Legislation Approval & HLAA

In August 2017, President Donald Trump signed into law the Over-the-Counter Hearing Aid Act designed to provide greater public accessibility and affordability with over-the-counter (OTC) hearing aids. The OTC Hearing Aid Act is designed to enable adults with perceived mild to moderate hearing loss to access OTC hearing aids without scheduling an appointment with an audiologist. The new law, which was nearly unanimously passed by the U.S. House and U.S. Senate, will now go under review by the Food and Drug Administration (FDA). This legislation shows a true congressional bipartisanship effort that will ultimately benefit all consumers with hearing loss, especially the millions of people who currently don’t have access to hearing health professional and hearing aid devices simply because they can’t afford the services or devices. The Hearing Loss Association of America (HLAA) has supported the OTC Hearing Aid Act since it was first introduced in December 2016. The objective was to create legislation that would directly benefit the consumer and not the monopolistic system that encourages costly hearing health care. The OTC Hearing Act will make certain types of hearing aids available over the counter to adults with mild to moderate hearing loss. In addition, the legislation requires the Food and Drug Administration to regulate this new category of OTC hearing aids to ensure they meet the same high standards for safety, consumer labeling and manufacturing protection that all other medical devices must meet. This gives consumers the option to purchase a safe, high-quality, FDA-regulated hearing device at a lower cost, rather than being at the mercy of large manufacturers and hearing health providers. Creating a new category of OTC hearing devices was one of the top recommendations in the HLAA report: “Priorities for Improving Access and Affordability,” issued by the National Academies of Sciences, Engineering, and Medicine (NAS) in June 2016, which HLAA fully supported. HLAA believes OTC hearing aids will provide accessible and affordable hearing health care to millions of people who might not otherwise seek help. HLAA has been working diligently with lawmakers on this legislation. It became clear that the consumer’s voice had a significant say in this conversation. Their unifying voice outweighed the interests of corporate groups opposing them. The current cost barriers for the consumer prevent them from accessing quality hearing aids a low cost. Until the FDA passes these regulations, the consumer will continue to be forced to choose between living a life with hearing loss or spending thousands on hearing aids, which for many consumers is a grim decision. HLAA also heard from people who have retired and who feel isolated and alone, simply because they cannot cover the cost of hearing aids. Hearing loss has totally disrupted their lives, impacting their communication at work and with their families, affecting their ability to participate in their communities and in activities that give their lives meaning and fulfillment. These are truly disheartening real-life scenarios that will soon be avoided because of the newly accepted legislation. Available, affordable and accessible OTC hearing aids will encourage more people to take the first step sooner toward taking charge of their hearing health. The next step is for regulations to be written. The FDA has been charged with creating this new category of hearing devices and writing the rules that will ensure the products are safe and effective. Matt Henderson Web Site https://soundtastic.com
Contact [email protected] Amazon Store https://www.amazon.com/stores/node/17783924011?_encoding=UTF8&fieldlbr_brands_browse-bin=Soundtastic&ref_=bl_dp_s_web_17783924011 Article Reference: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm532005.htm

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