Objective: To evaluate the safety and effectiveness of round window (RW), oval window (OW), CliP and Bell couplers for use with an active middle ear implant. Methods: This is a multicenter, long-term, prospective trial with consecutive enrollment, involving 6 university hospitals in Germany. Bone conduction, air conduction, implant-aided warbletone thresholds and Freiburger monosyllable word recognition scores were compared with unaided preimplantation results in 28 moderate-to-profound hearing-impaired patients after 12 months of follow-up. All patients had previously undergone failed reconstruction surgeries (up to 5 or more). In a subset of patients, additional speech tests at 12 months postoperatively were used to compare the aided with the unaided condition after implantation with the processor switched off. An established quality-of-life questionnaire for hearing aids was used to determine patient satisfaction. Results: Postoperative bone conduction remained stable. Mean functional gain for all couplers was 37 dB HL (RW = 42 dB, OW = 35 dB, Bell = 38 dB, CliP = 27 dB). The mean postoperative Freiburger monosyllable score was 71% at 65 dB SPL. The postimplantation mean SRT 50 (speech reception in quiet for 50% understanding of words in sentences) improved on average by 23 dB over unaided testing and signal-to-noise ratios also improved in all patients. The International Outcome Inventory for Hearing Aids (IOI-HA) quality-of-life questionnaire was scored very positively by all patients. Conclusion: A significant improvement was seen with all couplers, and patients were satisfied with the device at 12 months postoperatively. These results demonstrate that an active implant is an advantage in achieving good hearing benefit in patients with prior failed reconstruction surgery.

Rapid implementation of universal newborn hearing screening programs has exposed a need for a reliable test of middle ear function for timely identification of middle ear pathology and for differentiation between true sensorineural and conductive hearing losses. Use of higher probe tone frequencies for the assessment of immitance measures have proven to be more reliable and accurate in identifying MEE in infants. However a lack of classification-guidelines and age specific normative data exists. This study investigated the characteristics and normative values of high frequency tympanometric and acoustic reflex results for infants (n = 936 ears). Participants were 510 infants (262 male, 248 female) aged 0 – 12 months (mean age = 12.8 weeks) recruited from primary health care and immunization clinics in a South African community. A three-part procedure was performed on each test ear: 1) OAEs were recorded and pass results served as control variable for normal middle ear functioning; 2) 1000 Hz probe tone admittance, susceptance and conductance tympanograms were recorded and analysed in terms of shape, tympanometric peak pressure and maximum (peak) admittance; 3) 1000 Hz probe tone acoustic reflexes, measured with a 1000 Hz ipsilateral stimulus, were recorded and thresholds determined. Significant associations were observed between tympanogram shape, and OAE pass or fail results. 93% of ears with an OAE pass result displayed peaked tympanograms, while 79% of ears with absent OAE’s displayed flat tympanograms. Single peaked tympanograms were recorded in 782 ears (84%), double peaked tympanograms in 41 (4%) ears and flat sloping tympanograms in 112 (12%) ears. Admittance (Ya) tympanograms for the total sample displayed a mean admittance value of 2.9 mmho, with a standard deviation of 1.1 mmho. The 90th percent range was determined at 1.5 mmho (5th percentile) to 4.9 mmho (95th percentile). Mean tympanometric peak pressure in Ya tympanograms was 0.1 daPa, with a standard deviation of 61 daPa. The 90th percent range was -110 daPa to 90 daPa for the 5th and 95th percentiles respectively. Gender specific norms indicated a higher admittance for male ears. Age specific norms indicate a gradual increase in admittance indicating the need for age specific normative classification systems. Ipsilateral 1000 Hz stimuli acoustic reflex measurement proved successful with a 1000 Hz probe tone and present reflexes were recorded in 84% of ears tested. Significant association between acoustic reflex presence, OAE pass and peaked tympanogram results were observed. The normative tympanometric values derived from the cohort may serve as a guide for identification of middle ear effusion in neonates. High frequency tympanometry in combination with acoustic reflexes proves a useful measure for verifying middle ear functioning in young infants. / Dissertation (M (Communication Pathology))--University of Pretoria, 2006. / Speech-Language Pathology and Audiology / M (Communication Pathology) / unrestricted

