FDA Approves Cochlear Implants for Single-Sided Deafness, Asymmetric Hearing Loss

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 professio...
Source: American Speech-Language-Hearing Association (ASHA) Press Releases - Category: Speech-Language Pathology Authors: Tags: Audiology News Slider Hearing Assistive Technology hearing loss hearing loss treatment Source Type: blogs