PRA number
Published date
Product description
The Neuro Zti EVO and CLA cochlear implants
Zti EVO Implant:
Catalogue no: M80185
Serial number from and above NZB04074
Zti CLA Implant
Catalogue no: M80184
Serial number from and above NZA02454
ARTG 284148
(Oticon Medical A Division of Audmet Australia - Neuro ZTI CLA (M80184) - Stimulator, electrical, auditory, cochlea)
ARTG 284150
(Oticon Medical A Division of Audmet Australia - Neuro Zti EVO Cochlear Implant - Stimulator, electrical, auditory, cochlea)
What are the defects?
The implant may stop working due to a complete loss of communication between the implant and the sound processor.
What are the hazards?
If the implant stops working and shuts down and there is a loss of communication between the implant and the sound processor, users will not be able to hear sounds or instructions and this may lead to harm.
What should consumers do?
Oticon Medical will write to affected consumers to advise them of the issue and provide instructions.
Consumers should be aware of this issue and if they experience a sudden loss of communication, and the problem cannot be isolated to the external components, they should contact their audiologist to make an appointment to have the device checked and repaired.
Traders who sold this product
Audiologists
Where the product was sold
Dates available for sale
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.