You are here
FDA Approves New Cochlear Implant
The FDA has approved the Cochlear Osia 2 System (Cochlear Acoustics), the first active osseointegrated steady-state implant.
The Osia System can be used to treat hearing loss in adults and children 12 years and older with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness associated with conditions including chronic otitis media, otosclerosis and atresia/microtia.
The system features the Osia OSI200 Implant, which 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. On the outside, the Osia 2 Sound Processor captures sounds and sends both the sound signal and power to the internal implant.
The implant, which contains a transducer made of piezoelectric material, is designed differently from traditional bone conduction transducers. Driven by a wireless digital link, the transducer expands and contracts to create powerful vibrations that stimulate the inner ear while optimizing transfer of power and sound quality. 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.
One of the many advantages of the Piezo Power transducer, the manufacturer says, is its ability to amplify high frequencies, the area of sound most important for speech understanding.
Results of a multicenter clinical investigation show a significant improvement in patients' ability to hear in both noise and quiet compared to unaided and aided preoperative testing.
Source: Cochlear Limited, Dec. 11, 2019