FDA Approves Oticon’s Neuro Cochlear Implant System

The U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) to the Oticon Medical’s Neuro System to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s). With the expansion of its cochlear implant solutions to the US market, Oticon Medical is well positioned to become the world’s leading hearing expert within implantable hearing solutions. People with severe to profound hearing loss in 51 countries already benefit from the Neuro System. The innovative cochlear implant system delivers premium sound quality, award-winning aesthetic design and is designed for outstanding reliability¹. The Neuro System is expected to be made available to US hospitals and clinics in 2021.
 
As part of the Demant Group, a global leader in hearing healthcare, Oticon Medical is one of the world’s fastest growing hearing implant companies with the capabilities and resources needed to bring its proven expertise in cochlear implantation to the thousands of deaf and hearing-impaired people in the US. Global reach, combined with local contacts with clinics and users, gives Oticon Medical the ability to continue to build the long-term relationships critical for the successful delivery of services and support of the highest quality. For more than a decade, Oticon Medical has brought pioneering bone anchored implant solutions to patients with conductive and mixed hearing loss and single-sided deafness in the U.S.
 
“At Oticon Medical, we are passionate about using our combined expertise and resources to open up the world of sound to as many people as possible,” said John Sparacio, president of Oticon Medical North America. “We are committed to ongoing innovation in hearing implant technology and support now and in the future for cochlear implant candidates, users and professionals. The Neuro System is an outstanding example of that commitment. Our thoroughly trained and experienced team is now ready to bring a leading edge, highly reliable implant system to the U.S. market.”
 
Reference
¹ Neuro System Reliability Report 2020