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Over-The-Counter Hearing Aid Legislation to Become Law

  • Doctor putting hearing aid on young woman's ear

    Just last week the Senate passed the Over-the-Counter Hearing Aid Act of 2017. With hearing loss affecting 48 million Americans – about 20% of the population – this is a victory for our entire country!

    The Hearing Loss Association of America (HLAA) estimates that 20% of Americans – children and adults – suffer from hearing loss. Almost 15% of school-age children (ages 6-19) have some degree of hearing loss. By the age of 65, one out of every three people will suffer from hearing loss, and as the number of older adults increases, hearing loss will become a greater concern. Already hearing loss is, globally, the fifth leading cause of years lived with a disability, and is the third most common physical condition after arthritis and heart disease.

    US map with icons of people over it. Text: There are 48 million Americans who have significant hearing loss.

    Restrictions: High Costs and Regulations

    Individuals’ ability to manage hearing loss is influenced and affected by decisions and actions at many levels. In order for consumers to access the necessary services, technology, and support they need, changes must be made institutionally. Two main factors that limit consumers’ access to hearing devices are high costs of the devices and strict regulations, which can actually increase cost by requiring specialized medical consultations.

    High Costs

    Despite a high number of Americans touched by hearing loss, an estimated 86% of people who would benefit from hearing aids do not get them, primarily because of high cost. Hearing aids are not covered by Medicare, Medicaid, or most private insurance plans, and out-of-pocket costs for a single hearing aid average $2,400 – far out of reach for many consumers.

    86% of people who would benefit from hearing aids do not get them

    FDA Regulations on Hearing Aids

    In addition to the high cost of hearing aids, in 1977, the Food and Drug Administration (FDA) imposed a set of special regulations on hearing aids. These regulations required that individuals obtain a medical evaluation or sign a waiver of that evaluation before being allowed to purchase or use a hearing aid. The National Academies of Sciences, Engineering, and Medicine have extensively reviewed this policy and found “no evidence that the required medical evaluation or waiver of that evaluation provides any clinically meaningful benefit”. Thus, they recommended removing this restrictive regulation and recommended, along with the President’s Council of Advisors on Science and Technology (PCAST), that some types of hearing aids be made available over the counter.

    The Over-the-Counter Hearing Aid Act of 2017

    The Over-the-Counter Hearing Aid Act was first introduced in the Senate by Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) in March of this year, and the two have worked *assiduously* to ensure its passage, which would make a significant impact on creating hearing aids that are more affordable and more accessible to those who can benefit from them.

    The Act would implement several of the recommendations from the National Academies and PCAST to make hearing aids available over the counter for those with mild to moderate hearing loss. The law also will require the FDA to create regulations for this new category of device, affording Americans the option of an FDA-regulated assistive device at a much lower cost. It’s estimated that costs of these over-the-counter hearing aids could be reduced to a few hundred bucks, making them much more affordable than they are today.

    Now that the Act has passed through the House and Senate it will go to the president to sign into law. Once it’s signed the FDA will begin drafting the rules and regulations. The FDA has three years to complete this, although hopefully it will be completed much sooner.

    HLAA, which has supported this bill since its introduction, noted in a press release that, “For years, our number one request has been from people who want hearing aids but can’t afford them. This legislation is a step in the right direction and offers hope that the cost of all hearing aids will go down with the anticipated market innovation and competition it will bring. Everyone who needs hearing aids should be able to have them to stay connected to family, remain on the job, and enjoy a high quality of life.”

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