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.

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.

Extra- and Intracochlear Electrocochleography in Cochlear Implant Recipients.

OBJECTIVE: To monitor cochlear function by extra- and intra-cochlear electrocochleography (ECoG) during and after cochlear implantation and thereby to enhance the understanding of changes in cochlear function following cochlear implantation surgery. METHODS: ECoG responses to acoustic stimuli of 250, 500 and 1,000 Hz were recorded in 9 cochlear implant recipients with presurgical residual hearing. During surgery extracochlear ECoG recordings were performed before and after insertion of the cochlear implant electrode array. After insertion of the electrode array, intracochlear ECoG recordings were conducted using intracochlear electrode contacts as recording electrodes. Intracochlear ECoG recordings were performed up to 6 months after implantation.ECoG findings were correlated with findings from audiometric tests. RESULTS: Extra- and intracochlear ECoG responses could be recorded in all subjects. Extracochlear ECoG recordings during surgery showed moderate changes.Loss or reduction of the ECoG signal at all three frequencies did not occur during cochlear implantation. During the first week following surgery, conductive hearing loss, due to middle ear effusion, led to a decrease in intracochlear ECoG signal amplitudes. This was not attributable to changes of cochlear function. All persistent reductions in ECoG response magnitude after normalization of the tympanogram occurred during the first week following implantation. Thresholds of ECoG signals were at or below hearing thresholds in all cases. CONCLUSION: Gross intracochlear trauma during surgery appears to be rare. In the early postoperative phase the ability to assess cochlear status by ECoG recordings was limited due to the regular occurrence of middle ear effusion.Still, intracochlear ECoG along with tympanogram recordings suggests that any changes of low-frequency cochlear function occur mainly during the first week after cochlear implantation. ECoG seems to be a promising tool to objectively assess changes in cochlear function in cochlear implant recipients and may allow further insight into the mechanisms underlying the loss of residual hearing.

Assessment of a direct acoustic cochlear stimulator.

This study aimed to assess the functional results of a new, active, acoustic-mechanical hearing implant, the Direct Acoustic Cochlear Stimulation Partial Implant (DACS PI), in a preclinical study. The DACS PI is an electromagnetic device fixed to the mastoid by screws and coupled to a standard stapes prosthesis by an artificial incus (AI). The function of the DACS PI-aided reconstruction was assessed by determining: (1) the maximum equivalent sound pressure level (SPL) of the implant, which was obtained from measurements of the volume displacement at the round window in normal and implanted ears, and (2) the quality at the coupling interface between the AI of the DACS and the stapes prosthesis, which was quantified from measurements of relative motions between the AI and the prosthesis. Both measurements were performed with fresh temporal bones using a scanning laser Doppler interferometry system. The expected maximum equivalent SPL with a typical driving voltage of 0.3 V was about 115-125 dB SPL up to 1.5 kHz in reconstruction with the DACS PI, and decreased with a roll-off slope of about 65 dB/decade, reaching 90 dB SPL at 8 kHz. The large roll-off relative to a normal ear was presumed to be a relatively high inductive impedance of the coil of the DACS PI actuator at higher frequencies. Good coupling quality between the AI and the prosthesis was achieved below the resonance (∼1.5 kHz) of the DACS PI for all tested stapes prostheses. Above the resonance, the SMart Piston, which is composed of a shape-memory alloy, had the best coupling quality.

Errors in measurement of three-dimensional motions of the stapes using a laser Doppler vibrometer system.

Previous studies have suggested complex modes of physiological stapes motions based upon various measurements. The goal of this study was to analyze the detailed errors in measurement of the complex stapes motions using laser Doppler vibrometer (LDV) systems, which are highly sensitive to the stimulation intensity and the exact angulations of the stapes. Stapes motions were measured with acoustic stimuli as well as mechanical stimuli using a custom-made three-axis piezoelectric actuator, and errors in the motion components were analyzed. The ratio of error in each motion component was reduced by increasing the magnitude of the stimuli, but the improvement was limited when the motion component was small relative to other components. This problem was solved with an improved reflectivity on the measurement surface. Errors in estimating the position of the stapes also caused errors on the coordinates of the measurement points and the laser beam direction relative to the stapes footplate, thus producing errors in the 3-D motion components. This effect was small when the position error of the stapes footplate did not exceed 5 degrees.

The influence of postoperative tissue formation on sound transmission after stapes surgery.

In the surgical treatment of otosclerosis, the coupling between the stapes prosthesis and the long process of the incus is critical. After surgery, connective tissue and mucosa may grow over the coupling area and thereby influence the sound transmission properties of the incus-prosthesis interface. It was the hypothesis of this study that tissue ongrowth in the incus-prosthesis interface has little influence on sound transmission following stapes surgery. The goals of the study were to: (1) investigate the extent of postoperative tissue ongrowth over the stapes prosthesis; (2) objectively evaluate intra- and postoperative sound transmission properties of revision stapes surgery and compare the findings to those from primary surgery; (3) quantify the influence of ongrown tissue on sound transmission after stapes surgery. A group of 10 patients undergoing revision stapes surgery was investigated with audiological evaluations and intraoperative laser Doppler interferometry, and with scanning electron microscopy of the explanted incus with its adherent prosthesis in 6 patients. Results were compared to a group of patients undergoing primary otosclerosis surgery and temporal bone experiments. Results indicated that tissue grows over the prosthesis, as identified in all specimens. Sound transmission properties were evaluated intraoperatively (i.e., incus mobility and prosthesis-fixation quality), and found to correlate well with the functional hearing results. Ongrowing mucosa in the incus-prosthesis interface had only a minimal effect on sound transmission properties and cannot compensate adequately for insufficient prosthesis fixation. Therefore, it is essential that the stapes prosthesis is properly fixed during primary otosclerosis surgery.

A new implantable middle ear hearing device for mixed hearing loss: A feasibility study in human temporal bones.

HYPOTHESIS: To assess the feasibility of a new, active middle ear device in temporal bones (TB). BACKGROUND: This device is designed for patients with mixed hearing loss subsequent to chronic middle ear infection, surgery, or trauma. This Bell-Vibroplasty is built from a VIBRANT MED-EL Vibrant Soundbridge and a Kurz Bell titanium partial ossicular replacement prosthesis. METHODS: In three fresh TBs, healthy and reconstructed middle ears were analyzed by means of laser Doppler interferometry. The sound transmission properties of a partial ossicular replacement prosthesis and a passive and an active Bell-Vibroplasty were compared with healthy middle ear function. RESULTS: The measurements provided reliable results with small standard deviations and good signal-to-noise ratios. The performance levels of the partial ossicular replacement prosthesis and of the passive Bell-Vibroplasty were comparable with that of healthy middle ear function. The activated Bell-Vibroplasty provided linear function and a flat frequency response within the measured frequency range (500 Hz-8 kHz), with peak deviations of less than 10 dB. The maximum output of the Bell-Vibroplasty was equivalent to 125-dB sound pressure level. CONCLUSION: Bell-Vibroplasty is feasible in TBs. Bell-Vibroplasty performance in TBs is sufficient to allow for a clinical trial as a next step.