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 defeat the purpose of the hybrid implant. One of its principal functions, after all, is to preserve and use patients’ remaining natural low-frequency hearing while electronically restoring their lost high-frequency hearing.
The FDA’s decision to approve use of the implant in spite of the problems it observed underscores the growing understanding of the value of hearing implant technology, even when there are problems associated with it. [Read more…]