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The Federal Trade Commission staff has submitted a comment to the Food and Drug Administration (FDA) in response to FDA’s request for comment on its proposed rule on establishing over-the-counter hearing aids.

The comment supports the proposed rule, which is likely to promote competition and innovation in the market for hearing aids, to the benefit of health care consumers. As noted in the proposed rule, tens of millions of US consumers suffer hearing loss, resulting in significant associated health problems. But most of them lack hearing aids, due at least in part to the high cost of buying the devices.

According to the staff comment, barriers to access to hearing health care may include more than just prices for hearing aids themselves. Restricted channels of distribution often limit consumer choice to, for example, expensive bundles of hearing aids and extended services that many consumers may not want or be likely to use. In addition, a lack of pricing transparency makes it difficult for consumers to make “apples to apples” comparisons between available models, and between bundles of devices and services.

The FTC staff’s comment states the FDA’s proposed rule would establish an over-the-counter category of hearing aids, streamline regulations, and preempt contrary state laws and regulations. As a result, the rule is likely to foster: 

  • development and entry into the market of lower priced safe and effective hearing aids;
  • new channels of distribution;
  • increased availability and diversity of lower priced bundles of hearing aids and services;
  • development and entry of remote and web-based ancillary tools for hearing aids; and
  • increased competition in markets for existing hearing aids.

In 2017, the FTC held a public workshop on competition, innovation, and consumer protection issues in hearing healthcare. The record from the workshop supports the FDA’s efforts to make hearing products more accessible as a significant way to increase competition, reduce prices, and improve access to hearing aids.

The Commission vote approving the comment to the Food and Drug Administration was 4-0.

The Federal Trade Commission develops policy initiatives on issues that affect competition, consumers, and the U.S. economy. The FTC will never demand money, make threats, tell you to transfer money, or promise you a prize. Follow the FTC on social media, read consumer alerts and the business blog, and sign up to get the latest FTC news and alerts.

Contact Information

Media Contact

Staff Contact

Dan Gilman
Office of Policy Planning