June 9, 2024 - WASHINGTON – Last week, Sen. Chuck Grassley (R-Iowa) made public a Government Accountability Office (GAO) report he requested to assess the impacts of the Over-the-Counter (OTC) Hearing Aid Act, a law he and Sen. Elizabeth Warren (D-Mass.) championed in 2017. For five years following enactment, Grassley and Warren pressed the Food and Drug Administration (FDA) to finalize rules necessary for implementation; due to FDA delays, OTC hearing aid rollout has been underway for less than two years. 

“Since day one, the goal of this bipartisan effort has been to streamline access high-quality, effective hearing aids. After many years of work, that goal has not changed,” Grassley said. “Just because Congress gets a law on the books, that doesn’t always mean the executive branch will execute it immediately or properly: oversight brings accountability. This GAO report will help my colleagues and I continue to closely monitor our law’s implementation and advance efforts like the Medicare Audiology Access Improvement Act.”

Full Report HERE | Key Findings Below

Timeline. FDA took five years (2017-2022) to propose and finalize rules for OTC hearing aids.

Consumer Demand. Data show an uptick in internet searches among consumers seeking information on “vendors, cost and reviews of specific device brands” following the FDA’s 2022 final rulemaking. Anecdotal evidence indicates more consumers sought hearing loss treatment after OTC category rollout. This heightened demand further supports the need to pass a Grassley-backed bill that would better enable seniors to secure hearing and balance health care services under Medicare.

Cost. Depending on technologies, OTC hearing aids range from $200 to $1,000.

Device Efficacy. Preliminary research suggests OTC hearing aids can be as effective as prescription hearing loss treatment alternatives.

Geographic Considerations. The OTC category could improve hearing loss treatment options for rural residents.

Outstanding Barriers. Among accessibility hurdles, the report cites consumers’ and professionals’ resistance to embracing OTC options, diagnoses challenges and costs. Grassley’s bipartisan Medicare Audiology Access Improvement Act (see “Consumer Demand”) would help alleviate these barriers for consumers and professionals alike.

Additional Oversight. FDA is routinely conducting premarket reviews and post-market oversight of OTC hearing aids. The agency is required to analyze OTC hearing aid adverse events and submit a report to Congress by August 2024.
Source: Senator Chuck Grassley