medel bonebridge implant

MED-EL Bone Conduction Implant System Granted FDA De Novo Clearance

MED-EL USA announced this week that the U.S. Food and Drug Administration (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.

Unlike many bone anchored hearing aids, which include an abutment that protrudes through the skin and may require ongoing medical treatment and maintenance, the company’s new BONEBRIDGE system places the implant completely underneath the skin, with the audio processor placed over the skin with “minimal pressure”.

 

BONEBRIDGE Bone Conduction Hearing Implant System

 

The BONEBRIDGE system is made up of two components: the internal BCI 601 implant, and the SAMBA audio processor:

Sound in the environment is captured by the SAMBA audio processor, converted into signals, which are transferred through the skin to the implant. The implant then converts the signal into mechanical vibrations 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.  

The SAMBA audio processor includes adaptive directional microphones to help make listening more comfortable in the presence of noise. A feature called Speech Tracking is said to enable the processor to automatically recognize the direction from which speech is coming and makes the corresponding adjustment to the directionality of the microphone.

The SAMBA remote control allows recipients to select one of five programs, each with its own individual settings, for particular situations such as a noisy environment or for television and music. The processors can be individualized with more than 20 interchangeable color and design options.

 

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.”

Raymond Gamble, CEO & President, MED-EL North America

 

 

According to the announcement, MED-EL USA anticipates that BONEBRIDGE will be available in 2018.

 

Source: MED-EL

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