Proactive Planning: Preparing Your Practice Pre-OTC

By Sarah Sydlowski

This article is a part of the March/April 2018, Volume 30, Number 2, Audiology Today issue.

By now, audiologists are well aware that 2017 was a landmark year for audiology, or more specifically, for the industry that provides devices to manage our patients' hearing loss. Following the release of a series of reports calling for increased affordability and accessibility of hearing aids, including those from the Federal Trade Commission (FTC), the President's Council of Advisors on Science and Technology (PCAST), and the National Academies of Science, Engineering and Medicine (NASEM), President Trump signed the FDA Reauthorization Act of 2017 into law. Contained within this law is language that compels the Food and Drug Administration (FDA) to develop proposed regulations for over-the-counter hearing aids.

Although the labeling and introduction of these devices is likely years away, the eventual disruption of the market is top of mind for anyone currently dispensing hearing devices. In reality, consumers are already being inundated with information about personal sound amplification products (PSAPs) and "hearables," which, although not regulated by the FDA or labeled for the management of hearing loss, are readily available and becoming more visible.

The extent to which this disruption will be an innovation for hearing health care remains to be seen. In the interim, audiologists are left with questions of the unknown. Some audiologists may feel threatened by the changing environment in which emphasis is placed on the device, and the value of diagnostic and therapeutic care may seem to be minimized. Others may view looming changes as an opportunity to expand their practice to reach individuals who may not have previously considered investigating options to manage their hearing loss. Some audiologists may be worried that potential patients could do more harm by not seeking appropriate care or misusing over-the-counter (OTC) devices. Most audiologists should and do have questions about what the reality of the impact of OTC devices will be on their practices, their patients, and the reputation of the profession.

While OTC devices have not yet entered the marketplace, the American Academy of Audiology (the Academy) recognizes that members have questions now. As the only organization of, by, and for audiologists, the Academy is committed to supporting its members in this changing health-care environment.