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International audience; This Review outlines the development of DNA-based therapeutics for treatment of hearing loss, and in particular, considers the potential to utilize the properties of recombinant neurotrophins to improve cochlear auditory (spiral ganglion) neuron survival and repair. This potential to reduce spiral ganglion neuron death and indeed re-grow the auditory nerve fibres has been the subject of considerable preclinical evaluation over decades with the view of improving the neural interface with cochlear implants. This provides the context for discussion about the development of a novel means of using cochlear implant electrode arrays for gene electrotransfer. Mesenchymal cells which line the cochlear perilymphatic compartment can be selectively transfected with (naked) plasmid DNA using array - based gene electrotransfer, termed 'close-field electroporation'. This technology is able to drive expression of brain derived neurotrophic factor (BDNF) in the deafened guinea pig model, causing re-growth of the spiral ganglion peripheral neurites towards the mesenchymla cells, and hence into close proximity with cochlear implant electrodes within scala tympani. This was associated with functional enhancement of the cochlear implant neural interface (lower neural recruitment thresholds and expanded dynamic range, measured using electrically - evoked auditory brainstem responses). The basis for the efficiency of close-field electroporation arises from the compression of the electric field in proximity to the ganged cochlear implant electrodes. The regions close to the array with highest field strength corresponded closely to the distribution of bioreporter cells (adherent human embryonic kidney (HEK293)) expressing green fluorescent reporter protein (GFP) following gene electrotransfer. The optimization of the gene electrotransfer parameters using this cell-based model correlated closely with in vitro and in vivo cochlear gene delivery outcomes. The migration of the cochlear implant electrode array-based gene electrotransfer platform towards a clinical trial for neurotrophin-based enhancement of cochlear implants is supported by availability of a novel regulatory compliant mini-plasmid DNA backbone (pFAR4; plasmid Free of Antibiotic Resistance v.4) which could be used to package a 'humanized' neurotrophin expression cassette. A reporter cassette packaged into pFAR4 produced prominent GFP expression in the guinea pig basal turn perilymphatic scalae. More broadly, close-field gene electrotransfer may lend itself to a spectrum of potential DNA therapeutics applications benefitting from titratable, localised, delivery of naked DNA, for gene augmentation, targeted gene regulation, or gene substitution strategies. (C) 2019 Elsevier B.V. All rights reserved.

The cochlear implant is considered one of the most successful neural prostheses to date, which was made possible by visionaries who continued to develop the cochlear implant through multiple technological and clinical challenges. However, patients without a functional auditory nerve or implantable cochlea cannot benefit from a cochlear implant. The focus of the paper is to review the development and translation of a new type of central auditory prosthesis for this group of patients that is known as the auditory midbrain implant (AMI) and is designed for electrical stimulation within the inferior colliculus. The rationale and results for the first AMI clinical study using a multi-site single-shank array will be presented initially. Although the AMI has achieved encouraging results in terms of safety and improvements in lip-reading capabilities and environmental awareness, it has not yet provided sufficient speech perception. Animal and human data will then be presented to show that a two-shank AMI array can potentially improve hearing performance by targeting specific neurons of the inferior colliculus. A new two-shank array, stimulation strategy, and surgical approach are planned for the AMI that are expected to improve hearing performance in the patients who will be implanted in an upcoming clinical trial funded by the National Institutes of Health. Positive outcomes from this clinical trial will motivate new efforts and developments toward improving central auditory prostheses for those who cannot sufficiently benefit from cochlear implants. This article is part of a Special Issue entitledLasker Award.

