On 24 June 2021, Oticon Medical received a pre-market approval (PMA) from the FDA (the US Food and Drug Administration) for the company’s Neuro Cochlear Implant System.
The Neuro System is designed to overcome severe-to-profound hearing loss and is the first new cochlear implant technology to earn FDA pre-market approval in more than 20 years.
The process to gain the pre-market approval is notoriously complex for devices in Class III, like the Neuro System, because this category receives the highest level of regulatory scrutiny. To finally reach this milestone is a great win for Oticon Medical and the Demant group.
This achievement is only the beginning, and the thoroughly trained and experienced team behind the Neuro System is ready to bring a leading edge and highly reliable implant system to the US market.
“Earning FDA premarket approval for the Neuro System is a significant achievement, and one that will enable us to bring new implant hearing technology with exceptional sound quality, enhanced aesthetics, user friendliness and reliability to more patients than ever before.” said Jes Olsen, President of Oticon Medical.