Zusammenfassung
Laser-Doppler-vibrometrische (LDV-)Messungen an humanen Felsenbeinen stellen das Standardverfahren zur Vorhersage der Leistungsfähigkeit von aktiven Mittelohrimplantaten (AMEI) dar und werden als präklinische Versuche in der Entwicklung, im Zulassungsprozess, in der Weiterentwicklung und Indikationserweiterung von AMEI eingesetzt. Die optimale Ankopplung des Schallwandlers an bewegliche Strukturen des Mittel- bzw. Innenohrs ist ausschlaggebend für die Leistung des Implantats bzw. die Hörverbesserung für den Patienten. Die Cochlea kann dabei über das ovale Fenster (Vorwärtsstimulation) oder das runde Fenster (Rückwärtsstimulation) angeregt werden. Für die Vorwärtsstimulation definiert die internationale Norm der American Society for Testing and Materials (ASTM F2504-05) ein Verfahren, das die physiologisch normale Funktion der im Versuch verwendeten Felsenbeine sicherstellt. Für die Rückwärtsübertragung, bei der der Zustand der Felsenbeine noch kritischer ist, fehlt eine vergleichbare Standardmethode. Eine entsprechende Präparation und Aufbewahrung der humanen Felsenbeine sowie ein hinsichtlich Kalibrierung, Reproduzierbarkeit von Messpositionen und -winkeln geeigneter LDV-Versuchsaufbau liefern Ergebnisse, die zum einen den Vergleich verschiedener Ankopplungsarten ermöglichen und zum anderen sehr gut mit klinischen Daten korrelieren.
Abstract
Laser Doppler vibrometric (LDV) measurements on human temporal bones represent the standard method for predicting the performance of active middle ear implants (AMEI) and are used as preclinical tests in the development, approval process, and indication expansion of AMEI. The quality of the coupling of the floating mass transducer to the mobile structures of the middle ear is decisive for the performance of the implant and patients’ hearing perception. The cochlea can be stimulated via the oval window (forward stimulation) or the round window (reverse stimulation). For forward stimulation, the ASTM standard F2504-05 defines a method to ensure physiologically normal properties of the temporal bones used in the experiments. For reverse stimulation, which depends even more critically on the quality of the temporal bone, a comparable standard method is lacking. Appropriate preparation and storage of the human petrous bone as well as suitable LDV test setups with respect to calibration and reproducibility of measuring positions and angles provide results that allow a comparison of different types of coupling and also correlate well with clinical data.
Abbreviations
- AMEI:
-
Aktives Mittelohrimplantat
- ASTM:
-
American Society for Testing and Materials
- FMT:
-
Floating Mass Transducer
- LDV:
-
Laser-Doppler-Vibrometer
- SP-Coupler:
-
Short-Process-Coupler
- VORP:
-
Vibrating Ossicular Replacement Prosthesis
- VSB:
-
Vibrant SoundBridge
Literatur
Alberty J, Filler TJ, Schmäl F, Peuker ET (2002) Thiel method fixed cadaver ears. A new procedure for graduate and continuing education in middle ear surgery. HNO 50(8):739
Arnold A, Stieger C, Candreia C, Pfiffner F, Kompis M (2010) Factors improving the vibration transfer of the floating mass transducer at the round window. Otol Neurotol 31(1):122–128
Baumgartner WD, Böheim K, Hagen R, Müller J, Lenarz T, Reiss S, Opie J (2010) The vibrant soundbridge for conductive and mixed hearing losses: European multicenter study results. Adv Otorhinolaryngol 69:38–50
Beleites T, Neudert M, Bornitz M, Zahnert T (2014) Sound transfer of active middle ear implants. Otolaryngol Clin North Am 47(6):859–891
