Electric-Acoustic System (EAS) Investigational Hearing Device Trial Launched with First U.S. Patient Implant
University of North Carolina-Chapel Hill kicks off trial
Durham, NC –(April 4, 2007) –MED-EL Corporation announced today the first U.S. implantation in the pivotal study of the Electric-Acoustic System (EAS). EAS is an investigational medical device being studied in adults that combines a cochlear implant system with hearing aid technology. EAS is designed to provide benefit in speech perception and sound quality to a completely new population of people with sensorineural hearing loss with residual hearing, specifically in the low frequency range. Candidates for the EAS procedure are adults who have enough hearing that they would not be considered candidates for a traditional cochlear implant procedure.
Today is the first day that the trial opened in the United States. The implant was performed by Craig Buchman, M.D., the Medical Director of the Carolina Children’s Communicative Disorders Program, Chief of Neurotology and Skull Base Surgery, and Professor of Otolaryngology and Head and Neck Surgery at the University of North Carolina at Chapel Hill.
“We hope to confirm earlier findings that show EAS users benefit from the natural sound perceptions provided by acoustic amplification in addition to the electrical stimulation of the cochlear implant. In terms of listening to music, this may help patients identify melodies and offers a higher quality than can be achieved with cochlear implant use alone,” said Dr. Buchman. “In addition, EAS has the potential to provide a new option for people who have a hearing loss in the high frequencies that is difficult to fit with hearing aids, but still have enough remaining low-frequency hearing to obtain some benefit from a hearing aid. This population has ‘fallen between the cracks’ in terms of the treatment options at our disposal.”
Combined electric-acoustic stimulation realizes the vision of using hearing aid and cochlear implant technology together in the same ear. The hearing aid acoustically amplifies low frequencies, while the cochlear implant electrically stimulates the middle and high frequencies. The inner ear processes acoustic and electric stimuli simultaneously. Results of international studies show a highly synergistic effect between hearing aid and cochlear implant technology, particularly evident in speech understanding in noise. The purpose of the clinical trial is to demonstrate the safety and potential benefit of the new MED-EL EAS, DUET® system, as well as to monitor residual hearing levels to ensure that remaining hearing can be functionally maintained.
EAS uses the investigational FLEXeas Electrode, a thin electrode designed to reduce insertion trauma and occupy less space in the cochlear canal compared to previous designs. This cochlear implant electrode array was developed by MED-EL specifically for atraumatic insertion so that the residual hearing is preserved. In addition, special surgical techniques are employed in order to preserve remaining hearing in the ear that is receiving the implant. After surgery, the patients wear the investigational DUET® speech processor. An estimated 55 subjects will be implanted with the EAS at approximately 15 study sites in the United States. Trial subjects are intensively involved with the investigation for approximately 15 months.
Trial sites are still recruiting subjects in this study. To participate in the trial, subjects must meet inclusion criteria such as being 18 years of age or older, have moderate sloping to severe/profound hearing loss in the ear to be implanted based on audiologic testing, and have received minimal benefit from optimally-fit hearing aid(s). Potential candidates can contact MED-EL Toll Free at (888) MED-EL-CI (633-3524), or by e-mail at implants@medelus.com to learn more about participating in this trial.
About EAS
The unique EAS system, DUET®, has been developed and is available in Europe from worldwide hearing implant leader MED-EL. Participants in a similar study conducted in Europe first experienced the EAS concept by using a hearing aid in the same ear as a cochlear implant speech processor. Although study results were promising, participants noticed that wearing the two hearing devices in the same ear was somewhat cumbersome. U.S. study participants are the first to have the opportunity to listen with the DUET® speech processor, a unique approach that integrates cochlear implant speech processing and hearing aid technology into one compact device. Successfully providing combined stimulation in an easy-to-wear package, the DUET® processor is the first and only device of its kind worldwide.
About MED-EL Corporation
Since its founders developed one of the world’s first cochlear implants in 1975, MED-EL has repeatedly set new standards in hearing implant technologies, developing and manufacturing technologically advanced hearing solutions for people with varying degrees of hearing loss. MED-EL hearing implant systems, currently used in 80 countries, combines the latest scientific advances, engineering and manufacturing techniques for outstanding performance, safety and reliability.
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