FDA Finalizes Historic Rule Providing Access to Over-the-Counter Hearing Aids

Posted by Chad Birt on Sep 6, 2022 7:00:00 AM
Chad Birt

In 2017, Congress passed bipartisan legislation requiring the Food and Drug Administration (FDA) to develop a grouping of over-the-counter hearing aids. Though passed more than five years ago, the law is only being implemented now. 


On August 16, 2022, the FDA issued its final rule “to improve access to hearing aids, which may, in turn, lower costs for millions of Americans.” Specifically, the rule establishes a new category of hearing aids that don’t require a prescription.

The final rule change will impact hearing health in several ways:


  • Adults who need hearing aids will be able to buy them without an exam or fitting by an audiologist.
  • All FDA-approved hearing aids within the new category must have input-controlled compression and user-adjustable volume control.
  • The limit of amplification for this class of hearing aids is proposed at 120 dB (i.e., the loudness of an emergency siren.) This number is 10 dB above the output limit.
  • The rule takes effect in 60 days.


The FDA didn’t finalize the new rule before seriously considering various factors. Key decision makers reviewed more than 1,000 comments from members of the public, considering the pros and cons. 


To avoid any confusion, the FDA also issued a final rule on regulatory requirements for hearing aid devices and personal sound amplification products (PSAPs). This clarifies “the differences between hearing aids, which are medical devices, and PSAPs, consumer products that help people with normal hearing amplify sounds.”

How will the FDA’s final rule benefit people with hearing loss?


The Biden Administration has made it a top priority to expand affordable access to health care since entering office. 


Health and Human Services Secretary, Xavier Bacerra, emphasized this point, when announcing the new hearing aid rule, noting that the “action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.” 


That’s great news, considering that the average cost of one hearing aid is between $2,000-$3,000. And, since most health insurance companies don’t provide coverage for hearing aids, the rule is a welcome relief for older adults with fixed incomes or tight budgets.

Hearing aids provide health benefits, too


The benefits of the FDA’s new rule aren’t just financial. 


Clinical studies suggest that older adults who wear hearing aids are less likely to suffer slip and fall injuries or experience anxiety and depression. There’s even some evidence that hearing aids can improve brain function and enhance working memory.


Hearing aids may also complement interpersonal relationships; when you’re able to hear your friends, family members, and colleagues it’s easier to connect, communicate, and interact with them.

How do audiologists and other hearing experts feel about the new rule?


The response to the FDA’s new over-the-counter hearing aid rule from audiologists and other medical experts has been overwhelmingly positive. Up to 31 million Americans don’t have health insurance or the funds to visit a hearing specialist out-of-pocket. The new rule increases accessibility to care, but there’s also the potential for challenges.


For example, hearing loss affects everyone differently. An over-the-counter hearing aid might help one person, but not another. What’s more, OTC hearing aids require patients to do their homework. So, individuals won’t be able to ask their doctor questions when comparing brands or specs. 


There will likely be hiccups as the new program rolls out, but the potential for improved hearing and more affordable access to health care is exciting. To learn more about the FDA’s OTC hearing aid rule, click here.

What’s your take on the FDA’s OTC Hearing Aid Rule?


Are you a pharmaceutical or biotechnology professional? If so, what’s your take on the FDA’s OTC hearing aid rule? If you have an opinion, either way, we’d love to hear your thoughts. Fill out the blank form below and then click the “submit comment” button. We hope you join the conversation!

Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, biostatistics, biometrics, FSP, clinical trials, online meetings, project management, Good Clinical Practice, healthy living, patient enrollment, FDA inspections, medical research, food and drug administration, medical patients

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