MED-EL Cochlear Implant Becomes First FDA-Approved Option for Children Seven Months and Older

First and Only Cochlear Implant FDA Approved for Youngest Infant Population

DURHAM, N.C.--(BUSINESS WIRE)--MED-EL USA announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for MED-EL cochlear implants for children seven months and older with bilateral sensorineural hearing loss (SNHL). This makes MED-EL’s cochlear implant system the only FDA-approved option for infants this young, offering the potential for earlier access to sound and speech development.

“Giving infants the opportunity to hear early in life is critical to maximizing the development of hearing and spoken language. It is extremely gratifying to have led this clinical trial demonstrating the safety and effectiveness of the latest implant technology for children as young as seven months. My hope is this will mean more children will experience the gift of sound soon after birth,” said Nancy M. Young, M.D., Lillian S. Wells Professor of Pediatric Otolaryngology, Medical Director of Cochlear Implant Program, Ann & Robert H. Lurie Children’s Hospital of Chicago.

This FDA approval also includes expansion of audiologic and speech indications for children aged 12 months and older, offering the broadest pediatric indications of any hearing implant manufacturer.

“Many children with significant hearing loss use hearing aids but cannot hear all the sounds essential for understanding spoken language. They must work so much harder than their hearing peers. Expanding the eligibility of these children for cochlear implantation is so important to improving their hearing, language, literacy, and quality of life,” said Dr. Young.

“This is an incredible step forward for families with young children with hearing loss,” said John Sparacio, President and CEO of MED-EL USA. “Giving children access to sound as early as possible can make a world of difference for their future. We are committed to giving every child the best possible start in life through our closest to natural hearing philosophy paired with our advancements in safety and technology.”

Key Data Highlights:

• An FDA study in two groups of children shows that MED-EL cochlear implants are safe and effective for children seven-71 months old with bilateral SNHL who cannot hear well enough with hearing aids.
• Overall, 110 of 123 children, including 81% in one group and 88% in the other group, showed clinical success with the cochlear implant in the first year.
• The rate of major complications was low in both study groups. All complications were known risks of cochlear implantation, and children implanted under 12 months old did not have more complications than other children.
• A post-approval study is planned to collect more data in children implanted at ages seven months to 17 years, 11 months who meet the new labeling criteria for MED-EL cochlear implants.

For more information about MED-EL cochlear implants, visit www.medel.com.

About MED-EL

Medical Electronics, a leader in implantable hearing solutions, is driven by a mission to overcome hearing loss as a barrier to communication and quality of life. 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 more than 3,000 employees from around 90 nations and 30 locations worldwide.

The company offers the widest range of implantable and non-implantable solutions to treat all types of hearing loss, enabling people in 139 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 surgical and non-surgical bone conduction devices. www.medel.com