Cochlear Receives FDA Clearance for its Innovative Osia 2 Hearing Implant System

Cochlear Osia 2 FDA clearance
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Cochlear, a leading implantable hearing devices manufacturer, received FDA clearance of its Osia® 2 System. The Osia System is the world’s first active osseointegrated steady-state implant (OSI), a new category of bone conduction hearing solutions that uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear (cochlea).

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The system features the new Osia OSI200 Implant that attaches to an osseointegrated BI300 Implant to send sound through the bone. The thin profile and monolithic design of the implant help to simplify surgery for the system, Cochlear said in a press release.

On the outside, the new Osia 2 Sound Processor captures sounds and sends both the sound signal and power to the internal implant.

In the heart of the implant, lies the primary innovation of the Osia System. It contains the Piezo Power transducer made of piezoelectric material. The design is completely different than traditional bone conduction transducers, and with no movement between the parts, it is designed to deliver long-term performance and durability when implanted. Driven by a wireless digital link, this transducer expands and contracts to create powerful vibrations that stimulate the inner ear while optimizing transfer of power and sound quality.

A man and a woman sitting on a bench
Image: PRNewswire

“At Cochlear we have been working to develop this technology for quite some time,” said Mats Dotevall, Director of Design and Development and Director of Clinical Affairs at Cochlear Acoustics. “We aimed to leverage Cochlear’s long history of innovation in both the cochlear implant and bone conduction implant spaces to create something entirely new. Rather than implanting a conventional electromagnetic transducer, we chose to work with piezoelectric material because of its unrivalled suitability for this type of implanted application.”

The Osia System has shown excellent results following a one-year, multicenter clinical investigation. The results were recently presented at OSSEO 2019 International Congress.

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“We are thrilled to introduce the new Cochlear Osia System, a first-of-its-kind innovation in implantable hearing solutions.” said Rom Mendel, President of Cochlear Acoustics. “The Osia System was developed through our efforts to listen to the recipients and clinicians who utilize our hearing implants every day. So far, we have been overwhelmed by the positive reception of the Osia System by both clinicians and patients, and it’s been incredible to see the improvement in recipients’ lives as they are able to hear better in the areas where we know they struggle.”