FDA Cleared New Cochlear Osia 2 System

Cochlear, the global leader in implantable hearing solutions, announced the U.S. Food and Drug Administration cleared the new Cochlear 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.
 
In the U.S., the Osia System can be used by adults and children 12 years and older with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness (SSD); it is also available to treat hearing loss associated with an array of conditions including chronic otitis media (COM), otosclerosis and atresia/microtia. It will be available in select clinics across the U.S. as a part of a limited release. Full U.S. commercial availability for eligible patients is expected in early 2020. 
 
The new bone conduction hearing solution uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear (cochlea). 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. Learn more about the new implant and sound processor technology in the full press release here.
 
The Osia System showed positive results following a one-year, multicenter clinical investigation on the first-generation device, demonstrating significant improvement in patients’ ability to hear in both noise and quiet, and yielded a significant improvement in ratings of patients’ overall health-related quality of life. Findings from the full one-year clinical investigation and other data on the Osia System will be presented at the upcoming OSSEO 2019 International Congress in Miami Beach, Florida December 11-14, 2019.