On August 16, the Food and Drug Administration (FDA) finalized rulemaking to allow hearing aids to be purchased over-the-counter (OTC), which is widely expected to increase access for millions of Americans with mild to moderate hearing loss. This rule was 5 years in the making – why now?
Background
While FDA has regulated hearing aids for decades, the agency had previously only focused on assuring safety and effectiveness of prescription hearing aids. In 2017, Congress stepped in and passed a law to require the agency to issue rules for over-the-counter devices. Lawmakers were hoping establishing a new category of hearing aids would address:
- Cost: Lack of competition in the market means hearing aids can cost between $2,000 and $7,000 per pair.
- Coverage: Most commercial insurance plans and Medicare don’t cover the cost of hearing aids for people with mild to moderate hearing loss because they’re not considered an essential medical device – or in other words, they’re considered “elective.”
- Access: Additionally, getting hearing aids requires a prescription from an audiologist or other specialist. Buying devices in a retail setting or online would provide more options for consumers.
A Rule that Was Years in the Making
It’s taken a long time for the idea of over-the-counter hearing aid sales to go from initial concept to final rule. Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) got so fed up with the agency dragging its feet that they introduced legislation to require FDA to issue rulemaking on OTC hearing aids. Even though the bill was signed into law as part of the FDA Reauthorization Act of 2017, it still took the agency 5 years to finalize the rule. Why?
COVID. Yes, the needed change in focus of the agency to address COVID was a no-brainer, but President Trump signed the bill 2+ years before the virus struck….
Change in administration. Yes there was a change in administration but it took President Biden until July 2021 to issue an executive order directing his own agency to issue rule making.
So why the delay? It turns out that balancing stakeholder concerns was complicated. When FDA issued the proposed rule in October 2021, the agency received more than 1,000 comments from the public. Here is where the rule ended up:
- Output levels: Lowers the maximum sound output to reduce the risk from over-amplification of sound
- Volume control: Requires all OTC aids have a user-adjustable volume control
- Label and packaging language: Simplifies phrasing so safety concerns can be easily understood
- State authority: Retains authority by States to require an audiological evaluation for minors and other previously granted State exemptions applicable to non-OTC hearing aids
What’s Next?
The final rule goes into effect in 60 days, which is the date that over-the-counter hearing aids can officially be marketed. Already, Best Buy has announced that it plans to have hearing aids available in 300 of its 1,000 stores by the fall.
Even though Congressional Democrats weren’t able to get Medicare coverage for hearing aids signed into law, the rule signals real financial relief and a step toward health equity for millions. Good news for consumers makes for good politics…right ahead of the November 8th elections.