Hearing aid implant patients who have an Advanced Bionics product may need to have it removed, after reports it is causing pain, loud sounds and shocking sensations in patients.
Advanced Bionics is recalling its HiRes 90K cochlear implant, according to the U.S. Food and Drug Administration. The company is a global leader in developing advanced cochlear implant systems.
A cochlear implant is an electronic device which acts as a bionic ear for people who are nearly deaf or hard of hearing. It is an important piece of technology, as hundreds of thousands of people have them implanted.
Two patients have already complained of severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.
The cause of malfunctioning is under investigation, and all devices not yet implanted are being sought by the company, according to news reports. The company plans on instigating certain changes to ensure the highest product quality and safety for patients. Currently, the risk of experiencing a defect is low, according to FDA officials.
As a North Charleston personal injury lawyer , I recommend everyone with the Advanced Bionics implant report adverse effects to the FDA’s MedWatch program at 1-800-FDA-1088, or online at www.fda.gov/medwatch .