Staff Standpoint | July 2016 Hearing Review

By Karl E. Strom, Editor in chief

Karl Strom As this edition of The Hearing Review was going to press, the National Academies of Sciences’ (NAS, formerly known as the Institute of Medicine or IOM) Committee on Accessible and Affordable Hearing Health Care for Adults unveiled its 12 recommendations for improving consumers’ access to quality hearing care (see the Special Report on p 8). On first pass, the recommendations outlined in the report, Hearing Health Care for Adults: Priorities for Improving Access and Affordability, are fairly comprehensive and ambitious.

Without doubt, the most controversial portions of the report are the Committee’s recommendations for an over-the-counter (OTC) class of hearing devices and the ending of the so-called “waiver system” that requires consumers to see a physician or sign a waiver prior to purchasing a hearing aid. These two provisions are key obstacles or safeguards  (depending on your viewpoint) relative to a non-professional pathway to obtaining a hearing aid, and they could bring substantial change for the industry.

The Hearing Review has devoted countless pages to the OTC debate dating back to the mid-90s. In February, David Smriga provided a counterpoint to the PCAST recommendations, pointing out some important errors that decision-makers should recognize before moving forward with regulatory changes. Similarly, on page 18 of this edition, Chase Smith, Laura Wilbur, and Kim Cavitt present an article that raises almost as many questions as answers about the electroacoustic performance of PSAPs and their possible treatment of hearing loss.

But the fact is this: No one really knows how or even if the FDA will respond to the NAS and PCAST recommendations. Frankly, I wouldn’t want to be in the FDA’s shoes (see last month’s Staff Standpoint); they would have to weigh the very real health risks of allowing an OTC hearing aid class against the substantial benefits of earlier amplification options. Almost certainly, the devil is in the details, and the law of unintended consequences looms large. My guess is that it will take them some time to deliberate on the OTC and waiver controversies.

Meanwhile, I hope the other 10 recommendations made by the NAS Committee are not lost in the heat of these two issues. Most of the “other” recommendations (see pages 8-10) revolve around improving hearing care, empowering consumers, and the overwhelming need to bring the benefits of hearing healthcare to the public. This can only be accomplished if we have greater cohesion and cooperation between all the stakeholders in hearing healthcare and the general healthcare systems, as well as more support for research and funding for basic public information about hearing loss and its treatment. Due to space issues, not all of the entities that need to be involved are listed in this month’s Special Report. But Committee Chair Dan Blazer was very clear that it’s necessary for everyone involved in hearing care to cooperate and build bridges with one another. This includes hearing healthcare professionals and their associations, academic institutions, researchers, consumer advocacy organizations, The National Institutes of Health (and NIDCD), the Centers for Disease Control and Prevention, the Patient-Centered Outcomes Research Institute, the Department of Defense and the VA, as well as state public health and vocational rehabilitation agencies.  And, ultimately, positive change will also hinge on wise decisions by the FDA, The Centers for Medicare & Medicaid Services (CMS), The Federal Communications Commission (FCC), and the Federal Trade Commission (FTC).

In the August 2015 Hearing Review, I wrote an article titled “Speculation on the Institute of Medicine’s Second Meeting on Accessible and Affordable Hearing Health Care” that —if I do say so myself—predicted pretty well the findings of the Committee. In that article, I also wrote: “There is really no telling what will come of all this. The IOM is an independent, non-governmental, non-profit organization that serves as the health arm of the National Academies of Sciences…Some of the IOM reports have lingered in obscurity, while others have played a major role in forming government policy and decision-making.”

The NAS report has a lot for the FDA to consider. But, perhaps more importantly, it points out the need for greater cooperation and bridge-building on numerous fronts in hearing healthcare.

Link to NAS Committee on Accessible and Affordable Hearing Health Care for Adults webpage.