The aim of this study was to analyse the tissue surrounding the University of Melbourne's (UOMs) multi-channel cochlear implant electrode array and cochlear limited replacements, after long-term implantations. In particular, it aimed to identify the particulate material in the fibrous tissue capsule of the arrays implanted in 1978, 1983, and 1998, by using the Australian Synchrotron for X-ray fluorescence microscopy (XFM) to reveal the characteristic spectrum of metal, in particular platinum. This also helped to determine its format and chemical state. Tissue was retrieved following the recipient's death in 2007.Tissue was fixed and sections taken across the UOM and Cochlear Corporation (CI-22 and CI-24) electrode tracks. These were stained with Masson's trichrome. The Australian Synchrotron enabled XFM to accurately identify platinum from its characteristic fluorescence spectrum.There was a fibrous tissue capsule (about 100-µm thick) and small regions of calcification around the UOM and CI-22 arrays, but a thinner capsule (40-60-µm thick) around CI-24, and a greater degree of calcification. Dark particulate matter was observed within macrophages and especially in fibrous tissue in proximity to the UOM and CI-22 arrays. This was identified as platinum using X-ray fluorescence. There was also diffusion of platinum into the tissue surrounding the UOM and CI-22 electrodes and fine particles had penetrated the spiral ligament.The larger particulate matter in the tissue around the UOM and CI-22 arrays suggested that it had flaked off in the manufacturing of the UOM electrodes. The more diffuse spread of platinum in the tissue around the UOM and CI-22 electrodes was likely due to electrolysis, probably from charge imbalance with the bipolar pulses from the UOM implant. This did not occur with the Cochlear CI-24 device. Furthermore, the widespread fine particles of platinum could have also been due to corrosion, especially from the UOM electrodes.

Objective Multi-centre collaborative study to develop and refine the design of a prototype thin perimodiolar cochlear implant electrode array and to assess feasibility for use in human subjects. Study Design Multi-centre temporal bone insertion studies. Materials and Methods The modiolar research array (MRA) is a thin pre-curved electrode that is held straight for initial insertion with an external sheath rather than an internal stylet. Between November 2006 and February 2009, six iterations of electrode design were studied in 21 separate insertion studies in which 140 electrode insertions were performed in 85 human temporal bones by 12 surgeons. These studies aimed at addressing four fundamental questions related to the electrode concept, being: (1) Could a sheath result in additional intra-cochlear trauma? (2) Could a sheath accommodate variations in cochlea size and anatomies? (3) Could a sheath be inserted via the round window? and (4) Could a sheath be safely removed once the electrode had been inserted? These questions were investigated within these studies using a number of evaluation techniques, including X-ray and microfluoroscopy, acrylic fixation and temporal bone histologic sectioning, temporal bone microdissection of cochlear structures with electrode visualization, rotational tomography, and insertion force analysis. Results Frequent examples of electrode rotation and tip fold-over were demonstrated with the initial designs. This was typically caused by excessive curvature of the electrode tip, and also difficulty in handling of the electrode and sheath. The degree of tip curvature was progressively relaxed in subsequent versions with a corresponding reduction in the frequency of tip fold-over. Modifications to the sheath facilitated electrode insertion and sheath removal. Insertion studies with the final MRA design demonstrated minimal trauma, excellent perimodiolar placement, and very small electrode dimensions within scala tympani. Force measurements in temporal bones demonstrated negligible force on cochlear structures with angular insertion depths of between 390 and 450°. Conclusion The MRA is a novel, very thin perimodiolar prototype electrode array that has been developed using a systematic collaborative approach. The different evaluation techniques employed by the investigators contributed to the early identification of issues and generation of solutions. Regarding the four fundamental questions related to the electrode concept, the studies demonstrated that (1) the sheath did not result in additional intra-cochlear trauma; (2) the sheath could accommodate variations in cochlea size and anatomies; (3) the sheath was more successfully inserted via a cochleostomy than via the round window; and (4) the sheath could be safely removed once the electrode had been inserted.

The cochlear implant can restore speech perception in patients with sensorineural hearing loss. However, it is ineffective for those without an implantable cochlea or a functional auditory nerve. These patients can be implanted with the auditory brainstem implant (ABI), which stimulates the surface of the cochlear nucleus. Unfortunately, the ABI has achieved limited success in its main patient group [i.e., those with neurofibromatosis type 2 (NF2)] and requires a difficult surgical procedure. These limitations have motivated us to develop a new hearing prosthesis that stimulates the midbrain with a penetrating electrode array. We recently implanted three patients with the auditory midbrain implant (AMI), and it has proven to be safe with minimal movement over time. The AMI provides loudness, pitch, temporal, and directional cues, features that have shown to be important for speech perception and more complex sound processing. Thus far, all three patients obtain enhancements in lip reading capabilities and environmental awareness and some improvements in speech perception comparable with that of NF2 ABI patients. Considering that our midbrain target is more surgically exposable than the cochlear nucleus, this argues for the use of the AMI as an alternative to the ABI. Fortunately, we were able to stimulate different midbrain regions in our patients and investigate the functional organization of the human central auditory system. These findings provide some insight into how we may need to stimulate the midbrain to improve hearing performance with the AMI.

