Recall of HiRes Ultra and Ultra 3D cochlear implant
Advanced Bionics have issued a voluntary recall of an initial version of their HiRes Ultra and Ultra 3D cochlear implant due to reported decreased performance of the device.
Posted on 26 January 2022
After an increased number of complaints regarding hearing performance degradation in early 2020, cochlear implant company Advanced Bionics announced that they would be recalling the implant.
Advanced Bionics reported that the performance issues were due to body fluid entering into the electrode, leading to interruption of stimulation that could negatively impact device performance. As of 11 February 2020, fewer than 0.5% of over 16,000 implants were explanted for this reason.
The company adds that the only reported risk to people who experience a lower performance from the implant would be the risks associated with repeat surgery, which may be needed for users whose devices are not performing as well as expected.
People who have HiRes Ultra and Ultra 3D implants were advised to continue using them as normal, but to be mindful of symptoms that suggest they are not performing as well as they should.
Some of the possible symptoms of the HiRes Ultra and Ultra 3D cochlear implant not functioning properly include hearing performance degradation over time and reduced ability to hear high pitched sounds. If any of these symptoms are experienced, Advanced Bionics recommends getting the device checked by an Audiologist.
Leigh Day product safety and consumer law solicitor Tina Patel represents clients who have complained of a lower standard of performance from the HiRes Ultra and Ultra 3D cochlear implants and have required revision surgery.
Tina Patel said:
“People who suffer hearing difficulties who have had surgery to have these devices implanted should be confident of it performing well. News of the recall is concerning and if others who have experienced a poor performance from the implant would like to get in touch, I would be happy to talk through their potential claim.”
For further information contact Tina Patel at firstname.lastname@example.org or 020 7650 1373