On Oct. 19, 2021, the U.S. Food and Drug Administration (FDA) issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans.<\/p>\n
The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule will allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist.<\/p>\n
The action follows President Joe Biden\u2019s July 2021 executive order, which called for the FDA to take steps to allow stores to sell hearing aids over the counter.<\/p>\n
You may see OTC hearing aids in stores as early as October 2022, which is when the rule takes effect.<\/p>\n
Issued in August 2022, the final action also updates existing rules for prescription hearing aids for consistency with the new OTC category, removes the conditions for sale for hearing aids and includes provisions that address some of the effects of the FDA OTC hearing aid regulations on state regulation of hearing aids.<\/p>\n
In addition to the final OTC rule, the FDA also issued guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs). This clarifies the difference between hearing aids, which are medical devices, and PSAPs, which are products that help people with normal hearing amplify sounds.<\/p>\n
You may have questions about OTC hearing aids, so we\u2019d like to address some common myths about hearing loss and these new devices.<\/p>\n
Myth: Buying OTC Hearing Aids & Skipping My Hearing Evaluation Is Okay Reality:<\/strong>\u00a0Hearing loss is a medical issue that requires care from a licensed professional. Today\u2019s Hearing audiologists all hold doctorates in audiology that qualify them to diagnose, manage and treat hearing and balance problems.<\/p>\n In addition, audiologists diagnose conditions like excessive earwax and look for underlying medical issues that contribute to hearing loss, which could have long-term health consequences if left untreated.<\/p>\n Myth: OTC Hearing Aids Are for Everyone Reality:<\/strong>\u00a0Without an evaluation by an audiologist, there\u2019s no way to know a patient\u2019s degree of hearing loss. OTC hearing aids are designed only for people with mild-to-moderate hearing loss and are not recommended for children or people with severe cases.<\/p>\n Myth: OTC Hearing Aids Work Great \u00a0<\/strong><\/p>\n Reality:<\/strong>\u00a0OTC hearing aids ship with factory presets. Every case of hearing loss is unique, so the chance of finding a pair that works for your specific needs is slim, and retailers will likely not provide adjustments. When you purchase devices from us, you receive six to 10 follow-ups and routine adjustments during your first year of use. This process is necessary to provide the correct amplification levels over the proper frequencies, ensuring you hear your best.<\/p>\n Myth: I Can\u2019t Afford Traditional Hearing Aids<\/strong><\/p>\n Reality:<\/strong>\u00a0Medical-grade hearing aids vary in price range based on your specific needs. We have options for every budget, including flexible financing plans and a leasing program with payments as low as $100\/month.<\/p>\n The cost of hearing aids isn\u2019t just for the devices\u2014it also includes all follow-up visits, adjustments and counseling. Unfortunately, insurance companies and Medicare do not reimburse audiologists for these types of necessary services.<\/p>\n When you choose to seek treatment from a Today\u2019s Hearing doctor of audiology, your customized treatment plan includes an in-depth hearing test, one-on-one consultations, follow-up care and repairs.<\/p>\n Plus, we provide troubleshooting support to help you with Bluetooth\u00ae connectivity and device adjustments, malfunctions, cleanings and comfort. We also offer communication counseling to discuss communication strategies and tips for hearing aid use.<\/p>\n Have questions about your hearing aid options? Ask our audiologists.<\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" On Oct. 19, 2021, the U.S. Food and Drug Administration (FDA) issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule will allow hearing aids…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"none","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"categories":[11],"tags":[],"_links":{"self":[{"href":"https:\/\/tohear.com\/wp-json\/wp\/v2\/posts\/1480"}],"collection":[{"href":"https:\/\/tohear.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tohear.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tohear.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/tohear.com\/wp-json\/wp\/v2\/comments?post=1480"}],"version-history":[{"count":0,"href":"https:\/\/tohear.com\/wp-json\/wp\/v2\/posts\/1480\/revisions"}],"wp:attachment":[{"href":"https:\/\/tohear.com\/wp-json\/wp\/v2\/media?parent=1480"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tohear.com\/wp-json\/wp\/v2\/categories?post=1480"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tohear.com\/wp-json\/wp\/v2\/tags?post=1480"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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