Comments filed with FDA on hearing device recommendation

Kathi Mestayer
105 Gilley Drive
Williamsburg, VA 23188
Kwren@widomaker.com
(757) 229-6575

May 6, 2016

Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
http://www.regulations.gov

RE: Docket # FDA-2015-N-4602

I am a hard-of-hearing person from a hard-of-hearing family (hereditary sensorineural hearing loss), and an advocate in volunteer hearing loss organizations for over 20 years. I have no financial interest in the issues being considered by the FDA in this matter.

To date, I have read the PCAST report, listened to presentations about it on webinars, and reviewed the files afterwards. And I keep reaching the same conclusion: several of the major assumptions that the PCAST recommendations are based on are wrong – materially wrong. They have been credibly disputed, repeatedly, by groups of qualified experts.

When recommendations rely for their validity on basic “facts” that cannot be defended, it calls into question the credibility of the whole enterprise. Below are a few examples that have significant consequences to the hard-of-hearing public, myself included.

The PCAST recommendations rest on a few key assumptions that are flawed, including the following:

1. Using the wrong price as the basis for recommendations.

The PCAST report says that the average price of a hearing aid is now $2400 per aid, which appears once again in PCAST’s powerpoint presentation at the April 21, 2016 Workshop. Using this as the baseline price to justify upending the market is indefensible. The source of the $2400/aid number, Hearing Review’s 2013 Survey, states, in its discussion of data from 1980-2013, that it is on the high side, and that big-box (e.g. Costco) outlets are under-represented in their survey. To quote the 2013 survey’s discussion of data compiled from a number of sources:

“Figure 6 summarizes previously published survey data from Hearing Instruments, Hearing Review, Hearing Journal, and the Phonak Practice Management surveys since 1980. What it suggests is that this survey’s results—particularly if you consider it is probably skewed by a higher usage for premium product lines—confirms flattening to declining hearing aid prices during the past decade not just as an aggregate result of rapid volume growth in the VA, mass retailers like Costco, and discounting by chains and networks, but also as actual lower prices in independent, private-practice dispensing businesses in response to a more competitive, price-focused market.”

The $2400 number does appear in Table 2 of the Hearing Review Survey report, but the extensive discussion, by the authors of the survey, is not apparent in PCAST’s analysis.

Why it matters.

The $2400 number creates an overstated sense of urgency. The cost of hearing aids does need to come down (while preserving quality and consumer protection). But using that number creates the impression that the system is more broken than it is, and that sweeping changes are needed to solve a problem that is in the process of solving itself. According to the Hearing Review Survey that PCAST cites, prices are already coming down.

A recent visit to Costco revealed a price of $1799.99 for a pair ($900/aid) of their higher-end aids, manufactured by Resound, according to the Hearing Instrument Specialist. Might something in that range, or even lower, be a more-realistic indicator of affordability?

The misperception is spreading. The New York Times has now picked up the story, and writes, “Hearing aids cost an average of nearly $2,400 each, or close to $5,000 a pair, according to the White House advisory group.” (PCAST) We now have a public debate based on misinformation, which most people may never realize is the case.

2. Making a circular argument.

PCAST defines its recommended lower-level category of hearing devices (PSAPs) as limited to use by those with “normal, bilateral, gradual onset, mild-to-moderate age-related hearing loss.” In practical terms, that creates a special group of consumers… everyone who meets all of those criteria…who, by definition, do not need, and would not have, the benefit of FDA’s current protections.

And, as consumers, we would now be in the driver’s seat. Who better to figure out (aka “self-diagnose,” in the recommendations) whether we fit into all of those categories? Take “gradual.” Is there any grey area between gradual, kind of gradual and sudden-ish? Overnight? Over a week? And what does “normal” mean? How does one self-diagnose conductive hearing loss, and know to consult a doctor about the possibility of surgical correction? If you tend to use the phone on your right side, does that mean your hearing loss is not bilateral, or just worse in that ear? My hearing loss started at about age 45; is that “age-related?” An audiological exam would help with those decisions, but if the new regulations apply to you, that’s not a requirement, and neither is a doctor’s visit. There are currently remote online/phone screening programs, but they are only valid for determining whether you need to see a doctor. And you are perfectly capable of making that decision based on your self-diagnosis.

