Making the world a better place: this is the battle cry of Silicon Valley and the driving force behind innovation in technology. Now a decade old, the Apple iPhone has revolutionized the way we interact with the world and each other. The rapid growth and innovation of technology has radiated to many different areas of our lives – including hearing health and the advent of over-the-counter (OTC) hearing aids.
The Hearing Loss Association of America (HLAA) puts it best: “Practically every industry has been disrupted with innovative technology. The hearing health care market is no different. We could not have considered over-the-counter hearing wearable devices 20 years ago, but innovation is pushing its way into the hearing health care market. Innovation has the potential to create more variety and better products. Competition from new players in the market has the potential to drive down cost not only for OTC hearing aids, but for all hearing aids.” In recent months, the passage of the Over-the-Counter Hearing Aid Act of 2017 has created an important moment in hearing health care in the US.
The Over-the-Counter Hearing Aid Act of 2017 (HR 1652)
In August 2017, the House of Representatives passed the OTC Hearing Aid Act of 2017 as part of a greater bundle of the Food and Drug Administration Reauthorization Act. With this OTC Hearing Aid legislation, “the bill mandates that the Food and Drug Administration (FDA) create an over-the-counter hearing device category for people with mild-to-moderate hearing loss.” Lauded by the HLAA and the Consumer Technology Association (CTA), this legislation “has sent a message to America that people with hearing loss need – and deserve – more affordable and accessible hearing health care.”
In this legislation, the FDA is required to “regulate this new category of OTC hearing aids to ensure they meet the same high standards for safety, consumer labeling, and manufacturing protection that all other medical devices must meet” and to “establish an OTC hearing aid category for adults with ‘perceived’ mild-to-moderate hearing loss within three years of passage of the legislation.”
OTC Hearing Aids Hold Their Own Against Traditional Hearing Aids
Published in the September 2017 Journal of the American Medical Association, a study found that when it comes to traditionally prescribed hearing aids and “personal sound amplification products” – known as PSAPS, or OTC hearing devices – there was “very little difference between the hearing aid, which costs about $1,900 per ear and some of the PSAPs, which mostly cost between $300 and $350 a year.” In other words, OTC devices provide wearers with features that amplify sound and help with speech intelligibility at a fraction of the cost of traditional hearing aids. According to the report, participants of this study who used PSAPs had an experience nearly as effective as people who used hearing aids.
How can we be sure that these devices are both effective and safe? As the FDA continues to develop regulation and safety for these devices, Nicholas Reed, an audiology instructor at the Johns Hopkins School of Medicine, says, “Over-the-counter hearing measures would regulate these devices and force them to meet standards.”
Conflicting Views on Over-the-Counter Hearing Aids
For many national organizations, medical professionals, and public servants that have spent decades raising awareness around hearing loss and hearing health care, the passage of the OTC Hearing Aid Act was a victory. However, there are certain complaints about this act. For one, the American Speech Language Hearing Association (ASHA) believes it is unwise for people to treat themselves for hearing loss, at it is a complicated and nuanced medical condition that requires attention from a licensed hearing professional.
In the US, people who experience hearing loss tend to wait an estimated seven to ten years before they decide to seek treatment. During this time, untreated hearing loss can take a toll on one’s overall health and well-being, radiating into areas as seemingly disconnected as your employment to the risk for developing dementia. Dr. Frank Lin, a leading researcher on the link between untreated hearing loss and dementia from Johns Hopkins University, has published a number of studies that encourage early detection and treatment of hearing loss. He writes in favor of OTC hearing aid legislation: “The important point is that access to OTC hearing aids by consumers would bring hearing technologies out from under the explicit control of a relatively small group of individuals who serve as the intermediaries to hearing care.”
When it comes to treating hearing loss, the HLAA notes an important shift “toward patient-centered care. The easily-available medical information online allows people to take control of their own health care. The old medical model of the doctor making decisions for patients is long gone in many situations. People with hearing loss should have the tools they need to make informed decisions about their own hearing health.”
According to the HLAA, “An estimated 86% of people who would benefit from them do not use them.” Citing cost and access as main reasons, the HLAA points out that this new act would remove the barriers around Americans accessing treatment for their hearing loss, providing them with well-regulated, educated, and affordable options for treating hearing loss. As such, the availability of OTC hearing aids could greatly impact the health and well-being of a greater number of Americans who struggle with hearing loss.