{"id":524,"date":"2020-10-05T08:32:37","date_gmt":"2020-10-04T23:32:37","guid":{"rendered":"https:\/\/www.oliveunion.com\/ustest\/how-do-i-know-which-hearing-aids-are-fda-approved\/"},"modified":"2020-11-20T12:41:57","modified_gmt":"2020-11-20T03:41:57","slug":"how-do-i-know-which-hearing-aids-are-fda-approved","status":"publish","type":"post","link":"https:\/\/www.oliveunion.com\/ustest\/hearing-device\/how-do-i-know-which-hearing-aids-are-fda-approved\/","title":{"rendered":"How Do I Know Which Hearing Aids Are FDA-Approved?"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">If you\u2019ve been shopping around for a hearing aid, you might have noticed the claim \u2018FDA-registered\u2019 attested by some brands.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">This article explains why it\u2019s necessary for hearing aids to be FDA-approved and what devices count as an FDA hearing aid.<\/span><\/p>\n<p><\/p>\n<div id=\"toc_container\" class=\"no_bullets\"><p class=\"toc_title\">Contents<\/p><ul class=\"toc_list\"><li><a href=\"#FDA_Hearing_Aids_and_Accessibility\"><span class=\"toc_number toc_depth_1\">1<\/span> FDA Hearing Aids and Accessibility<\/a><\/li><li><a href=\"#What_Does_it_Mean_if_a_Hearing_Aid_is_FDA_Registered\"><span class=\"toc_number toc_depth_1\">2<\/span> What Does it Mean if a Hearing Aid is FDA Registered?<\/a><\/li><li><a href=\"#What_are_the_FDA_Regulations_for_Hearing_Aids\"><span class=\"toc_number toc_depth_1\">3<\/span> What are the FDA Regulations for Hearing Aids?<\/a><\/li><li><a href=\"#What_are_PSAPs\"><span class=\"toc_number toc_depth_1\">4<\/span> What are PSAPs?<\/a><\/li><li><a href=\"#Are_PSAPs_Approved_by_the_FDA\"><span class=\"toc_number toc_depth_1\">5<\/span> Are PSAPs Approved by the FDA?<\/a><\/li><li><a href=\"#Can_You_Buy_FDA_Approved_Hearing_Aids_Over_the_Counter\"><span class=\"toc_number toc_depth_1\">6<\/span> Can You Buy FDA Approved Hearing Aids Over the Counter?\u00a0<\/a><\/li><\/ul><\/div>\n<h2><span id=\"FDA_Hearing_Aids_and_Accessibility\"><b>FDA Hearing Aids and Accessibility<\/b><\/span><\/h2>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">Accessible hearing aids are important now more than ever.\u00a0<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">Hearing loss is an extremely prevalent health condition in the United States (and worldwide) and should be treated as a public health priority.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">More and more Americans are diagnosed with hearing loss every day, yet it remains a fact that only<\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3665209\/\"><span style=\"font-weight: 400;\"> one in four adults that could benefit from hearing aids ever use them.\u00a0<\/span><\/a><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">This has led hearing healthcare professionals and policymakers to brainstorm effective ways to improve access to hearing loss treatment for all U.S. citizens.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">There are multiple regulations in place that research has proven to act as a barrier for those attempting to get help for their hearing loss. Making it easier for everyone to find and access this support by changing these regulations would be an important first step. The biggest hurdles for most people include the high price of hearing aids and the fact that you can\u2019t purchase them Over-the-Counter (OTC), so these seem like obvious targets for improvement.\u00a0\u00a0<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">Attempts to allow OTC hearing aids are already underway. According to the <\/span><a href=\"https:\/\/www.nidcd.nih.gov\/health\/over-counter-hearing-aids\"><span style=\"font-weight: 400;\">NIDCD<\/span><\/a><span style=\"font-weight: 400;\">, the FDA Reauthorization Act of 2017 has directed the FDA to create a category of OTC hearing aids for adults who might have mild-to-moderate hearing loss. This requires the FDA to put forward a proposed rule by August 18, 2020, and a final rule after the close of the comment period.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">If the FDA created guidelines and quality standards for OTC hearing aids, this would allow hearing aids to be sold cheaply and conveniently. While the cost of prescription aids can cost $5000 or more for a set, new OTC options would hopefully range from $600 to $1000 per set.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">This change in accessibility will mean that many more people will be able to treat their hearing loss with a hearing aid. However, steps must be taken to ensure patients continue to receive high-quality treatment.