Why it matters

The self-diagnosis point. This doesn’t exactly sound like a list of criteria for which (to quote the PCAST report) “consumers should be able to self-diagnose, self-treat, and self-monitor the condition.” It’s not even a single (“the”) condition; it’s a cluster of conditions – some related, some not.

Why would we want to make a subjective, gray-area-intensive definition the dividing line between people whose health is protected by a doctor’s visit requirement (or strongly-worded waiver) and those who just can hit “add to cart” online?

If this definition, with the specious self-diagnosis assumption, were adopted, the new category of hearing devices would fit very neatly into an existing category — FDA’s looser requirements for Over-the-Counter (OTC) products. But, in this case, it’s not a good fit.

3. The false analogy…that hearing aids are like reading glasses.

On the surface, the analogy seems intuitive. But, according to James Battey, Director of NIH’s NIDCD, “We don’t have the equivalent of eyeglasses for hearing loss.”

Why it matters

Using the false analogy reframes the question as simply being about our over-regulation of basic devices, like reading glasses. But, as Dr. Battey puts it so succinctly, seeing is not hearing, and diagnosing and mitigating the two are not functional equivalents.

Where does this leave the consumer?

Sometimes, disruption is just….disruptive. We saw that with bitcoin and subprime mortgages. The demographic we are talking about here, people in the older cohorts, are more vulnerable to opportunistic marketing, especially online. Opening the floodgates should be done very, very thoughtfully. Especially when you can get hearing aids today by major manufacturers at Costco for under $800 per aid. And, you can already go online, pick a PSAP, and hit “add to cart” if you are so inclined. But at least you won’t think that what you’re buying are the equivalent of what we have all come to know, for decades, as hearing aids.

Inferring a false continuum doesn’t help consumers. If we take PCAST’s advice and expand the term ‘hearing aid’ to PSAPS (“basic hearing aids”), consumers will be tempted to think of both types of hearing aids as on a continuum, with the “basic hearing aids” the less-expensive equivalent. But, in fact, the “basic hearing aids” would be in a completely different regulatory regime, with: usage recommended only to those who have all of the self-diagnosed conditions, more-variable performance, and exemption from the existing mandated trial periods in most states. If we decide that it is needed, we can regulate PSAP selling practices online without diluting the term “hearing aid” and confusing consumers in the process.

The proposed consumer decision process. So, as a new potential hearing-aid user, if I diagnose myself into all of the categories the “basic hearing aids” apply to, I could go online (or to a store) and buy them without knowing the degree of my hearing loss, whether I need two aids or one, what to expect in terms of performance, and how to know whether they are the right devices for my needs.

If they don’t meet my expectations (which are very often too high for first-time users, who think they actually might work as well as glasses), there is a very good chance that they will end up in my dresser drawer. When people ask me about hearing aids, I would say, “I tried hearing aids but they don’t work.” And I would, in fact, be less likely to try a non-basic hearing aid, because it sounds like a higher-priced version of what’s in my dresser drawer. Without the word “basic.”

The Bottom Line

I agree with most of the cited problems in the hearing-aid market today. The challenges are real and consequential. It matters.

But the points that I have made above are material to PCAST’s conclusions and recommendations, as well as to their consequences, intended and otherwise. The problems, and questions, are complex. More thought and deliberation needs to be given to creating a firm, empirical foundation for defining the problem, evaluating options, and weighing the difficult tradeoffs, as is always the case when looking to protect the public’s interests and allow for innovation.

Conclusion

I am hopeful that the FDA will continue to aggressively safeguard the health and wellbeing of the hard-of-hearing, our families, friends, and community. To upend the regulatory framework now, based on flawed data and analysis, is not in our best interests. It would be an ill-considered fix of an overstated problem that is finally correcting itself via market forces and innovation, and would create a host of new difficulties.

Respectfully Submitted,

Kathi Mestayer

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