Finite element modeling of sound transmission with perforations of tympanic membrane.

A three-dimensional finite element (FE) model of human ear with structures of the external ear canal, middle ear, and cochlea has been developed recently. In this paper, the FE model was used to predict the effect of tympanic membrane (TM) perforations on sound transmission through the middle ear. Two perforations were made in the posterior-inferior quadrant and inferior site of the TM in the model with areas of 1.33 and 0.82 mm(2), respectively. These perforations were also created in human temporal bones with the same size and location. The vibrations of the TM (umbo) and stapes footplate were calculated from the model and measured from the temporal bones using laser Doppler vibrometers. The sound pressure in the middle ear cavity was derived from the model and measured from the bones. The results demonstrate that the TM perforations can be simulated in the FE model with geometrical visualization. The FE model provides reasonable predictions on effects of perforation size and location on middle ear transfer function. The middle ear structure-function relationship can be revealed with multi-field coupled FE analysis.

Combined effect of fluid and pressure on middle ear function.

In our previous studies, the effects of effusion and pressure on sound transmission were investigated separately. The aim of this study is to investigate the combined effect of fluid and pressure on middle ear function. An otitis media with effusion model was created by injecting saline solution and air pressure simultaneously into the middle ear of human temporal bones. Tympanic membrane displacement in response to 90 dB SPL sound input was measured by a laser vibrometer and the compliance of the middle ear was measured by a tympanometer. The movement of the tympanic membrane at the umbo was reduced up to 17 dB by the combination of fluid and pressure in the middle ear over the auditory frequency range. The fluid and pressure effects on the umbo movement in the fluid-pressure combination are not additive. The combined effect of fluid and pressure on the umbo movement is different compared with that of only fluid or pressure change in the middle ear. Negative pressure in fluid-pressure combination had more effect on middle ear function than positive pressure. Tympanometry can detect the middle ear pressure of the fluid-pressure combination. This study provides quantitative information for analysis of the combined effect of fluid and pressure on tympanic membrane movement.

Bacterial contamination of stethoscopes with antimicrobial diaphragm covers.

Antimicrobial stethoscope covers impregnated with silver ions have been developed to prevent surface contamination and potential transmission of bacterial pathogens to patients. To test their practical utility, covers were distributed with the manufacturers' recommendations to a mixed group of health care professionals in a medical/surgical intensive care unit and an emergency department. Seventy-four clinicians were selected from a convenience sample for surface cultures and standard questioning regarding cleaning and cover use. Surface colony counts were significantly lower for uncovered stethoscope diaphragms (mean, 71.4 colonies) compared with covers used 1 week old (mean, 335.6 colonies). After controlling for type of clinician, frequency of stethoscope cleaning, and method of stethoscope cleaning, only the presence of a stethoscope cover was associated with higher colony counts (P<.0001). We question the practical utility of the antimicrobial diaphragm covers evaluated in this study for reducing the surface colonization of potentially harmful microorganisms.

Fixation and detachment of superior and anterior malleolar ligaments in human middle ear: experiment and modeling.

The aim of this study is to investigate the function of the superior malleolar ligament (SML) and the anterior malleolar ligament (AML) in human middle ear for sound transmission through simulations of fixation and detachment of these ligaments in human temporal bones and a finite element (FE) ear model. Two laser vibrometers were used to measure the vibrations of the tympanic membrane (TM) and stapes footplate. A 3-D FE ear model was used to predict the transfer function of the middle ear with ligament fixation and detachment. The results demonstrate that fixations and detachments of the SML and AML had different effects on TM and stapes footplate movements. Fixation of the SML resulted in a reduction of displacement of the TM (umbo) and the footplate at low frequencies (f<1000 Hz), but also caused a shift of displacement peak to higher frequencies. Fixation of both SML and AML caused a reduction of 15 dB at umbo or stapes at low frequencies. Detachment of the SML had almost no effect on TM and footplate mobility, but AML detachment had a minor effect on TM and footplate movement. The FE model was able to predict the effects of SML and AML fixation and detachment.

Tympanometry and laser Doppler interferometry measurements on otitis media with effusion model in human temporal bones.