Although the Vibrant Soundbridge is one of the most frequently used active middle ear implants, data regarding how middle ear ventilation disorders may affect the transmission behavior of its floating mass transducer are still insufficient. Studies involving coupling the floating mass transducer to the stapes head are particularly lacking. This temporal bone study evaluated the influence of simulated middle ear ventilation disorders on the middle ear transfer function in the reconstructed middle ear. The middle ear transfer function was measured using Laser Doppler Vibrometry after vibroplasty onto the stapes head, with or without tympanic membrane reconstruction. Middle ear ventilation disorders were simulated through changes in static pressure via the external ear channel with a maximum pressure of þ3 kPa. Slice thickness of tympanic membrane reconstruction material was measured using micro-CT. When the reconstructed ossicular chain and the reconstructed tympanic membrane were mechanically excited by the floating mass transducer under conditions of ambient static pressure, the transmission behavior was found to be independent of the type of tissue used. Increase in static pressure up to þ3 kPa caused maximum low frequency transmission loss of 15 dB when elastic grafts were used and 5 dB when stiff tissue was inserted. At high frequencies, measured loss of up to 5 dB was relatively independent of the tissue stiffness. Increase in static pressure led to displacement of the tissues towards the vestibulum and caused stiffening, especially of the annular ligament. Stiffening-induced transmission losses were mainly found at low frequencies and could not be compensated by the floating mass transducer in this range. Above 1300 Hz, the continuous force spectrum of the actuator sufficiently protected against loss of amplitude. To minimize postoperative transmission loss due to persisting ventilation disorders, choosing a very stiff tympanic membrane reconstruction material seems to be appropriate.:Inhaltsverzeichnis Abkürzungsverzeichnis V 1 Einleitung 1 1.1 Einführung 1 1.2 Operationen zur Hörverbesserung 2 1.3 Mittelohrimplantate 6 1.4 Belüftungsstörungen des Mittelohres 12 1.5 Fragestellungen, Forschungshypothesen und Zielstellung der Arbeit 18 2 Material und Methoden 20 2.1 Laserdopplervibrometrische Messungen am Felsenbeinpräparat 20 2.2 Untersuchung der Trommelfellersatzmaterialien mittels optischer Messverfahren 3 Ergebnisse 42 3.1 Ermittelung der Trommelfellersatzmaterialdicken und -steifigkeiten mittels optischer Messverfahren 42 3.2 Messung der Mittelohrübertragungsfunktion am Felsenbeinpräparat 62 4 Diskussion 104 4.1 Bestimmung der Trommelfellersatzmaterialdicken und -steifigkeiten mittels optischer Messverfahren 104 4.2 Messung der Mittelohrübertragungsfunktion am Felsenbeinpräparat 110 4.3 Ausblick und Konsequenzen der Untersuchungen zur Paukenminderbelüftung auf die Vibroplastik und die Tympanoplastik Typ III 131 4.4 Funktionelles Hörergebnis nach Implantation einer VSB beim Vorliegen einer Schallleitungsschwerhörigkeit oder kombinierten Schwerhörigkeit 133 4.5 Schlussfolgerung 134

Fragestellung: Mögliche Interaktionen zwischen Mittelohrdruck und Gleichgewichtsstörungen werden seit vielen Jahren diskutiert. Der Rolle der druckausgelösten Trommelfellbewegungen, die bei degenerativ fixierten Ossikelgelenken aufgrund des Hydraulikfaktors eine viel grössere Kraft ausüben als der direkte Druck an den Innenohrfenstern, wurde dabei nur geringe Aufmerksamkeit gewidmet. Patienten und Methodik: Wir untersuchten bei 19 Patienten mit einseitigem Morbus Ménière die durch wechselnde Drucke im äusseren Gehörgang (analog zur Tympanometrie) ausgelösten Interaktionen zwischen Trommelfellauslenkungen und vestibulären Reaktionen in der Elektronystagmographie und in der Posturographie. Ergebnisse und Schlussfolgerungen: Bei schnellen und langsamen Druckwechseln konnten zwischen –600 und +400 daPa weder auf dem gesunden noch auf dem erkrankten Ohr im Elektronystagmogramm Nystagmen nachgewiesen werden. Die posturographische Aufzeichnung der vestibulospinalen Reaktionen auf einer Luzerner Messplatte erwies sich dagegen als sensibler. Die Längenzunahme der Schwankungslinie zeigte bei beiden durchgeführten Druckwechseln auf dem kranken Ohr signifikante