No abstract

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.

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.