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FDA & Statistics ...........................................

Jul 17 2018 by Priscilla James Category General Views

The FDA has cited that hearing loss affects over 30 million people in the United States and is having a significant impact on communication, social participation,

The FDA has cited that hearing loss affects over 30 million people in the United States and is having a significant impact on communication, social participation, and overall health and quality of life for these individuals. Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid or device seek a solution. In addition, 1 in 3 persons over the age of 65 years live with some form of hearing loss. This means that an entire generation of people is faced with the personal and social impacts of hearing loss. With an additional 600 million people worldwide experiencing some form of hearing loss, there is a significant opportunity for U.S. manufacturers to take the lead in designing, developing, and manufacturing the next era of hearing aids and devices. With the approved Over-the-Counter Hearing Aid Act legislation and the pending regulations being finalized by the FDA, an estimated 90 percent of people who would benefit from hearing aids and hearing devices will finally have access to them over the counter. The current barrier to this market is the high cost of hearing aids and access to hearing health professionals. Each hearing aid can cost over $2,500; in order to purchase pair, the individual is faced with a $5,000 expense. Unbelievably, in most cases, hearing aids are not covered by individual health care insurance. So, the consumer is faced with this entire burden. Given the size of hearing devices and the generation faced with hearing loss, these devices can be lost, stolen, or unexpectedly damaged, which may amount to an additional $5,000 liability to replace them. With the upcoming FDA regulations, the consumer will be better protected and educated, ensuring that they have the opportunity to compare and purchase hearing devices at approximately 10% of the cost of current hearing aids. For those individuals who have severe and profound hearing loss, it is important that they seek a hearing professional to examine their impairment to make a recommendation on what hearing aid will best assist them.

Matt Henderson  

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Article Reference: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm532005.htm