US Senate votes to allow sale of over-the-counter hearing aids

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OTC

The new legislation that will make it possible to sell hearing aids without a prescription was passed by the United States Senate on Thursday August 3, 2017. According to the AARP, a non-profit advocacy group, the new rules could reduce the cost of hearing aids for consumers by thousands of dollars and open up the possibility of hearing rehabilitation to people who are not currently able to afford prescription devices. These conventional devices, sold in the context of a hearing assessment by a physician and fitted by hearing aid specialists, are not covered by Medicare (federal health insurance for people who are 65 and over) or private health insurance.

The bill requires the US Food and Drug Administration (FDA) to create a new category for OTC hearing aids, and to set regulations governing the devices. The regulations must provide “reasonable” assurances of safety and efficacy, and establish output limits and labeling requirements. Importantly, they must also describe requirements for the sale of hearing aids in person at pharmacies and stores, by mail, or online, without a prescription.

Sen. Elizabeth Warren (Democrat for Massachusetts), one of the bill’s sponsors, said in a statement that the new law would make hearing aids available to millions of Americans who currently cannot afford them. “We will increase competition, spur innovation and bring down prices,” Warren said. Co-sponsor of the bill, Sen. Charles Grassley (Republican for Iowa), commented saying “the more products available, the more consumers will be able to find something that works for them.”

Source: AARP; Congress.gov.

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