Device profile of the MED-EL cochlear implant system for hearing loss: overview of its safety and efficacy

References

• MED-EL I Cochlear implant reliability [Internet]. [cited 2020 Feb 9] Available from: https://www.medel.com/en-gb/hearing-solutions/cochlear-implants/reliability
   Google Scholar
• Quintern J, Jaeger RJ, Baumann U. Neural prostheses. In:  Brandt T, Caplan LR,  Dichgans J,  Diener HC, Kennard C, editors. Neurological disorders. San Diego, CA: Academic Press; 2003. p. 1199–1219.
   Google Scholar
• Wilson BS The remarkable cochlear implant and possibilities for the next large step forward [Internet]. [cited 2020 Feb 21]. Available from: https://acousticstoday.org/the-remarkable-cochlear-implant-and-possibilities-for-the-next-large-step-forward-blake-s-wilson/
   Google Scholar
• MED-EL. About MED-EL: our timeline [Internet]. [cited 2020 Feb 21]. Available from: https://www.medel.com/en-gb/about-medel/our-history
   Google Scholar
• Bahmer A, Adel Y, Baumann U. Preventing facial nerve stimulation by triphasic pulse stimulation in cochlear implant users: intraoperative recordings. Otol Neurotol. 2017;38:e438–e444.
   PubMed Web of Science ®Google Scholar
• Bahmer A, Baumann U. The underlying mechanism of preventing facial nerve stimulation by triphasic pulse stimulation in cochlear implant users assessed with objective measure. Otol Neurotol. 2016;37:1131–1137.
   PubMed Web of Science ®Google Scholar
• Bahmer A, Baumann U. Effects of electrical pulse polarity shape on intra cochlear neural responses in humans: triphasic pulses with cathodic second phase. Hear Res. 2013;306:123–130.
   PubMed Web of Science ®Google Scholar
• Leinung M, Loth A, Gröger M, et al. Cochlear implant magnet dislocation after MRI: surgical management and outcome. Eur Arch Otorhinolaryngol. 2020;277:1297–1304.
   PubMed Web of Science ®Google Scholar
• MED-EL medical electronics. SYNCHRONY surgical guideline [Internet]. Innsbruck. [cited 2020 Feb 21]. Available from: https://s3.medel.com/documents/AW/AW32151_30_Surgical%20Guideline%20SYNCHRONY%20-%20EN%20English_Web.pdf
   Google Scholar
• MED-EL medical electronics. Important safety information [Internet]. [cited 2020 Feb 23]. Available from: https://www.medel.com/en-gb/important-safety-information
   Google Scholar
• Muehloecker C, Nielsen SB, Jaeger A. Using the insertion test device for choosing the best suited cochlear implant electrode variant. Int Congress Series. 2004;1273:101–104.
   Google Scholar
• MED-EL Medical Electronics. Electrode arrays: designed for atraumatic implantation providing superior hearing performance [Internet]. [cited 2020 Feb 21]. Available from: https://s3.medel.com/pdf/21617.pdf
   Google Scholar
• Dazert S, Thomas JP, Buchner A, et al. Off the ear with no loss in speech understanding: comparing the RONDO and the OPUS 2 cochlear implant audio processors. Eur Arch Otorhinolaryngol. 2017;274:1391–1395.
   PubMed Web of Science ®Google Scholar
• Ilberg CA, Von, Baumann U, Kiefer J, et al. Electric-acoustic stimulation of the auditory system: A review of the first decade. Audiol Neuro Otol. 2011;16(Suppl 2):1–30.
   Google Scholar
• Food and drug administration. Summary of safety and effectiveness data: PMA P000025/S084: [Internet]. Silver Spring, MD; 2016 [cited 2020 Feb 21]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf/p000025s084b.pdf
   Google Scholar
• MED-EL Medical Electronics. SONNET (Me1310) and SONNET EAS (Me1320) audio processors: user manual [Internet]. Innsbruck. Available from: https://cochlearimplanthelp.files.wordpress.com/2019/05/med-el-sonnet-2-user-manual.pdf
   Google Scholar
• MED-EL Medical Electronics. Accessories: waterWear [Internet]. [cited 2020 Feb 21]. Available from: https://www.medel.com/en-gb/hearing-solutions/accessories/waterwear
   Google Scholar
• Zierhofer CM, inventor; MED-EL Elektromedizinische Geräte GmbH Innsbruck (AT), assignee. Multichannel cochlear implant with neural response telemetry. United States Patent US 6,600,955 B1. 2003 Jul 29.
   Google Scholar
• Zeng F-G, Rebscher S, Harrison W, et al. Cochlear implants: system design, integration, and evaluation. IEEE Rev Biomed Eng. 2008;1:115–142.
   PubMedGoogle Scholar
• Strahl SB, Dierker A, Spitzer P, et al. AutoART – A system for automatic determination of eCAP thresholds. In: Rahne T, editor Proceedings of the 21. Annual Meeting of the German Audiological Society; Halle a.d.S.; 2018.
