Over-the-Counter (OTC) hearing aids herald a new golden age for consumer access and affordability and will lead to improvements in technology innovation and public health outcomes in the coming years. Consumers and hearing healthcare providers alike are uniquely positioned to benefit from this new finalized OTC rule. While nothing can replace the high-touch, hands on service delivery of a skilled licensed professional, OTC hearing aids will provide much needed relief to tens of millions of un- and under-served Americans suffering from perceived mild-to-moderate hearing loss currently with limited and expensive options to treat their perceived mild-to-moderate hearing loss.

OTC hearing aids have been a long time in the making. In 2016, the United States spent nearly twice as much on overall health care as other high-income countries yet had poorer population health outcomes. In 2016, then-President Obama commissioned research by the President’s Council of Advisors in Science and Technology (PCAST) and the National Academies of Science, Engineering, and Medicine (NASEM). Among their findings was that even if every single audiologist and hearing instrument dispenser was fitting people full time with hearing aids, there would still be a huge and growing unmet need in the United States for hearing healthcare forming the foundation for the new OTC hearing aid category.

For many years, traditional hearing aid industry manufacturer incumbents have embraced concepts around incremental innovation, where they simply add another microphone or additional processing strategy to an already mature product platform, with marginal impact to the consumer experience.

In recent years, industry incumbents are also leading massive consolidation efforts within the hearing healthcare industry where small groups of private practice hearing healthcare providers are bought up and fully owned by the large manufacturers.

While this can help streamline distribution channels for hearing aid products and ensure process consistency among providers, this can also serve as a barrier to entry for many consumers and leaves the industry in a spot of stagnant innovation that is ripe for disruption.

Regulations involving dispensing hearing aids effectively became what economists call a barrier to entry, as it reduces the ability for consumers to effectively comparison shop thereby reducing competitive pressure on pricing. If there is no incentive for companies to create a better product for a better price, you will inevitably get high costs and potentially fewer health outcomes.

Many insurance plans still do not cover hearing aids, forcing consumers to cover the costs entirely out-of-pocket. This can represent additional strain on already stretched thin budgets of American senior citizens and others on a fixed income. OTC hearing aids can provide additional opportunities for audiologists and hearing healthcare providers precisely because they require consumers to self-identify and self-manage their condition.

If the floodgates are opened to a larger range of people, it could encourage consumers to learn more about their condition, and therefore improve the health literacy of the public. The downstream effect of this is to increase the perceived value of the audiologist beyond mere salespeople of a medical device, which audiologists everywhere should applaud. This provides an effective and straightforward on-ramp for consumers to comparison shop, experience their options, and take ownership of the management of their condition, which for many will include hearing healthcare providers as key partners in the overall journey to better health and well-being.

Consumers will directly benefit from an unprecedented ability to comparison shop between products that will be right for their needs, while also learning more about their unique needs and where they need the most help. This may encourage new entrants into this newly forming market segment and will likely result in key product innovation like new methods of self-fitting and self-selection of preferred audio settings, much like an advanced “tone control” on your home stereo system.

Opponents of the now finalized OTC rule suggest that the care of the hearing professional is essential for best patient outcomes. I tend to agree with this sentiment. That said, many Americans would be thrilled to settle for any outcome, not just the best outcome. It is a common misconception that consumers will pick OTC hearing aids over seeing their audiologist or hearing healthcare provider. What actually happens is that consumers will now have the option to pick OTC hearing aids over nothing.

The consequences of untreated hearing loss include earlier and more severe onset of dementia and other disease processes that can result in progressive cognitive decline. By giving the control and power back to the consumer to identify and manage their condition, it allows audiologists and other hearing healthcare providers to function as key allies and advocates for the aspects of audiology that can have a lasting impact on people’s lives beyond just the prescription and sale of a device.

This will also help elevate the least privileged among us to be able to access affordable care in a way that does not compromise safety and satisfaction due to the robust special controls the FDA is requiring in the final rule. People come in all different shapes, sizes, colors, and preferences. The landmark OTC hearing aid final rule will allow consumers the ability to select products that meet them where they are at and match their needs the best in a way only the consumer themselves can decide. Consumers can feel confident that the products labeled as “OTC hearing aids” will be safe and effective due to the robust special controls the FDA has enumerated in the final OTC rule.

In my opinion, in the next five years, hearing healthcare will see more innovation and consumer choice than has been available in the previous fifty years. Allowing consumers to choose the product that is right for them, and to take ownership of their health condition will improve health literacy and reduce health disparities in outcomes among Americans of all stripes. It is on this basis that a new golden age of hearing healthcare can emerge and flourish, with new levels of consumer choice and technology innovation. The free market always wins, and the future has never looked brighter.

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