Cochlear implant maker Med-El USA said yesterday it won FDA de novo clearance for its Bonebridge bone conducting hearing implant system, with plans to launch the device this year.
The newly cleared system is indicated for individuals 12 years and older with conductive hearing loss, mixed hearing loss or single-sided deafness, the Durham, N.C.-based company said.
The Bonebridge system consists of two components, and implanted BCI 601 device and the company’s Samba audio processor which can be worn discretely beneath the hair, Med-El said. The implant is designed to be placed completely underneath the skin, while the audio processor applies only minimal pressure to the skin, the company said.
The Samba audio processor includes adaptive directional microphones designed to automatically identify and minimize noise interference, Med-El said, intended to control for loud background noise.
“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,” Med-El NA prez & CEO Raymond Gamble said in a press release.
In May, Med-El said it won FDA approval for its Rondo 2 cochlear implant audio processor with an expected launch of the device this fall.