The impact of round window reinforcement on middle and inner ear mechanics with air and bone conduction stimulation.

The round window (RW) membrane plays an important role in normal inner ear mechanics. Occlusion or reinforcement of the RW has been described in the context of congenital anomalies or after cochlear implantation and is applied as a surgical treatment for hyperacusis. Multiple lumped and finite element models predict a low-frequency hearing loss with air conduction of up to 20 dB after RW reinforcement and limited to no effect on hearing with bone conduction stimulation. Experimental verification of these results, however, remains limited. Here, we present an experimental study measuring the impact of RW reinforcement on the middle and inner ear mechanics with air and bone conduction stimulation. In a within-specimen repeated measures design with human cadaveric specimens (n = 6), we compared the intracochlear pressures in scala vestibuli (PSV) and scala tympani (PST) before and after RW reinforcement with soft tissue, cartilage, and bone cement. The differential pressure (PDIFF) across the basilar membrane - known to be closely related to the hearing sensation - was calculated as the complex difference between PSV and PST. With air conduction stimulation, both PSV and PSTincreased on average up to 22 dB at frequencies below 1500 Hz with larger effect sizes for PST compared to PSV. The PDIFF, in contrast, decreased up to 11 dB at frequencies between 700 and 800 Hz after reinforcement with bone cement. With bone conduction, the average within-specimen effects were less than 5 dB for either PSV, PST, or PDIFF. The inter-specimen variability with bone conduction, however, was considerably larger than with air conduction. This experimental study shows that RW reinforcement impacts air conduction stimulation at low frequencies. Bone conduction stimulation seems to be largely unaffected. From a clinical point of view, these results support the hypothesis that delayed loss of air conduction hearing after cochlear implantation could be partially explained by the impact of RW reinforcement.

Objective preclinical measures for bone conduction implants.

The study evaluates the accuracy of predicting intracochlear pressure during bone conduction stimulation using promontory velocity and ear canal pressure, as less invasive alternatives to intracochlear pressure. Stimulating with a percutaneous bone conduction device implanted in six human cadaveric ears, measurements were taken across various intensities, frequencies, and stimulation positions. Results indicate that intracochlear pressure linearly correlates with ear canal pressure (R2 = 0.43, RMSE = 6.85 dB), and promontory velocity (R2 = 0.47, RMSE = 6.60 dB). Normalizing data to mitigate the influence of stimulation position leads to a substantial improvement in these correlations. R2 values increased substantially to 0.93 for both the ear canal pressure and the promontory velocity, with RMSE reduced considerably to 2.02 (for ear canal pressure) and 1.94 dB (for promontory velocity). Conclusively, both ear canal pressure and promontory velocity showed potential in predicting intracochlear pressure and the prediction accuracy notably enhanced when accounting for stimulation position. Ultimately, these findings advocate for the continued use of intracochlear pressure measurements to evaluate future bone conduction devices and illuminate the role of stimulation position in influencing the dynamics of bone conduction pathways.

Intracochlear pressure as an objective measure for perceived loudness with bone conduction implants.

BACKGROUND: The generally accepted method to assess the functionality of novel bone conduction implants in a preclinical stage is to experimentally measure the vibratory response of the cochlear promontory. Yet, bone conduction of sound is a complex propagation phenomenon, depending on both frequency and amplitude, involving different conduction pathways. OBJECTIVES: The aim of this study is to validate the use of intracochlear sound pressure (ICP) as an objective indicator for perceived loudness for bone conduction stimulation. It is investigated whether a correlation exists between intracochlear sound pressure measurements in cadaveric temporal bones and clinically obtained results using the outcome of a loudness balancing experiment. METHODS: Ten normal hearing subjects were asked to balance the perceived loudness between air conducted (AC) sound and bone conducted (BC) sound by changing the AC stimulus. Mean balanced thresholds were calculated and used as stimulation levels in a cadaver trial (N = 4) where intracochlear sound pressure was measured during AC and BC stimulation to assess the correlation with the measured clinical data. The intracochlear pressure was measured at the relatively low stimulation amplitude of 80 dBHL using a lock-in amplification technique. RESULTS: Applying AC and BC stimulation at equal perceived loudness on cadaveric heads yield a similar differential intracochlear pressure, with differences between AC and BC falling within the range of variability of normal hearing test subjects. CONCLUSION: Comparing the perceived loudness at 80 dB HL for both AC and BC validates intracochlear pressure as an objective indicator of the cochlear drive. The measurement setup is more time-intensive than measuring the vibratory response of the cochlear promontory, yet it provides direct information on the level of the cochlear scalae.

