July 19, 2019 – (DURHAM, NC) – MED-EL USA announced today 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.
Read the official press release here.
May 13, 2013 – (Innsbruck, Austria) – MED-EL has become the first hearing implant company to receive approval for marketing cochlear implants for the indication of Single-Sided Deafness in countries that acknowledge the CE mark.
The CE marking or formerly EC mark, is a mandatory conformity marking for products sold in the European Economic Area (EEA) since 1993.