Cochlear Limited announced the U.S. Food and Drug Administration (FDA) clearance of 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 that uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear (cochlea). 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. On the outside, the new Osia 2 Sound Processor captures sounds and sends both the sound signal and power to the internal implant. The Osia System is available to treat hearing loss associated with an array of conditions including chronic otitis media (COM), otosclerosis and atresia/microtia. In the U.S., it can be used by adults and children 12 years and older with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness (SSD). The system delivers high power and gain and has a fitting range up to 55 dB sensorineural hearing level (SNHL).1,2 The principal innovation of the Osia System lies in the heart of the implant, which 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 optimising transfer of power and sound quality.3 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 is its ability to amplify high frequencies, the area of sound most important for speech understanding. The Osia 2 Sound Processor is slim and sits off the ear, providing discreet, comfortable hearing. It features the advanced signal processing and wireless connectivity technologies available with Cochlear's leading acoustic implant systems, such as Made for iPhone technology, and it is compatible with Cochlear's True Wireless™ accessories. The new Osia Smart App lets the user adjust the sound processor easily from a compatible smartphone or Apple Watch®. The sound processor comes with five changeable color cover options. Additionally, the Osia 2 Sound Processor is dust and moisture resistant, and with an optional Aqua+ waterproof accessory, recipients can enjoy water activities with sound. The Osia 2 System will soon be available in select clinics across the United States as a part of a limited release. Full commercial availability for eligible patients is expected in early 2020. Health Canada approval for the Osia 2 System is expected in early 2020. Availability in other countries is subject to regulatory approvals.