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Everyone has taken over-the-counter medications and seen their benefits, but what about over-the-counter hearing aids?

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On August 2017, President Trump signed the Food and Drug Administration Reauthorization Act of 2017, under which fell the Over-the-Counter (OTC) Hearing Aid Act. The OTC Hearing Aid Act gives the public access to better-regulated (and cheaper!) hearing aids.

Understanding Over-The-Counter (OTC) Hearing Aids

OTC hearing aids are hearing aids that do not require a prescription. Similar to how you can get certain medications over-the-counter, without getting a script from your primary care doctor, they are hearing aids you can get without the involvement of an audiologist or licensed hearing dispenser.

Though not currently available, there are plans in place for OTC hearing aids to hit the market. Once available, people with hearing loss across the nation will be able to buy these devices preprogrammed.

How Over-the-Counter Hearing Aids Increases Accessibility

Before the Act passed, the only option for OTC hearing devices was Personal Sound Amplification Products.

They do not generally go inside the ear and do not treat hearing loss; they only raise the volume and amplify sounds. However, there are currently some options for pseudo-OTC Hearing Aids.

The twist is that many require audiograms from trained audiologists. This process is technically not OTC since the prescription is necessary, but it is similar to OTC because the hearing aids do not come directly from the doctor.

Companies like Audicus are disrupting the hearing aid industry by providing lower-cost hearing aids and an Online Hearing Test.

The net result is access to hearing care that previously could only be found in the audiologist’s office.

OTC Hearing Aid Act & the FDA

Like many other laws, the concept of OTC hearing aids came to fruition with the goal of solving a big problem: hearing equity. The main benefit of over-the-counter hearing aids is that it increases accessibility to hearing care for all.

Elizabeth Warren (D-Massachusetts) and Chuck Grassley (R-Iowa) introduced this bipartisan bill quickly after the removal of the “physician waiver” system. Through the old process, patients were required to visit their physician in order to receive hearing aids. As outlined in the OTC Hearing Aid Act, patients are no longer required to see a doctor and can even get their hearing aids without a physician’s order.

The Act also called upon the FDA to create regulations for hearing devices, simply to ensure safety and protection for users and producers. Congress also required the FDA to monitor users and their approval of the process.

OTC hearing aids are inspected by a government entity as opposed to individual retailers. The idea behind this is to prevent certain major technology giants to overtake the hearing aid world and continue to increase prices.

The OTC Hearing Act and FDA want to provide a safe, affordable option.

FDA Updated Regulations for Over-the-Counter Hearing Aids

Congress gave the FDA 3 years to come up with additional regulations. Under their current guidelines, minors are still required to see a doctor to receive a hearing aid prescription.

The FDA currently requires hearing aids to be labeled with information about medical conditions that demand additional medical attention. They also require companies to provide information about hearing aids and instructions on how to properly use them.

The FDA has not made great strides toward altering these regulations under the OTC Hearing Aid Act of 2017. Audiologists hope the regulations will prevent future hearing loss since, when left untreated or improperly treated, hearing loss only worsens.

Additionally, without a trained professional looking inside consumers’ ears, larger issues for hearing loss may go unnoticed and untreated (earwax build-up, perforated eardrum, etc). The FDA must keep all of this in mind when updating its regulations.

By: Diana Michel

References: Congress.gov, Hearing Review, AARP, FDA.gov