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.

10-year follow-up after implantation of the Bryan Cervical Disc Prosthesis.

PURPOSE: Cervical arthroplasty is being used as an alternative for cervical fusion, but long-term follow-up results have rarely been reported. In this paper, we present 10-year follow-up results after implantation of the Bryan Cervical Disc Prosthesis in a single center. METHODS: 89 patients underwent implantation of a single-level Bryan Cervical Disc Prosthesis to treat radiculopathy and/or myelopathy. Clinical (Neurological Success, Neck Disability Index (NDI), Neck- and Arm-Pain, and SF-36) and radiological follow-up was prospectively organized up to 10 years after surgery. Adverse events and second surgeries were recorded and evaluated. RESULTS: Ten-year follow-up data were available for 72 (81%) patients. Maintenance or improvement of the neurological state was seen in 89% of patients after 10-year follow-up. SF-36 PCS scores improved significantly at all follow-up points. SF-36 MCS improvement was significant at 4 and 6 year, but not at 8- and 10-year follow-up. Significant improvement for NDI, and Neck- and Arm-Pain scores was found for the subgroup of patients in whom these data were available. Mean angular motion of the prosthesis at 10-year follow-up was 8.6°. Mobility of the device, defined as >2° of angular motion, was reached in 81% of patients. During the study period, 21 patients (24%) developed new or recurrent radiculopathy or myelopathy, the majority of these being treated conservatively. Seven patients (8%) required 8 additional spine surgeries to treat persistent or recurrent symptoms. Of these, 2 patients (2%) were reoperated at the index level and at 5 (6%) an adjacent level. CONCLUSION: In this study, favorable long-term clinical outcome after implantation of the Bryan Cervical Disc Prosthesis was seen, with the majority of prostheses remaining mobile after 10-year follow-up. However, still 6% of patients required adjacent level surgery.

Feasibility of an implanted microphone for cochlear implant listening.

This study aimed at evaluating the feasibility of an implanted microphone for cochlear implants (CI) by comparison of hearing outcomes, sound quality and patient satisfaction of a subcutaneous microphone to a standard external microphone of a behind-the-ear sound processor. In this prospective feasibility study with a within-subject repeated measures design comparing the microphone modalities, ten experienced adult unilateral CI users received an implantable contralateral subcutaneous microphone attached to a percutaneous plug. The signal was pre-processed and fed into their CI sound processor. Subjects compared listening modes at home for a period of up to 4 months. At the end of the study the microphone was explanted. Aided audiometric thresholds, speech understanding in quiet, and sound quality questionnaires were assessed. On average thresholds (250, 500, 750, 1k, 2k, 3k, 4k and 6 kHz) with the subcutaneous microphone were 44.9 dB, compared to 36.4 dB for the external mode. Speech understanding on sentences in quiet was high, within approximately 90% of performance levels compared to hearing with an external microphone. Body sounds were audible but not annoying to almost all subjects. This feasibility study with a research device shows significantly better results than previous studies with implanted microphones. This is attributed to technology enhancements and careful fitting. Listening effort was somewhat increased with an implanted microphone. Under good sound conditions, speech performance is nearly similar to that of external microphones demonstrating that an implanted microphone is feasible in a range of normal listening conditions.

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.

Postoperative segmental malalignment after surgery with the Bryan cervical disc prosthesis: is it related to the mechanics and design of the prosthesis?