The Impact of Location and Device Coupling on the Performance of the Osia System Actuator.

Active transcutaneous bone conduction (BC) devices offer the benefit of improved power output compared to passive transcutaneous devices and remove the risk of skin infections that are more common in traditional percutaneous BC devices. Despite these advantages, more research is needed on implant location, device coupling, and their influence on device performance. This study is aimed at quantifying the extent to which certain parameters affect device output when using the Osia® system actuator. Parameters under study are (1) implant location, (2) comparison with the actuator of a state-of-the-art BC device, (3) bone undergrowth simulation, and (4) skull fixation. Five human cadaveric heads were implanted with the actuator at three different implant locations: (1) recommended, (2) posterior Osia® positions, and (3) standard Baha® position. At each location, the cochlear promontory velocity and the intracochlear pressure difference were measured. A percutaneous bone conduction actuator was used as a reference for the obtained measurements. Stimulation levels corresponded to a hearing level of 60 dB HL for frequencies between 250 and 6000 Hz. In addition, bone cement was used as a simulation for reactive bone growth. Results obtained in four heads indicate an improved power transmission of the transcutaneous actuator when implanted at the recommended position compared to the actuator of the percutaneous device on its respective recommended location when stimulating at an identical force level. A correlation was found between the promontory vibration and the actuator position, indicating that the same level of stimulation leads to higher promontory vibrations when the device is implanted closer to the ear canal. This is mainly reflected at frequencies higher than 1 kHz, where an increase was observed in both measurement modalities. At lower frequencies (<1 kHz), the power transmission is less influenced by the implant position and differences between the acquired responses are limited. In addition, when no rigid coupling to the skull is provided, power transfer losses of up to 30 dB can be expected.

A Miniature, Fiber-Optic Vibrometer for Measuring Unintended Acoustic Output of Active Hearing Implants during Magnetic Resonance Imaging.

Making use of magnetic resonance imaging (MRI) for diagnostics on patients with implanted medical devices requires caution due to mutual interactions between the device and the electromagnetic fields used by the scanner that can cause a number of adverse events. The presented study offers a novel test method to quantify the risk of unintended output of acoustically stimulating hearing implants. The design and operating principle of an all-optical, MRI safe vibrometer is outlined, followed by an experimental verification of a prototype. Results obtained in an MRI environment indicate that the system can detect peak displacements down to 8 pm for audible frequencies. Feasibility testing was performed with an active middle ear implant that was exposed to several pulse sequences in a 1.5 Tesla MRI environment. Magnetic field induced actuator vibrations, measured during scanning, turned out to be equivalent to estimated sound pressure levels between 25 and 85 dB SPL, depending on the signal frequency. These sound pressure levels are situated well below ambient sound pressure levels generated by the MRI scanning process. The presented case study therefore indicates a limited risk of audible unintended output for the examined hearing implant during MRI.

Safety of active auditory implants in magnetic resonance imaging.

Magnetic resonance imaging (MRI) has become the gold standard for the diagnosis of many pathologies. Using MRI in patients with auditory implants can however raise concerns due to mutual interactions between the implant and imaging device, resulting in potential patient risks. Several implant manufacturers have been working towards more MRI safe devices. Older devices are however often labelled for more stringent conditions, possibly creating confusion with patients and professionals. With this myriad of different devices that are implanted in patients for lifetimes of at least 20 years, it is crucial that both patients and professionals have a clear understanding of the safety of their devices. This work aims at providing an exhaustive overview on the MRI safety of active auditory implants. The available industry standards that are followed by manufacturers are outlined and an overview of the latest scientific developments focusing on the last five years is provided. In addition, based on the analysis of the adverse events reported to the Food and Drug Administration (FDA) and in literature within the past ten years, a systematic review of the most commonly occurring issues for patients with auditory implants in the MRI environment is provided. Results indicate that despite the release of more MRI conditional active hearing implants on the market, adverse events still occur. An extensive overview is provided on the MRI safety of active auditory implants, aiming to increase the understanding of the topic for healthcare professionals and contribute to safer scanning conditions for patients.

Stability of the standard incus coupling of the Carina middle ear actuator after 1.5T MRI.

