FDA approves MED-EL USA's cochlear implants for single-sided deafness and asymmetric hearing loss

MED-EL USA announced that the FDA has approved the company’s cochlear implant system for single-sided deafness (SSD) and asymmetric hearing loss (AHL). This is the first and only time that cochlear implants have been approved for these indications in the United States.

MED-EL Cochlear Implant (CI) Systems, including SYNCHRONY and the recently FDA-approved SYNCHRONY 2, are now indicated for individuals aged 5 years and older with SSD who have profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear, or individuals aged 5 years and older with AHL who have profound sensorineural hearing loss in one ear and mild to moderately severe sensorineural hearing loss in the other ear, with a difference of at least 15 dB in pure tone averages between ears. No changes to the approved devices in the MED-EL CI system are required for the new indications.

SSD and AHL can be caused by viral infections, Meniere’s disease, or trauma to the head or ear. In some cases, the causes of SSD or AHL are unknown. Recent data estimates that 7.2% of Americans report some degree of hearing loss on one side, with 5.7% having mild and 1.5% reporting moderate-or-worse hearing loss on one side, translating to an estimated 4.9 million American Adults facing SSD. Until now, treatment options were limited to hearing aids and CROS systems that provide limited or no benefit for people with profound hearing loss in one ear.

People with SSD and AHL experience difficulties hearing in certain listening situations such as noisy environments, and these difficulties have a negative impact on communication and social interaction. SSD can negatively affect speech and language development in children and work performance among adults. These difficulties can be attributed to the lack of binaural summation, the head shadowing sounds on the opposite side of the hearing ear and the inability to localize sounds.

Previously available options in the US such as CROS hearing aids and bone conduction devices do not restore binaural hearing in SSD or AHL patients as they only reroute the signal to the hearing ear. These therapeutic options restore neither sound localization nor spatial hearing, which means patients still face significant difficulties with communication in daily life.