STUDY DESIGN: In a radiographic study, postoperative segmental alignment was compared between 2 cohorts of 20 consecutive patients operated with a Bryan Cervical Disc Prosthesis. In group 2, patients with severe preoperative kyphosis were excluded for disc replacement surgery and the surgical technique was slightly altered to avoid asymmetric overdrilling of the posterior part of the cranial endplate of the caudal vertebral body. OBJECTIVE: The aim was to investigate whether this change in patient inclusion criteria and modification of the surgical technique had an influence on postoperative segmental alignment and whether postoperative kyphosis is related to the mechanical properties and/or the design of the prosthesis. SUMMARY OF BACKGROUND DATA: Several research groups reported segmental kyphosis after treatment of degenerative disc disease with the Bryan Cervical Disc Prosthesis. METHODS: On the basis of lateral radiographs, the disc insertion angle (as a postoperative estimate for the intraoperative angle of approach) and the angle of the functional spinal unit (FSU) and disc angle (both as measures for segmental alignment) were calculated. RESULTS: In group 1, 80% of the patients had a kyphotic FSU angle and 40% had a kyphotic disc angle preoperatively. At follow-up, 65% of the patients had a kyphotic FSU angle, whereas 55% had a kyphotic disc angle. In group 2, 40% of the patients had a kyphotic FSU angle and 5% had a kyphotic disc angle preoperatively. At follow-up, 40% of the patients had a kyphotic FSU angle, whereas 5% had a kyphotic disc angle. Due to the change in patient inclusion criteria, there was a significant difference in preoperative FSU angle between groups 1 and 2; however, no significant difference in preoperative disc angle was found. Owing to the change in surgical technique, the disc insertion angle was significantly different between both the groups. A difference in postoperative FSU angle, however, nonsignificant, between both the groups was observed. There was a significant difference in postoperative disc angle between both the groups; group 1 showed significantly more kyphosis of the shells, than group 2. CONCLUSIONS: This study shows that segmental malalignment with the Bryan Disc can be reduced and is therefore not device related. Proper patient selection and a modified surgical technique can prevent this adverse outcome.

Qualitative and quantitative assessment of degeneration of cervical intervertebral discs and facet joints.

Degeneration of intervertebral discs and facet joints is one of the most frequently encountered spinal disorders. In order to describe and quantify degeneration and evaluate a possible relationship between degeneration and biomechanical parameters, e.g., the intervertebral range of motion and intradiscal pressure, a scoring system for degeneration is mandatory. However, few scoring systems for the assessment of degeneration of the cervical spine exist. Therefore, two separate objective scoring systems to qualitatively and quantitatively assess the degree of cervical intervertebral disc and facet joint degeneration were developed and validated. The scoring system for cervical disc degeneration consists of three variables which are individually scored on neutral lateral radiographs: "height loss" (0-4 points), "anterior osteophytes" (0-3 points) and "endplate sclerosis" (0-2 points). The scoring system for facet joint degeneration consists of four variables which are individually scored on neutral computed tomography scans: "hypertrophy" (0-2 points), "osteophytes" (0-1 point), "irregularity" on the articular surface (0-1 point) and "joint space narrowing" (0-1 point). Each variable contributes with varying importance to the overall degeneration score (max 9 points for the scoring system of cervical disc degeneration and max 5 points for facet joint degeneration). Degeneration of 20 discs and facet joints of 20 patients was blindly assessed by four raters: two neurosurgeons (one senior and one junior) and two radiologists (one senior and one junior), firstly based on first subjective impression and secondly using the scoring systems. Measurement errors and inter- and intra-rater agreement were determined. The measurement error of the scoring system for cervical disc degeneration was 11.1 versus 17.9% of the subjective impression results. This scoring system showed excellent intra-rater agreement (ICC = 0.86, 0.75-0.93) and excellent inter-rater agreement (ICC = 0.78, 0.64-0.88). Surgeons as well as radiologists and seniors as well as juniors obtained excellent inter- and intra-rater agreement. The measurement error of the scoring system for cervical facet joint degeneration was 20.1 versus 24.2% of the subjective impression results. This scoring system showed good intra-rater agreement (ICC = 0.71, 0.42-0.89) and fair inter-rater agreement (ICC = 0.49, 0.26-0.74). Both scoring systems fulfilled the criteria for recommendation proposed by Kettler and Wilke. Our scoring systems can be reliable and objective tools for assessing cervical disc and facet joint degeneration. Moreover, the scoring system of cervical disc degeneration was shown to be experience- and discipline-independent.

Does Heterotopic Ossification in Cervical Arthroplasty Affect Clinical Outcome?

OBJECTIVE: To investigate the occurrence and progression of heterotopic ossification (HO) in patients treated by anterior cervical discectomy with arthroplasty. It was evaluated if HO affects clinical outcome and range of motion (ROM). Risk factors of HO was studied as well. METHODS: Patients who underwent anterior cervical discectomy with arthroplasty for a cervical radiculopathy because of a herniated disc from the NECK and PROCON trial were analyzed for HO at 12 and 24 months postoperatively. HO was scored according to the McAfee-Mehren classification. The index ROM was defined by a custom developed image analysis tool, and global cervical ROM was measured by Cobb's angle. Clinical outcome was evaluated by means of the Neck Disability Index and the 36-Item Short Form Health Survey. RESULTS: The occurrence of HO was 60% at 1 year, and it increased to 76% at 2-year follow-up. A total of 31% of patients were scored as high-grade HO at 1-year follow-up, and this percentage increased to 50% at 2-year follow-up. Clinical outcome does not correlate to HO grade, and no risk factor for high-grade HO could be identified. The ROM at the index level was significantly higher in low-grade HO group than those patients with high-grade HO, but in 15%-38% HO grade does not correspond to ROM. CONCLUSIONS: HO occurs in three fourths of the patients at 2 years after surgery, but does not necessarily correspond to clinical outcome, nor loss or preservation of ROM. The McAfee-Mehren classification should be combined with ROM evaluation to properly study HO.

