By Kaitlin Coyne, JHBL Staff Member
As hard as it is to be faced with the reality of suffering from hearing loss, that reality seems even worse when a hard-of-hearing individual sees the cost of purchasing hearing aids. The average cost range of prescription hearing aids is $2,000 to $8,000.[i] Insurance rarely foots the entire bill, or even close to it, when an individual finds themselves in this precarious situation.[ii] This is because they are defined as “elective” medical devices rather than an essential one.[iii] But, while they are not accepted as essential medical devices, the Food and Drug Administration (FDA) has long required a medical evaluation, prescription, and a hefty sum of money to obtain a pair.[iv]
Congress passed the FDA Reauthorization Act in 2017, which allowed the FDA to create a category of hearing aids permitted to be sold over-the-counter (OTC). These OTC hearing aids were intended for individuals eighteen years old and older with mild to moderate hearing loss. The goal was to lower costs and increase accessibility. Specifically, it was predicted that the new average cost for an OTC hearing aid would be approximately $600 per pair.[v] In turn, people experiencing hearing loss could avoid astronomical costs and walk into a local drug store to purchase hearing aids. This also presents an avenue for those extremely familiar with their hearing loss and know their preferences and need. The OTC hearing aid option would provide a much easier process for those long-time customers. This new move does not target a small market either. About thirty million people in the United States have hearing loss in both ears.[vi]
This process has been ongoing since 2017 but the momentous day when hearing aids became available OTC finally arrived on October 17, 2022. As anticipated, companies are eager to dive into this new market. Leading hearing device manufacturers, such as, Lexie, Jabra and Eargo, have already made devices available.[vii] Walgreens and Walmart announced that they will be selling OTC hearing aids as well.[viii] Hearing aids will undoubtedly be as common as reading glasses in stores.
For a large part, OTC hearing aids are well-received. But some professionals forecast that the lower costs of OTC hearing aids are not an enticing enough justification for completely disposing of the medical evaluation and prescription requirement. Labeling that states OTC hearing aids are intended for consumers eighteen years and older will still be required, but there are no enforcements in place. The problem with this is that the cause of hearing for individuals under eighteen years old is often a result of an underlying medical condition whereas for adults and seniors, the cause is often a result of aging and environment. If children under eighteen years old begin to rely on OTC hearing aids rather than seeking professional help, there might be a new problem that is an increase in undiagnosed illnesses. For example, approximately one in ten children who have bacterial meningitis develop deafness as a result.[ix] So what happens when a parent, without much money to spend on their child’s medical expenses, suspects their child is suffering from hearing loss? Rather than see a medical professional, they will go to their local CVS to purchase OTC hearing aids. But what if this hearing loss is actually a side effect of their child contracting bacterial meningitis? One might blame the parents, claiming that they should have been cautioned by the label, but this could very well be the case for individuals of any age over eighteen. Further, the question remains unanswered about what a parent should do if they cannot afford the cost of a hearing aid for their child, but are advised against purchasing OTC hearing aids for them. This leaves a very large population of hard of hearing individuals unaccounted for in the prediction that OTC hearing aids will lower costs.
OTC hearing aids are also intended for individuals with mild to moderate hearing loss. Even when an individual with mild to moderate hearing loss sees an audiologist, it can take multiple visits to ensure the fit and sound are perfected enough to avoid discomfort, pain, or worse, more hearing loss.[x] Individuals that purchase OTC hearing aids risk injury by not consulting with a professional before wearing them every day. Asking people to sacrifice the quality of hearing healthcare in order to even receive any kind of sounds like a band aid on a bullet wound. People will purchase OTC hearing aids, realize how uncomfortable or potentially unhelpful they are, and abandon them, leaving them right back where they started. This creates an unsustainable option.
Finally, there is a misconception that the OTC hearing aids are of the same quality that audiologists have been recommending and prescribing in the past. The reality is that OTC hearing aids are not synonymous to prescription hearing aids. OTC hearing aids will lack the personalization quality available in prescription hearing aids. Individual fittings for hearing aids are so important because it ensures that the devices are unique to individual ear shape, volume and sound preferences. Those who argue the difference is worth the cost decrease may have valid reasons for thinking so, but this difference should be clarified rather than contributing to the narrative that these fancy hearing aids are the same ones that consumers are purchasing at CVS and Walgreens.
