FDA Premarket Approval Granted for Neuro Cochlear Implant System

Oticon Medical announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) to the company’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 U.S. 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 reliability.¹ 
 
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 expertise in cochlear implantation to the thousands of deaf and hearing-impaired people in the United States. 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 United States.
 
“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 experienced team is now ready to bring a leading-edge implant system to the U.S. market.”
 
The Neuro System is the first new cochlear implant technology to earn FDA premarket approval in more than 20 years. The Neuro System is designated as a Class III device by the FDA, a category that receives the highest level of regulatory scrutiny. Products in this category undergo a rigorous and thorough review process to determine safety and effectiveness.
 
The Neuro Zti is the most compact implant on the market, providing a powerful future-proof electronic platform that enables patients to enjoy the wide variety of sound in everyday life today and in the future. The design of the Neuro Zti implant has been optimized to enable a minimally invasive surgical procedure that is designed to reduce the time needed for surgery and to minimize complications associated with healing. The Neuro 2 sound processor is the smallest behind-the-ear processor on the market and has been awarded a number of design prizes for its aesthetic design and usability. The sound processing technology is built on an Oticon Hearing Aid platform that integrates advanced hearing aid technology based on more than a century of audiological and sound processing expertise.
 
“For more than 12 years, our focus on products, patient outcomes and support have been essential drivers of Oticon Medical’s success,” said Jes Olsen, president of Oticon Medical. “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.”
 
Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the power of sound to people at every stage of life. As part of the Demant group, a global leader in hearing healthcare with more than 16,500 people in over 30 countries and users benefitting from our products and solutions in more than 130 countries, the company have access to one of the world’s strongest research and development teams, the latest technological advances and insights into hearing care.

Reference 
¹ Neuro System Reliability Report 2020