FDA Allows Sales of Over-the-Counter Hearing Aids After Five Years of Consideration

After years of deliberation, the FDA enacted a rule that would allow the sale of over-the-counter (OTC) hearing aids to provide wider access to millions of Americans. The hearing aids would be in an OTC category of their own to cater to adults with mild to moderate hearing impairment, reserving prescription hearing aids for severe cases and children. Despite taking so long to come to fruition, now that the FDA set the ruling, OTC hearing aids could come as early as mid-October.

The Long Road to OTC Hearing Aids

According to the FDA, approximately 30 million adults could benefit from a hearing aid, but only one-fifth of those seek help. The average cost of hearing aids is about $2,000 and usually requires professional fittings and exams that insurance companies seldom cover. The OTC hearing aid ruling could provide relief to those in need by providing cheaper alternatives that do not require hearing exams or fittings to address mild to moderate hearing impairment issues. 

The journey to OTC hearing aids started in 2017 after Congress passed legislation ordering the FDA to create a new category of OTC hearing aid options for consumers. Years passed with the request appearing to have fallen to the wayside until President Biden mentioned the issue in an executive order in July 2021. In it, he demanded the FDA publish a proposed rule for the wider availability of low-cost hearing aids within 120 days, which the FDA obliged in October 2021. 

Now, the FDA finalized the rule, bringing the OTC hearing aid category closer to consumers than ever. The FDA noted the OTC category would only apply to some air-conduction hearing devices for adults with mild to moderate hearing impairments. Anything for children or those with a severe hearing impairment would still require a prescription. 

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Good for the People, Good for Competition

The FDA said it based the decision on over 1,000 public comments after the proposed rule in October 2021. The regulatory agency said it would address certain comments that were more prominent, particularly ones addressing safety concerns. 

Of those comments, though, Senators Chuck Grassley and Elizabeth Warren argue in an investigational report published in June that the leading hearing aid manufacturers influenced many comments to alter the specifications for OTC hearing aids. Grassley and Warren said that most comments are directed at limiting the output and gain limits of eventual OTC devices, which would benefit the major hearing aid manufacturers because the new OTC devices would not be strong enough to suit the needs of many consumers. 

The report highlights Starkey Hearing Technologies as one of the companies tampering with the comments submitted to the FDA. Starkey sponsored the “Listen Carefully” campaign, which provided a prompt for users to base their comments on to send to the FDA. Among these and other tactics, Grassley and Warren’s team estimate that hearing-aid companies influenced about a quarter of the comments submitted to the FDA. 

Regardless of the report’s findings, the FDA acquiesced to many comment requests, including lowering the maximum output sound. Still, more readily available access to hearing aid devices without the need for a prescription will be a benefit to millions across the country who may be going without it for one reason or another. 

Author

Reed Slater