Unterschiede gegenüber der Messung bei Reizung des gesunden Ohres. Diese Methode ist somit der klassischen Prüfung des Hennebertschen Fistelsymptoms überlegen. Das vestibulospinale System reagiert möglicherweise empfindlicher als das vestibulookuläre auf Druckschwankungen der Perilymphe. Darüber hinaus könnte der nachgewiesene Zusammenhang der druckausgelösten Trommelfellbewegungen mit cochleovestibulären Symptomen bei einigen Patienten mit M. Ménière den Erfolg einer Paukenröhrcheneinlage erklären, da hiermit aussendruckinduzierte Trommelfellbewegungen und damit verbundene Perilymphschwankungen von vornherein unterbunden werden. / Objectives: Interactions between middle ear pressure and vestibular disturbances have been discussed for many years. Less attention has been paid to the influence of ear drum movements caused by pressure changes in the external auditory meatus. Because of the hydraulic amplification in case of fixed ossicular joints the impact of these movements is bigger than the direct pressure on the internal ear windows. Material and Patients: We examined the interaction between ear drum movements and vestibular reactions caused in the external auditory meatus of 19 patients suffering from unilateral Ménière’s disease. Results and Conclusions: Both fast as well as slow pressure changes between –600 and +400 daPa were not able to induce nystagmus in the electronystagmogram of either the healthy or the damaged ear. Posturographic recordings of the vestibulospinal responses on the ‘Luzerner measuring platform’ were significantly more sensitive. The increase in length of the postural staggering line showed significant differences between the healthy and the damaged ear for fast and for slow pressure changes compared to calibration. In conclusion, the sensitivity of this examination is superior to the classical examination of Hennebert’s fistula symptom. The vestibulospinal system is more sensitive towards pressure changes of the perilymph than the vestibuloocular system. The proven correlation between ear drum movements and internal ear symptomatology could explain the success of the treatment of patients suffering from Ménière’s disease with tympanic grommets. Thus grommets prevent the pressure-induced ear drum movements and avoid perilymph movements induced by pressure changes. / Chez les patients souffrant de la maladie de Ménière, les variations de pression entraıˆnent des mouvements du tympan, influant ainsi sur les réactions vestibulaires. Objectifs: Si l’on s’est longtemps intéressé aux possibles interactions entre la pression de l’oreille moyenne et les troubles de l’équilibre, on a en revanche prêté moins d’attention à l’influence que peuvent exercer les mouvements du tympan dus aux variations de pression dans le conduit auditif externe. Or, lorsque les articulations ossiculaires sont bloquées, l’amplification hydraulique fait que ces mouvements ont un impact plus important que la pression directe exercée aux fenêtres de l’oreille interne. Méthodes et patients: Chez 19 malades souffrant d’un syndrome de Ménière unilatéral, nous avons étudié par ENG et posturographie la relation entre les réactions vestibulaires et les mouvements du tympan que déclenchent les variations de pression dans le conduit auditif externe. Résultats et conclusions: Qu’il s’agisse de variations de pression lentes ou rapides (entre –600 et +400 daPa), de l’oreille saine ou déficiente, l’ENG n’a révélé aucun nystagmus. En revanche, les enregistrements posturographiques des réactions vestibulo-spinales sur la plate-forme de mesure de Lucerne ont été plus sensibles. L’allongement de la courbe de variation a montré des différences significatives entre l’oreille saine et déficiente, que ce soit lors de variations de pression rapides ou lentes. En conclusion, la précision de ce type d’examen se révèle nettement supérieure à celle de l’examen classique du signe de la fistule d’Hennebert (signe d’Hennebert). Le système vestibulo-spinal réagit apparemment de manière plus sensible que le système vestibulo-oculaire aux variations de pression du périlymphe. De plus, la relation que l’on a établie entre les mouvements du tympan dus aux variations de pression et les symptômes vestibulo-cochléaires pourrait expliquer les succès de la pose de diabolos chez certains patients souffrant de la maladie de Ménière. Ces diabolos empêchent les mouvements du tympan liés au changement de pression, évitant ainsi les mouvements du périlymphe. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

