March 03, 2017

JAMA Internal Medicine Op-ed: Over-the-Counter Hearing Aids: The Path Forward

Untreated hearing loss is a major health problem in the United States, particularly for older Americans. Approximately 48 million Americans, including half of those in their 70s, have hearing loss in at least 1 ear. The risk of hearing loss in older adults is about 10 to 20 times higher than the risk of heart disease and 100 times higher than the risk of cancer. Despite the large numbers with hearing loss, only a small share-roughly 14%, according to one analysis-actually use a hearing aid.

Many factors are responsible for this large gap, including the lack of routine hearing screenings for older adults and social stigma that discourages people with hearing loss from seeking treatment. But the way that hearing aids are regulated and sold is also to blame for this disparity. Researchers, consumer advocates, and policymakers are demonstrating a growing interest in reforming the hearing aid market to increase access to these devices.

Both the President's Council of Advisors on Science and Technology (PCAST) and the National Academies of Sciences, Engineering, and Medicine (NAS) recently released major reports on hearing loss, and the convergence in their recommendations could not have been clearer: certain types of hearing aids designed to address mild to moderate hearing loss in adults can be safely made available over the counter. Adopting the recommendations in these reports will substantially expand access to hearing technologies for the millions of Americans with hearing loss. In December 2016, the US Food and Drug Administration (FDA) took a promising step by announcing that it would no longer enforce a requirement that individuals obtain a medical evaluation or sign a waiver prior to purchasing hearing aids. The agency also announced a commitment to consider creating a category of over-the-counter hearing aids, including by proposing to modify regulations to expand access to innovative, lower-cost technologies.

We have also proposed bipartisan legislation that would put PCAST's and NAS's recommendations into action, make good on the FDA's promise, and take important steps to fix a broken market for hearing aids. We introduced the Over the Counter Hearing Aid Act of 2016 in the 114th Congress, and plan to introduce the bill again in the 115th Congress.

Several features of the hearing aid market make these devices inaccessible to individuals with hearing loss. First, hearing aids are expensive, and Medicare and most private insurance plans do not cover the cost. Out-of-pocket costs for a single device average more than $2000, and individuals with hearing loss in both ears may require 2 hearing aids to properly treat their condition. These costs are simply too high for many people to afford, so instead they go without treatment for their hearing loss.

Second, the way that hearing aids are sold makes it difficult for consumers to compare costs and shop for the best value. Instead of being sold as stand-alone products that consumers purchase and then pay for à la carte fitting services, devices are typically sold as part of a "bundle" or package of services that include fees for evaluation, follow-up, and adjustments (whether or not individuals end up using these services).

Finally, dispensers and audiology practices often present consumers with a limited range of products, sometimes all from a single manufacturer that may have provided incentives for the retailer to sell their products. Dispensers may then use proprietary software to tune the hearing aids, locking consumers in to coming back to the same retailer for any follow-up adjustments.

These problems in the hearing aid market stem from the way hearing aids are currently regulated, and they can and should be addressed through legislation as well as related changes to FDA rules. The FDA's decision to end enforcement of the requirement-put in place in 1977-that individuals obtain a medical evaluation before purchasing a hearing aid is a good step in the right direction.

However, PCAST and the NAS both recommended that the FDA go further than simply doing away with the medical evaluation requirement and create a new category of over-the-counter hearing aids for adults with mild to moderate hearing loss. This would require issuing regulations to ensure that this new category of devices is labeled and marketed safely. Importantly, when the FDA issues such regulations, these new federal rules will also preempt the patchwork of state laws governing access to hearing aids, which are currently the major reason that Americans with hearing loss must go through dispensers and audiologists to purchase these devices.

To fulfill its commitment to allow over-the-counter hearing aids, the FDA should also revise its current regulations for personal sound amplification products (PSAPs). These are consumer devices that may amplify sound but do not address hearing loss. Such revisions are needed to clearly distinguish among OTC hearing aids, hearing aids that are not available over the counter, and other types of devices that do not address hearing loss. PCAST and the NAS have recommended withdrawing or revising the FDA's current draft guidance on PSAPs, which has proven difficult to implement and confusing to consumers.

Evidence indicates that making some types of hearing aids available over the counter would substantially lower the costs of these devices. Indeed, PCAST4 found "considerable evidence that hearing aids can be profitably sold for a fraction of today's end-user cost."

Critics argue that individuals cannot self-diagnose their hearing loss and contend that it will compromise consumer safety to allow access to hearing aids over the counter. But the NAS study found no evidence that the medical evaluation requirement provided any clinically meaningful benefit. And individuals with hearing loss know they are having trouble hearing-they may have trouble following conversations or hearing the television, and their friends and family often help alert them that they are not hearing as well as in the past. In the current regulatory environment, however, people simply lack affordable solutions to help them treat their hearing loss. The FDA should regulate over-the-counter hearing aids to ensure that these devices are safe, high-quality products. That is why our bill requires the FDA to develop these safety and quality regulations when such a category of devices is created.

The costs of untreated hearing loss are both mundane and life-threatening: they range from not being able to participate in conversations and difficulty hearing the television or radio, to an increased risk of dementia and falls, social isolation, and depression. There is no one-size-fits-all solution to addressing these issues, but increasing access to innovative, low-cost hearing technologies must be part of the policy response to the untreated hearing loss now experienced by millions of Americans. We look forward to continuing to work on these policies and pressing for their advancement in Congress and at the FDA.

Read the op-ed on JAMA Internal Medicine's website here.

By:  Senators Elizabeth Warren and Chuck Grassly
Source: JAMA Internal Medicine