DOI: http://dx.doi.org/10.18203/issn.2454-5929.ijohns20212898

Round window versus conventional bony cochleostomy technique in pediatric cochlear implantation; A Randomized controlled double blinded trial.

Shama Shishodia, Dipu Saurav

Abstract


Background: Objective of the study was to investigate the outcomes of cochlear implantation when done via two different techniques namely, the round window or the bony cochleostomy.

Methods: A single-center, double-blinded randomized controlled trial including forty prelingual, bilateral severe to profoundly deaf children less than six years from the year 2014 to 2016 in a tertiary referral center in India were randomly allocated to round window and bony cochleostomy group. Our primary outcome measures were intraoperative neural response telemetry levels, behavioral threshold (t) and comfortable (c) loudness levels. The secondary subjective outcomes were measured via the category of auditory performance (CAP) and the meaningful auditory integration scale (MAIS) score. The cases were followed up for 9 months.

Results: Intra-operative, electrically evoked compound action potentials (ECAP) showed comparable mean thresholds for both the techniques except intermediate electrodes (p~0.04) showed lower values for the round window. Similarly, a lower threshold (p~0.03) and comfortable mean current levels (p~0.03) were noticed for the round window group at 6 months post-implantation. Secondary speech perception outcome scores measured via category of auditory performance (CAP) and MAIS score were comparable. 

Conclusions: The round window insertion technique has physiological benefit as compared to the bony cochleostomy as evidenced by better stimulation levels in the intermediate electrodes and lower mean threshold and comfortable levels in the round window with more beneficial peri-modiolar position of electrode arrays. However, comparable speech perception outcomes revealed no clinical benefit in the cochlear implant performance depending on the technique of electrode insertion. 


Keywords


Cochlear implantation, Round window cochleostomy, Bony cochleostomy, Neural response telemetry

Full Text:

PDF

References


Tucci DL, Merson MH, Wilson BS. A summary of the literature on global hearing impairment: Current status and priorities for action, Otol. Neurotol. 2010;31(1):31-41.

Oziębło D, Obrycka A, Lorens A, Skarżyński H, Ołdak M. Cochlear Implantation Outcome in Children with DFNB1 locus Pathogenic Variants, J. Clin. Med. 2020; 9(1):228.

Shearer AE, Hildebrand MS, Smith RJ. Hereditary Hearing Loss and Deafness Overview. GeneReviews. 1993.

Deltenre P, Van Maldergem L. Hearing loss and deafness in the pediatric population: Causes, diagnosis, and rehabilitation, in: Handb. Clin Neurol. 2013;113:1527-38.

Paludetti G, Conti G, DI Nardo W, De Corso E, Rolesi R, Picciotti PM et al. Infant hearing loss: from diagnosis to therapy Official Report of XXI Conference of Italian Society of Pediatric Otorhinolaryngology. Acta Otorhinolaryngol Ital. 2012;32(6):347-70.

Van Zon A, Smulders YE, Stegeman I, Ramakers GGJ, Kraaijenga VJC, Koenraads SPC et al. Stable benefits of bilateral over unilateral cochlear implantation after two years: A randomized controlled trial. Laryngoscope. 2017;27(5):1161-8.

Kaplan DM, Puterman M. Pediatric cochlear implants in prelingual deafness: Medium and long-term outcomes. Isr Med Assoc J. 2010;12(2):107-9.

Artières F, Vieu A, Mondain M, Uziel A, Venail F. Impact of early cochlear implantation on the linguistic development of the deaf child. Otol Neurotol. 2009;12(2):107-9.

Finley CC, Holden TA, Holden LK, Whiting BR, Chole RA, Neely GJ. Skinner, Role of electrode placement as a contributor to variability in cochlear implant outcomes. Otol Neurotol. 2008;29(7):920-8.

Addams-Williams J, Munaweera L, Coleman B, Shepherd R, Backhouse B. Cochlear implant electrode insertion: in defence of cochleostomy and factors against the round window membrane approach. Cochlear Implants Int. 2011;12(2):S36-9.

Roland PS, Wright CG, Isaacson B. Cochlear implant electrode insertion: The round window revisited, Laryngoscope. 2007;117(8):1397-402.

Thai-Van H, Chanal JM, Coudert C, Veuillet E, Truy E, Collet L. Relationship between NRT measurements and behavioral levels in children with the Nucleus 24 cochlear implant may change over time: Preliminary report. Int J Pediatr Otorhinolaryngol. 2001;58(2):153-62.

Al Muhaimeed H, Al Anazy F, Hamed O, Shubair E. Correlation between NRT measurement level and behavioral levels in pediatrics cochlear implant patients. Int J Pediatr Otorhinolaryngol. 2010.

Cuda D, Murri A. Assessment of cochlear trauma and telemetry measures after cochlear implantation: A comparative study between Nucleus® CI512 and CI532 electrode arrays. Audiol Res. 2019.