HYPOTHESIS: The aim of this study is to investigate the effect of middle ear fluid and pressure on tympanic membrane mobility by using laser Doppler interferometry and to compare these results with tympanometry. BACKGROUND: Tympanometry has been commonly used for evaluation of otitis media with effusion, a middle ear disease with fluid in the cavity. However, this test lacks specific interpretations of middle ear disorders based on tympanometric data. Laser interferometry, as an advanced research tool to measure middle ear function, may provide knowledge of how tympanic membrane mobility is affected by middle ear fluid and pressure. METHODS: An otitis media with effusion model was created in seven human temporal bones for conducting experiments with tympanometry and laser interferometry. Middle ear pressure varied from -20 to +20 cm water, and the amount of fluid in the middle ear was gradually increased to fill the cavity. RESULTS: The displacement of the tympanic membrane measured by laser interferometry at selected frequencies decreased significantly corresponding to the middle ear air pressure changes. Tympanometry detected middle ear pressure by the change of tympanometric peak location, but the tympanogram shape was not affected by the middle ear pressure. The middle ear fluid was detected by tympanometry with as little as 0.3 mL, and laser interferometry was able to measure the displacement change of the tympanic membrane with 0.2 or 0.3 mL fluid at different frequencies. CONCLUSION: Laser interferometry can detect the effect of middle ear pressure and fluid on tympanic membrane movement as well as tympanometry does.

Acoustic-structural coupled finite element analysis for sound transmission in human ear--pressure distributions.

A three-dimensional (3D) finite element (FE) model of human ear with accurate structural geometry of the external ear canal, tympanic membrane (TM), ossicles, middle ear suspensory ligaments, and middle ear cavity has been recently reported by our group. In present study, this 3D FE model was modified to include acoustic-structural interfaces for coupled analysis from the ear canal through the TM to middle ear cavity. Pressure distributions in the canal and middle ear cavity at different frequencies were computed under input sound pressure applied at different locations in the canal. The spectral distributions of middle ear pressure at the oval window, round window, and medial site of the umbo were calculated and the results demonstrated that there was no significant difference of pressures between those locations at frequency below 3.5 kHz. Finally, the influence of TM perforation on pressure distributions in the canal and middle ear cavity was investigated for perforations in the inferior-posterior and inferior sites of the TM in the FE model and human temporal bones. The results show that variation of middle ear pressure is related to the perforation type and location, and is sensitive to frequency.

Human middle ear transfer function measured by double laser interferometry system.

HYPOTHESIS: Simultaneous measurements of vibrations on the stapes footplate, incudostapedial (IS) joint, and tympanic membrane (TM) can be made in both normal and drained cochleae, and the stapes displacement transfer function (S-DTF) and TM displacement transfer function (TM-DTF) are derived. BACKGROUND: A single laser Doppler interferometer previously has been used for measuring movement of the stapes or TM in temporal bones. However, there may be a limitation to optimally describing acoustic-mechanical transmission when the interferometer and temporal bone are moved frequently during experimental recordings. Simultaneous measurements of vibrations of the TM and stapes footplate, or TM and IS joint may reveal different acoustic-mechanical characteristics of the middle ear. METHODS: Dual laser interferometers simultaneously measured vibrations of the TM, IS joint, and stapes in 10 temporal bones with both intact and drained cochleae. From these measurements, the middle ear transfer function was expressed as the S-DTF, TM-DTF, and displacement transmission ratio (DTR). RESULTS: Simultaneous displacements of the TM, IS joint, and stapes footplate induced by sound pressure in the ear canal were recorded in both amplitude and phase. The middle ear transfer functions in terms of displacement ratio confirmed published single interferometer data but provided new information from drained cochlea. CONCLUSION: Stapes and TM displacement transfer functions were determined using dual interferometry, provided accurate amplitude and phase relationships from stapes footplate, IS joint, and TM, with new data from drained and normal cochlea.

Middle ear electromagnetic semi-implantable hearing device: results of the phase II SOUNDTEC direct system clinical trial.

