FDA approves Boston Scientific ear system

Boston Scientific Corp. said today that the Food and Drug Administration approved its Harmony HiResolution Bionic Ear System.

The Natick, Mass. medical-products company said that the product delivers 120 spectral bands - five to 10 times more than competing systems - helping to significantly increase hearing potential for the severe-to-profoundly deaf.

The Harmony system was recently cleared by Health Canada and received European CE mark approval. The product, which is approved in the U.S. for adults only and for all patients in Canada and Europe, is expected to be available in early 2007. (Dow Jones)