Implants, made of synthetic materials, are naturally coated by a biofilm by the body, which may function as a favorable medium for bacteria growth.
Typical failure mechanisms include tissue damage and implant detachment due to bacteria generated biofilm.
The most commonly reported device failures are due to impacts, loss of hermeticity, and electrode lead malfunctions.
In order to improve and standardize failure reporting practices to the public, the AAMI is developing an American standard for cochlear implants in collaboration with the FDA, major cochlear implant manufacturers, the CALCE center for reliability, doctors, and clinicians.
[7] Individuals who have diabetes and those who disregard general oral hygiene are also at higher risk of having their implants fail.
[8] A 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process.