Federal database used to track trends in cochlear implant complications

Mar 22 2005

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.

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, the researchers found, but no other significant differences in events were noted.

The authors suggest that their analysis would have been strengthened by three improvements in the MAUDE database: the development of agreed-upon categories for complications; the development of a place for information needed to assess risk factors and estimation of the useful life of the implant (for example, patient age, any anatomical abnormality and previous implant history); and basic data measuring the patient's hearing and history of hearing loss.

"With the suggested improvements to the MAUDE database, it could become a powerful, sophisticated analytical tool for health care providers and patients alike," the authors conclude. "Used appropriately, it could provide crucial guidance in selecting an expensive but wonderfully life-enhancing therapy."