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Multicenter evaluation of Neurelec Digisonic® SP cochlear implant reliability

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Abstract

Over the past decade, the adoption of universal hearing screening in newborns has led to earlier detection of hearing problems and significant lowering of the age of first cochlear implantation. As a consequence, recipients are now expected to keep their cochlear implants (CIs) for a longer period of time. Comprehensive longitudinal information on CI reliability is essential for device choice. The aim of this study was to assess the reliability (in children and adults) of the latest generation of the Digisonic® SP CI launched in 2006 by Neurelec. Failure rate (FR) and cumulative survival rate (CSR) for a 5-year period were calculated. This survey is a multicenter retrospective study. A questionnaire was sent to nine CI centers requesting information about patients implanted with Neurelec Digisonic® SP CIs. FR and CSR over a 5-year period were calculated on this group. Collaborating centers collected data on 672 patients (362 children and 310 adults) implanted between March 2006 and March 2011. The overall rate of explantation was 2.23 % (15 cases): six devices were explanted due to device failure (0.89 %) and nine were explanted for medical reasons (1.34 %). Four patients were lost to follow-up. The CSR at 5 years was 98.51 % on all patients, 98.48 % for children and 98.57 % for adults. FR was 0.97 % for adults and 0.83 % for children. This first independent study that assesses FR and CSR on the current generation of Digisonic® SP CI represents an important resource that can help clinicians and patients during their device choice.

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References

  1. Leigh J, Dettman S, Dowell R, Sarant J (2011) Evidence-based approach for making cochlear implant recommendations for infants with residual hearing. Ear Hear 32(3):313–322

    Article  PubMed  Google Scholar 

  2. ISO_Standard (2000) Implants for surgery—cardiac pacemakers—Part2: reporting of the clinical performance of populations of pulse generators. In: Standard I (ed) 5841/2

  3. Battmer RD, Linz B, Lenarz T (2009) 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 30(4):455–463

    Article  PubMed  Google Scholar 

  4. Brown KD, Connell SS, Balkany TJ, Eshraghi AE, Telischi FF, Angeli SA (2009) Incidence and indications for revision cochlear implant surgery in adults and children. Laryngoscope 119(1):152–157

    Article  PubMed  Google Scholar 

  5. Maurer J, Marangos N, Ziegler E (2005) Reliability of cochlear implants. Otolaryngol Head Neck Surg 132(5):746–750

    Article  PubMed  Google Scholar 

  6. Soli SD, Zheng Y (2010) Long-term reliability of pediatric cochlear implants. Otol Neurotol 31(6):899–901

    Article  PubMed  Google Scholar 

  7. Battmer RD, O’Donoghue GM, Lenarz T (2007) A multicenter study of device failure in European cochlear implant centers. Ear Hear 28(2 Suppl):95S–99S

    Article  PubMed  Google Scholar 

  8. Venail F, Sicard M, Piron JP et al (2008) Reliability and complications of 500 consecutive cochlear implantations. Arch Otolaryngol Head Neck Surg 134(12):1276–1281

    Article  PubMed  Google Scholar 

  9. Battmer RD, Backous DD, Balkany TJ et al (2010) International classification of reliability for implanted cochlear implant receiver stimulators. Otol Neurotol 31(8):1190–1193

    Article  PubMed  Google Scholar 

  10. Balkany TJ, Hodges AV, Buchman CA et al (2005) Cochlear implant soft failures consensus development conference statement. Cochlear Implant Int 6(3):105–122

    Article  CAS  Google Scholar 

  11. Balkany TJ, Hodges AV, Buchman CA et al (2005) Cochlear implant soft failures consensus development conference statement. Otol Neurotol 26(4):815–818

    Article  PubMed  CAS  Google Scholar 

  12. Chung D, Kim AH, Parisier S et al (2010) Revision cochlear implant surgery in patients with suspected soft failures. Otol Neurotol 31(8):1194–1198

    Article  PubMed  Google Scholar 

  13. Kane JK, Mann EA (2007) ENT devices: cochlear implants. In: Brown LS, Bright RA, Tavris DR (eds) Medical device epidemiology and surveillance, Wiley, NY, pp 395–405

  14. McJunkin J, Jeyakumar A (2010) Complications in pediatric cochlear implants. Am J Otolaryngol 31(2):110–113

    Article  PubMed  Google Scholar 

  15. Guevara N, Sterkers O, Bebear JP et al (2010) Multicenter evaluation of the Digisonic SP cochlear implant fixation system with titanium screws in 156 patients. Ann Otol Rhinol Laryngol 119(8):501–505

    PubMed  Google Scholar 

  16. Cote M, Ferron P, Bergeron F, Bussieres R (2007) Cochlear reimplantation: causes of failure, outcomes, and audiologic performance. Laryngoscope 117(7):1225–1235

    Article  PubMed  Google Scholar 

  17. Cullen RD, Fayad JN, Luxford WM, Buchman CA (2008) Revision cochlear implant surgery in children. Otol Neurotol 29(2):214–220

    Article  PubMed  Google Scholar 

  18. Yu KC, Hegarty JL, Gantz BJ, Lalwani AK (2001) Conservative management of infections in cochlear implant recipients. Otolaryngol Head Neck Surg 125(1):66–70

    Article  PubMed  CAS  Google Scholar 

  19. Ray J, Gibson W, Sanli H (2004) Surgical complications of 844 consecutive cochlear implantations and observations on large versus small incisions. Cochlear Implants Int 5(3):87–95

    Article  PubMed  Google Scholar 

  20. Cohen NL (1995) Medical and surgical perspectives: issues in treatment and management of severe and profound hearing impairment. Ann Otol Rhinol Laryngol Suppl 166:149–150

    PubMed  CAS  Google Scholar 

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The authors declare that they have no conflict of interest.

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Correspondence to Luminiţa Rădulescu.

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Rădulescu, L., Cozma, S., Niemczyk, C. et al. Multicenter evaluation of Neurelec Digisonic® SP cochlear implant reliability. Eur Arch Otorhinolaryngol 270, 1507–1512 (2013). https://doi.org/10.1007/s00405-012-2266-2

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  • DOI: https://doi.org/10.1007/s00405-012-2266-2

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