<\/span><\/p>\n<h2><span id=\"What_Does_it_Mean_if_a_Hearing_Aid_is_FDA_Registered\"><b>What Does it Mean if a Hearing Aid is FDA Registered?<\/b><\/span><\/h2>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">The Food and Drug Administration (FDA) is the government agency in the United States responsible for protecting public health.\u00a0<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">They regulate several consumer products, including food, medications, vaccines, all medical devices, and most relevantly in this instance, hearing aids.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">The FDA must ensure the safety, efficacy, and security of these products and weigh up their risks.\u00a0<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">In the United States, all hearing aid manufacturers must register their devices with the FDA to be able to sell them in the country.\u00a0<\/span><\/p>\n<h2><span id=\"What_are_the_FDA_Regulations_for_Hearing_Aids\"><b>What are the FDA Regulations for Hearing Aids?<\/b><\/span><\/h2>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">Hearing aids are restricted devices and sales must follow applicable federal and state requirements.\u00a0<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">FDA hearing regulations define a <\/span><a href=\"https:\/\/www.fda.gov\/media\/75418\/download\"><span style=\"font-weight: 400;\">hearing aid<\/span><\/a><span style=\"font-weight: 400;\"> as \u201cany wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.\u201d This includes air conduction and bone conduction devices in their numerous styles.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">The FDA regulates hearing aids as they are medical devices. However, it does not consider sound amplifiers to be medical devices when labeled for recreational or other use by individuals with normal hearing. Some safety regulations related to sound output levels still apply to these products.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">Whilst Over-the-Counter (OTC) hearing aids are a new category of hearing aids that you will soon be able to buy directly (without visiting a hearing health professional), the OTC hearing aid category, as defined by <\/span><a href=\"https:\/\/www.fda.gov\/media\/114844\/download\"><span style=\"font-weight: 400;\">FDARA section 709<\/span><\/a><span style=\"font-weight: 400;\"> does not exist until the effective date of a published final regulation.\u00a0<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">Until then, no devices that are claimed to address hearing loss are, or can state that they are OTC hearing aids.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">There will still be regulations (that are now being established by the FDA) that OTC hearing aids will need to follow. These federal regulations will ensure that these accessible hearing aids are still safe and effective for people with mild-to-moderate hearing loss. They\u2019ll also set standards for clear and informative OTC hearing aid packaging such as making a requirement to include health warnings and advice on when to see a healthcare professional.<\/span><\/p>\n<p><\/p>\n<h2><span id=\"What_are_PSAPs\"><b>What are PSAPs?<\/b><\/span><\/h2>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">What all of this means for you as a consumer, right now, is that the current hearing devices you can buy directly without the advice of a healthcare professional are not intended for people with hearing loss. These hearing devices are not \u2018hearing aids,\u2019 but rather, Personal Sound Amplification Products (PSAPs) intended to boost environmental sounds in some situations for people without hearing loss.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">While PSAPs are not regulated as medical devices by the FDA, they will regulate the forthcoming OTC hearing aids as medical devices intended for people with mild-to-moderate hearing loss.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">They will operate like standard hearing aids, making sounds louder so that people who are hard of hearing will have an easier time hearing and communicating. However, you will fit them yourself and have some adjustment controls that many professionally fitted hearing aids lack.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">When available, you\u2019ll be able to buy these FDA-regulated OTC hearing aids directly in stores and online.<\/span><\/p>\n<p><\/p>\n<h2><span id=\"Are_PSAPs_Approved_by_the_FDA\"><b>Are PSAPs Approved by the FDA?<\/b><\/span><\/h2>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">According to the FDA, PSAPs are not intended to treat impaired hearing. Their purpose is to allow non-hearing-impaired individuals to amplify sounds in the environment for other reasons, such as greater enjoyment in recreational activities (including bird watching, hunting, and watching live performances or speeches).