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Tracking trends in cochlear implant complications using a federal database

CHICAGO Changes in the format of a federal database for mandatory reporting of major and minor complications for medical devices, including cochlear implants, could make it a valuable resource, according to an article in the March issue of Archives of Otolaryngology Head & Neck Surgery, one of the JAMA/Archives journals.

Although cochlear implants (medical devices that bypass damaged structures in the inner ear and directly stimulate the auditory nerve, allowing some deaf individuals to learn to hear and interpret sounds and speech) are popular and effective therapy, they remain expensive and require an extensive program of accompanying therapy, according to background information in the article. The researchers suggest that to insure the best outcome from the necessary investment of time and money, patients and clinicians need independent, third-party data sources that can go beyond the manufacture-supplied literature on device complications.

Rabindra R. Tambyraja, M.D., Ed.M., of Case Western Reserve University School of Medicine, Cleveland, and colleagues investigated the suitability of the Manufacturer User Facility and Distributor Experience (MAUDE) database, maintained by the Food and Drug Administration (FDA), for systematic analysis of cochlear implant complications and treatments and, in the process, analyze trends in cochlear implant complications for two periods, 2002 and pre-1998. "We believe that the MAUDE database afforded a unique opportunity to use worldwide data collected and organized by an impartial source, with a mandatory reporting requirement," the authors write.

"Confirming other studies, we found device failure to be the most commonly reported complication," the authors report. "We also found a significant decrease in device malfunction from the pre-1998 period to 2002, possibly reflecting increasing quality control and reliability on the part of manufacturers." Infection was significantly more common in 2002
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Contact: George Stamatis
216-368-3635
JAMA and Archives Journals
21-Mar-2005


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