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\n\n\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\n\n\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\n\n\n
You may see OTC hearing aids in stores as early as October 2022, which is when the rule takes effect.<\/p>\n\n\n\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\n\n\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. It is our hope that OTC hearing products will expand access and increase discussions about hearing healthcare products and ear and hearing health. For the consumer, it is important to know that OTC products are designed for people who have milder hearing losses and need help hearing in some places, some of the time. Before purchasing an OTC product, the consumer should visit an audiologist to confirm that their hearing problems are a result of living and aging, rather than disease. Consumers of OTC products should understand that the products are not customized. They serve as \u201csoundscape analyzers\u201d to increase the volume of sound and deliver that sound safely to our ears. These products are not prescribed, have poor battery life relative to hearing aids and plug your outer ear, making your voice sound hollow. These limitations of OTC products were the primary reasons listed for nonuse of hearing aids in the late 1970s and early 1980s.<\/p>\n\n\n\n
Reality:<\/strong> Hearing loss is a medical issue that requires care from a licensed professional. Audiologists hold a master\u2019s or doctorate degree in audiology that qualifies them to diagnose, manage and treat hearing and balance problems. In addition, hearing loss is not just a condition of aging. Hearing loss can be a result of, or an indication for, many health conditions.<\/p>\n\n\n\n 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 milder losses and are not recommended for children or people with severe cases.<\/p>\n\n\n\n Reality:<\/strong> OTC 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.<\/p>\n\n\n\n Reality:<\/strong> Medical-grade hearing aids vary in price range based upon your specific needs. Most practices have options for every budget, including flexible financing and\/or leasing plans.<\/p>\n\n\n\n In fact, entry level hearing aids are similar in price to the current group of OTC products being prepared for release. The difference is that an entry-level hearing aid is a Grade II medical device that can be reprogrammed as your hearing changes.<\/p>\n\n\n\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 rarely reimburse these services for adults. However, your audiologist can refer you to a clinician or therapist specializing in hearing rehabilitation if you need extended counseling or rehabilitation.<\/p>\n\n\n\n When you choose treatment from a Heuser Hearing Institute audiologist, you can take comfort in knowing that we first seek to determine the source of your hearing loss through a comprehensive evaluation. We then prioritize your needs with a customized rehabilitation and treatment plan. Heuser Hearing Institute is here to solve your ear and hearing-related problems. If an OTC product is right for you, we will make it part of your solution. If you need more than an entry level listening solution, you\u2019ll be in the hands of the region\u2019s premiere hearing health care, education and research facility. Our comprehensive services give back through direct support to Heuser Hearing & Language Academy. As a patient, you also help support children who are deaf and hard of hearing in our community.<\/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":"","schema":"","fname":"","lname":"","position":"","credentials":"","placeID":"","no_match":false,"name":"","company":"","review":"","address":"","city":"","state":"","zip":"","lat":"","lng":"","phone1":"","phone2":"","fax":"","mon1":"","mon2":"","tue1":"","tue2":"","wed1":"","wed2":"","thu1":"","thu2":"","fri1":"","fri2":"","sat1":"","sat2":"","sun1":"","sun2":"","hours-note":"","footnotes":""},"categories":[25],"tags":[],"_links":{"self":[{"href":"https:\/\/thehearinginstitute.org\/wp-json\/wp\/v2\/posts\/9063"}],"collection":[{"href":"https:\/\/thehearinginstitute.org\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thehearinginstitute.org\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thehearinginstitute.org\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thehearinginstitute.org\/wp-json\/wp\/v2\/comments?post=9063"}],"version-history":[{"count":6,"href":"https:\/\/thehearinginstitute.org\/wp-json\/wp\/v2\/posts\/9063\/revisions"}],"predecessor-version":[{"id":9663,"href":"https:\/\/thehearinginstitute.org\/wp-json\/wp\/v2\/posts\/9063\/revisions\/9663"}],"wp:attachment":[{"href":"https:\/\/thehearinginstitute.org\/wp-json\/wp\/v2\/media?parent=9063"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thehearinginstitute.org\/wp-json\/wp\/v2\/categories?post=9063"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thehearinginstitute.org\/wp-json\/wp\/v2\/tags?post=9063"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Myth: OTC Hearing Aids Are for Everyone<\/h2>\n\n\n\n
Myth: OTC Hearing Aids Work Great <\/h2>\n\n\n\n
Myth: I Can\u2019t Afford Traditional Hearing Aids<\/h2>\n\n\n\n