ORIGINAL ARTICLE
IMPLANT STABILITY IN ADULTS AND CHILDREN IMPLANTED WITH NON-PIN OR PIN COCHLEAR IMPLANT VARIANTS: SUCCESS WITH DIFFERENT SURGICAL TECHNIQUES
 
More details
Hide details
1
Department of Otorhinolaryngology, Head and Neck Surgery, Otto Koerner Rostock University Medical Center, Rostock, Germany
2
St Poelten University Hospital, ENT Department, St Poelten, Austria
3
Vienna General Hospital – Medical University Campus, University Hospital of Ear, Nose & Throat Diseases, Vienna, Austria
4
CHU de Rennes, Hôpital Pontchaillou, Service ORL, Rennes, France
5
Helios Klinikum Muenchen West, ENT Department, Munich, Germany
6
Oldenburg University Hospital, ENT Department, Oldenburg, Germany
7
Wuerzburg University Hospital, Hospital of Ear, Nose & Throat Diseases of Wuerzburg University, Wuerzburg, Germany
8
ENT Polyclinic, Klinikum rechts der Isar, Munich Technical University, Munich, Germany
9
Heidelberg University Hospital, ENT Department, Heidelberg, Germany
CORRESPONDING AUTHOR
Robert Mlynski   

Univ-Prof Dr med Robert Mlynski, Department of Otorhinolaryngology, Head and Neck Surgery, Otto Koerner Rostock University Medical Center, Doberaner Str 137-139, D-18057 Rostock, Germany; tel: +49 381 4948301; e-mail: robert.mlynski@med.uni-rostock.de
Publication date: 2020-04-07
 
J Hear Sci 2019;9(2):25–35
 
KEYWORDS
ABSTRACT
Background:
The primary aim of this study was to collect information on the surgical procedures used to implant two cochlear implant variants (non-pin and pin: Concerto and Concerto Pin from Med-El) in adults and children and to assess their medium-term stability. A secondary aim was to assess the safety of these variants, both of which permit a minimally invasive surgical protocol to be used. The pin variant has greater flexibility in positioning and fixing of the implant, with the pins ensuring implant stability; also it requires less or no drilling and no tie-down sutures.

Materials and Methods:
Non-pin and pin cochlear implant variants (Concerto and Concerto Pin from Med-El) were implanted in adults and children (n = 116) in 5 clinics. The different surgical techniques and methods of implant fixation were documented intraoperatively. Implant stability was subjectively assessed at first fitting and again approximately 3 and 6 months later. Safety was assessed based on the number and severity of adverse events.

Results:
With all non-pin variants suture fixation was always performed, but with the pin variant this was done for just 43% of adults and 49% of children (in the remainder, no additional fixation was performed). The study demonstrated the stability of both cochlear implant variants in children and adults, with no shifting or rocking observed. There were 33 adverse events reported during the study, 10 of which (9%) were classified as related to the device or procedure.

Conclusions:
Implant stability and safety can be achieved through various surgical techniques and fixation methods when implanting either the Concerto or Concerto Pin.

 
REFERENCES (19)
1.
Davis BM, Labadie RF, McMenomey SO, Haynes DS. Cochlear implant fixation using polypropylene mesh and titanium screws. Laryngoscope, 2004;114 (12): 2116-8.
 
2.
Mangus B, Rivas A, Tsai BS, Haynes DS, Roland JT. Surgical techniques in cochlear implants. Otolaryngol Clin North Am, 2012; 45 (1): 69-80.
 
3.
Mlynski R, Rak K, Kaulitz S, Kraus F, Hagen R, Radeloff A. New bone and fibrous tissue formation around ceramic cochlear implant receiver–stimulators and the measurement of their anchorage in the bony implant bed. Cochlear Implants Int, 2014; 15(6): 327-32.
 
4.
Stark T, Niedermeyer HP, Knopf A, Sudhoff H. Surgical technique for implantation of the MED-EL SONATA TI. ORL J Otorhinolaryngol Relat Spec, 2011; 73(4): 196-200.
 
5.
Balkany TJ, Whitley M, Shapira Y, et al. The temporalis pocket technique for cochlear implantation: an anatomic and clinical study. Otol Neurotol, 2009; 30(7): 903-7.
 
6.
Davids T, Ramsden JD, Gordon KA, James AL, Papsin BC. Soft tissue complications after small incision pediatric cochlear implantation. Laryngoscope, 2009; 119(5): 980-3.
 
7.
Lee DJ, Driver MS. Cochlear implant fixation using titanium screws. Laryngoscope, 2005; 115(5): 910-11.
 
8.
Djalilian HR, King T, Faust RA, Smith S, Levine SC. Securing cochlear implants to the skull: two alternate methods. Ear Nose Throat J, 2001; 80(3): 171-3.
 
9.
Adunka OF, Buchman CA. Cochlear implant fixation in children using periosteal sutures. Otol Neurotol, 2007; 28(6): 768-70.
 
10.
Sweeney AD, Carlson ML, Valenzuela CV, et al. 228 cases of cochlear implant receiver–stimulator placement in a tight subperiosteal pocket without fixation. Otolarnygol Head Neck Surg, 2015; 152(4): 712-7.
 
11.
Gekeler J, Luers JC, Lang-Roth R, Beutner D. Cochlear implant fixation: are sutures really necessary? Eur Arch Otorhinolaryngol, 2013; 270(2): 483-7.
 
12.
Loh C, Jiang D, Dezso A, Fitzgerald O’Connor A. Non-sutured fixation of cochlear implants using a minimally-invasive approach. Clin Otolaryngol, 2008; 33(3): 259-61.
 
13.
O’Donoghue GM, Nikolopoulos TP. Minimal access surgery for pediatric cochlear implantation. Otol Neurotol, 2002; 23(6): 891-4.
 
14.
Schnabl J, Wolf-Magele A, Pok SM, Url C, Zorowka P, Sprinzl G. Evaluation of a minimally invasive surgical fixation technique for young children with the Concerto Pin cochlear implant system. Eur Arch Otorhinolaryngol, 2015; 272(8): 1893-8.
 
15.
Kanonidou Z, Karystianou G. Anesthesia for the elderly. Hippokratia, 2007; 11(4): 175-177.
 
16.
Mueller J, Baumgartner W-D, Godey B, et al. The MED-EL SONATA TI 100 cochlear implant: an evaluation of its safety in adults and children. Acta Otolaryngol, 2011; 131(5): 504-11.
 
17.
Schnabl J, Markl A, Hormann R, Wolf-Magele A, Schartinger V, Sprinzl G. Concerto Pin: a novel concept of cochlear implant fixation. Otol Neurotol, 2012; 33(9): 1525-9.
 
18.
Postelmans JT, Cleffken B, Stokroos RJ. Post-operative complications of cochlear implantation in adults and children: five years’ experience in Maastricht. J Laryngol Otol, 2007; 121(4): 318-23.
 
19.
Arnoldner C, Baumgartner WD, Gstoettner W, Hamzavi J. Surgical considerations in cochlear implantation in children and adults: a review of 342 cases in Vienna. Acta Otolaryngol, 2005; 125(3): 228-34.