PSAPs and the OTC Hearing Aid Act

psapsWhat are PSAPs?

PSAP stands for Personal Sound Amplification Product.

They are available at Target or Walmart or Amazon for a fraction of the price of a traditional physician-prescribed hearing aid.

BUT…they can’t actually be called hearing aids and they can’t be marketed as a treatment for hearing loss. That’s because they are currently not regulated as medical devices by the Food and Drug Administration (FDA).

The FDA will only allow them to be sold as sound “amplifiers” to help with recreational activities, such as hunting, bird watching or eavesdropping  😉

Not being hard of hearing myself, I didn’t know much about PSAPs until I started doing a little research.

And I did that after reading Congress, in a rare bipartisan move (I know, mind-boggling, right?), earlier this year introduced a bill that would lift the restrictions on PSAPs and allow them to be sold as aids for mild to moderate hearing loss.

At first it seemed to me that the Over-the-Counter Hearing Aid Act of 2017 would be a win for the consumer.

After reading a little more about it, though, I’m not so sure.

What are the pros?

Access. First, it’s important to understand that PSAPs are already available to anyone who wants to buy one. They just can’t be marketed directly as hearing aids.

So a lot of people who might benefit from a PSAP don’t even know they are an option.  Currently, only about 20% of people with hearing loss use hearing aids. That’s partly due to the high cost, but also the inconvenience of scheduling multiple trips for fittings and programming.

Even mild to moderate hearing loss impacts quality of life. Being hard of hearing leads to isolation and even depression. Falls and other accidents can also result from poor hearing.

Millions more people could benefit from access to affordable, over-the-counter hearing aids.

Cost. Prescription hearing aids cost upwards of $2,500 and are usually not covered by insurance. Traditional Medicare does not cover medical devices, including hearing aids.

Most PSAPs cost less than $500. Costly visits with an ENT (ear nose throat) doctor or an audiologist aren’t required, either.

The lower cost makes them easier to replace, too, in case of loss or damage.

Performance. A recent study showed that quality over-the-counter “amplifiers” performed as well as prescription hearing aids.

With more better-quality devices coming to the market, consumers could have a wide variety of options to choose from. Competition usually helps keep prices down, as well.

Prescription hearing aids, on the other hand, are made by a limited number of manufacturers, which is another reason the prices have stayed high.

What are the cons?

More regulation + less competition = higher prices. The irony of the OTC Hearing Aid Act is that while it seeks to make hearing aids cheaper and more accessible for consumers, it does this by imposing FDA regulations onto those products.

And what happens when a manufacturer has to jump through more government hoops to bring a product to market? The costs go up, and some companies leave the market altogether because their hearing aids won’t meet FDA standards.

That will probably result in higher-quality products—probably—but more expensive, as well.

Self diagnosis and self treatment of hearing loss can be harmful. There are many causes of hearing loss and not all of them can be treated with a hearing aid, no matter the quality of the device.

The cheaper PSAPs on the market tend to fit poorly and have limited settings and volume levels. A too-high volume could cause ear damage over time.

Special interests abound! It was difficult to find an unbiased article about this piece of legislation.

Understandably, audiologists and traditional hearing aid manufacturers are against the bill. More patients with mild-to-moderate hearing loss will choose to buy over-the-counter. Does that mean prescription hearing aids would become a thing of the past? Doubtful, but fewer audiologists would be needed and high-priced hearing aids might become even more expensive.

The tech companies that will benefit from the OTC Hearing Aid Act are, of course, in favor of it and are working closely with the sponsors of the bill, Sen. Charles Grassley (R-Iowa) and Sen. Elizabeth Warren (D-Mass.). (Interesting to note that Bose is headquartered in Massachusetts.)

These companies are spending a lot of money on lobbying. Even though their products would face increased regulation, they could potentially reach millions more potential customers.

I’m cynical enough to believe neither side of the argument is just about what’s best for the consumer.

Still, I imagine the OTC Hearing Aid Act will eventually become law, seeing as it’s bipartisan and more money is being spent in favor of it than opposed.

I think it will drive the prices up, so I’m not happy about that. However, most OTC hearing aids will probably be the better quality ones and will still be cheaper than prescription hearing aids. That’s a positive.

Bottom line: Anyone experiencing hearing loss should see a physician to diagnose the cause and recommend appropriate treatment.

Consumer Reports advises against the cheaper PSAPs on the market in their online guide to buying a hearing aid, but acknowledges

With the right fit and adjustment, we found that the higher-end models can help those with mild to moderate hearing loss, especially when watching TV. Some adjustable models can even have the same functionality as an entry-level hearing aid.

Check out their guide for more information about both hearing aids and PSAPs.

And stay tuned for how Congress votes on the OTC Hearing Aid Act of 2017 (I predict it will pass).


Frugal Nurse

Image by Iain/CC BY SA-3.0



PSAPs and the OTC Hearing Aid Act — 2 Comments

  1. Thanks for this, I have been following these developments myself and appreciate your pros and cons. My hearing loss is such that I almost certainly would not the helped by any OTC PSAP, but I wait in hope of what the market might provide in the future. Of particular interest to me based on my past experience with expensive prescription aids are the PSAPS with frequency adjustment by a smartphone app. At present this can only be done by an audiologist running proprietary software.

    • Hi Ray! Nice to hear from you. Yes, the technology of the PSAPs appears to be rapidly advancing, and will be boosted even more if (when) the manufacturers get some real leverage in the OTC market. I will be curious to see how much more expensive these devices will be, and whether the price of prescription hearing aids will go up or down as a result. Also, will there be increased reports of harm caused by the OTC devices? All very interesting! Cheers, FN

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