for you. America Hears hearing aids range from approximately $800 to $1,300 each, well under half the price of comparable products from leading brands.

These products and others like them have the potential to unleash the growth potential of the global hearing-aid market, which has been stuck with single-digit growth over the past decade even as demographic changes would lead you to expect much higher growth rates. Lower costs and better technology and products add up to a disruptive force that has the potential to dramatically change the structure and growth outlook of the global hearing industry.

At Hearing Mojo we intend to follow the markets for over-the-counter hearing aids and personal sound amplifier products as closely as we follow traditional manufacturers’ products. We will look at all the announcements we see and try our best to determine which products come from credible manufacturers with good technology.


  1. Lisa N. says

    To Tom K. Also not only does Sam’s have a 90 day full return, they also have 12 months not interest. The hearing aids are made by Hearing Lab Tech in Texas. Starkey’s hearing aids are assembled in the USA. That’s it as well as Miracle Ear-Rexton (Siemens) hearing devices which are make in Indonesia. Hearing Lab Tech is fully made and assembles in the USA. They are half the cost because there isn’t much overhead. HLT makes the Liberty brand instruments that are Linear compared to the compression hearing aids like all the other brands. The linear is the same processing system that is put into the cochlear implants. The processing system is called ADRO (Adaptive Dynamic Range Optimization). They really work amazing in all hearing environments.

  2. hearless says

    Thank you Mojo for your excellent coverage of the hearing aids market. Is there information of why hearing aids from the big six companies sell for less in other countries? Starkey is made in America, why their products sell for less in other countries? Do you have the information of which of the low cost over the counter or internet aids come from the big six hearing aid companies?

    Is there a way that consumers as a whole can start a hearing aids price cost disclosure revolution? The same for getting insurance and Medicare to cover hearing aids cost, what can the people of the USA do to make that to happen?

    Is made in the USA motto applies t hearing aids? I wonder why Starkey is not in the forefront in selling good quality, low, low cost made in the USA hearing aids possible?

    Another good article would be what brands and countries are best to buy hearing aids from.

    Looking forward to getting some answers, thanks.

  3. says

    OTC hearing aids are a great idea. Tinnitus devices should go OTC as well. The FDA is just allowing a few players in by restricting trade.

  4. Tom K. says

    About Norm’s concern of a internet purchase, it appears from the pictures and also the product description that most products shown here very similar to those sold at SAM’s Clubs, who offers a 90 day – 100% money back refund; has a free hearing test at their audiology department. Prices are comparable.
    I’m a retired senior looking for my first set of aids so the purchase involves a fixed income stream and cost is as important as quality, service, longevity and durability in the Wisconsin hot/humid and cold weather. PACKERS ROCK!

  5. Lisa says

    This will truly be a wonderful thing for so many people! If you’re looking for a credible manufacturer with good technology then I suggest you take a look at the ICOT products. You will not be disappointed by their personal sound amplifiers! http://www.icotdls.com

  6. says

    How would it be possible to have a satisfactory hearing aids purchase over the internet or over the counter without the ability to adjust the sound settings to the hearing aids? If your trying to save money by cutting out the salesmen in white coats (audiologist) then don’t try to make me buy a dumbed down product. i only know of HearSource.com as a reasonable option to the high priced hearing aid racket.

  7. Frank G says

    There are some pretty good over-the-counter hearing aids out there. I have tried the songbird and the MDHearingAid – both are good but the MD was better! Certainly beats paying 10x more.

  8. James w benefiel says

    I think Paul’s suspicions are right on. When you can buy a 42 inch flat screen TV for $800 and an astoundingly good digital camera with touch screen for $250 or even my iPad for $500 and you see hearing aids for $2000 to $5000 plus you know you are being ripped off. Reading the FDA attempt to distinguish between a “hearing aid” and a “personal sound amplifier” it is easy to see what the game is…. Separating foolish old people from their money.

  9. says

    It seems an increasing number of people are ignoring health warnings about caring for their ears and hearing. After a careless diving accident I ended up with two hearing aids and tinnitus. I wear the aids 24/7. I learned to control the tinnitus and consider myself tinnitus free most of the time. I created a website to help others in need of tinnitus relief. Here’s a link if you want a visit
    Tinnitus Relief at http://www.TinnitusReliefReviews.com

    Best wishes to all.

    Miles Hartley.

  10. Giften says

    This is huge for the Personal Programmable Hearing Aid market such as with HearSource.com. With the influx of the baby boomers getting into the market this industry is going to explode. I think with most people they still want high end personal amplification devices but rather save some money in the process. The competition is heating up for market share and this will help drive down cost on all hearing aid products.

  11. says

    What an up-lifting article. The hearing aid industry has needed disruption for a long time and this could be just what the doctor ordered. You make a great point in that there have non-prescription hearing aids available for a long time (think cheesy infomercial) but the quality of these have been so bad that they are not threatening to the big providers. If the new offerings of over the counter hearing aids that you discuss have a marked improvement in quality this could be a game changer. I have always wondered if the high cost of hearing aids was not just a group of fat cats protecting their profit margins. I hope this lowers prices!


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