In order to get a better insight into the function of the human middle ear it is necessary to simulate its dynamic behaviour by means of the finite-element method. Three-dimensional measurements of the surfaces of the tympanic membrane and of the auditory ossicles malleus, incus and stapes are carried out and geometrical models are created. On the basis of these data, finite-element models are constructed and the dynamic behaviour of the combinations tympanic membrane with malleus in its elastic suspensions and stapes with annular ligament is simulated. Natural frequencies and mode shapes are computed by modal analysis. These investigations showed that the ossicles can be treated as rigid bodies only in a restricted frequency range from 0 to 3.5 kHz. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

Recently, optical coherence tomography (OCT) was utilized in multiple studies for structural and functional imaging of the middle ear and the tympanic membrane. Since Doppler OCT allows both, the spatially resolved measurement of the tympanic membrane oscillation and high-resolution imaging, it is regarded as a promising tool for future in vivo applications. In this study, Doppler OCT is utilized for the visualization of the tympanic membrane oscillation in temporal bones with simulated Eustachian catarrh, which was realized by generating a depression in the tympanic cavity. The transfer function, meaning the oscillation amplitude normalized to the applied sound pressure, is measured frequency resolved in the range from 0.5 kHz to 6 kHz and with a lateral spatial resolution of 0.4 mm. Typical oscillation patterns could be observed in case of ambient pressure in the tympanic cavity. Under depression the characteristic oscillation patterns were observed with widely congruent appearance but at higher frequencies.

Objetivo: comparar o reconhecimento de fala na situação de silêncio e ruído com a prótese auditiva de orelha média totalmente implantável Esteem® em relação à prótese auditiva. Descrever a satisfação auditiva e as complicações cirúrgicas encontradas. Desenho do Estudo: estudo exploratório, prospectivo, intragrupo, sujeito como seu próprio controle. Pacientes: usuários de prótese auditiva com perda neurossensoraial moderada a severa bilateral. Intervenção: dez pacientes submetidos a cirurgia para colocação da prótese totalmente implantável Esteem®. Aplicação de questionário SADL no pré- e pós-operatório. Desfechos: reconhecimento de fala no silêncio e ruído, resultados do SADL e complicações do procedimento foram avaliadas. Resultados: Não houve diferença estatisticamente significante entre reconhecimento de fala nas condições de silencio e ruído em relação as próteses auditivas (p=0,23 e p= 0,0438). Houve diferença estatisticamente significante no score do SADL pré- e pós-operatório (p= 0,0076). Houve três necessidades de reintervenção cirúrgica, em uma delas a prótese precisou ser removida. Conclusões: Melhora da satisfação auditiva, tendência a melhora no reconhecimento de fala nas situações de silêncio e ruído. Procedimento deve ser realizado por cirurgiões otológicos experientes. / Objective: to compare speech discrimination in silence and in noise with the Esteem® totally implantable hearing device versus hearing aids, and to describe satisfaction with amplification and surgical complications in patients undergoing implantation of the Esteem® device. Study Design: this was an exploratory, prospective, within-group, subject-as-own-control study. Setting: tertiary referral center. Patients: hearing aid users with moderate to severe bilateral sensorineural hearing loss. Interventions: ten patients underwent placement of the Esteem® totally implantable hearing device. The Satisfaction with Amplification in Daily Life (SADL) questionnaire was administered pre- and postoperatively. Main Outcome Measures: speech discrimination in silence and noise, SADL scores, and complications were evaluated. Results: there were no statistically significant differences between hearing aids and the Esteem® device in speech discrimination in silence (p=0.23) or noise (p=0.0438). There was a significant difference between pre and postoperative SADL scores (p=0.0076). Three patients required reintervention, and one ultimately required explantation of the device. Conclusions: Use of the Esteem® device was associated with improved satisfaction with amplification and a trend toward improvement in speech discrimination in silence and noise. Implantation of the device is challenging and should be performed by experienced otologic surgeons.

