Regulation of Hearing Aids in the US, Part 6 (it’s a long story)

The 1977 Final Rule Revisited… Revisited… Revisited …and Kept   Technological progress and market needs moved the industry forward, but the Final Rule remained as stated in 1977.  For example, in 1985, the FDA approved the Nuclear 22 Channel Cochlear Implant system for general use in adult patients with profound hearing loss after the device…

Read More