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The Cochlear Nucleus Implant was previously approved for patients with moderate to profound bilateral sensorineural hearing loss.
The US Food and Drug Administration (FDA) has approved Cochlear Nucleus Implants for the treatment of unilateral hearing loss (UHL)/single-sided deafness (SSD), the first to an implantable treatment option has been made available for this patient population.
The treatment, developed by Cochlear Limited, was previously approved by the FDA for patients with moderate to profound bilateral sensorineural hearing loss.
Unilateral hearing loss is when there is hearing loss in 1 ear, but near to near-normal hearing in the other ear. Single-sided deafness is specific to patients with severe to profound hearing loss in 1 ear and normal or near-normal hearing in the other ear.
The disease is known to impact quality of life, including mental fatigue due to increased listening effort and impacts to understanding speech in noise and localizing where sounds are coming from.
Approximately 60,000 individuals in the US are diagnosed with SSD annually.
Cochlear offers a number of products for this patient population, including a cochlear implant, the Cochlear Nucleus System, and bone conduction solutions, the Cochlear Osia System, and the Cochlear Baha System.
"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, said in a statement. "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."