Feb 21, 2020

HiRes Ultra / Ultra 3D Field Action Update

Tuesday, February 18, 2020 – Sonova, our parent company, announced withdrawal and stopped shipment of the first version HiRes Ultra and Ultra 3D products. (Sonova Press Release)


Tuesday, February 18, 2020 – Sonova, our parent company, announced withdrawal and stopped shipment of the first version HiRes Ultra and Ultra 3D products. (Sonova Press Release)

  • This voluntary action is being taken with great caution following recent increases in Ultra device explants.  These explants were based on reports of poor hearing performance.
  • As of February 11, of the more than 16,000 recipients of these implants worldwide, less than 0.5% have been explanted
  • We are currently working through the process to provide data to both healthcare professionals and recipients

Progress Tracker

Step 1 

Corporate Announcement
of Impending Field Action

   

Step 2 

Global Regulatory
Authority Alignment

   

Step 3 

Healthcare Professional
and Recipient Communication*


We Are Here

Step 1 

Corporate Announcement
of Impending Field Action

   

Step 2 

Global Regulatory
Authority Alignment

   

Step 3 

Healthcare Professional
and Recipient Communication*

- We Are Here - 

* Based on local data privacy regulations

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