Journal of Over-the-Counter (OTC) Hearing Aids. a new golden age for consumer access and affordability and will lead to improvements in technological innovation and public health outcomes in the coming years. Hearing healthcare consumers and providers are uniquely positioned to benefit from this newly finalized OTC rule. While there is no substitute for prompt, hands-on service delivery by a qualified licensed professional, OTC hearing aids will provide much-needed relief to the tens of millions of unserved and underserved Americans who currently suffer from presumed mild to moderate hearing loss with limited and expensive treatment options for their suspected mild to moderate hearing loss.
Over-the-counter hearing aids have been around for a long time. In 2016, the United States spent nearly twice as much on overall health care as other high-income countries, yet performed worse on population health. In 2016, then-President Obama commissioned a study by the President’s Council of Advisors on Science and Technology (PCAST) and the National Academies of Science, Engineering, and Medicine (NASEM). Among their findings is that even if every single audiologist and hearing aid provider fitted people full-time with hearing aids, there would still be a huge and growing unmet need in the United States for hearing health care, forming the basis for the new category over-the-counter hearing aids.
For many years, traditional hearing aid manufacturers have adopted concepts of incremental innovation, where they simply add another microphone or additional processing strategy to an already mature product platform, with little impact on the user experience.
In recent years, established companies in the industry have also led large-scale consolidation efforts in the hearing healthcare industry, where small groups of private hearing healthcare providers have been purchased and wholly owned by the major manufacturers.
While this can help streamline distribution channels for hearing aid products and ensure consistency of processes between suppliers, it can also serve as a barrier to entry for many users and leave the industry in a place of innovation stagnation. which is ripe for disruption.
Regulations involving the efficient distribution of hearing aids have become what economists call a barrier to entry because they reduce consumers’ ability to effectively comparison shop, thereby reducing competitive pressure on pricing. If there is no incentive for companies to create a better product at a better price, you will inevitably end up with high costs and potentially less health outcomes.
Many insurance plans still do not cover hearing aids, forcing consumers to cover the cost entirely out of pocket. This could put additional strain on the already stretched thin budgets of American senior citizens and other people on fixed incomes. OTC hearing aids can provide additional opportunities for audiologists and hearing healthcare providers precisely because they require users to self-identify and manage their condition.
If the floodgates are opened to a wider range of people, it may encourage consumers to learn more about their condition and therefore improve public health literacy. The downstream effect of this is to increase the perceived value of the audiologist beyond the mere salesperson of a medical device, which audiologists everywhere should applaud. This provides an efficient and easy platform for consumers to comparison shop, experience their options and take responsibility for managing their condition, which for many will involve hearing healthcare providers as key partners in the overall journey to better health and wellbeing – creature.
Consumers will directly benefit from the unprecedented ability to comparison shop products that fit their needs while learning more about their unique needs and where they need help the most. This could encourage new entrants into this nascent market segment and is likely to lead to key product innovations such as new self-tuning methods and self-selection of preferred audio settings, much like an advanced ‘tone control’ on your home stereo.
Opponents of the now-finalized OTC rule suggest that the care of a hearing care professional is essential for the best patient outcomes. I tend to agree with this opinion. Still, many Americans would be thrilled to settle for it any kind score, not just the best score. A common misconception is that consumers will choose over-the-counter hearing aids instead of seeing their audiologist or hearing care provider. What is actually happening is that consumers will now have the option of choosing over-the-counter hearing aids over nothing.
Consequences of untreated hearing loss include earlier and more severe onset of dementia and other disease processes that can lead to progressive cognitive decline. By returning control and power to the user to identify and manage their condition, it allows audiologists and other hearing healthcare providers to function as key allies and advocates for aspects of audiology that can have a lasting impact on people’s lives beyond just the prescription and sale of the device.
It will also help the least privileged among us access affordable care in a way that does not compromise safety and satisfaction because of the robust special controls that the FDA requires in the final rule. People come in different shapes, sizes, colors and preferences. The final OTC hearing aid final rule will allow consumers to choose products that meet them where they are and best meet their needs in a way that only the consumer can decide. Consumers can feel confident that products labeled as “over-the-counter hearing aids” will be safe and effective because of the robust special controls listed by the FDA in the OTC final rule.
In my opinion, hearing health care will see more innovation and consumer choice in the next five years than it has in the previous fifty years. Allowing consumers to choose the product that’s right for them and take responsibility for their health will improve health literacy and reduce disparities in health outcomes among Americans of all stripes. It is on this basis that a new golden age of hearing health care, with new levels of consumer choice and technological innovation, can emerge and flourish. The free market always wins and the future has never looked brighter.
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