MED-EL USA has secured approval from the US Food and Drug Administration (FDA) for its cochlear implant system for single-sided deafness (SSD) and asymmetric hearing loss (AHL) indications.
MED-EL Cochlear Implant (CI) systems, including Synchrony and Synchrony 2, have been approved to use for individuals aged five 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.
The cochlear implants can also be used for individuals aged five 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.
The FDA approval was based on clinical data from a study at the University of North Carolina, which included 40 participants aged 18 and older. The trial assessed speech perception in quiet and noise, sound localisation and quality of life.
MED-EL’s trial participants had single-sided sensorineural profound hearing loss in one ear or asymmetric hearing loss for less than 10 years. They had used a hearing aid regularly for at least some of that time.
All participants in the study have also used hearing devices such as hearing aid, bone-conduction device, or CROS hearing aid for the treatment of SSD.
Subjects in the non-randomised, non-blinded and repeated measures clinical study have been implanted with MED-EL Concert or Synchrony cochlear implant system.
According to the company, participants in both the SSD and AHL groups significantly improved in finding the direction of a sound after they had listened with the cochlear implant for 12 months.
MED-EL North America president and CEO Raymond Gamble said: “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.
“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.”