Feb 2020 swissinfo.ch
The American subsidiary of Swiss hearing aid firm Sonova expects to shell out up to CHF50 million (around $51 million) in a recall of sub-optimal cochlear implants. The company announced that its US subsidiary Advanced Bionics is conducting a product recall on the initial versions of the HiRes Ultra and Ultra 3D cochlear implant devices. It will retrieve un-implanted devices and replace them with recently approved new versions.
The company has seen an increase in cases of surgical removal of its implants due to deterioration in hearing performance. However, Sonova claims that less than 0.5% of patients with the implants have needed surgical removal and that the defects do not present a safety issue. The cost of the recall is estimated to be between CHF40 and CHF50 million. Despite the setback, Sonova expects its Hearing Instruments business to grow by 9 to 11% this year.
The outbreak of the coronavirus resulted in a one week pause for its Chinese operations. “At this time, this is not expected to materially impact Sonova’s results,” the company said.