Cochlear Limited (Cochlear™) released the fourth-generation cochlear implant system, Nucleus® Freedom™, in 2005. Freedom is based on 25 years of experience in cochlear implant research and development and incorporates advances in medicine, implantable materials, electronic technology, and sound coding. This article presents the development of Cochlear's implant systems, with an overview of the first 3 generations, and details of the Freedom system: the CI24RE receiver-stimulator, the Contour Advance™ electrode, the modular Freedom processor, the available speech coding strategies, the input processing options of SmartSound™ to improve the signal before coding as electrical signals, and the programming software. Preliminary results from multicenter studies with the Freedom system are reported, demonstrating better levels of performance compared with the previous systems. The final section presents the most recent implant reliability data, with the early findings at 18 months showing improved reliability of the Freedom implant compared with the earlier Nucleus 3 System. Also reported are some of the findings of Cochlear's collaborative research programs to improve recipient outcomes. Included are studies showing the benefits from bilateral implants, electroacoustic stimulation using an ipsilateral and/or contralateral hearing aid, advanced speech coding, and streamlined speech processor programming.

The auditory midbrain implant (AMI) is a new treatment for hearing restoration in patients with neural deafness or surgically inaccessible cochleae who cannot benefit from cochlear implants (CI). This includes neurofibromatosis type II (NF2) patients who, due to development and/or removal of vestibular schwannomas, usually experience complete damage of their auditory nerves. Although the auditory brainstem implant (ABI) provides sound awareness and aids lip-reading capabilities for these NF2 patients, it generally only achieves hearing performance levels comparable with a single-channel CI. In collaboration with Cochlear Ltd. (Lane Cove, Australia), we developed a human prototype AMI, which is designed for electrical stimulation along the well-defined tonotopic gradient of the inferior colliculus central nucleus (ICC). Considering that better speech perception and hearing performance has been correlated with a greater number of discriminable frequency channels of information available, the ability of the AMI to effectively activate discrete frequency regions within the ICC may enable better hearing performance than achieved by the ABI. Therefore, the goal of this study was to investigate if our AMI array could achieve low-threshold, frequency-specific activation within the ICC, and whether the levels for ICC activation via AMI stimulation were within safe limits for human application. We electrically stimulated different frequency regions within the ICC via the AMI array and recorded the corresponding neural activity in the primary auditory cortex (A1) using a multisite silicon probe in ketamine-anesthetized guinea pigs. Based on our results, AMI stimulation achieves lower thresholds and more localized, frequency-specific activation than CI stimulation. Furthermore, AMI stimulation achieves cortical activation with current levels that are within safe limits for central nervous system stimulation. This study confirms that our AMI design is sufficient for ensuring safe and effective activation of the ICC, and warrants further studies to translate the AMI into clinical application.

COCHLEAR IMPLANT SOFT FAILURES CONSENSUS DEVELOPMENT CONFERENCE STATEMENTThis Consensus Statement was prepared by a panel of experts representing the fields of otolaryngology, audiology, speech and language pathology, communication science, and engineering. Representatives to the conference were app

Our object is to develop a reliable, implantable and closed-loop functional electrical stimulator (FES) hybrid system for safe prolonged standing in paraplegic individuals. Open-loop FES systems rapidly induce muscle fatigue that limits paraplegic standing to less than 20 and typically 10 min. Since December 1991, a paraplegic male (CS: 23 years old, T10 level, Asia: A) has been implanted with the first Nucleus FES-22 channel stimulating system (Cochlear Ltd., Lane Cove, N.S.W., Australia). Epineural platinum disc electrodes (2.5 mm) were placed on branches of the femoral, gluteal and sciatic nerves, which can be activated to produce controlled lower extremity movements for exercise and standing. No medical complications have occurred during these 5 1/2 years of implantation. The ankles are stabilized with Andrews' ankle-foot braces, the knees are free to flex. With bilateral knee goniometers fitted to sense a 10 degrees angle flexion, this hybrid closed-loop stimulation system allows the patient to achieve safe uninterrupted standing for over 60 min. The stimulator has needed to be activated 'on' for 8% (range: 3-17%) of the standing times, preventing muscle fatigue, with little or no changes found in the vital signs. The patient can manipulate and transfer objects at arm length up to 2.2 kg with good stability. New, less obstrusive sensors are currently being tested for a safer and more reliable closed-loop system.

