Dec 2019 Mass Device

FDA Clearance for Osia Implantable Hearing SolutionThe FDA has cleared a second-generation pioezoelectric bone-conduction hearing implant from Cochlear. The Osia 2 system is an active osseointegrated, steady-state implant (OSI) that uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear. It is designed to treat hearing loss associated with chronic ear infections, otosclerosis and atresia/microtia. The FDA cleared it for use by adults and children 12 years and older with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness. The system delivers high power and gain and has a fitting range up to 55 dB sensorineural hearing level, according to the company.

Driven by a wireless digital link, a piezoelectric transducer expands and contracts to create vibrations that stimulate the inner ear while optimising transfer of power and sound quality, according to Cochlear. Piezoelectricity has been used for years in many products like microphones, high-end speakers and medical equipment, but this is the first time it is being used in this type of hearing implant application, the company added. It can amplify high frequencies, the area of sound most important for speech understanding.

A new Osia Smart app lets the user adjust the sound processor from a compatible smartphone or Apple Watch. The Osia 2 sound processor is dust- and moisture-resistant, and comes with an optional waterproof accessory.

Cochlear said it sought clearance for Osia 2 based on the results of a one-year, multicentre clinical investigation on a first-generation device and sponsored research in clinics around the world. The clinical trial showed a significant improvement in patients’ ability to hear in both noise and quiet compared to unaided and aided preoperative testing, the company added. Patients also reported improvement in their overall health-related quality of life.

“We have been working to develop this technology for quite some time,” said Mats Dotevall, Cochlear Acoustics’ director of design and development, in a news release. “Rather than implanting a conventional electromagnetic transducer, we chose to work with piezoelectric material because of its unrivaled suitability for this type of implanted application.”

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