FDA Approves Cochlear Nucleus Implants for UHL/SSD

Cochlear Limited obtained U.S. Food and Drug Administration (FDA) approval for its Cochlear Nucleus Implants to treat unilateral hearing loss (UHL)/single-sided deafness (SSD).
 
Cochlear implants are already FDA approved for moderate to profound bilateral sensorineural hearing loss, and this approval expands implantable treatment options to those with UHL/SSD to include cochlear implants. UHL is classified as hearing loss in one ear, and near-normal hearing in the opposite ear. SSD is specific to those with severe to profound hearing loss in one ear and normal or near-normal hearing in the other.
 
“It is not often that approvals to expand indications and increase awareness about effective treatments for hearing loss come along,” Christine Menapace, MA, Vice President, Clinical Affairs, Cochlear Americas, told the press. “Now with this approval, Cochlear is proud to offer the most hearing implant options available to those with unilateral hearing loss/single-sided deafness through our cochlear implant and bone conduction solutions. It is important that those with this type of hearing loss recognize the impact to their lives and understand there are several options available to them, and we encourage them to talk to their hearing health professional today to find out what would work best for them.”
 
“Unilateral sensorineural hearing loss has continued to gain greater acceptance in the field as an indication for cochlear implantation,” said Dr. Kevin Brown, Vice Chair, Chief of Neurotology and Executive Director of the Children’s Cochlear Implant Center at the University of North Carolina. “With this approval, it is important my industry colleagues and I ensure appropriate clinical guidance on how to effectively introduce this cochlear implant indication, outline a model for selecting patients that will benefit, and ensure success after implantation.”
 
Those with UHL/SSD are now supported by Cochlear’s Nucleus System, as well as bone conduction solutions including the Osia and Baha Systems.