Cost-effective Solution Overcoming Barriers

At present, hearing aids can often cost more than $2,500 a piece and such barriers to distribution channels may limit new entrants who could achieve technological breakthroughs that could offer a greater variety of lower-cost hearing aid options to those suffering from hearing loss. Fortunately, with the newly approved Over-the-Counter Hearing Aid Act, these barriers will soon be removed to new market entrants. "Today’s actions are an example of the FDA considering?exible approaches to regulation that encourage innovation in areas of rapid scienti?c progress," (FDA News Release, "FDA takes steps to improve hearing aid accessibility," 2016) said FDA Commissioner Robert Califf, M.D. "The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing" (FDA News Release, 2016). This will provide the consumer with more choices and lower costs to a large population of people experiencing hearing loss who are demanding access to hearing devices to enhance their hearing. Over-the-counter (OTC) hearing aids are just one option that should be available to adults with mild to moderate hearing loss. But with the innovation, and broad-based attention given to de?ning what hearing loss is, it will mean lower cost hearing devices for everyone. Hearing health care is not affordable; for example, hearing aids are not covered by Medicare and most insurance companies. Meaning people with mild to moderate hearing loss are by and large currently not seeking treatment from professionals – they’re simply ignoring their hearing loss. These decisions may impact these individuals’ hearing loss even further in the future. It’s a dif?cult predicament to be in. Hopefully, with the pending FDA hearing aid regulations, these serious issues will be alleviated. Currently, the cost of a hearing aid is typically "bundled" into the cost of the services needed to provide that hearing aid. So you might receive an audiogram, a hearing aid, follow-up services, and even batteries, all at one charge. In some cases, this entire process is monopolized by the hearing health professionals, allowing them to charge the consumer extraordinary prices for these services and hearing aids. Fortunately, the traditional hearing aid market is on the brink of a major disruption that will bene?t the consumer. Like most consumer products, what was released to the public initially as high-end unique pieces of technology are being reworked by third-party brands that want to replicate these medical devices into consumer electronics at lower prices. Right now, several corporations and startup businesses are working to create generic, nonprescribed hearing aids to compete with the major manufacturers. These new businesses are currently pigeonholed until the newly approved Over-the-Counter Hearing Aid Act takes effect. As of right now, hearing aids can only be prescribed by hearing professionals and audiologists. As another option, many of these new manufacturers are providing higher end personal sound ampli?ers (PSAPs) that have nearly identical components to hearing aids. Even though they cannot be de?ned as hearing aids, they enhance sounds identical to hearing aids. PSAPs are designed to increase the volume of everyday activities and in some cases have pre-programmed situational settings that cover most environmental settings in which one would?nd themselves. This feature is mostly found on higher end PSAPs and in most cases is the most important feature to a consumer. PSAPs can be purchased online or in many retail stores. These devices are sometimes viewed as alternatives to the expensive bundled packages offered by hearing care professionals, which include medical appointments, audiograms, and customization of the hearing aids and accessories. Given the access to hearing aid components and similar software used by major manufactures, high-end PSAPs are nearly identical to the levels of ampli?cation and directional functionality seen in regular hearing aids. It is recommended that individuals with profound hearing loss seek a hearing health professional before purchasing a PSAP or hearing aid. Hearing aids are considered medical devices but for some, they’re considered more of a luxury. Many people with mild to moderate hearing loss can purchase hearing devices that provide similar functionality to a hearing aid. These hearing ampli?er devices tend to be approximately 15% the cost of a comparable hearing aid and can be bought either online or from a retailer over the counter. The Food and Drug Administration (FDA) will soon regulate a new generation of OTC hearing aids with clear labeling of proper use, safety and ef?cacy. This would be a new option to allow adults with mild to moderate hearing loss to get affordable and easily accessible hearing aids. Matt Henderson Web Site https://soundtastic.com Contact support@soundtastic.com Amazon Store https://www.amazon.com/stores/node/17783924011?_encoding=UTF8&?eldlbr_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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