The Hippocratic oath requires doctors to, first and foremost, do no harm. A similar principle should guide policymakers when considering radical changes to the status quo.
Members of Congress and leading medical organizations are exploring ways to increase access to and utilization of hearing aids among the estimated 30 million Americans over age 60 experiencing hearing loss. Hearing loss is a critical health issue; if untreated, it is associated with greater health problems such as cognitive decline, depression and dementia. The Federal Trade Commission is holding a workshop on April 18 to more fully explore strategies to address this growing public health issue.
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One solution being advanced is to mandate the Food and Drug Administration (FDA) to make hearing devices available over-the–counter (OTC) for mild to moderate hearing loss. Sens. Charles Grassley
Chuck GrassleyCongress needs a do-over on fraud-laden ‘Immigrant Investor’ program Senators offer bill to boost police training in cyber crime McConnell’s shining moment MORE (R-Iowa) and Elizabeth Warren
Elizabeth WarrenIs Trump’s presidency the patriarchy’s last gasp? What’s the Rush? Policymakers should slow down before moving hearing aids OTC Warren brings in huge fundraising haul MORE (D-Mass.) have introduced The Over-the-Counter Hearing Aid Act to do just that. But is this the right prescription for the problem?
Proponents of the move argue that patient use of hearing aids would increase, yet no comprehensive scientific research exists to demonstrate the safety and health benefits of this approach, notably whether patients would be able to accurately self-diagnose and treat their hearing loss in an OTC environment.
In an effort to help fill the information vacuum, Amplifon, a hearing health care services provider, sponsored research to gather data on the safety and effectiveness of making hearing aids available over-the-counter to individuals with mild to moderate hearing loss.
In phase one of the pilot study, participants, age 60 or older, were asked to self-diagnose their mild to moderate hearing loss and treat it with an OTC option for six weeks. Most (75 percent) were not able to correctly self-diagnose their level of hearing loss.
Policymakers advancing the change in FDA policy assume that making hearing aids available OTC will improve access and utilization. But in the study, less than one-third (28 percent) of participants in the simulated OTC environment used the hearing device daily or almost daily; one-third (31 percent) used the device a few times a week, and the remaining one-third used the device sporadically. The inability of individuals to self-diagnose their hearing loss contributes to poor health outcomes, including lower hearing aid utilization and satisfaction rates.
At the end of the OTC study, participants whose hearing test showed some degree of hearing loss were invited to participate in a second phase of the study, which gave participants access to a hearing care professional for six weeks to diagnose and fit patients with hearing aid(s). Importantly, participants working with a health care professional were more than twice as likely to wear their hearing aid daily compared to the OTC approach (67 percent vs. 28 percent) – and for longer periods of time (11.4 vs. 8 hours daily).
As policymakers push to increase access and improve health outcomes for adults with mild to moderate hearing loss, this study shows more data is needed before rushing forward with an approach that potentially harms seniors.
Indeed, the current legislative approach seeks to bypass the traditional FDA regulatory path for moving drugs or healthcare products over-the-counter, i.e. products that have been determined safe and effective for use by the general public without treatment by a health professional.
Historically, a company seeking OTC status for its product submitted data to the FDA as part of a petition to change the product’s designation. In the past, congressional involvement was limited to encouraging FDA to investigate the merits of a change, rather than dictating the outcome. Before making any changes, the FDA process has been to analyze the data regarding consumer safety. Indeed, safety is the primary focus of the FDA – not issues of access and availability.
Surprisingly, in the rapidly moving debate regarding potentially making hearing aids available OTC, the usual regulatory process has been turned upside down.
If improving patient health is the goal, policymakers should stop the stampede toward making hearing aids available OTC. Instead, they should insist on additional, comprehensive research on the safety and efficacy of the proposed OTC approach in order to develop sound policies that appropriately balance the goal of increasing consumer access to hearing aids with the need to put patient health and safety first. Only then can we be sure to, “first, do no harm.”
Thomas J. Tedeschi is a Doctor of Audiology and the Chief Audiology Officer at Amplifon, a hearing health care company based in Plymouth, MN. Dr. Tedeschi is also co-author of Implications of an Over-the-Counter Approach to Hearing Healthcare: A Consumer Study, published December 22, 2016 in Hearing Review.
The views expressed by this author are their own and are not the views of The Hill.
