Objectives This study was conducted to demonstrate the safety and efficacy of the Otologics Middle Ear Transducer™ (MET™) Ossicular Stimulator and, in particular, to compare the audiologic benefits of this novel form of electromechanical stimulation with those of conventional acoustical amplification. Material and Methods A total of 282 patients were implanted with the device in Europe and the USA. Pure-tone audiometry, speech recognition and subjective assessment of benefit were tested before the surgery and 2, 3, 6 and 12 months afterwards. The US patients were fitted with a digital hearing aid for a minimum of 4 weeks prior to surgery, and the same benefit measures were performed with the digital hearing aid and their “walk-in” hearing aid. Results Group mean postoperative bone and air conduction thresholds did not change significantly from preoperative levels. Postoperative air conduction thresholds decreased slightly in some individual patients, due to the mass loading effect exerted by the transducer on the ossicles. Sufficient gain was available to reach target prescription levels for moderate to severely impaired hearing individuals. Speech and subjective assessment of patient preference indicated that patients did as well or better with the MET Ossicular Stimulator than with their “walk-in” aid or the standardized digital aid. Conclusion The capability of the MET Ossicular Stimulator to provide appropriate gain as a function of degree of hearing loss indicates that the device is a viable treatment for moderate to severe sensorineural hearing loss in adults.

Distortion product otoacoustic emissions (DPOAEs) can provide an objective and noninvasive assessment of the peripheral cochlear function. Auditory brainstem responses measured from implanted rhesus monkeys have shown that middle ear transducers, coupled directly to the incus, are capable of delivering the signals to the central auditory system. The DPOAEs were used as a noninvasive method of assessing the frequency specificity of this mechanical transduction. In two rhesus monkeys implanted with the middle ear transducers, one primary stimulating tone (f1) was presented acoustically, and the other primary tone (f2) was presented by the transducer, which converted the signal into a mechanical motion of the probe tip attached to the body of the incus. The nonlinear characteristics of the cochlea produced the distortion product responses at the expected frequencies (2f1 - f2). This demonstrates the fidelity of the middle ear implant signal transduction in vivo. The DPOAEs also indicate minimal changes in the post-implant middle ear transmission. This study demonstrates that the DPOAEs can be used to assess the function of implanted middle ear transducers objectively and noninvasively.

Distortion product otoacoustic emissions (DPOAEs) in rhesus monkeys were characterized and the optimal parameters for their generation were determined. Robust DPOAEs were readily measurable from the ear canals of six rhesus monkeys (n = 12 ears). The nonmonotonic behavior of the f2/f1 ratio functions in rhesus monkeys was found to be similar to other animals and humans. The optimal mean f2/f1 ratio of 1.21 and the effect of the primary frequency and level on the optimal f2/f1 ratios were also similar to human measurements. The contour of the rhesus monkey DPOAE 'audiograms' and their behavior were also comparable to human measurements with slight differences in peak frequencies. The rhesus monkey DPOAE input/output (I/O) functions were generally monotonic with a slope approaching unity with increasing frequency. Therefore, our study shows that many basic DPOAE characteristics are remarkably similar in the two species and emphasizes the appropriateness of the rhesus monkey as a model for DPOAE research. Detailed studies of the behavior of DPOAEs can be carried out in a model that is phylogenetically close to human both in hearing and in the gross structure and histology of the inner ear.

In preparation for future implantation of the implantable middle ear transducer in patients, a method was sought for preoperatively test fitting a model of the device, using computer generated three-dimensional (3-D) temporal bone images derived from spiral computed tomography (CT) data. A 3-D model of the implantable middle ear transducer was designed using NIH Image software on a Macintosh computer. High resolution human temporal bone CT scans were obtained using a spiral CT scanner (Siemens Somatom Plus S). The 3-D transducer model was superimposed onto 3-D reconstructions of the temporal bone using ANALYZE software on a computer graphics workstation (Sun SPARCstation 10), showing the transducer "implanted" in the temporal bone. Measurements were validated using a cadaver temporal bone. This process produced images demonstrating the "fit" of the current transducer design in the mastoid region of the adult temporal bone. It permitted assessment of the proximity of surrounding structures such as the external auditory meatus, dura, or sigmoid sinus. Preliminary cadaver validation measurements confirmed the accuracy of this method. Three-dimensional CT is a feasible method for preoperative planning of the surgical implantation of devices in the temporal bone. This method of 3-D test fitting will be used in the future to determine optimum orientation and size limitations for human implantable devices.

