In approving Cochlear Ltd.'s Nucleus Hybrid L24 Implant System for use in the United States, the U.S. Food and Drug Administration (FDA) had to balance some serious demonstrable risks against many obvious benefits of the new implant system. The biggest problem some early users experienced -- complete loss of their low-frequency hearing in the implanted ear -- might seem to … [Read more...] about Life At The Cutting Edge: FDA Weighed Tradeoffs In Approving Hybrid Cochlear Implant
FDA
Naming Names: Hearing Health Groups Ask FDA To Force Four Personal Amplifier Marketers To Stop Calling Their Products Hearing Aids
Many of the established players in the hearing industry have long been upset about lack of clarity in the lines drawn between hearing aids, which are regulated medical devices, and personal sound amplification products (PSAPs), which are unregulated. Now three major hearing health organizations are tackling the issue head on by calling on the U.S. Food and Drug Administration … [Read more...] about Naming Names: Hearing Health Groups Ask FDA To Force Four Personal Amplifier Marketers To Stop Calling Their Products Hearing Aids