Oticon Medical announced that the US 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 US market, Oticon Medical says “it 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 cochlear implant system delivers what Oticon says is “premium sound quality, award-winning aesthetic design, and a design that provides outstanding reliability[1]. ” The Neuro System is expected to be made available to US hospitals and clinics in 2021.
The mission of the American Cochlear Implant (ACI) Alliance is to advance access to the gift of hearing provided by cochlear implantation through research, advocacy and awareness.
Email to a Friend