FDA Approves Implant for Single-Sided Deafness | HCPLive

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.

The Condition

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 the 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.

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