Evaluation of Vibrant® Soundbridge™ positioning and results with laser doppler vibrometry and the finite element model.

The etiology of hearing loss originates from genetic factors and includes several other events including infections, working or living environment, as well as several endocrine and metabolic disorders. The Vibrant® Soundbridge™ (VSB) is an implantable hearing aid whose floating mass transducer (FMT) is attached to the long process of the incus. The device is used for pure sensorineural hearing loss with an intact middle ear. Variations in the manner of attachment may occur. Knowledge of the impact of such variations on the overall device performance may guide towards optimal transducer attachment during surgery. A mechanical modelling of the ear was first reported by von Békésy and indicated that the tympanic membrane (TM) moves as a stiff plate, and that the mallear and incudal ligaments act as a rotation axis for the ossicular chain at low frequencies. Experimental investigations and simulations with the model yield the same main results. The first fitting situation, where the FMT floats freely in the middle ear, provides by far the worst possible results. Contact to the stapes supra-structure of the FMT is necessary for optimal performance of the FMT. The mastoid specimen preserves its acoustic properties that have been shown to be similar to those in the vital human ear, under these conditions. Properly coupling the electromagnetic transducer to the ossicles can be difficult and it requires a certain degree of experience. A finite-element model (FEM) is useful for functional evaluation of the VSB since it enables easy modelling of the complicated middle ear structures and simulation of their dynamic behavior which makes it easy to understand it in detail without experiments.

Feasibility Study of a Mechanical Real-Time Feedback System for Optimizing the Sound Transfer in the Reconstructed Middle Ear.

OBJECTIVE: To evaluate electromechanical excitation as an alternative excitation mode for middle ear transfer function (METF) measurements as well as real-time feedback in prosthetic ossicular reconstruction. METHOD: In eight human cadaveric temporal bones, the ossicular chain was excited using acoustic and mechanical (floating mass transducer, FMT) stimulation to determine the METF. After disconnecting the ossicular chain and reconstruction with partial or total prosthesis the METFs were measured again. Continuous FMT stimulation was then applied to improve the prosthesis' position using real-time feedback of the METF. RESULTS: Mechanical stimulation of ossicular vibration showed characteristic differences to acoustic excitation resulting from the force characteristics of the FMT. Furthermore, the interspecimen METF variability was greater with electromechanical than acoustic stimulation because of interspecimen variability in the FMT coupling conditions. When the METF with FMT excitation was used as a real-time feedback tool, a measurable improvement in the quality of ossicular reconstruction could be achieved. CONCLUSIONS: Mechanical excitation is an effective and suitable alternative stimulation method in experimental METF measurements. The system provides real-time feedback for ossicular reconstruction in the experimental setting. Some influencing factors still need to be distinguished for reliable measurements. However, the method does not yet meet the requirements for clinical application as an intraoperative, real-time monitoring tool. However, the system could be an excellent model for high-end cadaveric temporal bone training in ossiculoplasty.

A New Intraoperative Real-time Monitoring System for Reconstructive Middle Ear Surgery: An Experimental and Clinical Feasibility Study.

HYPOTHESIS: Electromagnetical excitation of ossicular vibration is suitable for middle ear transmission measurements in the experimental and clinical setting. Thereby, it can be used as a real-time monitoring system for quality control in ossiculoplasty. BACKGROUND: Positioning and coupling of middle ear prosthesis are a precondition for good postoperative hearing results, but at the same time completely dependent upon the surgeon's subjective judgment during surgery. We evaluated an electromagnetically driven measurement system that enables for in vitro and in vivo transmission measurements and thus can be used as a real-time monitoring tool in ossicular reconstruction. METHODS: For electromagnetical excitation a magnet was placed on the umbo of the malleus handle and driven by a magnetic field. The induced stapes displacement was picked up by laser Doppler vibrometry on the footplate. Measurements were performed on the intact ossicular chain in five cadaveric temporal bones and during five cochlear implant surgeries. Additionally, two ossiculoplasties were performed under real-time transmission feedback with the monitoring system. RESULTS: Experimentally, the equivalent sound pressure level of the electromagnetic excitation was about 70 to 80 dB which is 10 to 20 dB less than the acoustic stimulation. In the intraoperative setup the generated stapes displacements were about 5 to 20 dB smaller compared with the temporal bone experiments. Applied as real-time feedback system, an improvement in the middle ear transfer function of 4.5 dB in total and 20 dB in partial ossicular reconstruction were achieved. CONCLUSION: The electromagnetical excitation and measurement system is comparable to the gold standard with acoustical stimulation in both, the experimental setup in temporal bones as well as in vivo. The technical feasibility of the electromagnetical excitation method has been proven and it is shown that it can be used as a real-time monitoring system for ossiculoplasty in the operation room.

Experimental investigation of rotational tomography in reconstructed middle ears with clinical implications.

A large air-bone-gap after ossiculoplasty may be due to a malpositioned or displaced prosthesis. Rotational tomography (RT) has the potential to provide high-resolution images of implants without artifacts and with less radiation dosage than CT scan. Twenty-seven temporal bone specimens underwent measurements of middle ear transfer function using Laser-Doppler-Vibrometry (LDV) before and after placement of ossicular replacement prostheses (PORPs, TORPs) made of titanium. RT was performed on all specimens. RT allowed 3-dimensional viewing of the temporal bone, accurate localization of implants within the reconstructed middle ear and determination of angles between the inserted prostheses and the tympanic membrane (TM) and/or the malleus handle (MH). Presence or absence of contact between the implant and the TM, malleus or stapes could be clearly visualized. Displaced prostheses were readily identified. The functional LDV-measurements for TORPs showed a trend favoring coupling to the malleus handle, while for PORPs, coupling to the TM was favored. For PORPs, sound transmission was worse with increasing angles between the PORP and stapes superstructure (p<0.05). Following our experimental results RT is an innovative, relevant and useful imaging technique to obtain immediate postoperative feedback after ossicular reconstruction and to precisely determine the position of middle ear implants.