Limited data is available concerning the safety of active middle ear implants (AMEI) during Magnetic Resonance Imaging (MRI). Measurements in temporal bones are the gold standard for preclinical assessment of device safety. In this study the coupling stability of an actuator as used in a fully implantable AMEI was determined in temporal bones. Eleven temporal bones were implanted with the actuator according to the manufacturer's surgical guidelines. The actuator was coupled on the incus short process as recommended for sensorineural hearing loss. Temporal bones were exposed 10 times to the MRI magnetic field by entering the MRI suite in a clinically relevant way. Computed Tomography (CT) images were acquired before and after the experiment to investigate the risk of actuator dislocation. Based on the electrical impedance of the actuator, the loading of the actuator to the incus was confirmed. Relative actuator displacement was determined on the CT images by comparing the initial with the final actuator position in 3D space. Impedance curves were analyzed after each exposure to check the loading of the actuator to the ossicles. Analysis of CT images with a 0.30.6 mm in-plane resolution indicate no actuator displacement. The maximum detected change in impedance for all actuators was 8.43 Ω at the actuator's resonance frequency. Impedance curves measured when the actuator was retracted from the short process after the experiment still indicate the presence of a clear resonance peak. No actuator displacement or dislocation could be detected in the analysis of CT images and the measured impedance curves. Impedance curves obtained when the actuator was retracted from the incus short process still show a clear resonance peak, indicating the device is still functional after the MRI exposures.

Reducing Artifacts in Intracochlear Pressure Measurements to Study Sound Transmission by Bone Conduction Stimulation in Humans.

HYPOTHESIS: Intracochlear pressure (ICP) measurements during bone conduction (BC) stimulation may be affected by motion of the pressure sensor relative to the cochlear promontory bone, demonstrating the need to cement the sensor firmly to the cochlear bone. BACKGROUND: ICP is a promising measurement tool for investigating the cochlear drive in BC transmission, but its use is not yet standardized. Previous ICP studies have reported artificially increased pressure due to motion of the sensor relative to the temporal bone. The artifact can be reduced by firmly cementing the sensor to the bone, but this is destructive for the sensor. Previous studies used a custom-made sensor; the use of commercially available sensors, however, is more generic, but also more challenging to combine with the cement. Therefore, the goals of the current study are: firstly, to evaluate a non-destructive cementing method suitable for a commercially available sensor, and secondly, to investigate ICP measurements during BC stimulation in more detail. METHODS: To study the effect of sensor cementing, three fixation conditions were investigated on six fresh-frozen temporal bones: 1) alginate, 2) alginate and dental composite, 3) alginate and dental composite, released from micromanipulators. Pressures in scala tympani and vestibuli were measured simultaneously, while velocity measurements were performed on the cochlear promontory and sensor. The ratio between sensor and promontory bone velocity was computed to quantify the relative motion. RESULTS: For air conduction stimulation, results were in line with those from previous ICP studies, indicating that baseline measurements were valid and could be used to interpret the results obtained with BC stimulation. Results showed that cementing the sensors and releasing them from the micromanipulators is crucial for valid ICP measurements. When the sensors were only sealed with alginate, the pressure was overestimated, especially at low and mid-frequencies. When the sensors were cemented and held in the micromanipulators, the pressure was underestimated. Compared with the scala tympani measurements, ICP measurements showed a lower scala vestibuli pressure below 1 kHz, and a higher pressure above 1 kHz. CONCLUSION: Dental composite is effective as a cement to attach commercially available sensors to the cochlear promontory bone. When sensors are firmly attached, valid ICP measurements can be obtained with BC stimulation.

A foldable electrode array for 3D recording of deep-seated abnormal brain cavities.

OBJECTIVE: This study describes the design and microfabrication of a foldable thin-film neural implant and investigates its suitability for electrical recording of deep-lying brain cavity walls. APPROACH: A new type of foldable neural electrode array is presented, which can be inserted through a cannula. The microfabricated electrode is specifically designed for electrical recording of the cavity wall of thalamic lesions resulting from stroke. The proof-of-concept is demonstrated by measurements in rat brain cavities. On implantation, the electrode array unfolds in the brain cavity, contacting the cavity walls and allowing recording at multiple anatomical locations. A three-layer microfabrication process based on UV-lithography and Reactive Ion Etching is described. Electrochemical characterization of the electrode is performed in addition to an in vivo experiment in which the implantation procedure and the unfolding of the electrode are tested and visualized. MAIN RESULTS: Electrochemical characterization validated the suitability of the electrode for in vivo use. CT imaging confirmed the unfolding of the electrode in the brain cavity and analysis of recorded local field potentials showed the ability to record neural signals of biological origin. SIGNIFICANCE: The conducted research confirms that it is possible to record neural activity from the inside wall of brain cavities at various anatomical locations after a single implantation procedure. This opens up possibilities towards research of abnormal brain cavities and the clinical conditions associated with them, such as central post-stroke pain.