Incerti PV, Ching TYC, Hou S, Van Buynder P, Flynn C, Cowan R. Programming characteristics of cochlear implants in children: effects of aetiology and age at implantation. Int J Audiol. 2018;1-14.

Umat C, Hufaidah KS, Azlizawati AR. Auditory functionality and early use of speech in a group of pediatric cochlear implant users. Med J Malaysia. 2010;65(1):7-13.

Kameswaran M, Raghunandhan S, Natarajan K, Basheeth N. Clinical audit of outcomes in cochlear implantation an Indian experience. Indian J Otolaryngol Head Neck Surg. 2006;58(1):69-73.

Hamerschmidt R, Schuch LH, Rezende RK, Wiemes GRM, de Oliveira AKP, Mocellin M. A comparison between neural response telemetry via cochleostomy or the round window approach in cochlear implantation. Braz J Otorhinolaryngol. 2012;78(4):71-5.

Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. BMJ. 2010;8:18.

Mohammed A, Sarwat S. The side of cochlear implantation and speech intelligibility in pediatric and adult cochlear implantees. Egypt J Otolaryngol. 2014;30:362-66.

Poley M, Overmyer E, Craun P, Holcomb M, Reilly B, White D et al. Does pediatric cochlear implant insertion technique affect intraoperative neural response telemetry thresholds? Int J Pediatr Otorhinolaryngol. 2015;30(99):185-8.

Paprocki A, Biskup B, Kozłowska K, Kuniszyk A, Bien D, Niemczyk K. The topographical anatomy of the round window and related structures for the purpose of cochlear implant surgery. Folia Morphol. 2004;63(3):309-12.

Adunka O, Unkelbach MH, Mack M, Hambek M, Gstoettner W, Kiefer J. Cochlear implantation via the round window membrane minimizes trauma to cochlear structures: A histologically controlled insertion study. Acta Otolaryngol. 2004;124(7):807-12.

Connor CMD, Craig HK, Raudenbush SW, Heavner K, Zwolan TA. The age at which young deaf children receive cochlear implants and their vocabulary and speech-production growth: Is there an added value for early implantation? Ear Hear. 2006;27(6):628-44.

Duchesne L. Can Age at Cochlear Implantation Predict Learning and Cognitive Abilities? Hear J. 2019;28(3):1318-34.

Kileny PR, Zwolan TA, Ashbaugh C. The influence of age at implantation on performance with a cochlear implant in children Otol Neurotol. 2001;22(1):42-6.

Archbold S, Sach T, O’Neill C, Lutman M, Gregory S. Outcomes from cochlear implantation for child and family: Parental perspectives. Deaf Educ Int. 2008;10(3):120-142.

Percy-Smith L, Cayé-Thomasen P, Gudman M, Jensen JH, Thomsen J. Self-esteem and social well-being of children with cochlear implant compared to normal-hearing children. Int J Pediatr Otorhinolaryngol. 2008;72(7):1113-20.

Martines F, Martines E, Ballacchino A, Salvago P. Speech perception outcomes after cochlear implantation in prelingually deaf infants: The Western Sicily experience. Int J Pediatr Otorhinolaryngol. 2013.01:023.

Govaerts PJ, De Beukelaer, Daemers K, De Ceulaer G, Yperman M, Somers T et al. Outcome of cochlear implantation at different ages from 0 to 6 years, Otol. Neurotol. 2002;129492.

Papsin BC. Cochlear Implantation in Children With Anomalous Cochleovestibular Anatomy. Laryngoscope. 2005;1097.

Mittmann P, Rademacher G, Mutze S, Hassepass F, Ernst A, Todt I. Evaluation of the relationship between the NRT-Ratio, cochlear anatomy, and insertions depth of perimodiolar cochlear implant electrodes. Biomed Res Int. 2015;706253.

Rajati M, Ghassemi MM, Bakhshaee M, Tale MR, Tayarani H. Effect of stylet removal on neural response telemetry and stapedial reflex thresholds during cochlear implantation, Auris Nasus Larynx. 2014;1016:10.015.

Telmesani LM, Said NM. Effect of cochlear implant electrode array design on auditory nerve and behavioral response in children. Int J Pediatr Otorhinolaryngol. 2015;8.

Andrade C. Internal, external, and ecological validity in research design, conduct, and evaluation Indian J Psychol Med. 2018;4103.

Briggs RJS, Tykocinski M, Xu J, Risi F, Svehla M, Cowan R et al. Comparison of round window and cochleostomy approaches with a prototype hearing preservation electrode, in: Audiol Neurotol. 2006;5613.

Jiam NT, Jiradejvong P, Pearl MS, Limb CJ. The effect of round Windowvs cochleostomy surgical approaches on cochlear implant electrode position a flat-panel computed tomography study. JAMA Otolaryngol Head Neck Surg. 2016;1512.

