FDA clearance offered for most candidates over age 12
MED-EL USA recently announced the country’s first BONEBRIDGE™ Hearing Implant System surgery was completed at Texas Children’s Hospital.
Otolaryngologist Yi-Chun Carol Liu, MD, performed the surgery on an 18-year old, with the device was successfully activated on November 13, 2018.
Cleared by the U.S. Food and Drug Administration (FDA) in July 2018, BONEBRIDGE represents an entirely new approach to bone conduction hearing technology, and is cleared for use in conductive and mixed hearing losses as well as single-sided deafness for candidates age 12 and older. BONEBRIDGE is the world’s first bone conduction implant that combines the benefits of intact skin with direct drive stimulation of the bone for optimal sound and improved quality of life.
“Since the FDA clearance of BONEBRIDGE and ADHEAR earlier this year, we have been actively working with surgeons, audiologists, and hearing implant centers around the country to ensure that our game-changing surgical and non-surgical bone conduction hearing technologies can get to candidates,” said Raymond Gamble, CEO & President, MED-EL North America.
BONEBRIDGE consists of two components: the internal 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 and comfortable daily wear of their audio processor.