Oticon Medical has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its Neuro cochlear implant system.
The Neuro System is claimed to be the first new cochlear implant technology to secure FDA premarket approval in over 20 years. It is indicated for the treatment of individuals 18 years or older with bilateral severe-to-profound sensorineural hearing loss.
The advanced cochlear implant system, which is already available in 51 countries, enables to provide enhanced sound quality.
Oticon Medical plans to make the Neuro System available to US hospitals and clinics this year.
Oticon Medical North America president John Sparacio said: “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.”
The Neuro Zti offers a future-proof electronic platform to enable patients to hear a variety of sound in everyday life.
Oticon has optimised the design of the Neuro Zti implant to facilitate a minimally invasive surgical procedure and minimise complications associated with healing.
According to the company, the Neuro 2 sound processor is the smallest behind-the-ear processor on the market.
The sound processing technology is based on an Oticon Hearing Aid platform, which incorporates advanced hearing aid technology.
Oticon Medical president Jes Olsen said: “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 part of the Demant group, a global player in hearing healthcare with more than 16,500 people in more than 30 countries.
The company is engaged in providing bone anchored implant solutions to patients with conductive and mixed hearing loss and single-sided deafness in the US.
