The U.S. Food and Drug Administration has approved MED-EL USA’s cochlear implant system for single-sided deafness and asymmetric hearing loss. This is the first time cochlear implants have been green-lighted for these indications in the United States.
MED-EL Cochlear Implant Systems, including SYNCHRONY and the recently FDA-approved SYNCHRONY 2, are now approved for people 5 years and older with single-sided deafness who have profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear. They’re also approved for people 5 years and older with asymmetric hearing loss 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.
According to a white paper from the American Cochlear Implant Alliance, despite normal hearing in one ear, children with significant unilateral hearing loss face educational, social, cognitive, and behavioral challenges. These children also face communication challenges—including difficulties with language and understanding speech in noise—and report poorer quality of life than their peers with normal hearing in both ears.
The FDA approval will benefit people who have struggled with single-sided deafness or asymmetric hearing loss who do not benefit from traditional amplification, says Regina E. Zappi, associate director of audiology professional practices at ASHA. “People with single-sided deafness have extremely poor word recognition abilities in their dead ear (ear with profound sensorineural hearing loss) and even the most optimally fit standard hearing aid would not provide clarity, but rather distortion,” she says.
What causes single-sided deafness or asymmetric hearing loss? Trauma to the ear, acoustic neuroma, viral and bacterial infections, and circulatory disorders may contribute to these types of hearing loss. In some cases, the cause is unknown. “If you or someone you love has concerns about a possible hearing loss, seeking a baseline hearing evaluation from an audiologist is the best next step,” Zappi says. “Untreated hearing loss is known to contribute to depression and social isolation, which can directly affect a person’s quality of life.”
Previous treatment options for patients with single-sided deafness or asymmetric hearing loss included CROS (contralateral routing of sound) systems, BiCROS systems, or bone-anchored hearing systems.
Jillian Kornak is writer/editor for the ASHA Leader. firstname.lastname@example.org.