Posted by - Hearing Aids.

Advocates for lower-cost hearing aids got a boost yesterday when two U.S. Senators – a Republican and a Democrat – announced legislation that would ease restrictions on the sale of over-the-counter hearing aids.

Warren and Grassley

Senators Chuck Grassley (R-Iowa) Elizabeth Warren (D-Mass)

The Over-the-Counter Hearing Aid Act of 2016, sponsored by Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa), would allow certain hearing aids to be sold over the counter and would eliminate the “burdensome requirement” that consumers get a medical evaluation or sign a medical waiver before purchasing OTC hearing aids. The Act would also require the FDA to issue regulations containing safety and labeling requirements for OTC hearing aids and to update its draft guidance on Personal Sound Amplification Products (PSAPs). The senators said they would introduce the legislation when Congress reconvenes before the end of the year.

Goal: Lower Costs and Easier Access

The new law would implement recent recommendations from the President’s Council of Advisors on Science and Technology (PCAST) and the National Academies of Sciences, Engineering, and Medicine (The Academies), which have advocated making some types of hearing aids available over the counter, and removing the medical evaluation/waiver requirement. Both PCAST and The Academies concluded that the access restrictions to new lower-cost amplification devices, designed to compensate for age-related mild-to-moderate hearing loss, have contributed to high costs – estimated at $2400 per hearing aid. In its report, PCAST said “There is considerable evidence that hearing aids can be profitably sold for a fraction of today’s end-user cost.”

If you can buy non-prescription reading glasses over the counter, it makes sense that you should be able to buy basic, safe hearing aids, too. The goal is that by making more products more easily available to consumers, competition will increase and lead to lower costs. – Sen. Grassley

In their announcement, the senators noted that while approximately 30 million Americans experience age-related hearing loss, fewer than 15 percent of those with hearing loss use assistive hearing technology, often because they cannot afford costly hearing aids. “Millions of people in Massachusetts and across the country experience hearing loss as they get older, but they are unable to get the hearing aids they need because of high costs and complicated regulations,” said Sen. Warren. “This bipartisan bill is a simple fix that that will make hearing aids easier to access and – unlike in the current marketplace – will make it easier for consumers to shop for the best value.”

Audiologists Struggle with Competition

A more open market for low-cost hearing aids threatens to disrupt traditional distribution channels – especially the business model employed by audiologists who “bundle” the costs of hearing tests, hearing-aid programming and other patient services with the sale of the product. Independent audiologists have already been squeezed by competition from low-cost retailers like Costco, which provides in-store clinical services including hearing aid programming and after-sale support. Online hearing aid discounters, which limit the amount audiologists can make on servicing hearing aid customers, have also put increasing pressure on independents.

The proposed legislation also addresses another threat to traditional audiologists – the low-cost PSAP. Personal Sound Amplification Products, which are based on many of the same digital technologies as entry-level hearing aids, cannot currently be marketed as “hearing aids,” or be promoted as a remedy for the symptoms of hearing loss. Regardless of the marketing restrictions, PSAPs are often sold to consumers with hearing loss who purchase the devices for low-cost hearing assistance. The proposed legislation would require the FDA to come up with new classifications – and marketing guidelines – for both OTC hearing aids and PSAPs, making it easier for consumers to learn about, and access, such devices.

Lobbying For and Against Has Already Started

The Hearing Loss Association of America (HLAA), “the nation’s leading organization representing people with hearing loss,” strongly supports PCASTs recommendations – as does the Consumer Technology Association (formerly CEA). On the other hand, the Hearing Industries Association (HIA), a global hearing aid manufacturers association, “strongly opposes PCAST’s recommendation that OTC hearing aids be permitted in the United States, and its recommendation that these ‘basic’ hearing aids be exempt from the FDA regulations that protect American consumers…HIA also believes that PCAST’s recommendation that PSAPs be allowed to be promoted for hearing loss is contrary to the best interests of patients.” The American Academy of Audiology (AAA), and International Hearing Society (IHS), also oppose PCASTs recommendations. The Academy of Doctors of Audiology (ADA) has taken a less black and white position (see ADA’s position).

See where relevant organizations, hearing professionals, and hearing aid consumers stand in Over-The-Counter Hearing Aids Controversy

Given that the legislation was introduced by senators from both sides of the aisle, there is a good chance it will get plenty of attention. The stakes are high: access to affordable hearing assistance and the interests of consumer electronics manufacturers are going head-to-head with the interests of professional caregivers who deliver much-needed audiological services. Perhaps the coming debate will reveal some common ground and solutions.

Download copy of legislation

Download fact sheet from Sen. Warren and Sen. Grassley

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