Performance evaluation of a novel piezoelectric subcutaneous bone conduction device.

OBJECTIVES: Evaluation of the transfer function efficiency of a newly-developed piezo-electric actuator for active subcutaneous bone conduction hearing aid. METHODS: The experiments were conducted on four Thiel embalmed whole head cadaver specimens. A novel actuator based on piezo-electric transduction (PZTA), part of a subcutaneous bone conduction hearing aid device, was sequentially implanted on three locations: 1) Immediately posterior to pinna; 2) 50-60 mm posterior to pinna, approximately the same distance as between the BAHA (bone anchored hearing aid) location and the ear canal, but the same horizontal level as location 1; 3) the traditional BAHA location. Using a single point 3-dimensional laser Doppler vibrometer (LDV) system, three types of motion measurements were performed at the cochlear promontory for each stimulation location: 1) ipsilateral side, 2) contralateral side, 3) measurements 1 and 2 were repeated after mastoidectomy on the ipsilateral side. RESULTS: On average, stimulation at locations 1 and 2 show a trend for higher promontory motion relative to location 3 (BAHA location) above 1 kHz. Stimulation at location 1 had an average improvement of 1-6 dB at 2-4 kHz, and 1-18 dB at 6-8 kHz. The spatial composition of the motion showed significant contributions from both in-plane and out-of-plane (along ear canal) motion components, with in-plane components being dominant at mid and high frequencies for locations 2 and 3. Stimulation at locations 1 and 3 produced similar transcranial attenuation at mid frequencies (0.6-4 kHz), with a potential trend of higher attenuation (seen in 3 or the 4 samples) for location 1 at higher frequencies (>4 kHz). The mastoidectomy affected negatively mostly the high frequencies (6-8 kHz) for stimulation at location 1, with no significant change for location 3. CONCLUSION: The sound transfer function efficacy of a novel subcutaneous bone conduction device has been quantified, and the influence of stimulation location and mastoidectomy have been analyzed based on promontory motion in Thiel-preserved cadaver heads.

Sheep as a large animal ear model: Middle-ear ossicular velocities and intracochlear sound pressure.

Animals are frequently used for the development and testing of new hearing devices. Dimensions of the middle ear and cochlea differ significantly between humans and commonly used animals, such as rodents or cats. The sheep cochlea is anatomically more like the human cochlea in size and number of turns. This study investigated the middle-ear ossicular velocities and intracochlear sound pressure (ICSP) in sheep temporal bones, with the aim of characterizing the sheep as an experimental model for implantable hearing devices. Measurements were made on fresh sheep temporal bones. Velocity responses of the middle ear ossicles at the umbo, long process of the incus and stapes footplate were measured in the frequency range of 0.25-8 kHz using a laser Doppler vibrometer system. Results were normalized by the corresponding sound pressure level in the external ear canal (PEC). Sequentially, ICSPs at the scala vestibuli and tympani were then recorded with custom MEMS-based hydrophones, while presenting identical acoustic stimuli. The sheep middle ear transmitted most effectively around 4.8 kHz, with a maximum stapes velocity of 0.2 mm/s/Pa. At the same frequency, the ICSP measurements in the scala vestibuli and tympani showed the maximum gain relative to the PEC (24 dB and 5 dB, respectively). The greatest pressure difference across the cochlear partition occurred between 4 and 6 kHz. A comparison between the results of this study and human reference data showed middle-ear resonance and best cochlear sensitivity at higher frequencies in sheep. In summary, sheep can be an appropriate large animal model for research and development of implantable hearing devices.

Influence of stimulation position on the sensitivity for bone conduction hearing aids without skin penetration.

OBJECTIVE: This study explores the influence of stimulation position on bone conduction (BC) hearing sensitivity with a BC transducer attached using a headband. DESIGN: (1) The cochlear promontory motion was measured in cadaver heads using laser Doppler vibrometry while seven different positions around the pinna were stimulated using a bone anchored hearing aid transducer attached using a headband. (2) The BC hearing thresholds were measured in human subjects, with the bone vibrator Radioear B71 attached to the same seven stimulation positions. STUDY SAMPLE: Three cadaver heads and twenty participants. RESULTS: Stimulation on a position superior-anterior to the pinna generated the largest promontory motion and the lowest BC thresholds. Stimulations on the positions superior to the pinna, the mastoid, and posterior-inferior to the pinna showed similar magnitudes of promontory motion and similar levels of BC thresholds. CONCLUSION: Stimulations on the regions superior to the pinna, the mastoid, and posterior-inferior to the pinna provide stable BC transmission, and are insensitive to small changes of the stimulation position. Therefore it is reliable to use the mastoid to determine BC thresholds in clinical audiometry. However, stimulation on a position superior-anterior to the pinna provides more efficient BC transmission than stimulation on the mastoid.