Manual accuracy in microsurgery is reduced by tremor and limited access. A surgical approach through the middle ear also puts delicate structures at risk, while the surgeon is often working at an unergonomic position. At this point a micromanipulator could have a positive influence. A system was developed to measure “working accuracy”, time and precision during manipulation in the middle ear. 10 ENT- surgeons simulated a perforation of the stapedial footplate on a modified 3D print of a human skull in a mock OR. Each trial was repeated more than 200 times aiming manually and using a micro-manipulator. Data of over 4000 measurements was tested and graphically processed. Work strain was evaluated with a questionnaire. Accuracy for manual and micromanipulator perforation revealed a small difference. Learning curves showed a stronger decrease both in deviation and time when the micromanipulator was used. Also a lower work strain was apparent. The micromanipulator has the potential as an aiding device in ear surgery. / Die manuelle Genauigkeit in der Mikrochirurgie wird duch Tremor und limitierten Zugang eingeschränkt. Ein chirurgischer Eingriff am Mittelohr birgt außerdem ein Verletzungspotential für empfindliche anatomische Strukturen. Überdies ist die Sitzposition des Operateurs oft unergonomisch. Ein neuartiger Mikromanipulator kann auf diese Faktoren einen positiven Einfluss haben. Eine spezielle Software wurde entwickelt und Genauigkeit, Zeit und Präzision bei einem Eingriff am Mittelohr zu bestimmen. 10 Kopf- Hals- Chirurgen simulierten die Perforation der Steigbügelfußplatte an einem 3D Modell eines menschlichen Schädels in einem Demonstrations- OP. Jeder Versuch wurde mehr als 200 mal zunächst manuell und später mit Hilfe des Mikromanipulators wiederholt. Die Daten von mehr als 4000 Messversuchen wurden getestet und grafisch dargestellt. Die Arbeitsbelastung wure mittels eines Fragebogens evaluiert. Manuelle und mikromanipulatorgestütze Genauigkeit zeigten einen signifikanten, jedoch ,absolut betrachtet,sehr geringen Unterschied der Genauigkeit. Die Lernkurven zeigten einen steileren Verlauf sowohl im Hinblick auf Genauigkeit als auch Versuchszeit, wenn der Mikromanipulator zur Anwendung kam. Weiterhin war eine geringere Arbeitsbelastung zu erkennen. Der Mikromanipulator birgt Potential als kompaktes Hilfsmittel für die Ohrchirurgie.

