Now more than ever, consumers are looking for products to arrive at their doorstep, including hearing aids. With new legislation rolling out this month, there is a lot of noise in the hearing aid marketplace, which obscures the key differences between these very different products.<\/p>\n
This month, the FDA is scheduled to release a draft of regulations for Over-the-Counter hearing aids as part of the FDA Reauthorization Act. President Trump signed FDARA into law three years ago, which covers a range of new regulations. However, I am most interested in the new regulations for medical devices which allow the first development of FDA approved Over-the-Counter hearing aids\u2014a pursuit to make hearing aid technology more affordable and accessible. Or so they say.<\/p>\n
With the confusion surrounding this development, my aim is to reduce some of the noise and help you understand what is going on and how it may impact the world of hearing aids for the better, and possibly for the worse. In my estimation, 80% of the folks I see in my clinic with hearing loss are candidates for hearing aids. The hearing aid journey is already so daunting due to stigma, denial, and cost, that demystifying these distinctions is important if people are going to hear better.<\/p>\n
Until now, hearing aid consumers were required to have medical authorization in order to purchase hearing aids\u2014not to be confused with PSAPs, personal sound amplifying products, which only enhance sound and are no solution for hearing loss. PSAPs are considered Direct-to-Consumer products and are not regulated by the FDA. You can find PSAPs online or at pharmacies, Walmart and the like. Technically, this term\u2014Direct-to-Consumer\u2014defines any item a consumer purchases directly without the use of a middleman or a retailer. And, in the case of DTC hearing devices as of now, without the use of a physician or FDA approval.<\/p>\n
The DTC hearing device marketplace is wildly unregulated. In fact, hearing aid manufacturers have made false claims that their DTC hearing devices are official OTC hearing aids. However, hearing aids are still considered restricted devices\u2014products that must be distributed by a licensed professional. The FDA stated that any product claiming OTC hearing aid status is false because that category doesn\u2019t exist yet. This was published in their letter to hearing aid manufacturers in July of 2018. Unfortunately, while the FDA is aware of this mislabeling, they haven\u2019t enforced their own guidelines\u2014this is cause for concern and confusion when OTC hearing aids become legitimate. Regardless, any DTC product claiming to address hearing loss as an OTC hearing aid is not to be trusted.<\/p>\n
However, everything changes this month! Supposedly, the FDA will decide the criterion for products to be able to claim OTC hearing aid status on August 18th<\/sup>. Then there will be a time for the public to contribute comments. I suspect these official products will not hit the market until the end of this year, at the earliest. My hope is that the FDA will enforce their guidelines so that the DTC hearing aid market has a fighting chance to be considered a legitimate option for people.<\/p>\n FDARA also includes the authorization of self-fitting hearing aid technology, so that electronic companies\u2014like Bose, Samsung and Apple\u2014can create devices that sync with mobile apps, giving the consumer total control of their hearing aid . . . and their hearing loss. While Bose is authorized to market their hearing aid products, I doubt these tech companies will be able to release their new products soon. I\u2019m really not sure how these products will relate to today\u2019s standard hearing aid; I have no idea how much they will cost and what kinds of support their companies will offer. I predict we will see more existing hearing aid manufacturers creating OTC versions before these tech companies will\u2014simply because of their familiarity with hearing aid production.<\/p>\n The new OTC category will aim to treat \u201cperceived mild to moderate\u201d hearing loss. In my clinic alone, many people falsely perceive their hearing loss, so I\u2019m leery of this self-help approach. I\u2019m especially concerned for people with actual severe hearing loss who decide to go the OTC route, and then abandon hearing aids altogether when their OTC hearing aids cannot treat their severe hearing loss. Also, OTC devices will come pre-programmed, which leaves a large margin for error. This will lead to dissatisfaction since consumers won\u2019t have access to correct and adjust settings. Again, this will encourage the wrong perception of what hearing aids can offer a person with hearing loss.