Voluntary Field Corrective Action of HiRes Ultra and Ultra 3D

Summary

Company Announcement Date:
February 20, 2020
FDA Publish Date:
March 10, 2020
Product Type:
Medical Devices
Reason for Announcement:
Reports of hearing performance degradation
Company Name:
Advanced Bionics
Brand Name:
HiRes Ultra and Ultra 3D
Product Description:
Cochlear implants

Company Announcement

Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has begun notifying regulatory authorities that it will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 30 cochlear implant devices due to a decrease in performance experienced by a small percentage of recipients.

AB’s priority is to ensure that all cochlear implant recipients and health care providers have the information they need to understand this situation and that they receive the necessary support. Existing recipients of HiRes Ultra and Ultra 3D may continue to use their device as normal. If recipients experience issues of hearing degradation they should visit their audiologist or other health care provider. In addition, we will begin the notification process for device recipients worldwide, where allowed, to make them aware of the potential issue

This voluntary action is being taken in an abundance of caution in response to recent increases in Ultra device explants related to low impedances and reports of hearing performance degradation. As of February 11, 2020, of the more than 16,000 recipients of these implants, less than 0.5% have been explanted for this reason. Please note that this device-related issue may manifest in performance degradation that could require revision surgery. The only potential for patient harm are the risks associated with a surgery.

AB has identified factors that contribute to the clinical symptoms leading to explant and hearing performance degradation. This information will be provided to health care professionals and recipients in geographies that allow. As of February 11th, in the small number of cases that have been explanted, fluid ingress at the electrode has occurred leading to interruption of stimulation. The hermetic seal of the implant case has been shown to be intact

In our efforts to continually improve our products and in response to early reports of this issue AB has developed several improvements to the device to address the issue (new version). AB has received regulatory approval from the FDA in the US and TUV SUD in Europe for these improvements. AB is in the process of submitting these improvements to additional global regulatory agencies. AB plans to distribute products in these geographies as soon as approvals are obtained. AB will continue to distribute the HiRes 90K Advantage cochlear implant as well as the new version of HiRes Ultra and Ultra 3D based on market availability.

Previous generations of AB cochlear implants and external sound processors and accessories are not included in the scope of this voluntary field action

AB’s primary concern is the safety and hearing performance of our recipients as well as the reliability of our products. AB continues to take all necessary corrective and preventative efforts to address this unforeseen occurrence.

ABOUT ADVANCED BIONICS

Advanced Bionics is a global leader in developing hearing solutions for individuals with severe-to-profound hearing loss who no longer benefit from hearing aids. Founded in 1993 and a subsidiary of the Sonova Group since 2009, AB develops cutting-edge cochlear implant technology that allows recipients to hear their best. AB joined Phonak as part of the Sonova Group of companies and began a collaboration unlike any other in the industry. Since then, the innovation leaders in cochlear implants and hearing aids have continuously combined technologies to deliver new, unequalled hearing solutions. With sales in more than 50 countries and a proven track record for developing high-performing, state-of-theart products, AB’s talented worldwide group of technologists and professionals are driven to engage with patients and professionals, work with integrity, and stay firmly committed to the best possible performance.

MEDIA CONTACT

International
Patrick Lehn
Senior Corporate Communications Manager- Sonova Group
Patrick.Lehn@sonova.comExternal Link Disclaimer

North America
Chris Bingham
Vice President of Global Marketing – Advanced Bionics
ChristoP-her. Bingham@a dva nc e dbionics.comExternal Link Disclaimer


Company Contact Information

Media:
Patrick Lehn
Patrick.Lehn@sonova.com