Audiology in Brief Med-El Corporation launched a U.S. Food and Drug Administration clinical trial for the study of the Electric-Acoustic System (EAS). This investigational device combines a cochlear implant system with hearing aid technology. EAS is designed to provide benefits in speech perception and sound quality to a population of people with ... News in Brief
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News in Brief  |   June 01, 2007
Audiology in Brief
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Hearing Disorders / News in Brief
News in Brief   |   June 01, 2007
Audiology in Brief
The ASHA Leader, June 2007, Vol. 12, 5. doi:10.1044/leader.NIB.12082007.5
The ASHA Leader, June 2007, Vol. 12, 5. doi:10.1044/leader.NIB.12082007.5
Electric-Acoustic System Clinical Trial Launched
Med-El Corporation launched a U.S. Food and Drug Administration clinical trial for the study of the Electric-Acoustic System (EAS). This investigational device combines a cochlear implant system with hearing aid technology. EAS is designed to provide benefits in speech perception and sound quality to a population of people with residual low-frequency hearing who would not be considered as cochlear implant candidates.
Combined electric-acoustic stimulation uses hearing aid and cochlear implant (CI) technology in the same ear. The hearing aid acoustically amplifies low frequencies, while the CI 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. The clinical trial will demonstrate the safety and benefit of the new EAS system, as well as monitor residual hearing levels to ensure remaining hearing can be functionally maintained.
EAS uses the investigational electrode designed for atraumatic insertion so that residual hearing is preserved. In addition, special surgical techniques are employed to preserve remaining hearing in the ear receiving the implant. Approximately 55 subjects will be implanted with the EAS at approximately 15 study sites and will be involved with the investigation for 15 months.
Trial sites are still recruiting subjects, who must be adults with moderate sloping to severe/profound hearing loss in the ear to be implanted, and who have received minimal benefit from optimally fit hearing aid(s). Contact Med-El at 888-633-3524 or implants@medelus.com.
iPods and Pacemakers
A Michigan high school student, in collaboration with cardiologists, presented research at the May 2007 annual meeting of the Heart Rhythm Society that suggests that Apple iPods can cause cardiac implantable pacemakers to malfunction.
Jay Thaker, 17, working in collaboration with cardiologist Krit Jongnarangsin and colleagues at Michigan State University and the University of Michigan, concluded that iPods cause various types of interference in pacemakers in 50% of patients tested. iPods, and presumably other types of MP3 players, appear to produce electromagnetic fields that can interfere with pacemaker function. Similar effects occur when pacemakers are in proximity to theft-detection systems and airport metal detectors, according to the U.S. Food and Drug Administration.
Investigators conducted a single-blind study to evaluate potential interactions between iPods and pacemakers in 35 women and 48 men with a mean age of 76.1 (plus or minus 8.6 years). Most (74) had dual-chamber devices, and nine had single-chamber devices.
The authors tested four different types of iPods with pacemakers in both unipolar and bipolar configurations. The technician monitoring ECG/pacemaker telemetry was blinded to both the pacemaker settings and the type of iPod test.
The study revealed that three different types of interference can occur between an iPod and a pacemaker. Two types of iPod interferenceCoversensing and telemetry interferenceCwere the most persistent, occurring for more than 50% of application time, and occurred more commonly with the hard-drive-basic music player (iPod 3G) and photo models, with pacemakers in both unipolar and bipolar configurations. The third type of interferenceCcomplete pacemaker inhibitionCoccurred in just 1.2% of patients (one patient). However, the investigators noted that none of the patients with interference reported experiencing symptoms.
Thaker hopes to enroll at Michigan State University in the fall so he can work with some of the researchers from his iPod project.
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FROM THIS ISSUE
June 2007
Volume 12, Issue 8