The company Regeneron announced that its gene therapy for deafness has been cleared by the U.S. Food and Drug Administration. (Image credit: Capuski/Getty Images) The U.S. Food and Drug Administration (FDA) has approved the first-ever gene therapy for inherited deafness. The therapy, called Otarmeni, is approved to treat a form of hearing loss caused by mutations in the OTOF gene, which codes for a protein called otoferlin. Cells in the inner ear need otoferlin to translate vibrations into signals that can be interpreted by the brain. When people carry two defective copies of the OTOF gene — one from each parent — this line of communication between the inner ear and brain is cut, resulting in severe-to-profound hearing loss . Some participants improved to the point that they could hear whispers, while all the participants who responded to the therapy reached a level of hearing that does not typically require cochlear implantation — meaning the use of a device to bypass the inner ear and restore some hearing.…