Recall of affected non-implanted Oticon Medical Neuro Zti EVO and Neuro Zti CLA implants due to possible communication loss between implant and sound processor

A Dear Healthcare Professional Letter has been issued by Demant Singapore Pte Ltd to inform healthcare professionals of a recall of affected non-implanted Oticon Medical Neuro Zti EVO implants (serial numbers NZB04074 and above) and Neuro Zti CLA implants (serial numbers NZ02454 and above) due to an increase in the number of Neuro Zti device explants and devices under surveillance to be explanted because of a loss of hermeticity. The explantations have been performed after reports of complete loss of communication between the implant and the sound processor. Investigations have shown that it relates to a manufacturing deviation affecting potentially 3,976 Neuro Zti implants. There are no safety concerns for current recipients implanted with the affected implants and most Neuro Zti recipients are not likely to experience the problem as the prevalence is very low. Hence, existing Neuro Zti recipients may continue to use their devices as normal; device explantation is not recommended as the device may work as intended for the expected lifetime. For new implantations, healthcare professionals are advised to postpone forthcoming surgeries or utilise an alternate cochlear implant solution until further notice. Please refer to the letter for details. Published: 22 Oct 2021

Dear Healthcare Professional Letters