This review highlights the advances that polymers, specifically thermoplastics, are making in the active implantable medical device (AIMD) sector. An overview of the increasing use of polymers in medical and non-medical industries is provided. Polymers of interest are discussed, and their relevant properties as metal replacements are highlighted. The challenges for implementing polymer components in AIMDs are described, with focus on hermeticity, joining methods and material degradation in an industry where assurance of patient safety is mandatory.

The auditory midbrain implant (AMI), which is designed for stimulation of the inferior colliculus (IC), is now in clinical trials. The AMI consists of a single shank array (20 contacts) and uses a stimulation strategy originally designed for cochlear implants since it is already approved for human use and we do not yet know how to optimally activate the auditory midbrain. The goal of this study was to investigate the effects of different pulse rates and phase durations on loudness and pitch percepts because these parameters are required to implement the AMI stimulation strategy. Although each patient was implanted into a different region (i.e. lateral lemniscus, central nucleus of IC, dorsal cortex of IC), they generally exhibited similar threshold versus phase duration, threshold versus pulse rate, and pitch versus pulse rate curves. In particular, stimulation with 100 mus/phase, 250 pulse per second (pps) pulse trains achieved an optimal balance among safety, energy, and current threshold requirements while avoiding rate pitch effects. However, we observed large differences across patients in loudness adaptation to continuous pulse stimulation over long time scales. One patient (implanted in dorsal cortex of IC) even experienced complete loudness decay and elevation of thresholds with daily stimulation. Comparing these results with those of cochlear implant and auditory brainstem implant patients, it appears that stimulation of higher order neurons exhibits less and even no loudness summation for higher rate stimuli and greater current leakage for longer phase durations than that of cochlear neurons. The fact that all midbrain regions we stimulated, which includes three distinctly different nuclei, exhibited similar loudness summation effects (i.e. none for pulse rates above 250 pps) suggests a possible shift in some coding properties that is affected more by which stage along the auditory pathway rather than the types of neurons are being stimulated. However, loudness adaptation occurs at multiple stages from the cochlea up to the midbrain.

Objective: To evaluate the effectiveness and issues associated with a research totally implantable cochlear implant (TIKI). Study Design: Limited patient trial. Setting: Tertiary referral center. Patients: Three adult human subjects with severe-to-profound sensorineural hearing loss. Interventions: Subjects were implanted with a research TIKI developed by Cochlear Limited and the Co-operative Research Centre for Cochlear Implant and Hearing Aid Innovation. The TIKI has a lithium ion rechargeable battery, a package-mounted internal microphone, and sound-processing electronics that enable the use of Binvisible hearing[ without the use of an externaldevice. The TIKIalso functionswithan externalESPrit 3G sound processor as a conventional cochlear implant. The standard surgical technique was modified to accommodate the larger device package. Postoperatively, subjects used TIKI in both invisible hearing and the conventional ESPrit 3G modes. Main Outcome Measures: Device use was recorded in both invisible hearing and ESPrit 3G listening modes. Performance of the internal battery and microphone was assessed over time. Psychophysical MAP data were collected, and speech perception was measured at 1, 3, 6, and 12 months postoperatively in both listening modes. Results: There were no surgical or postoperative complications. All subjects use both invisible hearing and conventional ESPrit 3G modes. Speech perception outcomes for all patients showed improvement from preoperative scores. As a consequence of the reduced sensitivity of the implanted microphone, speech perception results using the invisible hearing mode were significantly lower than the ESPrit 3G mode. Subjects reported some body noise interference that limited use of the invisible hearing mode; however, all continue to use the invisible hearing mode on a limited daily basis. The rechargeable battery functioned well, with a cycle time indicating the lowpower implant design is effective and will deliver long battery life. Conclusion: This study demonstrates that the challenges in developing a safe and effective TIKI can be overcome. Three subjects implanted with the research TIKI all reported benefit from routine use. For each subject, hearing outcomes using invisible hearing mode were not as good as when using the external ESPrit 3G sound processor in the conventional mode. Key Words: Cochlear implantsVTotally implantable. Otol Neurotol 29:114Y119, 2008.

