FDA approvals, certifications

FDA approvals

Med-El USA’s cochlear implant (CI) system is approved for single-sided deafness (SSD) and asymmetric hearing loss (AHL). CI’s Synchrony and recently FDA-approved Synchrony-2 are now indicated for individuals 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 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 15dB in pure tone averages between ears. 

Florida Anodize System & Technologies Inc.’s quality management system for its medical device surface coating services was audited by TUV SUD and found to be in full compliance with ISO 13485:2016.

Nanotech Precision, a manufacturer of micro-sized instruments and electrodes, has received ISO 13485:2016 for medical devices and quality management systems.