The FDA gives the green light to the first gene therapy for deafness

Sierra Smith holds her son, Travis, whose deafness was successfully treated with gene therapy. Regeneron Pharmaceuticals hide caption toggle caption Regeneron Pharmaceuticals The Food and Drug Administration approved the first gene therapy to restore hearing for people who were born deaf. The decision , while only immediately affecting people born with a very rare form of genetic deafness, is being hailed as a milestone in the quest to treat hearing loss. "It's the first time in history there's a new drug for hearing loss," says Zheng-Yi Chen , an associate scientist at Mass Eye and Ear in Boston who was not involved in the development of the therapy approved by the FDA Thursday. But his research team reported very promising results with a similar approach Wednesday. "I think it's an historical event, a landmark, a great development for the whole field," he says of the approval. A newborn's failed hearing test When Sierra Smith gave birth to her son, Travis, the hospital immediately told her something was wrong. "The hospital told me that he failed his newborn hearing test. But they thought it was just fluid in the ears and that it would be fine in a couple of months," says Smith, 26, who lives in East Greenbush, N.Y. But he wasn't. It turned out Travis was born with a rare genetic defect that had left him profoundly deaf. "He was 100% deaf," Smith says. …