Cochlear Implants
This article was originally published in RAJ Devices
Executive Summary
Vaccination recommendations
Vaccination recommendations
The Advisory Committee on Immunization Practices (ACIP) to the US Centers for Disease Control and Prevention (CDC) has adopted the CDC's October 2002 recommendations regarding the use of vaccinations for people with cochlear implant devices1. This follows a US study that concludes that children with cochlear implants are at a greater risk of developing pneumococcal meningitis than children without implants2.
The study, conducted by the CDC, the FDA and US state and city health departments and published in the New England Journal of Medicine (NEJM), involved 4 264 children who received a cochlear implant in the US between 1 January 1997 and 6 August 2002, and who were younger than age six at the time of the implant. The study also determined that children who had CLARION implants that contained a `positioner' had 4.5 times the risk of developing meningitis. These implants were recalled in 2002 by Advanced Bionics.
The ACIP makes the following recommendations for children who have or may receive cochlear implants:
- physicians and parents of children who have received cochlear implants should review the child's vaccination status and make sure she or he is up-to-date for age on pneumococcal vaccinations according to schedules used for children at high risk and on Haemophilus influenzae type b (Hib) vaccinations;
- children should be up-to-date for age on vaccinations at least two weeks prior to cochlear implant surgery, if possible; and
- physicians should assist parents in assessing the benefits and risks of cochlear implant surgery.
In a recent issue of its Morbidity and Mortality Weekly Report, the CDC recommended that all people with cochlear implants receive age-appropriate pneumococcal vaccination with 7-valent pneumococcal conjugate vaccine (PCV7) (Prevnar®), 23-valent pneumococcal polysaccharide vaccine (PPV23) (Pneumovax®), or both3. Specific vaccination recommendations are divided by age range and length of time with one of the implants.
The FDA has issued a guidance document to industry entitled Implantable Middle Ear Hearing Device , replacing one issued in 20024 (see page 317). It includes advice on providing proof that the devices have been tested and sterilised.
Background
The CDC and the FDA began investigating a possible link between the implants and meningitis in mid-2002 after receiving reports of bacterial meningitis among recipients of cochlear implants. As soon as the FDA became aware of a possible association between cochlear implants and bacterial meningitis, it issued a public health Internet notice and began working with manufacturers of cochlear implants to determine the nature and scope of the problem5.
References
1. US Centers for Disease Control and Prevention (CDC) press release, 30 July 2003, www.cdc.gov
2. New England Journal of Medicine , 31 July 2003, 349 , 435-445
3. CDC Morbidity and Mortality Weekly Report, 31 July 2003, www.cdc.gov/mmwr
4. FDA Guidance for Industry and FDA Staff: Implantable Middle Ear Hearing Device, 1 August 2003, www.fda.gov
5. FDA Public Health Web Notification: Risk of Bacterial Meningitis in Children with Cochlear Implants, 17 October 2002, www.fda.gov