Recommendations based on investigation findings

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As a result of these investigations, the cochlear implant community has become highly aware of the association of bacterial meningitis with cochlear implantation. Although the numbers of reported cases remains relatively small when considering a worldwide implant population now greater than 60 000 individuals, FDA has strongly recommended measures to mitigate risk factors identified by these studies, including the following:

1. Specific pneumococcal vaccination recommendations for the cochlear implant population were developed by the CDC during the cohort study and have been posted on both CDC and FDA websites [1].

2. FDA has worked with manufacturers to update their labeling to reflect the current knowledge of the occurrence of meningitis in the cochlear implant population, as well as measures to reduce the risk of meningitis with their device, e.g. vaccinations, recommendations regarding use of tissue seals around the cochleostomy site.

3. FDA has recommended that implant recipients, their families, and healthcare providers be vigilant regarding early signs and symptoms of bacterial meningitis.

4. As described above, prompt diagnosis and treatment of otitis media are strongly recommended because many of the meningitis cases were preceded by middle ear infections.

Finally, the positioner component has been strongly implicated as a risk factor for meningitis, and, while several reasons for the increased risk have been offered [6] (e.g. larger cochleostomy requirement, increased inner ear trauma, inadequate fibrous-tissue seal at cochleostomy), the reasons for the actual causal factor(s) remain unknown. Although no longer marketed, there are several thousand adult and pediatric patients currently implanted with positioners, and the long-term risk of the implanted positioner is unknown. Currently, a CDC-FDA collaborative follow-up study on the original pediatric cohort is under way to determine whether the incidence of meningitis remains elevated after 2 years following implantation. Additionally, CDC is reviewing data from the Danish medical registry in an effort to estimate the background incidence of meningitis in the unimplanted deaf population. This estimate may be useful in clarifying the relative contributions of device-related risk factors vs. non-device-related risk factors for meningitis in cochlear implant recipients compared to the general population.

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