According to industry sources, the June 9 dissemination meeting of the National Academies of Sciences, Engineering, and Medicine (NASEM) will include a “strawman” proposal for the FDA’s regulation of over-the-counter (OTC) hearing aids. The meeting, which will be held at the Keck Center in Washington, DC, is a follow-up to NASEM’s December 6 dissemination meeting, at which the US Food and Drug Administration’s (FDA) Eric Mann, MD, PhD, announced the agency would no longer be enforcing the so-called “physician waiver” system that had been in place since 1977 and that FDA would be pursuing a regulatory framework for OTC hearing aids.
The “strawman” proposal is likely to be based on the NASEM report’s 12 recommendations, which have essentially become a blueprint for ongoing discussions about OTC hearing aids. Both NASEM and President’s Council of Advisors on Science and Technology (PCAST) recommended the establishment of an OTC hearing aid class, and their reports were followed by the Over the Counter [OTC] Hearing Aid Act of 2017 (S 670) which would require FDA to establish an OTC category within 3 years of the bill’s passage. The “strawman” proposal is not part FDA’s formal rulemaking process, but instead would serve as a starting point for discussions between meeting participants. No details about the specifics of the proposal were available prior to the meeting. In April, the FTC also held a workshop that discussed technology and competition in hearing aid distribution, as well as how OTC hearing aids might impact customer satisfaction, the use of amplification products, consumer safety, and professional care.
Although there is still considerable debate about the merits and scientific rationale for an OTC category, an OTC category appears to be all but inevitable. The organizations lined up in support of it include AARP, the Academy of Doctors of Audiology (ADA), the Hearing Loss Association of America (HLAA), the Consumer Technology Association (CTA), Consumers Union, The Gerontological Society of America, and the National Committee to Preserve Social Security & Medicare. The Hearing Industries Association (HIA) and the American Speech Language Hearing Association (ASHA) have both voiced some strong objections and caveats relative to issues involving an OTC category. ASHA advocates for restricting OTC hearing aids to people with mild hearing loss and establishing safe levels of gain and output (power) for these hearing aids; ensuring the devices are made available only for adults; establishing a means for collecting information on consumer safety and other potential complaints (eg, QSRs); and requiring labeling that clearly highlights red flags while strongly recommending audiologic diagnostic and rehabilitative services. HIA recently created a 13-point commentary, published in the June 2017 edition of The Hearing Review, calling into question frequent assertions about hearing aid market penetration, cost/accessibility, quality standards, and more. (Shortly after this blog was posted, HIA reasserted its position, emphasizing that, should a new OTC device category be created, the medical devices should meet the same FDA standards as existing hearing aids and should be offered only to people with mild hearing loss.)
As such, among the many sticking points that the FDA will need to sort out are Quality System Regulations (QSRs), if any, for the new class of devices, the severity of hearing losses covered by an OTC category, and the requirements surrounding the self-assessment methods for hearing loss. For example, while the Warren-Grassley OTC Hearing Aid Act contains the wording “mild-to-moderate,” there are many hearing care professionals who fear that the typical definition of a “moderate loss” (ie, 40-70 dB) include those unlikely to benefit from a do-it-yourself approach. Likewise, at the recent FTC workshop, those involved in hearing aid manufacturing indicated that the QSR requirements do not impede innovation or new entrants to the market, while requiring companies to maintain basic quality standards, as well as (for example) systems for handling complaints and returns. Others characterized these regulations as unnecessarily expensive and restrictive.
The June 9 NASEM meeting will be structured essentially the same as its December 6 meeting. The morning will open with updates from NASEM, HLAA, FDA, FTC, Centers for Disease Control and Prevention (CDC), and the National Institute on Deafness and Other Communication Disorders (NIDCD). The meeting will then feature four concurrent break-out sessions: 1) Public Awareness and Consumer Measures; 2) Quality Metrics and Health Professional Education; 3) Innovation in Services–Access and Affordability; and 4) Consumer Comparisons–Evaluation Criteria and Standardized Terminology. The afternoon will be devoted to OTC hearing devices, and package labeling and safety, as well as quality requirements and considerations. For more information, visit the NASEM agenda page.