MED-EL USA has secured de novo clearance from the US Food and Drug Administration (FDA) for its Bonebridge bone conduction hearing implant system.
The Bonebridge system has been approved to treat individuals 12 years and older who were diagnosed with conductive hearing loss, mixed hearing loss, or single-sided deafness.
MED-EL USA expects that the Bonebridg system will be available in the US in 2018.
The company first introduced Bonebridge system in Europe in 2012, and is claimed to be the world’s first and only active bone conduction hearing implant.
Bonebridge features two components such as the internal BCI 601 implant and the sleek Samba audio processor, which can be worn beneath the hair.
The bone conduction hearing implant system provides intact skin technology compared to bone anchored hearing aids with an abutment that protrudes through the skin and needs lifelong medical treatment and maintenance.
The recipients are said to experience a low complication rate, as the implant is placed completely underneath the skin and the audio processor places minimal pressure on the skin.
Bonebridge’s audio processor will capture sound from the environment and converts into signals, which are transferred through the skin to the implant.
The implant converts the signal into mechanical vibrations, which are transferred directly to the bone of the skull.
Later, the bone conducts these vibrations to the inner ear where they are interpreted as sound and converted into nerve signals and transmitted to the auditory nerve.
Samba audio processor is installed with adaptive directional microphones, which automatically identify and minimize noise interference.
The speech tracking feature allows Samba to automatically recognize the direction from which speech is coming and makes the corresponding adjustment to the directionality of the microphone.
MED-EL North America CEO and president Raymond Gamble said: “MED-EL USA is pleased to expand our cutting-edge line of implantable hearing devices to include BONEBRIDGE for conductive hearing loss, mixed hearing loss and single-sided deafness.
“Like all of our hearing implants, BONEBRIDGE is engineered to be future-ready, meaning that recipients will always be able to benefit from the latest external processing technology. We welcome those to the MED-EL family who have lived with these types of hearing loss because they have not wanted to pursue the limited surgical options currently on the market.”