OBJECTIVE: To assess the safety and efficacy of the SOUNDTEC Direct System, a partially implantable electromagnetic middle ear hearing device. STUDY DESIGN: Food and Drug Administration Phase II clinical trial of 103 patients at 10 sites across the United States. SETTING: Tertiary referral medical centers. PATIENTS: Individuals with bilateral moderate to moderately severe sensorineural hearing impairment who had worn optimally fit hearing aids for at least 45 days. INTERVENTIONS: Therapeutic intervention included implantation of a 27-mg neodymium iron boron magnet encased in a laser-welded titanium canister onto the incudostapedial joint, followed, after a 10-week healing period, by fitting with a deep earmold coil assembly and activation of the sound processor. MAIN OUTCOME MEASURES: Functional gain, speech recognition in quiet and noise, articulation index scores, perceived aided benefit, sound quality judgments, satisfaction, and presence of feedback and occlusion with the Direct System were compared with those of the patients' optimally fit hearing aid. RESULTS: The results of this multicenter clinical trial were submitted to the Food and Drug Administration on April 13, 2001, and are presented here. The results with the use of the SOUNDTEC Direct System compared with an optimally fit hearing aid provided an average 7.9-dB increase in functional gain in the speech frequencies (500-4,000 Hz) and a 9.6 dB gain in high frequencies (2,000, 3,000, and 4,000 Hz). There was a statistically significant average increase of 5.3% in speech discrimination. The mean speech perception in noise test score was improved, but the improvement was not statistically significant. Subjective tests using abbreviated profile of hearing aid benefit and the Hough Ear Institute Profile demonstrated scores statistically improved over the hearing aid condition. These subjective tests measured areas such as the presence of occlusion and feedback, speech quality judgments, device preference, and perceived aided benefit. CONCLUSIONS: The results of this Phase II clinical trial demonstrate that the SOUNDTEC Direct System provided statistically significant reduction in feedback and occlusive effect as well as a statistically significant improvement in all the following categories: functional gain, articulation index scores, speech discrimination in quiet, perceived aided benefit, patient satisfaction and device preference over the patient's optimally fit hearing aid.

Homograft microlathed femur prosthesis in stapedectomy.

The use of homografts in ossiculoplasty has been well documented in the literature. In the early 1980s, nonossicular homograft otic capsule bone was used as a prosthetic material in stapedectomy. We began using homograft femur as a prosthetic material in the early 1990s. In this article, we report the results of a retrospective study of the use of homograft femur prostheses. A series of 300 stapedectomies was performed between Aug. 24, 1992, and Jan. 20, 2000. Total footplate removal with preservation of the posterior crus was our procedure of choice. However, in 116 of these cases, the posterior crus could not be used, and a homograft femur prosthesis was substituted. For these prostheses, all homograft femurs were obtained from the American Red Cross. All prostheses were prepared in the bone laboratory and stored in the bone bank until needed. After an adequate period of follow-up, we tabulated our results. We found that in 89 of 113 cases (78.8%) available for follow-up, the air-bone gap was completely closed. In addition, the air-bone gap was closed to within 5 dB in 11 patients (9.7%) and closed to within 10 dB in five patients (4.4%). In all, 105 of the 113 homograft femur prosthetic procedures (92.9%) resulted in a successful outcome.

A totally implantable hearing system--design and function characterization in 3D computational model and temporal bones.

Implantable middle ear hearing devices are emerging as an effective technology for patients with mild to moderately severe sensorineural hearing loss. Several devices with electromagnetic or piezoelectric transducers have been investigated or developed in the US and Europe since 1990. This paper reports a totally implantable hearing system (TIHS) currently under investigation in Oklahoma. The TIHS consists of implant transducer (magnet), implantable coil and microphone, DSP-audio signal processor, rechargeable battery, and remote control unit. The design of TIHS is based on a 3D finite element model of the human ear and the analysis of electromagnetic coupling of the transducer. Function of the TIHS is characterized over the auditory frequency range in three aspects: (1) mass loading effect on residual hearing with a passive implant, (2) efficiency of electromagnetic coupling between the implanted coil and magnet, and (3) functional gain of whole unit in response to acoustic input across the human skin. This paper focuses on mass loading effect and the efficiency of electromagnetic coupling of TIHS determined from the FE model of the human ear and the cadaver ears or temporal bones. Some preliminary data of whole unit function are also presented in the paper.

Laser interferometry measurements of middle ear fluid and pressure effects on sound transmission.

An otitis media with effusion model in human temporal bones with two laser vibrometers was created in this study. By measuring the displacement of the stapes from the medial side of the footplate, the transfer function of the middle ear, which is defined as the displacement transmission ratio (DTR) of the tympanic membrane to footplate, was derived under different middle ear pressure and fluid in the cavity with a correction factor for cochlear load. The results suggest that the DTR increases with increasing frequency up to 4k Hz when the middle ear pressure was changing from 0 to 20 or -20 cm H20 (e.g., +/-196 daPa) and fluid level was increasing from 0 to a full middle ear cavity. The positive and negative pressures show different effects on the DTR. The effect of fluid on DTR varies between three frequency ranges: f < 1k, between 1k and 4k, and f > 4k Hz. These findings show how the efficiency of the middle ear system for sound transmission changes during the presence of fluid in the cavity and variations of middle ear pressure.