Everyone has taken over the counter medications and seen their benefits, but what about over the counter hearing aids? In 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. Because of the OTC Hearing Aid Act, the public should now have greater access to better-regulated (and cheaper!) hearing aids.

OTC Hearing Aid Act & the FDA

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 the 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. This way, OTC hearing aids are inspected by a government entity as opposed to the individual retailers. Ideally, this will 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 towards 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 their regulations.

Current Over-the-Counter Hearing Aids

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 a 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 for tailoring and specification that previously could only be found in the audiologist’s office.

By: Diana Michel

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

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