Objetivo: comparar o reconhecimento de fala na situação de silêncio e ruído com a prótese auditiva de orelha média totalmente implantável Esteem® em relação à prótese auditiva. Descrever a satisfação auditiva e as complicações cirúrgicas encontradas. Desenho do Estudo: estudo exploratório, prospectivo, intragrupo, sujeito como seu próprio controle. Pacientes: usuários de prótese auditiva com perda neurossensoraial moderada a severa bilateral. Intervenção: dez pacientes submetidos a cirurgia para colocação da prótese totalmente implantável Esteem®. Aplicação de questionário SADL no pré- e pós-operatório. Desfechos: reconhecimento de fala no silêncio e ruído, resultados do SADL e complicações do procedimento foram avaliadas. Resultados: Não houve diferença estatisticamente significante entre reconhecimento de fala nas condições de silencio e ruído em relação as próteses auditivas (p=0,23 e p= 0,0438). Houve diferença estatisticamente significante no score do SADL pré- e pós-operatório (p= 0,0076). Houve três necessidades de reintervenção cirúrgica, em uma delas a prótese precisou ser removida. Conclusões: Melhora da satisfação auditiva, tendência a melhora no reconhecimento de fala nas situações de silêncio e ruído. Procedimento deve ser realizado por cirurgiões otológicos experientes. / Objective: to compare speech discrimination in silence and in noise with the Esteem® totally implantable hearing device versus hearing aids, and to describe satisfaction with amplification and surgical complications in patients undergoing implantation of the Esteem® device. Study Design: this was an exploratory, prospective, within-group, subject-as-own-control study. Setting: tertiary referral center. Patients: hearing aid users with moderate to severe bilateral sensorineural hearing loss. Interventions: ten patients underwent placement of the Esteem® totally implantable hearing device. The Satisfaction with Amplification in Daily Life (SADL) questionnaire was administered pre- and postoperatively. Main Outcome Measures: speech discrimination in silence and noise, SADL scores, and complications were evaluated. Results: there were no statistically significant differences between hearing aids and the Esteem® device in speech discrimination in silence (p=0.23) or noise (p=0.0438). There was a significant difference between pre and postoperative SADL scores (p=0.0076). Three patients required reintervention, and one ultimately required explantation of the device. Conclusions: Use of the Esteem® device was associated with improved satisfaction with amplification and a trend toward improvement in speech discrimination in silence and noise. Implantation of the device is challenging and should be performed by experienced otologic surgeons.

Apart from isolated programs in private and public health care sectors, South Africa has no existing systematic public infant hearing screening program at community level. As a result, early identification of hearing loss is certainly not being attained for the majority of infants in South Africa with far-reaching effects for individuals, families and society at large. Screening programs at primary health care immunization clinics have been proposed as an alternative to hospital-based programs in South Africa. The objective of this study was to evaluate the first systematic community-based infant hearing screening program in a developing South African community in the Western Cape. A combined descriptive and exploratory research methodology was followed incorporating aspects of a program evaluation design. The study was of a quantitative nature and the required data were collected by means of a questionnaire and OAE testing conducted by clinic nurses on subjects. A community-based universal infant hearing screening program initiated at eight primary health care clinics in the Cape Metropolitan area was evaluated over a 19-month research period. During this time 6227 infants who were candidates for screening attended their 6, 10 or 14-week immunization visit at the relevant clinic. Clinic nurses were trained as screening personnel. A two-stage distortion product otoacoustic emissions screening protocol was utilized. The target disorder for this study was bilateral permanent congenital and early onset hearing loss and infants referring the first screen were scheduled for a 4-week follow-up visit at the clinic. Diagnostic audiological and medical evaluations were scheduled at referral hospitals when indicated. The study evaluated the efficacy of the program based on coverage, referral and follow-up rates and diagnostic outcomes according to guidelines specified by the Health Professions Council of South Africa 2007 Position Statement. Overall coverage rate across the eight clinics was 32.4% with 2018 infants (aged 0- 14 weeks) screened. The mean age of the sample at first stage screen was 3.9 weeks of age and 13.5 weeks of age for first hospital visit. Overall first stage screen referral rate was 9.5% with 62 subjects (3%) referred for diagnostic services at hospital level after a follow-up screen. The average follow-up rate for rescreens at clinic level was 85.1% and for initial diagnostic assessments at hospital level it was 91.8%. Although minimal hearing loss was not the primary focus of the screening program the outcomes did include those subjects with fluctuating conductive hearing loss and permanent unilateral hearing loss. Prevalence rates were 4.5/1000 with significant hearing loss, including sensorineural (1.5/1000) and conductive (3/1000) losses, and 12.9/1000 for subjects with middle ear effusion.<p-> The community-based infant hearing screening program was valuable in attaining high follow-up return rates but reaching sufficient coverage may require dedicated screening personnel as opposed to existing nursing personnel. Furthermore, consideration of an alternative community-based platform such as midwife obstetric units may improve coverage and referral rates and prevalence of permanent congenital and early onset hearing loss. / Dissertation (MCommunication Pathology)--University of Pretoria, 2013. / Speech-Language Pathology and Audiology / Unrestricted