<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">More than anything, the FDA wants to ensure that PSAPs aren&#8217;t mistaken or used as substitutes for approved hearing aids recommended by hearing health professionals.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">They advise that PSAPs only be used after ruling out hearing loss as a reason for getting one, which requires getting a hearing test by a healthcare professional. The biggest reason for this being that they can lead to more damage to your hearing if there is a delayed diagnosis of a treatable condition.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">As PSAPs are not medical devices, there is no regulatory classification, product code or definition for these products, or requirements for listing these products with the FDA.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">Manufacturers of PSAPs must comply with the requirements to repurchase, repair, or replace products and must also report defects or adverse effects.<\/span><\/p>\n<p><\/p>\n<h2><span id=\"Can_You_Buy_FDA_Approved_Hearing_Aids_Over_the_Counter\"><b>Can You Buy FDA Approved Hearing Aids Over the Counter?\u00a0<\/b><\/span><\/h2>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">There are currently no products that can claim to address hearing loss as OTC hearing aids. The FDA has clarified that hearing aids continue to be restricted devices.\u00a0<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">The terms used for hearing aids is confusing at the moment, but the FDA should lay out some clearer OTC guidelines and requirements no later than <\/span><a href=\"https:\/\/www.healthline.com\/health-news\/why-is-it-so-hard-to-get-a-hearing-aid-otc#FDA-requirements-are-expected-to-clarify-OTC-hearing-device-market\"><span style=\"font-weight: 400;\">spring 2021<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">Despite all these changes surrounding OTC hearing aids, it\u2019s important to remember that even when these new rules go through, getting your hands on a hearing device is only one part of the process of treating hearing loss. We would always recommend seeing an audiologist for a comprehensive hearing test and to get their expert guidance.<\/span><\/p>\n<p><\/p>\n<p><span style=\"font-weight: 400;\">Click here to find out <\/span><a href=\"https:\/\/www.oliveunion.com\/\"><span style=\"font-weight: 400;\">more about hearing aids<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><\/p>\n<p><b>The information in this guide has been written using the following reliable sources:<\/b><\/p>\n<p><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/medical-devices\/consumer-products\/hearing-aids\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/medical-devices\/consumer-products\/hearing-aids<\/span><\/a><\/p>\n<p><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/media\/75418\/download\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/75418\/download<\/span><\/a><\/p>\n<p><\/p>\n<p><a href=\"https:\/\/www.nidcd.nih.gov\/health\/over-counter-hearing-aids\"><span style=\"font-weight: 400;\">https:\/\/www.nidcd.nih.gov\/health\/over-counter-hearing-aids<\/span><\/a><\/p>\n<p><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/media\/114844\/download\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/114844\/download<\/span><\/a><\/p>\n<p><\/p>\n<p><a href=\"https:\/\/www.healthline.com\/health-news\/why-is-it-so-hard-to-get-a-hearing-aid-otc#FDA-requirements-are-expected-to-clarify-OTC-hearing-device-market\"><span style=\"font-weight: 400;\">https:\/\/www.healthline.com\/health-news\/why-is-it-so-hard-to-get-a-hearing-aid-otc#FDA-requirements-are-expected-to-clarify-OTC-hearing-device-market<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>There are many hearing aids and amplifiers that can help boost your hearing, but which devices counts as FDA hearing aids? Read on to find out everything you need to know about FDA-approved hearing devices.<\/p>\n","protected":false},"author":1,"featured_media":708,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.oliveunion.com\/ustest\/hearing-device\/how-do-i-know-which-hearing-aids-are-fda-approved\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How Do I Know Which Hearing Aids Are FDA-Approved? - Olive Union\" \/>\n<meta property=\"og:description\" content=\"There are many hearing aids and amplifiers that can help boost your hearing, but which devices counts as FDA hearing aids? 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