Bone conduction implant obtains FDA De Novo clearance
MED-EL has announced that the FDA has granted de novo clearance for the BONEBRIDGE bone conduction hearing implant system for individuals 12 years and older who have been diagnosed with conductive hearing loss, mixed hearing loss, or single-sided deafness. Since its introduction in Europe in 2012, BONEBRIDGE remains the world’s first and only active bone conduction hearing implant, and is widely considered a breakthrough in bone conduction technology.
BONEBRIDGE consists of two components: the internal BCI 601 implant, and the sleek, award-winning SAMBA audio processor, which can be worn discretely beneath the hair.
Unlike bone anchored hearing aids with an abutment that protrudes through the skin and requires lifelong medical treatment and maintenance, BONEBRIDGE offers intact skin technology. As the implant is placed completely underneath the skin and the audio processor places minimal pressure on the skin, BONEBRIDGE recipients enjoy a low complication rate.
Sound in the environment is captured by BONEBRIDGE’s audio processor, the SAMBA, and is converted into signals which are transferred through the skin to the implant. The implant converts the signal into mechanical vibrations that are transferred directly to the bone of the skull.
The bone then conducts these vibrations to the inner ear where they are interpreted as sound, converted into nerve signals and transmitted to the auditory nerve. This process bypasses the non-functioning outer and middle ear, where conductive or mixed hearing loss occurs.
The SAMBA audio processor is equipped with adaptive directional microphones that automatically identify and minimise noise interference. This feature is particularly helpful in situations where there is loud background noise, such as in a restaurant.
The Speech Tracking feature enables SAMBA to automatically recognise the direction from which speech is coming and makes the corresponding adjustment to the directionality of the microphone.
With the SAMBA remote control, recipients can select one of five programs, each with its own individual settings, for particular situations such as a noisy environment or for television and music. SAMBA processors may be individualised with more than 20 interchangeable color and design covers.
“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,” said Raymond
Gamble, CEO & President, MED-EL North America. “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.”