Response of the human tympanic membrane to transient acoustic and mechanical stimuli: Preliminary results.

The response of the tympanic membrane (TM) to transient environmental sounds and the contributions of different parts of the TM to middle-ear sound transmission were investigated by measuring the TM response to global transients (acoustic clicks) and to local transients (mechanical impulses) applied to the umbo and various locations on the TM. A lightly-fixed human temporal bone was prepared by removing the ear canal, inner ear, and stapes, leaving the incus, malleus, and TM intact. Motion of nearly the entire TM was measured by a digital holography system with a high speed camera at a rate of 42 000 frames per second, giving a temporal resolution of <24 µs for the duration of the TM response. The entire TM responded nearly instantaneously to acoustic transient stimuli, though the peak displacement and decay time constant varied with location. With local mechanical transients, the TM responded first locally at the site of stimulation, and the response spread approximately symmetrically and circumferentially around the umbo and manubrium. Acoustic and mechanical transients provide distinct and complementary stimuli for the study of TM response. Spatial variations in decay and rate of spread of response imply local variations in TM stiffness, mass, and damping.

A method to measure sound transmission via the malleus-incus complex.

BACKGROUND: The malleus-incus complex (MIC) plays a crucial role in the hearing process as it transforms and transmits acoustically-induced motion of the tympanic membrane, through the stapes, into the inner-ear. However, the transfer function of the MIC under physiologically-relevant acoustic stimulation is still under debate, especially due to insufficient quantitative data of the vibrational behavior of the MIC. This study focuses on the investigation of the sound transformation through the MIC, based on measurements of three-dimensional motions of the malleus and incus with a full six degrees of freedom (6 DOF). METHODS: The motion of the MIC was measured in two cadaveric human temporal bones with intact middle-ear structures excited via a loudspeaker embedded in an artificial ear canal, in the frequency range of 0.5-5 kHz. Three-dimensional (3D) shapes of the middle-ear ossicles were obtained by sequent micro-CT imaging, and an intrinsic frame based on the middle-ear anatomy was defined. All data were registered into the intrinsic frame, and rigid body motions of the malleus and incus were calculated with full six degrees of freedom. Then, the transfer function of the MIC, defined as velocity of the incus lenticular process relative to velocity of the malleus umbo, was obtained and analyzed. RESULTS: Based on the transfer function of the MIC, the motion of the lenticularis relative to the umbo reduces with frequency, particularly in the 2-5 kHz range. Analysis of the individual motion components of the transfer function indicates a predominant medial-lateral component at frequencies below 1 kHz, with low but considerable anterior-posterior and superior-inferior components that become prominent in the 2-5 kHz range. CONCLUSION: The transfer function of the human MIC, based on motion of the umbo and lenticularis, has been visualized and analyzed. While the magnitude of the transfer function decreases with frequency, its spatio-temporal complexity increases significantly.

Measurements of three-dimensional shape and sound-induced motion of the chinchilla tympanic membrane.

UNLABELLED: Opto-electronic computer holographic measurements were made of the tympanic membrane (TM) in cadaveric chinchillas. Measurements with two laser wavelengths were used to compute the 3D-shape of the TM. Single laser wavelength measurements locked to eight distinct phases of a tonal stimulus were used to determine the magnitude and the relative phase of the surface displacements. These measurements were made at over 250,000 points on the TM surface. The measured motions contained spatial phase variations consistent with relatively low-order (large spatial frequency) modal motions and smaller magnitude higher-order (smaller spatial frequency) motions that appear to travel, but may also be explained by losses within the membrane. The measurement of shape and thin shell theory allowed us to separate the measured motions into those components orthogonal to the plane of the tympanic ring, and those components within the plane of the tympanic ring based on the 3D-shape. The predicted in-plane motion components are generally smaller than the out-of-plane perpendicular component of motion. Since the derivation of in-plane and out-of plane depended primarily on the membrane shape, the relative sizes of the predicted motion components did not vary with frequency. SUMMARY: A new method for simultaneously measuring the shape and sound-induced motion of the tympanic membrane is utilized to estimate the 3D motion on the membrane surface. This article is part of a special issue entitled "MEMRO 2012".