Saunders E, Cohen L, Aschendorff A, Shapiro W, Knight M, Stecker M et al. Threshold, comfortable level and impedance changes as a function of electrode-modiolar distance. Ear Hear. 2002;1097

Christov F, Munder P, Berg L, Bagus H, Lang S, Arweiler-Harbeck D. ECAP analysis in cochlear implant patients as a function of patient’s age and electrode-design. Eur Ann Otorhinolaryngol Head Neck Dis. 2016;15.

Hughes ML, Vander Werff KR, Brown CJ, Abbas PJ, Kelsay DMR, Teagle MFB et al. A longitudinal study of electrode impedance, the electrically evoked compound action potential, and behavioral measures in nucleus 24 cochlear

Di Nardo W, Ippolito S, Quaranta N, Cadoni G, Galli J. Correlation between NRT measurement and behavioural levels in patients with the Nucleus 24 cochlear implant. Acta Otorhinolaryngol Ital. 2003;23(5):352-5.

Karatas E, Aud MD, Baglam T, Durucu C, Baysal E, Kanlikama M. Intraoperative electrically evoked stapedius reflex thresholds in children undergone cochlear implantation: Round window and cochleostomy approaches. Int J Pediatr Otorhinolaryngol. 2011;16:2.

Bakhshaee M, Ghasemi MM, Shakeri MT, Razmara N, Tayarani H, Tale MR. Speech development in children after cochlear implantation. Eur Arch Oto-Rhino-Laryngol. 2007;10:1007:1.

Zhong Y, Xu T, Dong R, Lyu J, Liu B, Chen X. The analysis of reliability and validity of the IT-MAIS, MAIS and MUSS, Int. J. Pediatr. Otorhinolaryngol. 2017;101:2017.

Santos JRA. Cronbach’s alpha: A tool for assessing the reliability of scales. J Ext. 1999.

Lim CR, Harris K, Dawson J, Beard DJ, Fitzpatrick R, Price AJ. Floor and ceiling effects in the OHS: An analysis of the NHS PROMs data set. BMJ Open. 2015;1136:007765.

Kang BJ, Kim AH. Comparison of cochlear implant performance after round window electrode insertion compared with traditional cochleostomy, in: Otolaryngol. Head Neck Surg. (United States). 2013;1177:1945.

Zhou H, Chen Z, Shi H, Wu Y, Yin S. Categories of Auditory Performance and Speech Intelligibility Ratings of Early-Implanted Children without Speech Training, PLoS One. 2013;10:1371.

Robbins AMC, Koch DB, Osberger MJ, Zimmerman-Phillips S, Kishon-Rabin L. Effect of Age at Cochlear Implantation on Auditory Skill Development in Infants and Toddlers, in: Arch. Otolaryngol. 2004;10:1001.

Naderpour M, Aminzadeh Z, Moghaddam YJ, Pourshiri B, Ariafar A, Akhondi A. Comparison of the pediatric cochlear implantation using round window and cochleostomy. Iran J Otorhinolaryngol. 2020;22038.

Santa Maria PL, Gluth MB, Yuan Y, Atlas MD, Blevins NH. Hearing preservation surgery for cochlear implantation: A meta-analysis. Otol Neurotol. 2014;1097.

Hamada S, Omara A, Sefein I, Younes A. The impact of electrode type on intraoperative and postoperative telemetry measures in cochlear implant using different surgical technique. Egypt J Otolaryngol. 2016;4103:1012-5574

Cheng X, Wang B, Liu Y, Yuan Y, Shu Y, Chen B. Comparable electrode impedance and speech perception at 12 months after cochlear implantation using round window versus cochleostomy: An analysis of 40 patients. ORL. 2018;80(5-6):248-58.

Korsager LEH, Schmidt JH, Faber C, Wanscher JH. Vestibular Outcome after Cochlear Implantation Is Not Related to Surgical Technique: A Double Blinded, Randomized Clinical Trial of Round Window Approach Versus Cochleostomy. Otol Neurotol. 2018;1097-1695.

Jiam NT, Limb CJ. The impact of round window vs cochleostomy surgical approaches on interscalar excursions in the cochlea: Preliminary results from a flat-panel computed tomography study. World J Otorhinolaryngol. Head Neck Surg. 2016;07:001.

Fan X, Xia M, Wang Z, Zhang H, Liu C, Wang N et al. Comparison of electrode position between round window and cochleostomy inserting approaches among young children: a cone-beam computed tomography study, Acta Otolaryngol. 2018;1478127.

Nayak BK. Understanding the relevance of sample size calculation. Indian J Ophthalmol. 2010;58(6):469-70.

Unverzagt S, Prondzinsky R, Peinemann F. Single-center trials tend to provide larger treatment effects than multicenter trials: A systematic review. J Clin Epidemiol. 2013;66(11):1271-80.