The FDA recently cleared Cochlear Limited‘s new Osia 2 System implantable bone conduction hearing solution for people with damaged natural hearing systems. Osia 2 breaks new ground in cochlear implants by relying on digital piezoelectric stimulation. The first-ever active osseointegrated steady-state implant (OSI) defines a new implant category.

The Osia 2 system comprises two parts: an external sound processor and the implant. The thin implant with a piezoelectric transducer is put under the skin behind the ear. The sound processor, positioned on the skin, is held in place by a magnetic field. Two microphones in the external component capture sound and the sound processor converts it to a digital signal which is then transmitted to the transducer in the implant. The transducer’s piezoelectric material vibrates in response to the incoming digital signal. A small titanium section of the implant that is fused to the bone transmits the vibrations further to the inner ear where they are converted to electrical signals by the patients nerves and sent to the brain. The Osia 2 implant bypasses the middle ear completely.

In multiple clinical tests Cochlear’s Osia 2 system outperformed unaided and aided preoperative hearing, Cochlear reported. The studies also noted significant improvements in the patient’s hearing-related quality of life. The piezoelectric transducer system was particularly notable for high-frequency sound amplification, an important aspect of speech comprehension. Following an initial limited release in the U.S., the Osia 2 System is scheduled for full commercial availability in early 2020.