The auditory midbrain implant (AMI) is a new central auditory prosthesis designed for penetrating stimulation of the human inferior colliculus. The major group of candidates for the AMI consists of neurofibromatosis type 2 (NF2) patients who develop neural deafness because of growth and/or surgical removal of bilateral acoustic neuromas. Because of the absence of a viable auditory nerve, these patients cannot benefit from cochlear implants. An alternative solution has been the auditory brainstem implant (ABI), which stimulates the cochlear nucleus. However, speech perception performance in NF2 ABI patients has been limited. The fact that the ABI is able to produce high levels of speech perception in nontumor patients (with inaccessible cochleae or posttraumatic damage to the cochlear nerve) suggests that limitations in ABI performance in NF2 patients may be associated with cochlear nucleus damage caused by the tumors or the tumor removal process. Thus, stimulation of the auditory midbrain proximal to the damaged cochlear nucleus may be a better alternative for hearing restoration in NF2 patients. We propose the central nucleus of the inferior colliculus (ICC) as the potential site. A penetrating electrode array aligned along the well-defined tonotopic gradient of the ICC should selectively activate different frequency regions, which is an important elementfor supporting good speech understanding. The goal of this article is to present the ICC as an alternative site for an auditory implant for NF2 patients and to describe the design of the first human prototype AMI. Practical considerations for implementation of the AMI will also be discussed.

Development of a micromachined electrode array for cochlear implant application is presented. The device is constructed from a silicon substrate with sputtered platinum electrodes and connection tracks. Electrochemical impedance spectroscopy (EIS) is used to study the properties of the electrode, and to identify potential problems caused by the micromachining process and materials. A variety of insulators are studied and a two-part epoxy is identified as an adequate insulator for operation under harsh electrochemical testing conditions. The semiconducting silicon substrate is found to contribute to the total impedance of the device at high frequencies due to the thin insulating oxide between the substrate and conducting tracks. This is a potential problem for micromachined electrodes operating under high frequencies or using square stimulating pulses. The charge-delivery properties are studied using both EIS and pulsed stimulation. It is found that platinum sputtered under particular conditions results in excellent surface conditions for optimum charge-delivery.© (2001) COPYRIGHT SPIE--The International Society for Optical Engineering. Downloading of the abstract is permitted for personal use only.

A cochlear implant is provided. The cochlear implant comprises a stimulator unit configured to generate electrical stimulation signals based on sound processor-encoded signals, and to generate one or more optical stimulation signals, and an implantable stimulating assembly. The implantable stimulating assembly is configured to be implanted into a basal region of a recipient's cochlea such that when the stimulating assembly is fully implanted, a distal end of the assembly extends to the basal turn of the cochlea. The stimulating assembly also comprises: an optical contact to deliver the one or more optical stimulation signals to the cochlea, and an electrical contact to deliver the electric stimulation signals to a basal region of the cochlea so as to cause perception by the recipient of one or more frequency components of the acoustic sound signal.

The sound processor and method uses a model of basilar membrane motion to select stimuli, based upon the predicted motion which the acoustic signal presented would produce in an acoustically excited normally hearing cochlea. The filter; used, in contrast to single channel per electrode approaches, cover multiple channels and overlap with each other. Consequently the stimuli presented produce a neural excitation pattern which approximates the spatio-temporal travelling wave observed on the basilar membrane in an acoustically excited normally hearing cochlea. Preferably, the predicted electrode stimuli are based upon the instantaneous predicted amplitude of the electrode location.

A study using nonsense syllables has shown that a multiple-channel cochlear implant with speech processor is effective in providing information about voicing and manner and to a lesser extent place distinctions. These distinctions supplement lipreading cues. Furthermore, the average percentage improvements in overall identification scores for multiple-channel electrical stimulation and lipreading compared to lipreading alone were 71 % for a laboratory-based speech processor and 122% for a wearable unit.

Animal experimental studies have shown length constants of 2-4 mm for bipolar and 8-16 mm for monopolar stimulations. Studies in models using saline-solution-filled tubes have allowed us to examine the radial and longitudinal current distribution for pseudobipolar stimulation and have demonstrated that current localization is the same for bipolar and pseudobipolar stimulation over a 6-10-dB operating range. With coincident pseudobipolar multiple-channel stimulation there was suppression of the current between the stimulus maxima and enhancement at the edges leading to less stimulus interaction. Experiments performed with a pseudobipolar electrode implanted into the human cochlea showed that there was significant spread of current along the ground electrode because the electrode ground impedance was significantly greater than the cochlear tissue impedances. Because this leads to less current returned at each ground electrode, the pseudobipolar array will result in less interaction for coincident stimulation.

