Recently, a link was discovered between bacterial meningitis and children with early versions of the Advanced Bionics cochlear implant. In 2002, a study was completed that showed that bacterial meningitis occurred in more children with cochlear implants that other children of the same age group. The FDA continued to receive reports of an increase in bacterial meningitis in children with cochlear implants.
This risk means that children with Advanced Bionics cochlear implants need to be monitored and observed very carefully for this particular infection, which can be fatal.
Cochlear implants are electronic hearing devices which were first approved by the FDA in the 1980s. They work by electrically stimulating nerves inside the inner ear.
The FDA indicated to patients and doctors that children with cochlear implants and a positioner get bacterial meningitis more frequently than those without the rubber wedge positioner or implants at all. Advanced Bionics was the only manufacturer the market the cochlear implants with the small rubber wedge positioners, who then stopper producing implants with the positioners entirely by 2002.
Advanced Bionics Products Recalled
| Recall Number | Z-0956-2009 |
| Trade Name/Product | HiRes90K Platinum Series Headpiece - HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar; CA 91342 USA. The HiRes90K headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss. |
| Reason for Recall | Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Seriesheadpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communicationfrequency is adjusted to match that of the internal device. Potential clinicalsymptoms include:-No lock-Intermittent lock-Implant locks; but cann |
| Recall Number | Z-0956-2009 |
| Trade Name/Product | S-Series Headpiece Short Range - S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar; CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. |
| Reason for Recall | Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Seriesheadpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communicationfrequency is adjusted to match that of the internal device. Potential clinicalsymptoms include:-No lock-Intermittent lock-Implant locks; but cann |
| Recall Number | Z-0958-2009 |
| Trade Name/Product | S-Series Headpiece Long Range - S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar; CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. |
| Reason for Recall | Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Seriesheadpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communicationfrequency is adjusted to match that of the internal device. Potential clinicalsymptoms include:-No lock-Intermittent lock-Implant locks; but can |
| Recall Number | Z-0957-2009 |
| Trade Name/Product | Platinum Series Headpiece - Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss |
| Reason for Recall | Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Seriesheadpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communicationfrequency is adjusted to match that of the internal device. Potential clinicalsymptoms include:-No lock-Intermittent lock-Implant locks; but can |
What are the signs and symptoms that a HiRes™90K might be starting to fail?
You or your child may experience:
- a sudden sensation of discomfort or pain
- a sudden loud noise or popping sound
- an intermittent functioning
- a complete loss of sound
- in children, an unwillingness to wear the external headpiece
Defective Cochlear Implant Attorneys
Those who have been injured by a cochlear implant might be entitled to compensation.
Talking with one of our lawyers might help you answer some of your questions, such as:
- Am I entitled to compensation for medical bills, disabilities, pain and/or suffering?
- How would i begin to pursue a defective cochlear implant suit?
- What are some comparable cases and their outcomes?
- Should I file and individual or class-action lawsuit?
To speak with one of our attorneys, please fill out our confidential questionnaire.