Med-El USA said today that the FDA has approved its cochlear implant for single-sided deafness and asymmetric hearing loss, a first for these indications in the U.S., according to the Durham, N.C.-based company.
Med-El’s cochlear implant systems, including Synchrony and the recently FDA-approved Synchrony 2, are now indicated for individuals aged 5 years and older who have profound sensorineural hearing loss in one ear and normal hearing or 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 system are required for the new indications.
The approval was based on clinical data from a study at the University of North Carolina at Chapel Hill with 40 participants ages 18 and older to evaluate speech perception in quiet and noise, sound localization and quality of life. Trial participants had single-sided sensorineural profound hearing loss in one ear or asymmetric hearing loss for less than 10 years and had used a hearing aid regularly for at least some of that time.
“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 Dillon, director of cochlear implant clinical research at UNC School of Medicine and lead trial researcher, in a news release. “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,” said Med-El North America president & CEO Raymond Gamble. “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.”
Single-sided deafness and asymmetric hearing loss may be caused by viral infections, Meniere’s disease or trauma to the head or ear. Individuals with either condition must obtain limited benefit from an appropriately fitted unilateral hearing aid in the ear to receive one of the newly approved cochlear implants for their condition.
