The bills will create a new class of hearing aids for people with mild to moderate hearing impairment (the majority of people who need assistance). They will loosen regulations so that regular consumer electronics companies like Bose can sell hearing aids directly to consumers who self-diagnose. (The Food and Drug Administration would have to set some performance and safety requirements for the devices, which could take a couple years to finalize.) The hope is that more competition will drive down prices: Hearing aids average $4,700 a pair in the U.S. (That typically includes the services of an audiologist.) Cost is one reason most people who have hearing loss don’t get the devices.
Stigma is another reason—something that companies like Doppler Labs are trying to remedy with stylish products that combine wireless earbud, Bluetooth headset, and hearing assistance functions in one device. The FDA bill must pass by September; advocates reckon it could clear both houses of Congress in June or July. SC