MED-EL USA announced this week that the country’s first BONEBRIDGE™ Hearing Implant System surgery was completed at Texas Children’s Hospital. According to the company’s announcement, the surgery was performed by Otolaryngologist Yi-Chun Carol Liu, MD, on an 18-year old, and the device was successfully activated on November 13, 2018.
Cleared by the U.S. Food and Drug Administration (FDA) in July 2018, BONEBRIDGE represents a 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 said to be 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”
–Raymond Gamble, CEO & President, MED-EL North America
BONEBRIDGE consists of two components: the internal implant, and the SAMBA audio processor, which can be worn discretely beneath the hair.
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”.