The Food and Drug Administration (FDA) has approved SYNCHRONY and SYNCHRONY 2 (MED-EL) cochlear implant systems for single-sided deafness and asymmetric hearing loss.
Specifically, the devices are now indicated for patients aged 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, or patients aged 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.
The approval was based on data from a study involving 40 patients aged 18 and older who 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.
Results showed that both groups had improvements in their ability to understand speech in quiet, listen to speech in noise, and find the direction of a sound source after one year of implant use.
To be implanted with either system, individuals must obtain limited benefit from an appropriately fitted unilateral hearing aid.
For more information visit medel.com.