   Google Scholar
• Wilson BS, Finley CC, Lawson DT, et al. Design and evaluation of a continuous interleaved sampling (CIS) processing strategy for multichannel cochlear implants. J Rehabil Res Dev. 1993;30:110–116.
   PubMed Web of Science ®Google Scholar
• Zierhofer CM, inventor; MED-EL Elektromedizinische Geräte GmbH Innsbruck (AT), assignee. Electrical nerve stimulation based on channel specific sampling sequences. United States Patent US 6,594,525 B1. 2003 Jul 15.
   Google Scholar
• Müller J, Brill S, Hagen R, et al. Clinical trial results with the MED-EL fine structure processing coding strategy in experienced cochlear implant users. ORL J Otorhinolaryngol Relat Spec. 2012;74:185–198.
   PubMed Web of Science ®Google Scholar
• Kleine Punte A, de Bodt M, van de Heyning PH. Long-term improvement of speech perception with the fine structure processing coding strategy in cochlear implants. ORL J Oto-Rhino-Lary. 2014;76:36–43.
   PubMed Web of Science ®Google Scholar
• Riss D, Hamzavi J-S, Blineder M, et al. FS4, FS4-p, and FSP: a 4-month crossover study of 3 fine structure sound-coding strategies. Ear Hear. 2014;35:e272–81.
   PubMed Web of Science ®Google Scholar
• Zierhofer CM, Schatzer R. Simultaneous intracochlear stimulation based on channel interaction compensation: analysis and first results. IEEE Trans Biomed Eng. 2008;55:1907–1916.
   PubMed Web of Science ®Google Scholar
• Bader P, Kals M, Schatzer R, et al. Compensation for channel interaction in a simultaneous cochlear implant coding strategy. J Acoust Soc Am. 2013;133:4124–4132.
   PubMed Web of Science ®Google Scholar
• Müller J, Baumgartner W-D, Godey B, et al. The MED-EL SONATATI 100 cochlear implant: an evaluation of its safety in adults and children. Acta Otolaryngol. 2011;131:504–511.
   PubMed Web of Science ®Google Scholar
• Kuzovkov V, Sugarova S, Yanov Y. The Mi1000 CONCERTO PIN cochlear implant: an evaluation of its safety and stability in adults and children. Acta Otolaryngol. 2016;136:236–240.
   PubMed Web of Science ®Google Scholar
• Rader T, Baumann U, Stöver T, et al. Management of cochlear implant electrode migration. Otol Neurotol. 2016;37:e341–8.
   PubMed Web of Science ®Google Scholar
• Leinung M, Helbig S, Adel Y, et al. The effect of a bone groove against cochlear implant electrode migration. Otol Neurotol. 2019;40:e511–e517.
   PubMed Web of Science ®Google Scholar
• Gabrielpillai J, Burck I, Baumann U, et al. Incidence for tip foldover during cochlear implantation. Otol Neurotol. 2018;39:1115–1121.
   PubMed Web of Science ®Google Scholar
• Gifford RH, Stecker GC. Binaural cue sensitivity in cochlear implant recipients with acoustic hearing preservation. Hear Res. 2020;390:107929. preprint.
   PubMed Web of Science ®Google Scholar
• Brockmeier SJ, Peterreins M, Lorens A, et al. Music perception in electric acoustic stimulation users as assessed by the. Mu S I C Test Adv Otorhinolaryngol. 2010;67:70–80.
   PubMedGoogle Scholar
• Rader T, Fastl H, Baumann U. Speech perception with combined electric-acoustic stimulation and bilateral cochlear implants in a multisource noise field. Ear Hear. 2013;34:324–332.
   PubMed Web of Science ®Google Scholar
• Helbig S, Adel Y, Leinung M, et al. Hearing preservation outcomes after cochlear implantation depending on the angle of insertion: indication for electric or electric-acoustic stimulation. Otol Neurotol. 2018;39:834–841.
   PubMed Web of Science ®Google Scholar
• Skarzynski H, van de Heyning PH, Agrawal S, et al. Towards a consensus on a hearing preservation classification system. Acta Otolaryngol Suppl. 2013;133:3–13.
   Google Scholar
• Snels C, IntHout J, Mylanus E, et al. Hearing preservation in cochlear implant surgery: a meta-analysis. Otol Neurotol. 2019;40:145–153.
   PubMed Web of Science ®Google Scholar
• Canfarotta MW, Dillon MT, Buss E, et al. Validating a new tablet-based tool in the determination of cochlear implant angular insertion depth. Otol Neurotol. 2019;40:1006–1010.
   PubMed Web of Science ®Google Scholar
• Giardina CK, Brown KD, Adunka OF, et al. Intracochlear electrocochleography. Ear Hear. 2019;40:833–848.
   PubMed Web of Science ®Google Scholar
• Fontenot TE, Giardina CK, Fitzpatrick DC. A model-based approach for separating the cochlear microphonic from the auditory nerve neurophonic in the ongoing response using electrocochleography. Front Neurosci. 2017;11:592.
