Recall!!

Things just get better and better! LOL
Advanced Bionics has voluntarily put out a recall on their implants. Scary thought huh? Once you think of all the aspects of this... not so much. Their last recall was in 2004 but no one was affected that already had the surgery. I will post their announcement for this one here...

**** Recall Notification****

Advanced Bionics HiRes 90K Cochlear Implant

Dear Cochlear Implant Recipient or Parent,

Our mission at Advanced Bionics is to improve the lives of the hearing impaired, and the

safety and well-being of our recipients is our first priority. Because we are committed to

ensuring that our products are as safe as possible, we are voluntarily informing you that

we have become aware of an issue with the HiRes 90K cochlear implant. The issue can

result in pain, overly loud sounds, and/or sudden shock sensation in the implanted ear

while the implant is receiving power. Thus far, our investigation shows that of the more

than 28,000 implanted HiRes 90K devices, only two explanted devices have been

confirmed to have this issue. There are 9 other patients with similar symptoms which

our investigations have not yet ruled out as related to this issue. For the two confirmed

cases, there were no symptoms upon initial activation of device. However, the patients

experienced symptoms after 8-10 days of use. Both recipients were re-implanted with

HiRes 90K devices and their clinicians report that they are progressing well.

We are conducting an extensive investigation of this issue using an independent

scientific research organization. Their current analysis suggests that, if present, the

issue will first occur within 90 days of device use. However, the onset of symptoms may

be delayed after initial activation, and they may continue to occur intermittently. In the

unlikely event that this symptom occurs, continued device use may lead to damage to

the inner ear and/or the auditory nerve. If you or your child experience pain related to

implant use, remove the external equipment immediately and contact your cochlear

implant clinician to schedule an appointment. If the evaluation of your device identifies

this problem, device replacement is advised.

It is important to note that it is not unusual for cochlear implant recipients to experience

overly loud sounds. Most of these cases can be resolved with standard troubleshooting,

such as the replacement of external equipment. The vast majority of these cases are

not signs of the issue described above and do not require explant of the device. We will

notify you again as more information from our investigation becomes available.

We sincerely regret any concern this notification may cause. Advanced Bionics assures

you that we will correct this issue and continue to improve our product reliability.

If you have any questions regarding this letter, please contact an Advanced Bionics

representative at 877-577-4628 (telephone) Monday – Friday 5:00 a.m. – 7:00 p.m. PST

or www.advancedbionics.com (live chat) Monday – Friday 5:00 a.m. – 7:00 p.m. PST.

In order to assure the effectiveness of this communication, please complete the

enclosed acknowledgment form and return it to us at your earliest convenience by using

one of the following options:

E-mail: confirm@advancedbionics.com

Fax: 661-362-7621

Mail: Self-Addressed stamped envelope

I am impressed with this company. They CARE about the people using their product. All surgeries since this recall have been canceled until they find the source of this problem. It was only 2 people out of 28,000. I'm not sure the other companies would do this. I love the fact they keep us informed.

I wanted to have this done ASAP even though the process is long and it's possible they will be producing implants before I am approved. This is just one more "bump in the road" and I am hopeful they will find the cause soon.