• (PLX AI) – Demant recalling non-implanted Oticon Medical Neuro Zti implants and temporarily halting sales of new implants after finding performance issues in a small subset of implants.
  • • Says no reported safety events
  • • As of 13 October, a total of 28 implants had either been explanted or were under surveillance to be explanted
  • • Company says there are no safety concerns for existing users, and most users are unlikely to experience any issues
  • • Demant expects no further sales of new cochlear implants in 2021, and the temporary halt in sales is likely to extend into 2022
  • • In addition to lost revenue, the voluntary field corrective action will also result in certain one-off costs, which are expected to amount to DKK 70-100 million in 2021

Quelle: PLX AI