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March 28, 2005

More Info Needed on Cochlear Implants

From: Ivanhoe - USA - Mar 28, 2005

(Ivanhoe Newswire) -- Improving a federal database that collects information on cochlear implants could help patients and families decide whether to have the treatment, report investigators who looked at complication rates and other information in the Manufacturer User Facility and Distributor Experience (MAUDE) database.

The authors explain cochlear implants are a popular and effective therapy for the treatment of hearing loss, but the devices are expensive and require extensive therapy for users to actually reach the point where they can hear. Thus patients and families of children considering the device have many questions, which largely go unanswered due to lack of reliable information, including how long the implant will last, what the chances are it will fail or cause an infection, and which manufacturer or model has the lowest rate of complications. People also want to know if it will be possible to upgrade the device should newer and better models become available.

These investigators used the MAUDE database to track complications reported by manufacturers prior to 1998 and since 2002 to try to answer some of these questions. Results show device failure was the most common complication, although this problem decreased from the earlier to the later period. Infections were significantly more common in the later period, however.

Further analysis found the usefulness of the database could be markedly increased if scientists could agree on categories for complications, allow for the reporting of risk factors and estimates of the life of the implants, and include data on the patient's hearing and hearing loss history. The authors write, "With the suggested improvements made to the MAUDE database, it could become a powerful, sophisticated analytic tool for health care providers and patients alike. Used appropriately, it could provide crucial guidance in selecting an expensive but wonderfully life-enhancing therapy."

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SOURCE: Archives of Otolaryngology-Head & Neck Surgery, 2005;131:245-250

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