Individuals also experience hearing loss at varying degrees.[xi] Hearing loss can be, but not limited to, mild, moderate, moderately severe, severe and profound.[xii] So even if this new OTC category was the greatest plan to ever exist for individuals with mild to moderate hearing loss, it does nothing to resolve the astronomical costs that people with moderately severe hearing and worse will continue to experience. This circles back to the entire overarching question of, how can insurance companies continue to tell people with severe hearing loss that purchasing a hearing aid to restore whatever hearing they possibly can, is “elective”? This move by the FDA leaves insurance companies unscathed by their resistance to covering hearing aids. Hearing loss is present in one in three adults over the age of 65 yet Medicare does not cover hearing aids or exams for fitting hearing aids.[xiii] This fact remains largely unaddressed.
While many celebrate this week, there are still a lot of unanswered questions and pitfalls to encouraging consumers to purchase OTC hearing aids, especially for mild to moderate hearing loss. A lot of which could be resolved with a reasonable level of transparency. Expanding accessibility to hearing aids is significant but should not be treated lightly considering the risk of undiagnosed illnesses, declining quality of hearing healthcare, and exclusion of individuals with hearing loss that are not eligible for OTC hearing devices.
Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHBL or Suffolk University Law School.
[i] Phil Galewitz, You Can Now Buy Lower-Cost Hearing Aids Over the Counter. Here’s How, PBS (Oct. 17, 2022, 5:12 PM), https://www.pbs.org/newshour/health/you-can-now-buy-lower-cost-hearing-aids-over-the-counter-heres-how#:~:text=A%20pair%20of%20prescription%20devices,in%20the%20cheaper%20OTC%20aids.
[ii] Mandy Mroz, Insurance and Financial Assistance for Hearing Aids, Healthy Hearing (Sept. 14, 2022), https://www.healthyhearing.com/help/hearing-aids/insurance-financial-assistance.
[iii] Why Aren’t Hearing Aids Always Covered?, YourHearing (Sept. 15, 2020), https://www.yourhearing.com/blog/why-arent-hearing-aids-always-covered.
[iv] Over-the-Counter Hearing Aids, National Institute on Deafness and Other Communication Disorders, https://www.nidcd.nih.gov/health/over-counter-hearing-aids (last updated Aug. 16, 2022).
[v] Jaipreet Virdi, The Unintended Consequences of OTC Hearing Aids, Wired (Aug. 16, 2022, 12:30 PM), https://www.wired.com/story/fda-over-the-counter-hearing-aids-disability/.
[vi] Quick Statistics About Hearing, National Institute on Deafness and Other Communication Disorders, https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing#:~:text=One%20in%20eight%20people%20in,based%20on%20standard%20hearing%20examinations.&text=About%202%20percent%20of%20adults,adults%20aged%2055%20to%2064 (last updated March 25, 2021).
[vii] Julie Jargon, Hearing Aids Are Now For Sale Over the Counter: What You Need to Know, The Wall Street Journal (Oct. 19, 2022, 5:30 AM), https://www.wsj.com/articles/hearing-aids-are-now-for-sale-over-the-counter-what-you-need-to-know-11666135986.
[viii] Jessica Rendall, New FDA Rule in Effect: What to Know About Over-the-Counter Hearing Aids, CNET (Oct. 17, 2022 10:43 AM), https://www.cnet.com/health/medical/new-fda-rule-in-effect-what-to-know-about-over-the-counter-hearing-aids/.
[ix] Meningitis, National Deaf Children’s Society https://www.ndcs.org.uk/information-and-support/childhood-deafness/causes-of-deafness/meningitis/ (last visited Oct. 19, 2022).
[x] The Problem With Over-the-Counter Hearing Aids, Hear Again America (Feb. 15, 2022), https://hearagainamerica.com/the-problem-with-over-the-counter-hearing-aids/.
[xi] Degree of Hearing Loss, American Speech-Language-Hearing Association, https://www.asha.org/public/hearing/degree-of-hearing-loss/ (last visited Oct. 19, 2022).
[xii] Id.
[xiii] Age-Related Hearing Loss (Presbycusis), Johns Hopkins Medicine, https://www.hopkinsmedicine.org/health/conditions-and-diseases/presbycusis (last visited Oct. 20, 2022); Hearing Aids, Medicare,
https://www.medicare.gov/coverage/hearing-aids (last visited Oct. 18, 2022).