Cochlear implant unit sales of 18,461 was up 2%.
There were no donation sales to China in F09 (F08 700 units). Foreign exchange contracts losses were AUD17 million (F08 profit of AUD21.3 million).
Cochlear Baha BP100 is a new sound processor for those with a Baha implant. The Cochlear Baha BP100 has regulatory approval for sale in Europe (CE Mark) and the USA (510(K) submission has been cleared by FDA). The BP100 is currently being launched in Europe and the USA, with the roll-out, including training, spread across H1 F10.
Clinical validation results of the BP100 were reported at several major medical conferences held in June 2009. Cochlear Nucleus 5 is the next generation cochlear implant system. It consists of the next generation implant and next generation external processor.
Both the implant and external processor are compatible with the current Nucleus Freedom cochlear implant system, so the implant and the external processor can be released independently. Cochlear Nucleus 5 has received CE mark approval for sale in Europe. Timing of registration for reimbursement purposes (if needed) is country specific.
Roll out activities in Europe will occur across H1 F10, and in some European countries not until H2 F10. The implant has already been released in the UK. Regulatory (FDA) approval in the USA is via approval of PMA supplements (as the implant and externals are separate submissions).
USA regulatory approval has not yet been received for the implant or external processor submissions. In other countries such as Australia availability is governed by regulatory and other approvals which are not expected in F10. Clinical data on user acceptance testing of the Cochlear Nucleus 5 externals have been presented at several major medical conferences in June 2009.
Cochlear Limited operates in the implantable hearing device industry.