A multi-channel cochlear implant hearing prosthesis providing 22 separate channels of stimulation has been developed. The electronics for the implantable receiver-stimulator have been incorporated on a single chip, using digital circuits and employing CMOS technology. The chip is enclosed in a titanium capsule with platinum/ceramic electrode feed-throughs. A pocket-sized speech processor and directional microphone extract the following speech parameters: signal amplitude, fundamental frequency and formant frequency. The fundamental frequency is coded as electric pulse rate, and formant frequency by electrode position. The speech processor has been realized using hybrid circuits and CMOS gate arrays. The multi-channel prosthesis has undergone a clinical trial on four postlingually deaf patients with profound-total hearing losses. The speech perception results indicate that they were able to obtain open-set speech recognition scores for phonetically balanced words, CID sentences and spondees. In all cases the tests showed significant improvements when using the cochlear prosthesis combined with lipreading compared to lipreading alone.

The Melbourne/Cochlear multiple-electrode extracochlear implant is designed for deaf patients who are unsuited to multiple-electrode intracochlear implantation. The implant consists of a receiver-stimulator package connected via a lead wire assembly to six individual stimulating electrodes. There is a choice of two alternative surgical procedures, both of which are via a combined middle ear approach using anterior and posterior tympanotomies. Four active electrodes shaped into compressible platinum-iridium soft-balls are fed through the mastoid cavity and across the facial recess, and placed into cavities that are made over the cochlear turns that project to the medial wall of the middle ear. One hard-ball active electrode is placed into the round window niche. One hard-ball reference electrode is placed into the hypotympanum. An additional electrode wrapped around the lead wire assembly can be used as an alternative reference electrode. A specially designed insertion needle facilitates the placement and the fixation of the soft-ball electrodes.

A consonant confusion study was undertaken on a multiple-channel cochlear implant patient using a wearable speech processing device. This patient suffered from total bilateral deafness acquired postlingually. The consonants /b/, /p/, /m/, /v/, /f/, /d/, /t/, /n/, /z/, /s/, /g/, /k/ were presented in a VCV context with the vowel /a/ as in father by a male and female speaker under three conditions: lipreading alone; electrical stimulation alone using the wearable speech processor and multiple-channel cochlear implant; lipreading in conjunction with electrical stimulation. No significant difference was detected between the results for the male and female speakers. The percentage correct scores for the pooled results of both speakers were lipreading alone--30%; electrical stimulation alone--48%; lipreading with electrical stimulation--70%. Performance was significantly better for lipreading with electrical stimulation than for lipreading alone and for electrical stimulation alone than for lipreading alone. An information transmission analysis demonstrated the effective integration of visual and auditory information for lipreading with electrical stimulation. There was a significant improvement in performance for the electrical stimulation alone condition over the 2 months of the study in contrast to no such improvement for lipreading alone.

This is a publisher’s version of an article published in The Journal of Laryngology & Otology © 1983 Cambridge University Press. www.cambridge.org/

This is a publisher’s version of an article published in The Journal of Laryngology & Otology © 1980 Cambridge University Press. www.cambridge.org/

The Nucleus Multi-channel Implantable Hearing Prosthesis was developed in conjunction with the University of Melbourne. A 22 channel flexible electrode array is inserted into the cochlea through a round window opening. A cable leads from the electrode array to a demountable connector mounted on the Receiver-Stimulator unit (RSU). A custom CMOS integrated circuit is mounted inside the hermetically sealed titanium and ceramic RSU which is encased in silicone rubber and measures 34.5 mm diameter and 10.5 mm thick. Biphasic current pulse stimuli can be delivered to any selected electrode pairs at rates in excess of 1 kHz. A pocket-sized speech processor extracts spectral information from the incoming acoustic signal, and encodes stimulus information onto the single RF power/data signal transmitted to the RSU through the skin. The Speech Processor includes electronic memory circuits which are programmed with the information mapping acoustic parameters to stimulation parameters for each electrode for each patient. This MAP is established as a result of psychophysical experiments performed by the audiologist using the Diagnostic and Programming System based on a customized microcomputer.

