FDA OKs MED-EL USA’s Non-Surgical Bone Conduction Hearing Device

MED-EL USA, a provider of hearing implant solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared the next generation of non-surgical bone conduction hearing technology: ADHEAR. This innovation is a non-surgical bone conduction solution for conductive hearing loss. Any problem in the outer or middle ear that prevents sound from being conducted properly is known as a conductive hearing loss. Conductive hearing loss may be temporary or permanent. ADHEAR is an excellent option for people with conductive hearing loss who are not candidates for, or who would not like to undergo, bone conduction implant surgery. It is also a treatment option for candidates with single-sided deafness and normal hearing on the contralateral side.
 
ADHEAR is easy to use. 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 is simply clicked on and off the adapter each day. The audio processor picks up sound waves, converts them into vibrations and transmits them onto the bone via the adhesive adaptor. The bone then transfers the vibrations through the skull to the inner ear where they are processed as normal sound. Bone conduction uses the bones of the skull to transmit sound waves directly to the inner ear and may be an appropriate option for people who have hearing loss due to problems with the eardrum, ear canal or middle ear.
 
Until now, non-surgical bone conduction devices have required pressure against the head causing discomfort for the user. ADHEAR comfortably stays in position without applying pressure onto the skin, while its discreet location behind the ear makes it cosmetically appealing.
 
MED-EL acquired the device’s technology from the Swedish medical device company Otorix in 2016 and further developed ADHEAR at MED-EL’s headquarters in Innsbruck, Austria.
 
“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,” said Raymond Gamble, CEO & President, MED-EL North America. “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.”
 
MED-EL USA anticipates ADHEAR availability in Summer 2018. Trainings for hearing health professionals will be occurring throughout the country.