Chien W, Ravicz ME, Merchant SN, Rosowski JJ (2006) The effect of methodological differences in the measurement of stapes motion in live and cadaver ears. Audiol Neurotol 11(3):183–197
Colletti V, Soli SD, Carner M, Colletti L (2006) Treatment of mixed hearing losses via implantation of a vibratory transducer on the round window: Tratamiento de hipoacusias mixtas con un transductor vibratorio en la ventana redonda. Int J Audiol 45(10):600–608
Cremers CW, O’Connor AF, Helms J, Roberson J, Clarós P, Frenzel H, Orfila D (2010) International consensus on Vibrant Soundbridge® implantation in children and adolescents. Int J Pediatr Otorhinolaryngol 74(11):1267–1269
Fisch U, Cremers WRJ, Lenarz T, Weber B, Babighian G, Uziel AS, Fraysse B (2001) Clinical experience with the Vibrant Soundbridge implant device. Otol Neurotol 22(6):962–972
Fröhlich L, Rahne T, Plontke SK, Oberhoffner T, Dahl R, Mlynski R, Hoth S (2020) Intraoperative quantification of floating mass transducer coupling quality in active middle ear implants: a multicenter study. Eur Arch Otorhinolaryngol. https://doi.org/10.1007/s00405-020-06313-z
Grossöhmichen M, Waldmann B, Salcher R, Prenzler N, Lenarz T, Maier H (2017) Validation of methods for prediction of clinical output levels of active middle ear implants from measurements in human cadaveric ears. Sci Rep 7(1):1–10
Hato N, Stenfelt S, Goode RL (2003) Three-dimensional stapes footplate motion in human temporal bones. Audiol Neurotol 8(3):140–152
Jenkins HA, Atkins JS, Horlbeck D, Hoffer ME, Balough B, Alexiades G, Garvis W (2008) Otologics fully implantable hearing system: phase I trial 1‑year results. Otol Neurotol 29(4):534–541
Lenarz T, Zimmermann D, Maier H, Busch S (2018) Case report of a new coupler for round window application of an active middle ear implant. Otol Neurotol 39(10):e1060–e1063
Mlynski R, Dalhoff E, Heyd A, Wildenstein D, Hagen R, Gummer AW, Schraven SP (2015) Reinforced active middle ear implant fixation in incus vibroplasty. Ear Hear 36(1):72–81
Mlynski R, Mueller J, Hagen R (2010) Surgical approaches to position the vibrant soundbridge in conductive and mixed hearing loss. Oper Tech Otolaryngol Head Neck Surg 21(4):272–277
Mosnier I, Sterkers O, Bouccara D, Labassi S, Bebear JP, Bordure P, Lavieille JP (2008) Benefit of the Vibrant Soundbridge device in patients implanted for 5 to 8 years. Ear Hear 29(2):281–284
Müller M, Salcher R, Lenarz T, Maier H (2017) The Hannover coupler: controlled static prestress in round window stimulation with the floating mass transducer. Otol Neurotol 38(8):1186–1192
Nakajima HH, Dong W, Olson ES, Rosowski JJ, Ravicz ME, Merchant SN (2010) Evaluation of round window stimulation using the floating mass transducer by intracochlear sound pressure measurements in human temporal bones. Otol Neurotol 31(3):506–511
Puria S, Maria PL, Perkins R (2016) Temporal-Bone measurements of the maximum equivalent pressure output and maximum stable gain of a light driven hearing system that mechanically stimulates the Umbo. Otol Neurotol 37(2):160–166
Rajan GP, Lampacher P, Ambett R, Dittrich G, Kuthubutheen J, Wood B, Marino R (2011) Impact of floating mass transducer coupling and positioning in round window vibroplasty. Otol Neurotol 32(2):271–277
Ravicz ME, Merchant SN, Rosowski JJ (2000) Effect of freezing and thawing on stapes-cochlear input impedance in human temporal bones. Hear Res 150(1–2):215–224
