ADA Advocacy Alert - OTC Hearing Aid Act Passes US House

Yesterday, the U.S. House of Representatives passed by voice vote, H.R. 2430, the FDA Reauthorization Act.

The bill reauthorizes Food and Drug Administration (FDA) user fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products through fiscal year 2022. It also includes provisions to accelerate the review and approval of generic drugs, allow certain classes of medical devices to be reviewed by accredited persons and laboratories, and includes the Over the Counter Hearing Aid Act, which provides for the federal regulation of over-the-counter hearing aids for adults with perceived mild-to-moderate hearing loss.

H.R. 2430 was considered under a suspension of the rules, which is a procedure generally used to quickly pass non-controversial bills in the House of Representatives, and requires a two-thirds majority vote. The bill previously passed out of the Energy & Commerce committee unanimously (54-0).

The legislation will next go before the full U.S. Senate for consideration. While no timeline has yet been set for a Senate floor vote, the Senate is expected to act soon--Congress must reauthorize the user fee agreements before the end of September 2017.

The OTC Hearing Aid Act is consistent with recommendations from the National Academy of Sciences, Engineering, and Medicine (NASEM), which were released in June 2016. ADA anticipates that this legislation will be enacted in 2017, and views it as an unprecedented opportunity for audiologists to provide valuable services to more of the 80 percent of American adults with hearing loss who don’t currently seek treatment.

ADA has been actively preparing members for the eventual widespread availability of OTC hearing aids over the past three years. We continue to urge members to take ownership of the next evolution of hearing and balance care.

A recent Hearing Journal survey illustrates the lack of awareness among audiologists with regard to the PCAST and NASEM recommendations, and apprehension, particularly among those who are ill-informed and unprepared, for the future at hand.

ADA members have access to unrivaled business, clinical, and technological resources relevant to these issues. Here are some things that you can do right now to get ahead of the OTC hearing aid movement:

  1. Register for the AuDacity Conference and the OTC Symposium—and attend the ADA Member Business Meeting to be held in conjunction with the conference—Learn more and register now!
  2. Register for the ADA Hackathon—Learn more and register now!
  3. Tell Congress to support the Audiology Patient Choice Act—Learn more and contact your legislators!
  4. Consider incorporating value-based products into your practice. ADA, through its partnership with earVenture, offers FDA-registered hearing aids, direct to provider, starting at less than $100 each. Listen to a case study on how to effectively use these, or similar products, in your practice: Opportunity Abounds.
Despite what you may have heard elsewhere, the sky is not falling—the sky is the limit! ADA and its members continue to lead the way into the future of audiology—and that future is brighter than ever. For more information about ADA advocacy initiatives, please visit