PCAST to FDA: Tear Down That Wall!

The President’s Council of Advisors on Science and Technology (PCAST) has recommended that the FDA create a new category of hearing aids. The new “basic” hearing aids would not require an exam by an audiologist or dispenser before purchase. A hearing test and purchase of those aids would be allowed online. And they would be cheaper, which PCAST says is what we really need. Maybe they’re right. Kind of.
Frankly, I get PCAST’s basic point about affordability. Too few of the people who need hearing aids have them….only about 30% in the US. And there are real health issues associated with untreated hearing loss, like greater incidence of dementia, falls and depression…so it’s about more than just grandpa turning the tv way up.
Shortly after PCAST’s slide presentation and report were made public, the Hearing Industries Association (HIA) pointed people to the white paper in which they (HIA) challenge some of PCAST’s basic facts and recommendations. The HIA web site describes HIA as “the national trade association of manufacturers of hearing aids, assistive listening devices, component parts, and power sources.” So, it’s an industry group, representing pretty much every hearing-assistive technology company you (or I) can name. (If you click on the web site link, it’ll take you to the list).

So, how expensive are hearing aids?
The cost of hearing aids is undoubtedly a barrier for many people who need them. And one of PCAST’s major justifications for the FDA rule changes is that they need to be more affordable.
PCAST uses $2400 per aid as the average, or mean, cost. That number is based on a 2013 survey of hearing aid providers conducted by The Hearing Review, which reported $2400/aid as the weighted average cost of hearing aids at three price levels – Economy, Mid-Level, and Premium. But is that the right number for assessing affordability? I would argue that, to find out how affordable and accessible aids are, you would look at the lower end of the price range. The HIA study reports that $1647/ per aid as the weighted average cost of Economy aids.
Here’s what the Hearing Review’s 2103 survey says about their premium, mid- and economy level data:
In 2013, the average price of an economy level hearing aid (weighted by HIA statistics relative to hearing aid styles) was $1,657, while mid- and premium-level technology aids averaged $2,196 and $2,898, respectively. The average price of the very lowest priced hearing aid in a practice was $1,025 (median $995). Only 6% of practices in this survey offered a hearing aid for less than $500.
I would argue that even the $1657/aid number is a bit high. A quick look at Costco’s web site will show you that they are selling actual hearing aids for as little as $500 per aid (for the Kirkland basic model). Now, not everyone has access to Costco, and many prefer the traditional audiologist route. But either way, $2400/aid is just over the top.
My main point here, and I do have one, is that the sense of urgency conveyed in the PCAST report that is attributed to the cost of hearing aids is overstated. Not negligible, by any means. Indeed, a MarketTrak study of factors influencing the purchase of hearing aids shows that cost considerations are very significant (in that case, people were asked what would make them more likely to purchase aids).

But is it all about cost?
Maybe yes, maybe no. There are data from European countries that show that there are other forces at work. Market studies suggest that bringing the price down does have an impact, but not what you might expect. Despite the fact that some European countries have reimbursement policies for hearing aids, the adoption rates are not through the roof.
Here’s some text from the HIA white paper (p. 9):

“Despite these policy differences, hearing aid adoption rates across Europe are not very different than they are in the US, as revealed in the latest MarkeTrak (MT9) and EuroTak studies. For example, the hearing aid adoption rate in the US is estimated at 30.2%, as compared to 24.6% and 30.4%, in Italy and France which offer relatively low reimbursement. In Germany, with substantial reimbursement, the adoption rate is 34%, while the rate is 41.1% and 42.5 % in the United Kingdom and Norway respectively, both of which provide full reimbursement for hearing aids and services.”

In Europe, it looks like you get an increase of about one-third by making hearing aids and services free. So, making them affordable does make sense. But PCAST then goes a little overboard in suggesting how the market could be rearranged…that might cause other problems….

PCAST to FDA: Tear down that wall!
One of PCAST’s recommendations is to create a new category of low-tech, “basic” hearing aids:

“non-surgical, air-conduction hearing aids intended to address normal, bilateral, gradual onset, mild-to-moderate age-related hearing loss.”

The new “basic” aid is what we now call a PSAP (Personal Sound Amplifying Device). They are (now, anyway) the devices that come up if you search online for “hearing amplifier,” and range in price from $14.62 at Sears to $69.99 (reduced from $1,299.97!) on Amazon.
PSAPs are freely available now, but the manufacturers are not allowed to describe them as “hearing aids,” per FDA’s current rules. So, they would get the legitimacy and marketing boost of the hearing aid label (and, presumably, would have to meet other TBD FDA rules).
And, you would be able to buy them (and get your hearing checked) online…the visit to an audiologist or dispenser, which is a current requirement for the sale of hearing aids, would be waived for the “basic” aids.

Where do I sign up?
So…lower prices, online hearing check and purchase, without the need to see an expert. Sounds great.
But, don’t forget that this only applies for “basic” hearing aids that are for “normal, bilateral, gradual onset, mild-to-moderate age-related hearing loss.” And how are we supposed to know that our hearing loss meets all the parts of that description? Well, as long as our hearing loss is not hereditary, not asymmetrical, not conductive, not moderate-to-severe, not non-gradual. Okay, then.

In a nutshell
So, in a nutshell, my argument is that:
1. Affordability is a big issue, which I wrote about recently on Be Hear Now.

2. But it’s not the only issue that we need to solve (per the European data).
3. And there may be other ways to solve it (make insurance plans and/or Medicare provide some level of reimbursement, or a tax credit for hearing aids).
4. And the big-box retailers are really growing their investment in hearing-aid sales, which is making them more affordable already.
5. And opening the door to the devices that we find online, without any required screening or exam, might end up being a bad idea.

Well, it was good to get that off my chest. Thanks for sticking with my rant….in the unlikely event that you want even more information, there’s a thorough review of the whole issue, from both sides, on The Hearing Review website, here.  And the HIA white paper, here.

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