Maintaining range of motion after cervical discectomy does not prevent adjacent segment degeneration.

BACKGROUND: Motion preservation prostheses were introduced to prevent adjacent disc degeneration (ASD) and to diminish neck disability in the postsurgical follow-up. However, it is still a controversial issue, and the relationship between range of motion (ROM) and ASD has not been studied. PURPOSE: To compare the correlation between ROM of the cervical spine and the presence of radiological ASD after anterior discectomy. Clinical outcome was also correlated to ROM and ASD. STUDY DESIGN: Retrospective cohort study. METHODS: In all, 253 patients who underwent anterior discectomy for cervical radiculopathy due to a herniated disc were analyzed for segmental and global cervical ROM and the presence of ASD both preoperatively, and 12 and 24 months postoperatively. Patients who were included in two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty, anterior cervical discectomy with intervertebral cage, or anterior cervical discectomy without intervertebral cage for one level disc herniation were analyzed. ROM was defined by a custom-developed image analysis tool. ASD was defined by decrease in disc height and anterior osteophyte formation on X-rays. Clinical outcome was evaluated by means of the Neck Disability Index (NDI). RESULTS: Two years postoperatively, no correlation was demonstrated between ROM and ASD. The incidence of ASD was comparable in the three groups, being 34% at baseline, and 58% at 2-year follow-up. Likewise, ASD progression was comparable in the three treatment arms. No correlation was demonstrated between ROM and NDI or ASD and NDI. CONCLUSIONS: Since ROM is not correlated to ASD, and clinical outcome is not correlated to ROM either, the relevance of continued ROM at the target level seems absent.

Correlation between compression, tensile and tearing tests on healthy and calcified aortic tissues.

An anastomosis performed in calcified tissues tears up faster than in healthy tissues. This study develops and validates an in vitro non-destructive method to distinguish healthy from calcified aortic tissues. An uniaxial unconfined compression test is able to distinguish healthy from calcified aortas (p<0.01). The compressive E-modulus at a strain level of 10% is 227+/-34kPa for artificially calcified and 147+/-15kPa for healthy porcine aortic tissues. Calcified aortic tissues have a lower tensile strength than healthy porcine aortic tissues (p<0.05). The ultimate tensile strength is 1.34+/-0.18MPa and 1.55+/-0.31MPa for artificially calcified and healthy porcine aortic tissues respectively. Calcified aortic tissues have a lower resistance to tearing than healthy aortic tissues (p<0.05). The resistance to tearing is 1.78+/-0.33N/mm and 2.16+/-0.64N/mm for artificially calcified and healthy porcine aortic tissues respectively.

A MEMS Condenser Microphone-Based Intracochlear Acoustic Receiver.

GOAL: Intracochlear sound pressure (ICSP) measurements are limited by the small dimensions of the human inner ear and the requirements imposed by the liquid medium. A robust intracochlear acoustic receiver (ICAR) for repeated use with a simple data acquisition system that provides the required high sensitivity and small dimensions does not yet exist. The work described in this report aims to fill this gap and presents a new microelectromechanical systems (MEMS) condenser microphone (CMIC)-based ICAR concept suitable for ICSP measurements in human temporal bones. METHODS: The ICAR head consisted of a passive protective diaphragm (PD) sealing the MEMS CMIC against the liquid medium, enabling insertion into the inner ear. The components of the MEMS CMIC-based ICAR were expressed by a lumped element model (LEM) and compared to the performance of successfully fabricated ICARs. RESULTS: Good agreement was achieved between the LEM and the measurements with different sizes of the PD. The ICSP measurements in a human cadaver temporal bone yielded data in agreement with the literature. CONCLUSION: Our results confirm that the presented MEMS CMIC-based ICAR is a promising technology for measuring ICSP in human temporal bones in the audible frequency range. SIGNIFICANCE: A sensor for evaluation of the biomechanical hearing process by quantification of ICSP is presented. The concept has potential as an acoustic receiver in totally implantable cochlear implants.