The advantages of using a laser to cut a hole in the ossicular chain include increased precision, decreased likelihood of disarticulation, and elimination of noise-induced threshold shift associated with conventional drills. This study was designed to determine optimal energy settings and cooling technique to minimize tissue injury. Laser ablated holes were cut in rabbit femurs with different endostat fibers at power settings of 1.6 to 5.0 watts. Comparable burr holes were cut by a high-speed drill and the animals were sacrificed at different time intervals. Specimens were evaluated microscopically for tissue injury by the amount of cell necrosis of the surrounding osteocytes, bone marrow changes, and denaturation of bone matrix. Changes in healing were assessed by the production and ossification of the granulation tissue. Laser ablated holes created with 1.6 to 2.0 watts at 2 to 7 days demonstrated thermal damage comparable to conventionally drilled holes. At 14 to 28 days these holes demonstrated advanced healing and integrated lamellar bone. In contrast, higher power (> 3.5 watts) at 2 to 7 days demonstrated Significantly more osteocyte loss, marked bone marrow fibrosis, and bone matrix denaturation. At 14 to 28 days these holes showed evidence of delayed healing and osseous plugs not integrated with the surrounding bone.

The vestibulo-ocular reflex (VOR) serves to maintain retinal image stability during rotation by utilizing semicircular canal input to generate conjugate eye movements that are equal but opposite to head movements. The VOR is related to the optokinetic reflex (OKR) which maintains retinal image stability by generating eye movement which follows large field visual motion. Another visual system, that of smooth pursuit (SP), allows accurate tracking of small central retinal targets. The VOR, OKR, and SP systems work together during natural motion to collectively assure stability of the desired visual target image. When VOR performance fails, and image stability is lost during head movements, visual-vestibular interaction is employed to adaptively modify and improve the VOR.

Revascularized iliac bone has advantages over other revascularized bone grafts for the reconstruction of large mandibular defects. This is a detailed anatomical study of the blood supply to the iliac bone using microfil and Batson injection methods. It confirms and extends Taylor's study. Clinical results are reported for six cases of extensive mandibular defects which were reconstructed using this method.

Extracellular spikes were recorded under general anaesthesia from the cell bodies of efferent vestibular neurons located in the caudal pontine reticular nucleus of the pigeon. Discrete electrical stimuli, applied directly to the three ampullary nerve branches in one labyrinth and to the anterior ramus of the vestibular nerve trunk in the other labyrinth, evoked antidromic spikes which served to identify efferent neurons. Most cells could be antidromically driven only by stimuli to the vestibular nerve trunk (anterior ramus). The majority of cells exhibiting direct axonal connections to one individual semicircular canal crista ampullaris showed axon collateralization to one or two other cristae as well. Sixty percent of the efferent neurons responded with antidromic spikes to ipsilateral labyrinthine stimuli, 34% to contralateral stimuli, and 6% to both. Synaptic activation was observed in a few efferent and adjacent unidentified neurons. It is concluded that efferent neurons often send collaterals to various cristae in one labyrinth, and less frequently, to both labyrinths. Such projections are incompatible with the assumption that vestibular efferents provide a simple control mechanism which is related to the direction of head movement.

