On December 1, 2016, U.S. Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) introduced the Over-the-Counter Hearing Aid Act of 2016. This bill would make certain types of hearing aids available on an over-the-counter (OTC) basis, would remove the requirement for a medical evaluation (or signed waiver), and would also allow personal sound amplification products (PSAPs) to be sold for the treatment of hearing loss.
Last October, the President’s Council of Advisors on Science and Technology (PCAST) produced a report that included the recommendation for the FDA to create a class of OTC hearing aids. Then in June 2016, the National Academy of Sciences (NAS) issued a lengthy report making 12 recommendations for improving hearing health care. The recommendations included creating a class of devices to be sold OTC, again for adults with mild-to-moderate, age-related hearing loss.
The reactions to these recommendations have been predictable. On one end of the spectrum of reactions is support for allowing OTC devices to be available to the consumer, while the other end of the spectrum calls for an all-out effort to prohibit these type devices. The most common reasons to oppose these recommendations are the potential to miss a treatable pathology, and the probable poor outcomes due to inability to match the technology to the loss and/or functional deficit.
Often included with the calls to oppose the recommendations and the bill introduced by Senators Warren and Grassley is the question: “Where is the outrage, particularly from the national organizations?”
There are really two parts to the answer to this question. First, I can assure you that the national organizations are fully engaged on this issue. The Academy has to be deliberative and thoughtful in the response to this type of development, and “outrage” is not a response that will result in achieving the desired outcomes. Now that the bill has been introduced, and we understand the implications, we can form an effective response—one that takes into account the various economic, political, and relational considerations necessary, as well as the diversity of opinions of the members.
The second part of the answer to the question is that the outrage is right in front of us. It is the consumer outrage over the cost of hearing care, particularly amplification devices. It is the outrage over the lack of access to the full spectrum of devices that might be used to assist an individual with hearing or communication difficulties—and not just the ones that cost $3,000–$6,000. It is the outrage over two-for-one ads that treat the products as a commodity, rather than a treatment for hearing loss. It is the outrage over not being able to self-direct hearing care initially and being required to see an audiologist and/or physician prior to getting help for their communication problem.
This is the outrage that has led to these policy statements, and now the legislation, over the past year. We in the audiology community have done little to be responsive to the consumer demands for less costly hearing care. We have not changed our practices to offer the full range of services or products that might have allowed more people to overcome their communication deficits. We do not offer “PSAPs” or even the inexpensive hearing aids to any great degree. We get trained on how to make “sales,” particularly for the higher priced products, and then wonder why the consumer complains about the cost of hearing aids. We continue to bundle the cost of devices and services, and then wonder why the consumer doesn’t intuitively understand the process, or place a value on our professional services.
We also suffer from an access issue. There are simply not enough audiologists positioned geographically to meet the current demand for hearing care, much less the demand expected over the next several decades. So should we be outraged with Congress or federal agencies for allowing more people to access hearing care, or should we be outraged at ourselves and our academic programs for not recognizing and responding to the demand? Moreover, do we deny individuals access to a hearable that could be a consumer electronic because they cannot easily access audiologic services?
Clearly, these policy statements recommending or even mandating an OTC device for the treatment of hearing loss have the potential to be disruptive to the current model of delivery of hearing care services in general, and the delivery of hearing care devices specifically. But before we become outraged, perhaps we need to consider WHY these recommendations were made and WHY Senators Warren and Grassley felt compelled to introduce such a bill. It is easy to surmise that among the reasons is the general public believes that hearing care is not affordable and accessible, and they are outraged about it.