<\/p>\n Your hearing loss could not be more individual, and while hearing aids work, they require the nuance of time, counseling, and professional expertise to fit your ear and your hearing need. Hearing aids succeed to the degree they are customized, from measure of loss to ear anatomy. A professional hearing aid servicer\/provider will manage the feedback, noise, quiet, comfort, overall fit, earwax buildup, moisture, itching and guarantee that your hearing aid does the job it is supposed to do. On average, people wait 7 years to purchase hearing aids after realizing they could benefit from them. In that time, their hearing has declined, and their brain has actually formed new pathways for existing in the world, strengthening other senses while naturally weakening others. Therefore, it takes new hearing aid wearers time and counseling from a professional to establish a new normal. Frankly, this isn\u2019t a process that most people could figure out on their own.<\/p>\n It\u2019s unlikely that OTC hearing aid usage will cause direct harm; I suspect people won\u2019t wear them if and when they hurt or don\u2019t help. While I certainly support responding to pain, I fear people who could really benefit will throw away the worth of hearing aids when they quit their OTC pair, prolonging untreated hearing loss.<\/p>\n Untreated hearing loss is a serious health condition, especially as people age, leading to cognitive decline, depression, and falls. While many insurance companies and Medicare fail to support the gravity of this health issue, hearing loss is the third most common chronic physical health condition\u2014more chronic than diabetes and cancer. Treatment seems expensive, but unaddressed hearing loss poses an annual global cost of $750 billion. Nothing to sneer at!<\/p>\n Additionally, like other physically losses, untreated hearing loss perpetuates itself; it\u2019s not stagnant. Therefore, the longer a person waits to treat their hearing loss, the worse their hearing loss becomes. Likewise, the longer a person waits to purchase hearing aids, the longer a person needs to acclimate to the treatment with the nuanced help of a professional.<\/p>\n In conclusion, I understand that now more than ever, the convenience of having something shipped to your doorstep carries a new weight. It\u2019s not merely convenience; it\u2019s safety. And, I certainly won\u2019t underestimate the need to prioritize, both for your health and your finances. However, hearing loss is a serious and individual issue that requires the specialized care and counseling of professionals\u2014that can\u2019t be boxed! Even so, we are galvanized to move with the new normal and have found great success with programming hearing aids remotely.<\/p>\n As the options grow with the regulation of OTC hearing aids, do your research, get a second or third opinion, and always consider the source. When we listen, we can hear, and the value of personalized treatment is something you will actually hear.<\/p>\n -Dr. B<\/p>\n","protected":false},"excerpt":{"rendered":" New Normals; New Confusions Now more than ever, consumers are looking for products to arrive at their doorstep, including hearing aids. With new legislation rolling out this month, there is a lot of noise in the hearing aid marketplace, which obscures the key differences between these very different products. This month, the FDA is scheduled…<\/p>\n","protected":false},"author":1,"featured_media":6665,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"categories":[7],"tags":[24,25,26,27],"_links":{"self":[{"href":"https:\/\/drbenke.com\/wp-json\/wp\/v2\/posts\/6663"}],"collection":[{"href":"https:\/\/drbenke.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/drbenke.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/drbenke.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/drbenke.com\/wp-json\/wp\/v2\/comments?post=6663"}],"version-history":[{"count":0,"href":"https:\/\/drbenke.com\/wp-json\/wp\/v2\/posts\/6663\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/drbenke.com\/wp-json\/wp\/v2\/media\/6665"}],"wp:attachment":[{"href":"https:\/\/drbenke.com\/wp-json\/wp\/v2\/media?parent=6663"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/drbenke.com\/wp-json\/wp\/v2\/categories?post=6663"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/drbenke.com\/wp-json\/wp\/v2\/tags?post=6663"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Perception vs. Reality<\/h2>\n
Individual Issue; Collectively Solved<\/h2>\n
Untreated Hearing Loss is Mistreatment<\/h2>\n
The Value \u2013 Something You Can Hear<\/h2>\n