This week, the U.S. Food and Drug Administration (FDA) made an announcement that’s music to many consumers’ ears. They finalized a new ruling anticipated to increase access and affordability for hearing aids.
These essential tools for many have long received spotty coverage under Medicare and other forms of insurance, leaving consumers to either save up or make do without. Now, many more Americans should be able to access hearing aids without breaking the bank.
All facts and figures can be found in the FDA’s press release on the finalized ruling, unless specifically linked elsewhere.
That all sounds well and good, but how exactly does the FDA ruling make hearing aids less expensive or easier to get? The new ruling will allow hearing aids to be bought over the counter, both directly in stores and from online retailers. To further increase their availability, hearing aids will also no longer require a prescription, medical examination, or fitting adjustments. This is anticipated to benefit the nearly 30 million Americans who could use hearing aids, but currently don’t.
Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need. Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible. — Health and Human Services Secretary Xavier Becerra
Not all hearing aids will suddenly become available over the counter, however. This ruling creates a new category of hearing aid identified as over-the-counter (OTC) that will still follow standards to maintain safety and effectiveness. The FDA hopes that this new category will spur competition and innovation to further drive down costs. The effective date for this ruling is October 16, 2022, or 60 days after its publication in the Federal Register.
Hearing aids may be sold before the effective date, but manufacturers of these hearing aids will have 240 days after the publication to comply with any new or revised requirements from the ruling. Currently, the FDA believes that OTC hearing aids will be available as early as October 2022.
Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions. Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective, and affordable hearing aids from their neighborhood store or online. — FDA Commissioner Robert M. Califf, M.D.
This FDA ruling has been a long time coming. Congress actually passed a bipartisan order for the FDA to create an OTC category for hearing aids in 2017. This ruling was enforced when President Biden signed an executive order calling on the FDA to allow hearing airs to be sold over the counter within 120 days of the order.
Prior to the rule’s finalization, the FDA opened it up to public comment. It quickly received over 1,000 public comments from consumers, advocacy groups, manufacturers, agencies, and even members of Congress with proposals. Most had to do with ensuring safety and effectiveness. Some of these were used to reshape the ruling, including:
Lowering the maximum sound output to protect hearing from overamplification
Revising the insertion depth into the ear canal
Requiring all OTC hearing aids to have user-adjustable volume control
Simplifying the required device labeling to be easier to understand
● ● ●
This ruling is great news for anyone in need of a hearing aid or are experiencing mild to moderate hearing loss. It will certainly be interesting to watch a new category of medical device grow and see how it influences the rest of the field. Either way, it should make it easier to get your hands on hearing aids, hopefully making them more affordable in the process.