References and Notes

1. Kochkin S. 2009 BHSM kit. [Online]. 2009 May [Cited June 2009 1]; [1 screen]. Available from: URL:http://www.betterhearing.org/professionals/turnkey09.cfm

2. Kochkin S. Prevalence of hearing loss. Better Hearing Institute. [Online]. 2005 July [Cited June 2009]; [1 screen]. Available from: URL:http://www.betterhearing.org/hearing_loss/prevalence_of_hearing_loss/index.cfm

3. IEC 60529 Ed. 2.1 b Cor.1:2003 Corrigendum 1 - Degrees of protection provided by enclosures (IP Code).

4. Cochlear update March 2006 (White Paper). Pitch Steering with Sequential Stimulation of Intracochlear Electrodes (Cochlear 2006).

5. Kwon J et al. Dual-electrode pitch discrimination with sequential interleaved stimulation by cochlear implant users. J Acoust Soc Am 2006 Jul;120(1):EL1-6.

6. Nucleus Reliability Report, Vol. 9, August 2011. Seven years of data, launched in 2005.

7. Advanced Bionics - Auditory Reliability Report, February 2011. 5 years data, launched in 2005.

8. MED-El Website [Online]. 2011 [Cited September 2011];[1 screen]. Available from: URL:http://www.medel.com/us/show/index/id/280/title/Outstanding-Reliability-Data

9. Battmer RD et al. A multi-centre study of device failure in European cochlear implant centres. Ear Hear 2007 Apr;28(2 Suppl):95S-99S.

10. Cullen RD et al. Revision cochlear implant surgery in children. Otol Neurotol 2008;29(2):214-20.

11. Battmer RD et al. A review of device failure in more than 23 years of clinical experience of a cochlear implant program with more than 3,400 implantees. Otol Neurotol 2009 Jun;30(4):455-63.

12. The cochlear implants produced by Advanced Bionics and Med-El referenced in the following reliability studies were found to be more likely to fail than the Nucleus implants produced by Cochlear: Battmer RD et al. A multi-centre study of device failure in European cochlear implant centres. Ear Hear 2007 Apr;28(2 Suppl):95S-99S; Cullen RD et al. Revision cochlear implant surgery in children. Otol Neurotol 2008;29(2):214-20; Battmer RD et al. A review of device failure in more than 23 years of clinical experience of a cochlear implant program with more than 3,400 implantees. Otol Neurotol 2009 Jun;30(4):455-63.

13. Balkany T et al. Nucleus Freedom North American clinical trial. Otolaryngol Head Neck Surg 2007;136(5):757-762.

14. Pijil S et al. (2006) North American Freedom trial:Preliminary results adults. Cochlear Limited White Paper.

15. Bassim MK et al. Med-EL Combi40+ CochlearImplantation in Adults. Laryngoscope 2005;115:1568-1573.

16. Seguin C et al. (2005). Patient performance with the Advanced Bionics HiRes 90K Helix 1 Device with HiFocus Perimodiolar (Helix) Electrode. Advanced Bionics White Paper.

17. Wolfe, J. et al. Benefit of a commercially available cochlear implant processor with dual-microphone beamforming: A Multi-Center Study, Otology & Neurotology, 2011 [In Press].

18. The Nucleus Freedom Cochlear Implant System: Adult Post Market Surveillance Trials Results, June 2008.

19. Post Market Surveillance, P970051/5028; Poster presented at 12th Symposium on Cochlear Implants in Children, June 2009.

20. Based on Cochlear Surgeons’ Preference Survey: Internal Reliability Preferences. Data on file, June 2009.

21. Internal data on file, December 2010.

22. Internal data on file, July 2010.

23. 61% improvement is calculated from 9% per 1dB improvement. Litovsky, et. al. Simultaneous bilateral cochlear implantation in adults: a multicenter clinical study. Ear & Hearing, Vol 27 No. 6, 2006.

24) As derived from 1-year CSR Nucleus Report February/March 2006, Freedom Data and Advanced Bionics Recall Letter March 8, 2006, Advanced Bionics Data.

25) ISO 5841-2 2000 Implants for surgery – cardiac pacemakers – Part 2: Reporting of clinical performance of populations of pulse generators or leads

26) 24-month CSR for CI24RE implant, Nucleus Reliability Report February 2007

27) 24-month CSR for HiRes 90K implants, HiResolution Bionic Ear System Reliability Fall 2006

Document last modified: Tuesday, October 25, 2011