OTC Hearing Aids: “Nothing to See Here” Says GAO Report

June 12, 2024By Sara W. Koblitz & Jeffrey N. Gibbs

It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated.  (FDA once estimated that OTC hearing aids would save patients over $3000.)  A recent GAO Report hasn’t found that OTC hearing aids have had much impact.  While that’s not to say that OTC hearing aids aren’t working to address the critical issue of hearing loss, it seems that almost two years is still not enough time to assess market impact, or to show that some of the promises of significant savings for large numbers of consumers have been realized.

The category of OTC hearing aids was created by congressional mandate and implemented by FDA to address an “unmet public health need.”  With input from medical professionals, stakeholder, trade associations, and patient advocacy groups, FDA provided a pathway to market for air-conduction hearing aids without a prescription or the involvement of a licensed professional.  These OTC hearing aids are intended only for patients 18 and older and only those with mild-to-moderate hearing loss.

The GAO Report provides an overview of the rulemaking process for OTC hearing aids, the resulting OTC hearing aid regulatory scheme, and FDA’s interaction with other agencies when regulating OTC hearing aids.  While helpful background, it’s not new information.  What the GAO Report does provide though is a discussion of the effect of OTC hearing aid availability on patient access to hearing loss treatment.  Early research suggests that OTC hearing aids can be as effective as prescription hearing aids in certain circumstances, and published literature that FDA has reviewed has left the agency seeming hopeful.  But the GAO Report highlights the lack of research on OTC hearing aids thus far.  This is because “FDA officials and six external stakeholder groups . .  . said it was too early after implementation of the Rule to have data on its effects.”  Nevertheless, industry stakeholder report consumer interest in hearing loss treatment initially increased following  issuance of the OTC hearing aids rule and, anecdotally, a small initial increase in consumers accessing hearing health care.  Particularly interesting is that the increase in consumer interest isn’t limited to OTC hearing aids; industry noticed an increase in interest in audiologist assistance as well.    Another study found that consumers prefer working with hearing health care professionals in person rather than shopping online, while another study found many consumers had concerns about product safety absent professional oversight.

The Report highlights some of the barriers that remain for access to hearing treatment: consumer preference and professional concerns, difficulty in self-assessing hearing loss, and affordability.  Stakeholders also suggested to the GAO monitoring of the hearing aid market for concerns about marketing, pediatric use of hearing aids, return policies, and gain limits.  FDA seemingly dismissed most of these concerns, and, the Report notes, “[a]s of February 2024, FDA did not have any plans to revise its OTC hearing aid regulations.  The Agency “may issue technology specific regulations and guidance as new hearing technologies are approved and cleared by FDA.”  FDA does, however, expect to issue a report on OTC hearing aid adverse events to Congress by August 2024.

In all, the GAO Report did not provide much in the way of new information for industry.  As for whether the rules were worth all the trouble: It seems like it’s just too early to tell. However, at least in the short term, the issuance of the final rule has not resulted in the dramatic uptake of OTC hearing aids that some proponents had predicted.

Categories: Medical Devices