FDA OKs MED-EL’s Cochlear Implants for Single-Sided Deafness & Asymmetric Hearing Loss

MED-EL USA announced that the U.S. Food and Drug Administration (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.
 
“People living with single-sided deafness and asymmetric hearing loss have had limited technology options to improve their speech understanding, ability to localize sounds in their environment, and quality of life,” said Margaret T. Dillon, AuD, Associate Professor, Director of Cochlear Implant Clinical Research, and lead researcher on the SSD and AHL clinical trial at the University of North Carolina School of Medicine that was instrumental in the FDA approval. “Difficulty in speech understanding in noise and localizing sound are incredibly frustrating aspects of single-sided deafness and asymmetric hearing loss, and it was gratifying to be able to demonstrate the efficacy of MED-EL’s cochlear implants to help patients restore a sense of sound that they had been missing.”
 
“Today’s historic FDA approval is a significant advance for people who have struggled with single-sided deafness or asymmetric hearing loss for far too long. My father lived with single-sided deafness, which severely affected his ability to communicate and localize sound. His experience was a motivating factor in my choice to become an audiologist, so this has a very personal connection for me,” said Raymond Gamble, president & CEO, MED-EL North America. “This milestone demonstrates MED-EL’s leadership and commitment to truly living our mission of removing hearing loss as a barrier to communication—including this traditionally underserved population.”
 
Individuals with SSD or AHL must obtain limited benefit from an appropriately fitted unilateral hearing aid in the ear to be implanted. For adults, limited benefit from unilateral amplification is defined by test scores of 5% correct or less on monosyllabic consonant-nucleus-consonant (CNC) words in quiet when tested in the ear to be implanted alone. For children, insufficient functional access to sound in the ear to be implanted must be determined by aided speech perception test scores of 5% or less on developmentally appropriate monosyllabic word lists when tested in the ear to be implanted alone. Before implantation with a cochlear implant, individuals with SSD or AHL must have at least one month of experience wearing a hearing aid, a CROS hearing aid or other relevant device and not show any subjective benefit.