Oticon Medical today said the FDA has granted premarket approval for the company’s Neuro Cochlear Implant System.
Somerset, N.J.-based Oticon Medical designed the Neuro system to treat people 18 years or older with bilateral severe-to-profound sensorineural hearing loss and who have limited benefits from fitted hearing aids.
“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,” John Sparacio, Oticon Medical North America president, said in a news release. “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 US market.”
People in 51 countries have already benefited from the Neuro system. It provides premium sound quality, aesthetic design and reliability. The company plans to launch the system in the U.S. to hospitals and clinics later this year.
