In stark contrast to last week, the U.S. Senate voted 88-1 today to actually approve a healthcare-related bill. The FDA Reauthorization Act of 2017 funds the Food and Drug Administration for the next five years and incorporates several smaller bills, including the Over-the-Counter Hearing Aid Act of 2017. Already passed by the House of Representatives, the law will allow people with hearing difficulties to purchase a hearing aid almost as easily as they can buy any other set of wired or wireless headphones—without first visiting a doctor.
Currently, only companies certified as medical device makers are allowed to sell hearing aids, although consumer companies such as Bose, Doppler Labs, and Etymotic Research have been selling devices that incorporate hearing assistance into wireless headphones or earbuds. The legislation passed today (and virtually guaranteed to be signed by the president) will make it much easier for those companies to market their products as actual hearing aids, which consumers can buy without getting a medical exam or prescription.
That doesn’t mean any hearing aid maker can hang a shingle. The FDA will first set performance and safety guidelines. The process could take up to three years, but will probably go much faster, as it was already under way in anticipation of the legislation. One of the most important requirements will be providing apps or other simple tools that allow people, without the help of a doctor, to customize the devices to the specific amount of amplification, in the specific frequencies, that each ear requires.