Rosowski JJ, Chien W, Ravicz ME, Merchant SN (2007) Testing a method for quantifying the output of implantable middle ear hearing devices. Audiol Neurotol 12(4):265–276
Salcher R, Schwab B, Lenarz T, Maier H (2014) Round window stimulation with the floating mass transducer at constant pretension. Hear Res 314:1–9
Schraven SP, Dalhoff E, Wildenstein D, Hagen R, Gummer AW, Mlynski R (2014) Alternative fixation of an active middle ear implant at the short incus process. Audiol Neurotol 19(1):1–11
Schraven SP, Großmann W, Rak K, Shehata-Dieler W, Hagen R, Mlynski R (2016) Long-term stability of the active middle-ear implant with floating-mass transducer technology: a single-center study. Otol Neurotol 37(3):252–266
Schraven SP, Hirt B, Goll E, Heyd A, Gummer AW, Zenner HP, Dalhoff E (2012) Conditions for highly efficient and reproducible round-window stimulation in humans. Audiol Neurotol 17(2):133–138
Schraven SP, Hirt B, Gummer AW, Zenner HP, Dalhoff E (2011) Controlled round-window stimulation in human temporal bones yielding reproducible and functionally relevant stapedial responses. Hear Res 282(1–2):272–282
Schraven SP, Rak K, Cebulla M, Radeloff A, Grossmann W, Hagen R, Mlynski R (2018) Surgical impact of coupling an active middle ear implant to short incus process. Otol Neurotol 39(6):688–692
Shera CA, Zweig G (1992) An empirical bound on the compressibility of the cochlea. J Acoust Soc Am 92(3):1382–1388
Snik A, Cremers CWRJ (2004) Audiometric evaluation of an attempt to optimize the fixation of the transducer of a middle-ear implant to the ossicular chain with bone cement. Clin Otolaryngol Allied Sci 29(1):5–9
Standard ASTM (2014) Strandard of practice for describing system output of Implantable middle ear hearing devices. ASTM Int, West Conshohocken https://doi.org/10.1520/F2504-05
Stenfelt S, Hato N, Goode RL (2004) Fluid volume displacement at the oval and round windows with air and bone conduction stimulation. J Acoust Soc Am 115(2):797–812
Stieger C, Candreia C, Kompis M, Herrmann G, Pfiffner F, Widmer D, Arnold A (2012) Laser doppler vibrometric assessment of middle ear motion in Thiel-embalmed heads. Otol Neurotol 33(3):311–318
Stieger C, Rosowski JJ, Nakajima HH (2013) Comparison of forward (ear-canal) and reverse (round-window) sound stimulation of the cochlea. Hear Res 301:105–114
Todt I, Seidl RO, Gross M, Ernst A (2002) Comparison of different vibrant soundbridge audioprocessors with conventional hearing AIDS. Otol Neurotol 23(5):669–673
Uhler K, Anderson MC, Jenkins HA (2016) Long-term outcome data in patients following one year’s use of a fully implantable active middle ear implant. Audiol Neurotol 21(2):105–112
Wever EG, Lawrence M (1950) The acoustic pathways to the cochlea. J Acoust Soc Am 22(4):460–467
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S.P. Schraven, D. Dohr, N.M. Weiss, R. Mlynski und E. Dalhoff geben an, dass kein Interessenkonflikt besteht.
Für diesen Beitrag wurden von den Autoren keine Studien an Menschen oder Tieren durchgeführt. Für die aufgeführten Studien gelten die jeweils dort angegebenen ethischen Richtlinien.
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Schraven, S.P., Dohr, D., Weiss, N.M. et al. Laser-Doppler-vibrometrische Messungen an humanen Felsenbeinen. HNO 69, 491–500 (2021). https://doi.org/10.1007/s00106-021-00995-5
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DOI: https://doi.org/10.1007/s00106-021-00995-5
Schlüsselwörter
- Laser-Doppler-Vibrometer
- Humane Felsenbeine
- Aktive Mittelohrimplantate
- Vorwärtsübertragung
- Rückwärtsübertragung