In my November 2009 editorial, I took the FDA to task for what I perceive as lax enforcement on personal sound amplifier products (PSAPs), as well as some direct-mail hearing aids marketed online. Specifically, I objected to those products that sidestep FDA regulations (ie, the “medical waiver system” that requires informed hearing aid purchasers to sign a waiver statement declining a medical evaluation) by simply never placing the words “hearing” and “aid” next to each other in advertisements, while marketing devices that obviously target hearing-impaired consumers.

In this month’s HR (see our cover story), Better Hearing Institute Executive Director Sergei Kochkin, PhD, uses MarkeTrak data to estimate that there are approximately 1.2 million PSAP users and 300,000 direct-mail hearing aid users in the United States. Of these 1.5 million total users, about 3 out of 4 share the same hearing loss profile as those who purchase professionally prescribed custom hearing aids. Outwardly, this figure is shocking; it means that there are a total of 1.12 million PSAP and direct-mail hearing aid users with the same hearing loss profile as the 1.45 million people who purchased hearing aids in 2009.

However, when PSAP users were asked about the percentage chance (0 to 100%) they would purchase a custom hearing aid, the picture changes substantially. Factoring in all the responses, only 17.8% of the PSAP users indicated that they would have purchased custom hearing aids if PSAPs were not available. That amounts to 220,000 people—or only 2.6% of the 8.4 million hearing aid owner population, according to MarkeTrak VIII figures (October 2009 HR article).

In this light, it’s easier to understand the dilemma that the FDA faces when trying to regulate PSAPs. On the one hand, there is a large population of people who might see benefits from some kind of ersatz hearing aid product, but for whatever reason (eg, need or intended use, price, cosmetics, value, etc) will not consider custom hearing aids. At least not yet. On the other hand, it’s frightening to see the quality of some of these low-cost devices or envision the hearing-impaired users’ results with them. What is equally frightening is that many of these 1.2 million people (1.5 million if you choose to include mail-order aids) will conclude that “I’ve tried hearing aids, and they don’t help me.”

Obviously, this a problem for the hearing industry. To its credit, the FDA has struck a very consistent message. Eric Mann, MD, PhD, deputy director of the FDA’s Division of Ophthalmic, Neurological, and ENT Devices, has made it clear that only hearing aids are intended to make up for impaired hearing; consumers should buy a PSAP only after ruling out hearing loss as a reason for getting one. “If you suspect hearing loss, get your hearing evaluated by a health care professional,” says Mann.

These are sentiments that virtually everyone would agree on. In real life, however, the FDA’s current system ends up resembling “a wink and a nod.” Dr Kochkin’s article in this edition of HR shows—by virtue of the fact that the hearing loss profiles are so similar—hearing-impaired people are substituting PSAPs for custom hearing aids. So, in my view, the FDA needs to decide on ways to take a tougher stand whenever: 1) a PSAP resembles a hearing aid in all respects; and 2) when the marketing for those devices creeps into the realm of “compensation for hearing loss.”

Likewise, the hearing care field also has a decision to make, namely: Is this a market that professionals can serve practically? If we really are concerned about the deleterious effects (direct and indirect) of PSAPs on the custom hearing aid market, then we need to develop for this population segment more affordable and attractive hearing systems that dispensing professionals are willing to dispense and/or oversee when necessary. As pointed out in Table 1 in our cover story, on average this is a younger, less educated, milder-loss segment of the population with lower incomes; indeed, these are people who are buying one $50 hearing aid. Admittedly, that’s a pretty tall order. However, I think you could make an argument that it is our professional responsibility to serve these people—if economically feasible. And, when considering the Internet and other technological and market forces that could breed disruptive technologies, it may be at our own peril if we do not.

Karl Strom