MED-EL USA receives FDA clearance for ADHEAR, a revolutionary non-surgical bone conduction hearing solution

MED-EL ADHEAR Sound Processor

DURHAM, N.C.–(BUSINESS WIRE)–May 1, 2018–MED-EL USA, a leading 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.

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MED-EL USA receives FDA clearance for ADHEAR, a revolutionary non-surgical bone conduction hearing solution (Photo: Business Wire)

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. Hearing centers and potential candidates can contact MED-EL at www.medel.com/us/adhear or (888) MED-EL-CI (633-3524) for more information.

About Conductive Hearing Loss

Conductive hearing loss is caused by problems with the ear canal, ear drum, or middle ear and its tiny bones (the malleus, incus, and stapes). Causes of conductive hearing loss include congenital absence of the ear canal or failure of the ear canal to be open at birth, and congenital absence, malformation, or dysfunction of the middle ear structures. Conductive hearing loss can also be caused by infection, tumors, middle ear fluid from infection or Eustachian tube dysfunction, a foreign body, trauma (as in a skull fracture), and otosclerosis. 1

About MED-EL

MED-EL Medical Electronics, a leader in implantable hearing solutions, is driven by a mission to overcome hearing loss as a barrier to communication. The Austrian-based, privately owned business was co-founded by industry pioneers Ingeborg and Erwin Hochmair, whose ground-breaking research led to the development of the world’s first micro-electronic multi-channel cochlear implant (CI), which was successfully implanted in 1977 and was the basis for what is known as the modern CI today. This laid the foundation for the successful growth of the company in 1990, when they hired their first employees. To date, MED-EL has grown to more than 1,900 employees and 30 subsidiaries worldwide.

The company offers the widest range of implantable and non-implantable solutions to treat all types of hearing loss, enabling people in 121 countries to enjoy the gift of hearing with the help of a MED-EL device. MED-EL’s hearing solutions include cochlear and middle ear implant systems, a combined Electric Acoustic Stimulation hearing implant system, as well as bone conduction devices. www.medel.com

1 Hearing Loss Association of America. Types, Causes and Treatment. Accessed December 18, 2017.

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CONTACT: For MED-EL

Rebecca Novak Tibbitt, 704-341-1544

Rebecca@RNTCommunications.com

KEYWORD: UNITED STATES NORTH AMERICA NORTH CAROLINA

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY MEDICAL DEVICES FDA

SOURCE: MED-EL

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PUB: 05/01/2018 08:00 AM/DISC: 05/01/2018 08:01 AM

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