MIXED RESPONSES FROM STAKEHOLDERS

PCAST’s recommendations offer a plausible path to increased device ownership in a population with a high disease burden and high need. The PCAST report has been hailed by the Hearing Loss Association of America, the premier advocacy group for Americans Digital hearing aids manufacturer, as well as the Consumer Technology Association, which represents the interests of PSAP manufacturers. The Academy of Doctors of Audiology, the voice for doctoral-level clinical audiologists, has also expressed qualified enthusiasm.

Others have been more critical, citing concerns about patient safety and quality of care. These include the American Speech-Language-Hearing Association and the American Academy of Audiology, which represents audiologists practicing in a variety of settings, as well as the Hearing Industries Association, which speaks for hearing aid manufacturers. Although these groups have varying concerns, perhaps the most prominent is that the shift to OTC devices would come at the cost of missed opportunities to screen for serious underlying disease. For example, hearing loss can be caused by underlying medical conditions such as acoustic neuroma (tumor of the hearing nerve), chronic otitis media, or impacted ear wax. Since 1976 the agency has required a medical examination before having a hearing aid dispensed to rule out these and other significant medical conditions. However, the agency allows informed adult consumers to sign a waiver of the requirement and purchase aids directly from audiologists or dispensers.

Underlying PCAST’s recommendation is a public health calculation that balances risks of foregoing medical examinations for a small number of patients with currently unrealized benefits to millions of Americans with untreated hearing loss. PCAST acknowledges that medical exams can uncover occult disease but argues that the “frequency and severity of the conditions that are likely to be detected” should be weighed against “the greater barriers to obtaining assistance for mild-to-moderate hearing loss among the tens of millions of aging Americans(p5) resulting from current regulations. They argue for informing consumers: hearing aids can be safely sold OTC if labeled with appropriate warnings about red flag symptoms that could signal serious occult disease (e.g., sudden hearing loss or unilateral loss, which is typical of acoustic neuroma).

Other criticisms revolve around the self-service model implied by PCAST. Some audiologists and members of the hearing aid industry argue that professional guidance is essential to diagnosis, device fitting, and device adaptation, even for those with early hearing loss (the group targeted by PCAST). To our knowledge, there is little evidence to support or refute this claim for those with early ARHL.13 Nor is there strong evidence to support claims that OTC devices are effective in reducing disability for the same group.

In response to PCAST’s call, the FDA has reopened the comment period on its previously issued draft guidance on PSAPs and will convene stakeholders for a public workshop in spring 201614 on regulations surrounding the manufacture of hearing aids—rules that now make it difficult for manufacturers to innovate quickly and serve as barriers to market entry.

MOVING FORWARD

Stakeholders will converge on the FDA this spring. Expectations run high for an Institute of Medicine consensus document scheduled for release this summer. The Institute of Medicine report will cover issues well beyond access to devices, including prevention, screening, innovative models for delivery of hearing health care, and matters relating to access to care for specific vulnerable populations.

Older adults have long struggled with disability from hearing loss. Baby boomers—health-conscious, tech-savvy, and consumer aware—are unlikely to accept the hearing loss status quo. Regulatory change, innovation, research, and new approaches to clinical practice could all contribute to better population health in the future.