Direct Acoustic Stimulation at the Lateral Canal: An Alternative Route to the Inner Ear?

Severe to profound mixed hearing loss is associated with hearing rehabilitation difficulties. Recently, promising results for speech understanding were obtained with a direct acoustic cochlear implant (DACI). The surgical implantation of a DACI with standard coupling through a stapedotomy can however be regarded as challenging. Therefore, in this experimental study, the feasibility of direct acoustic stimulation was investigated at an anatomically and surgically more accessible inner ear site. DACI stimulation of the intact, blue-lined and opened lateral semicircular canal (LC) was investigated and compared with standard oval window (OW) coupling. Additionally, stapes footplate fixation was induced. Round window (RW) velocity, as a measure of the performance of the device and its coupling efficiency, was determined in fresh-frozen human cadaver heads. Using single point laser Doppler vibrometry, RW velocity could reliably be measured in low and middle frequency range, and equivalent sound pressure level (LE) output was calculated. Results for the different conditions obtained in five heads were analyzed in subsequent frequency ranges. Comparing the difference in RW membrane velocity showed higher LE in the LC opened condition [mean: 103 equivalent dB SPL], than in LC intact or blue-lined conditions [63 and 74 equivalent dB SPL, respectively]. No difference was observed between the LC opened and the standard OW condition. Inducing stapes fixation, however, led to a difference in the low frequency range of LE compared to LC opened. In conclusion, this feasibility study showed promising results for direct acoustic stimulation at this specific anatomically and surgically more accessible inner ear site. Future studies are needed to address the impact of LC stimulation on cochlear micromechanics and on the vestibular system like dizziness and risks of hearing loss.

Stochastic queueing-theory approach to human dynamics.

Recently, numerous studies have shown that human dynamics cannot be described accurately by exponential laws. For instance, Barabási [Nature (London) 435, 207 (2005)] demonstrates that waiting times of tasks to be performed by a human are more suitably modeled by power laws. He presumes that these power laws are caused by a priority selection mechanism among the tasks. Priority models are well-developed in queueing theory (e.g., for telecommunication applications), and this paper demonstrates the (quasi-)immediate applicability of such a stochastic priority model to human dynamics. By calculating generating functions and by studying them in their dominant singularity, we prove that nonexponential tails result naturally. Contrary to popular belief, however, these are not necessarily triggered by the priority selection mechanism.

Longitudinal prospective long-term radiographic follow-up after treatment of single-level cervical disk disease with the Bryan Cervical Disc.

BACKGROUND: Many short- and intermediate-term radiological and clinical studies on cervical arthroplasty with the Bryan Cervical Disc have been published, providing, most of the time, satisfactory results. OBJECTIVE: To prospectively assess the intermediate and long-term radiographic characteristics of disk replacement surgery with the Bryan Cervical Disc and to correlate these results with clinical outcome. METHODS: Range of motion was measured with a validated tool. Intervertebral disk degeneration was assessed with a quantitative scoring system. Heterotopic ossification was evaluated with a previously published scoring system. Device stability was investigated by measuring subsidence and anteroposterior migration. General clinical patient outcome was assessed with the Odom classification system. RESULTS: Eighty-nine patients were initially included in this prospective long-term study. One patient was reoperated on at the index level and 4 were reoperated on at an adjacent level; those patients were not further analyzed. The mobility at the treated level was preserved in > or = 85% of our cases. The insertion of the prosthesis did not lead to an increase in mobility at the adjacent levels. The degeneration score increased at both adjacent levels. Heterotopic ossification was present in 34% to 39% of the patients, depending on the follow-up point. No cases of anteroposterior migration or subsidence were found. More than 82% of all patients had a good to excellent clinical outcome in the long run. CONCLUSION: The device maintains preoperative motion at the index and adjacent levels, seems to protect against acceleration of adjacent-level degeneration as seen after anterior cervical discectomy and fusion, and remains securely anchored in the adjacent bone mass in the long run. Heterotopic ossification was frequently seen. The vast majority of all patients had a good to excellent clinical outcome.