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The Neuro system unique screw fixation

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By: Oticon Medical
Date: 11 March 2019

Receiver migration is one of the primary causes of device-related surgical complications in cochlear implantation2. For users, this can be painful3 and even cause extrusion leading to more surgery. To ensure the long-term stability of the receiver, the Neuro System uses a unique screw fixation system, successfully used for over 13 years by numerous surgeons.

A clinical study of 150 patients concluded that this unique screw fixation surgical technique efficiently prevents implant migration4 and an ongoing clinical trial conducted in Denmark and Canada with 50 patients confirms these results with no cases of receiver migration5.



Safe for all ages


The screw fixation technique attaches the receiver to the bone using two small biocompatible titanium screws. By avoiding any bone-bed drilling, it reduces the risk of any intracranial complications, such as hematoma, dura tearing or cerebrospinal fluid leakage6,7.

310x200-fixation-screw

The unique screw fixation system is designed so that the screws penetrate the bone at a typical depth of 1,7mm. This makes it a safe solution even for the thinner skulls of young children8,9 where the typical bone thickness is around 2mm9. On the contrary, when performing a bony bed, a 2.2mm deep recess is generally recommended10 and the procedure does not necessarily provide the accuracy required in paediatric cases11.

 

Safe, convenient and painless for MRI

According to the latest independent study by Todt et al, 201812 the unique screw fixation system of the Neuro Zti implant also plays a key role in achieving safe, convenient and painless MRI exams at 1.5 Tesla with magnet in place.

Neuro means reliability


The Neuro screw fixation system contributes to the outstanding overall safety and reliability of the Neuro System. The Neuro Zti implant has a Cumulative Survival Percentage (CSP) of 99.96% after 3 year13 making it one of the most reliable cochlear implants in the industry14,15,16.

Finally, a recent survey showed that using screw fixation during an implantation can save surgeons up to 44 minutes in the operating room17. This is a relevant factor in the cost-benefit evaluation, for example in bilateral cases. This technique literally takes just a few seconds to secure the implant.

 

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1. Oticon medical CI unique points – January 2019
2. Terry B, Kelt RE, Jeyakumar A. Delayed Complications After Cochlear Implantation. JAMA Otolaryngol Head Neck Surg. 2015 Nov; 141(11):1012-7. doi: 10.1001/jamaoto.2015.2154.
3. Celerier C, Rouillon I, Blanchard M, Parodi M, Denoyelle F, Loundon N. Pain After Cochlear Implantation: An Unusual Complication? Otol Neurotol. 2017 Aug; 38(7):956-961. doi:
4. Guevara et al. Multicenter Evaluation of the Digisonic SP Cochlear Implant Fixation System With Titanium Screws in 156 Patients; Annals of Otology, Rhinology & Laryngology 119(8):501-505.
5. The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults- NCT02941627
6. Benson AG. Delayed onset intracranial hemorrhage: a rare complication of a cochlear implant. Otolaryngol Head Neck Surg. 2010 Jun; 142(6):917-8. doi: 10.1016/j.otohns.2009.12.005. Epub 2010 Mar 15.
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8. Neuro Zti IFU states The Neuro Zti cochlear implant is designed for adults and children of all ages.
9. Li Z, Park BK, Liu W, Zhang J, Reed MP, Rupp JD, Hoff CN, Hu J. A statistical skull geometry model for children 0-3 years old. PLoS One. 2015 May 18;10(5):e0127322. doi: 10.1371/journal.pone.0127322. eCollection 2015
10. CI 522 physician guide
11. Horton JD, Friedmann DR, Roland JT Jr. Delayed Extradural CSF Collection Following Pediatric Cochlear Implantation: Report of Two Cases. Otol Neurotol. 2016 Jul;37(6):654-7. doi: 10.1097/MAO.0000000000001035.
12. Todt, I., Rademacher, G., Grupe G., Stratmann A., Ernst, A., Mutze S., Mittmann P. (2018). Cochlear implants and 1.5 T MRI scans: the effect of diametrically bipolar magnets and screw fixation on pain. Journal of Otolaryngology - Head and Neck Surgery (2018) 47:11
13. Oticon Medical reliability report. Data as of June 30th 2018
14. AB 2018 Global Implant Reliability Report. Data as of June 1st, 2018
15. MedEl Reliability webpage (http://www.medel.com/reliability-reporting/). Data as of April 2018
16. Cochlear Reliability Report, Volume 16, December 2017. Data as of December 31st 2017
17. M81371UK, Neuro System Insert version A 2016, reporting the results of the survey “Surgical Procedure Questionnaire, Neuro Zti Cochlear Implant” M80798
18. Merdad M, Wolter NE, Cushing SL, Gordon KA, Papsin BC. Surgical efficiency in bilateral cochlear implantation: a cost analysis. Cochlear Implants Int. 2014 Jan;15(1):43-7. doi: 10.1179/1754762813Y.0000000042. Epub 2013 Nov 25