In awake cats cells forming the lateral (LVST) and medial (MVST) vestibulospinal tracts were identified by employing antidromic stimulation of the spinal cord. Neuronal responses to bilateral vestibular, forelimb, hindlimb, and neck electrical nerve stimulation were analysed. Extracellular recording in the vestibular nuclei was performed via a glass micropipette saturated with Fast Green, to aid in later histological tract identification. The number of cells projecting to cervical and lumbar regions in the dorsal and ventral division of Deiters' nucleus did not differ significantly. An unexpectedly large number of MVST units was found in the descending nucleus. Some MVST units projected to the lumbar cord but in both the medial and descending nuclei, projections to the cervical cord were in majority. Almost all spinal projecting vestibular neurons received labyrinthine input and more than half received somatosensory input. The units could be separated into several populations on basis of excitatory and inhibitory labyrinthine response latencies indicating multiple pathways. As regards labyrinthine-somatosensory integration the two tracts were found to be quite similar. The extent and complexity of labyrinthine-somatosensory convergence indicate the importance of feed-back mechanisms upon postural controls also at the level of the vestibular nuclei.

1. Responses suggesting activation of the vestibular system, elicited by electrical stimulation of the human thalamus during 22 routine stereotaxic neurosurgical procedures, were examined in a retrospective study to determine the possible existence of vestibulothalamo-cortical projections in man. 2. Such responses were most frequently described as sensations of movement through space and were associated with two distinct vestibulothalamic projections: a) an anterior relay was situated ventral to the medial lemniscus, passing lateral to the red nucleus and dorsal to the subthalamic nucleus prior to terminating in the nucleus ventrointermedius (Vim) (comparable to VPLo in primates); b) a posterior relay associated with the auditory pathway (lateral lemniscus and brachium of the inferior colliculus) projected to the medial geniculate body. 3. The production of sensations of motion in conscious patients by stimulating areas that are similar to those reported constituting vestibulothalamic pathways in cats and primates implies a distinct primary sensory cortical projection for processing information from the vestibular receptors pertaining to the recognition of spatial movements.

The labyrinthine input to the vestibular nuclei was investigated in 24 awake cats. Stimulus consisted of electrical shocks given through bipolar silver wire electrodes, implanted in the utricular and lateral ampullar nerves. Throughout the vestibular nuclei, single units were recorded extracellularly with glass micropipettes filled with Fast Green. The tracts of the penetrating electrodes were identified histologically. In all four nuclei units responding to both labyrinths outnumbered unilaterally responding neurones with certain differences between the individual nuclei. Excitatory as well as inhibitory responses were observed, polysynaptic being more common than mono- or disynaptic ones. No monosynaptic contralateral responses were seen. The latency distribution of contralateral responses closely mirrored that of ipsilateral responses within each nucleus. Both excitatory and inhibitory responses fell into relatively segregated populations, based upon latency distribution. This implies separate pathways for labyrinthine input to the vestibular nuclei.

The neuronal pathway implicated in the vertical cervico-ocular reflex (COR) was investigated electrophysiologically in chloralose anesthetized cats. The effect of bilateral C2 dorsal root afferent stimulation on inferior oblique motoneurons (IO-MN) was investigated by intracellular recording. Control disynaptic excitatory postsynaptic potentials elicited in IO-MNs following stimulation of the contralateral anterior semicircular canal nerve (ACN) were invariably facilitated by conditioning stimulation to both ipsilateral and contralateral C2 dorsal roots (DR) in all motoneurons tested. This result indicates that inputs from the C2 DR of both sides and the contralateral ACN converge onto secondary vestibular neurons ('common interneurons') which project directly to the IO-MN. Common interneurons mediating vestibular and cervical excitation to the IO-MNs were studied in the vestibular nuclei on the side opposite to the motoneurons by extracellular recording. Nineteen vestibular neurons were identified as common interneurons; they were distributed in the caudal half of the lateral nucleus and the rostral half of the descending nucleus. The present experiment provides electrophysiological evidence of the projection of upper cervical afferents to the ipsilateral vestibular nuclei. The difference in neuronal organization between the horizontal and vertical COR is also briefly discussed.