MED-EL Obtains FDA Clearance for ADHEAR, Non-Surgical Bone Conduction Device

Image
HHTM
May 1, 2018

Hearing implant maker, MED-EL, announced today that it had received clearance from the US Food and Drug Administration (FDA) for its latest non-surgical bone conduction hearing technology: ADHEAR. According to the company, ADHEAR is an  option for people with conductive hearing loss, or single-sided deafness (SSD), that are either not candidates for, or who would not like to undergo, bone conduction implant surgery. 

With ADHEAR, a patented adhesive adapter is placed onto the skin behind the ear and is worn for three to seven days at a time. The lightweight audio processor, which transmits sound to the wearer via bone conduction, can be easily clicked on and off the adapter each day.

Other non-surgical bone conduction devices in the past have required a certain amount of pressure against the user’s head, which can cause discomfort. However, ADHEAR is said to offer a much more comfortable alternative that stays in position without applying pressure onto the skin, while maintaining a discreet placement behind the ear.

 

“MED-EL has always been at the forefront of innovative hearing loss technology and ADHEAR adds to our growing range of high-quality hearing loss solutions. It opens up a whole new world of sound to people with conductive hearing loss, enabling us to help more people overcome hearing loss as a barrier to communication.” –Raymond Gamble, CEO & President, MED-EL North America

 

According to the company’s press release, MED-EL acquired the technology from the Swedish medical device company Otorix in 2016 and then further developed ADHEAR at the company’s global headquarters in Innsbruck, Austria.

MED-EL says that it anticipates ADHEAR availability in the US in Summer 2018.

 

Source: MED-EL

 

 

Leave a Reply