Advanced Bionics recalls cochlear implant devices following reports of decreased performance


CI market

© Sonova

In what it has called "an abundance of caution", Sonova's US  Advanced Bionics (AB) brand has retrieved a limited number of its unimplanted HiRes Ultra and Ultra 3D cochlear implants (CIs), replacing them with a new, recently approved version of the device.

This "voluntary field corrective action" followed reports of decreased hearing performance, but the group insists that the the vast majority of HiRes Ultra and Ultra 3D implants continue to function properly, and that there has been no safety issue for recipients. AB’s quality system recorded recent increases in the number of explants of devices, but the firm stated publicly that "less than 0.5% of recipients have been explanted".

Bright outlook and strong growth for Sonova Hearing Instruments

Sonova's recently published fiscal 2019/20 first-half report points to stronger-than-expected growth in its Hearing Instrument business. A key highlight was the US, where Sonova's market share was lifted by an expansion of business with the US Department of Veterans Affairs (VA), as well as a new private label contract with a large US retailer, and strong growth in the independent channel.

The Group now expects sales to grow by 9%-11% (from 8%-10%) and the adjusted EBITA to rise between 14%-17% (from 12%-15%), subject to currency adjustments.

“While the voluntary field corrective action announced today is disappointing, it demonstrates our continued commitment to put patients first," said Arnd Kaldowski, CEO of Sonova. "I am very happy about the continued strong development of our Hearing Instruments business and the overall sales and profitability development of the Group, clearly demonstrating the success of our strategy.”

Source: Sonova/Nasdaq