   PubMed Web of Science ®Google Scholar
• Helbig S, Adel Y, Rader T, et al. Long-term hearing preservation outcomes after cochlear implantation for electric-acoustic stimulation. Otol Neurotol. 2016;37:e353–9.
   PubMed Web of Science ®Google Scholar
• Günther S, Baumann U, Stöver T. Early fitting in cochlear implantation: benefits and limits. Otol Neurotol. 2018;39:e250–e256.
   PubMedGoogle Scholar
• Pals C, Sarampalis A, Beynon A, et al. Effect of spectral channels on speech recognition, comprehension, and listening effort in cochlear-implant users. Trends Hear. 2020;24:1–15.
   Web of Science ®Google Scholar
• Blamey P, Artieres F, Başkent D, et al. Factors affecting auditory performance of postlinguistically deaf adults using cochlear implants: an update with 2251 patients. Audiol Neuro Otol. 2013;18:36–47.
   PubMed Web of Science ®Google Scholar
• Zeh R, Baumann U. Stationäre Rehabilitationsmaßnahmen bei erwachsenen CI-Trägern:  Ergebnisse in Abhängigkeit von der Dauer der Taubheit, Nutzungsdauer und Alter [Inpatient rehabilitation of adult CI users: Results in dependency of duration of deafness, CI experience and age]. HNO. 2015;63:557–576.
   PubMedGoogle Scholar
• Helms J, Müller J, Schön F, et al. Evaluation of performance with the COMBI 40 cochlear implant in adults: a multicentric clinical study. ORL. 1997;59:23–35.
   Google Scholar
• Wimmer W, Weder S, Caversaccio M, et al. Speech intelligibility in noise with a pinna effect imitating cochlear implant processor. Otol Neurotol. 2016;37:19–23.
   PubMed Web of Science ®Google Scholar
• Honeder C, Liepins R, Arnoldner C, et al. Fixed and adaptive beamforming improves speech perception in noise in cochlear implant recipients equipped with the MED-EL SONNET audio processor. PLoS ONE. 2018;13:e0190718.
   PubMed Web of Science ®Google Scholar
• Hagen R, Radeloff A, Stark T, et al. Microphone directionality and wind noise reduction enhance speech perception in users of the MED-EL SONNET audio processor. Cochlear Implants Int. 2020;21:53–65.
   PubMedGoogle Scholar
• Weissgerber T, Stöver T, Baumann U. Speech perception in noise: impact of directional microphones in users of combined electric-acoustic stimulation. PLoS ONE. 2019;14:e0213251.
   PubMed Web of Science ®Google Scholar
• Limb CJ, Roy AT. Technological, biological, and acoustical constraints to music perception in cochlear implant users. Hear Res. 2014;308:13–26.
   PubMed Web of Science ®Google Scholar
• Zeng F-G, Tang Q, Lu T. Abnormal pitch perception produced by cochlear implant stimulation. PLoS ONE. 2014;9:e88662.
   PubMed Web of Science ®Google Scholar
• Rader T, Döge J, Adel Y, et al. Place dependent stimulation rates improve pitch perception in cochlear implantees with single-sided deafness. Hear Res. 2016;339:94–103.
   PubMed Web of Science ®Google Scholar
• Schatzer R, Vermeire K, Visser D, et al. Electric-acoustic pitch comparisons in single-sided-deaf cochlear implant users: frequency-place functions and rate pitch. Hear Res. 2014;309:26–35.
   PubMed Web of Science ®Google Scholar
• Sharma SD, Cushing SL, Papsin BC, et al. Hearing and speech benefits of cochlear implantation in children: A review of the literature. Int J Ped ORL. 2020;133:109984.
   PubMed Web of Science ®Google Scholar
• MED-EL. Zwei sind besser als Eines: 18 Jahre Hören mit zwei CIs [Internet]. cited 2020 May 3. Available from: https://www.youtube.com/watch?v=4lr__rpQglM
   Google Scholar
• van de Heyning PH, Atlas M, Baumgartner W-D, et al. The reliability of hearing implants: report on the type and incidence of cochlear implant failures. Cochlear Implants Int. 2020;21(4):228 -237.
   Google Scholar
• Wang JT, Wang AY, Psarros C, et al. Rates of revision and device failure in cochlear implant surgery: a 30-year experience. Laryngoscope. 2014;124:2393–2399.
   PubMed Web of Science ®Google Scholar
• Lassaletta L, Polak M, Huesers J, et al. Usefulness of electrical auditory brainstem responses to assess the functionality of the cochlear nerve using an intracochlear test electrode. Otol Neurotol. 2017;38:e413–e420.
   PubMed Web of Science ®Google Scholar
• Caversaccio M, Gavaghan K, Wimmer W, et al. Robotic cochlear implantation: surgical procedure and first clinical experience. Acta Otolaryngol. 2017;137:447-454.
   Web of Science ®Google Scholar
• Du X, Brett PN, Zhang Y, et al. A hand-guided robotic drill for cochleostomy on human cadavers. RSRR. 2018;5:13–18.
   Google Scholar