Cochlear Limited obtained U.S. Food and Drug Administration (FDA) approval of Cochlear™ Nucleus® Implants for the treatment of unilateral hearing loss (UHL)/single-sided deafness (SSD). Cochlear implants are already FDA approved for those with moderate to profound bilateral sensorineural hearing loss. With this approval, for the first time Cochlear can expand implantable treatment options for those with UHL/SSD to include cochlear implants.

UHL is classified as hearing loss in one ear and near to near-normal hearing in the opposite ear, and SSD is specific to individuals with severe to profound hearing loss in one ear and normal or near-normal hearing in the other ear. Every year, about 60,000 people in the United States acquire SSD.