The banded electrode array is a simple and effective array for multiple-channel cochlear stimulation and meets the necessary design requirements.

The University of Melbourne Departments of Otolaryngology and Electrical Engineering (UMDOLEE) receiving and stimulating component of a multiple-electrode cochlear implant hearing prosthesis produces constant stimulation. It has a stimulating pulse shape that minimizes the production of toxic substances and loss of metal from the electrodes, and this is achieved with a biphasic rectangular waveform where the first phase is negative with respect to ground. The duration of each stimulus phase in 180 msec, which is long enough to allow low levels of current stimulation, and short enough to permit rates of 1000 pulses/second to be achieved. In order to be consistent with our present understanding of the perception of pitch, the device permits the independent stimulation of a number of electrodes. Furthermore, to electrically isolate the stimulus to small areas, there is the capacity to vary the current and set the threshold independently at individual electrodes. The phase and amplitude of the pulses to neighbouring electrodes with also be varied to assist in localizing the current flow. The pattern to stimulation to individual or groups of electrodes can also be altered to enable studies to be carried out to determine ways of conveying frequency and intensity information over a more normal dynamic range.

A 22-electrode implantable hearing prosthesis uses a wearable speech processor which estimates three speech signal parameters. These are voice pitch, second formant frequency and flattened spectrum amplitude. The signal is monitored continuously for periodicity in the range 80-400 Hz and, if this is present, stimulation occurs at the same rate. Otherwise, as in the case of unvoiced sounds, it occurs at the random rate of fluctuation of the signal envelope. The second formant is obtained by filtering to extract the dominant peak in the midband region and by continuous measurement of the zero crossing rate. The amplitude measured is that of the whole speech spectrum, pre-emphasized by differentiation. The values that are presented to the patient are the parameter estimates immediately prior to the stimulation pulse. Second formant frequency is coded by selection of an appropriate electrode in the cochlea and amplitude by a suitably controlled current. Automatic gain control is used to keep the dynamic range of the amplitude estimate within the 30 dB range of the circuitry.

This multiple-electrode array for round window cochlear implantation is a robust, reliable system for inserting 20 mm along the scala tympani with a minimum of trauma and can provide for bipolar stimulation.

Over recent years there has been increasing awareness of the potential damage to the fragile structures of the cochlea that could be caused by the insertion of intracochlear electrodes. Temporal bone histologic studies from chronically implanted human patients have shown that intracochlear electrodes can cause significant insertion trauma. This paper describes how the mechanical properties of the electrode array can influence insertion trauma, and compares the properties of solid wire electrodes with those of a tapered electrode array. The maximum force that can be applied by the tip of the solid wire electrode is 25 times what can be applied by the tapered electrode array, whereas the tapered array is ten times more flexible. These differences in mechanical properties suggest that evidence for insertion trauma should be assessed on an electrode-by-electrode basis.

The basic problem of measuring the angular dependence ofreflection coefficient in solids is the d•culty of steering around the acoustic tmun. Although pure dectronic scanning is posablc too, only some kind of mechanical solution seems to be practicable. As for mechanical scanning, we may choose to movc the transduce• along a curved surface, •$., a cylindrical one, a;ming the beam at the same point in the center and hitting the interface plane on the axis of the cylinder at different angles of incidence. On the other hand, we may choose to move the transducer along a plane surface using some device to convert his motion into rotation around the given interface point. Former experiments • howed that mechanical scanners based on the first method are inevitably very sensitive to mechanical misalignments and acceptable reproducibility can be achieved only by rather expensive and highly sophisticated quipment. We found it simpler to move the transducer along a plane surface and to convert this movement into rotation by a diffraction grating (geometrical means, such as a paraboloid reflector, are much more difficult to machine). The geometrical arrangement of the diffraction scanner is shown in Fig. 1. The aluminum scanner was designed so that it could measure reflection coelficients in a relatively large angular range between 30 and 60 deg. The two similar broadband contact transducers are moved symmetrically to the center. Their perpendicular alignment with respect o the grating is ensured by two simple rails. The angle of incidence of the through-transmitted signal is uniquely determined by the positions of the transducers and easily calculated from the measured distance between them. The output Sj_enal iS ira/ted to the •l•t burst arriving before many stray pulses due to multiple reflections. Only certain frequency components diffracted into the right direction reach the receiver in th• first burst, therefore, in spite of using broadband transducers, the measurement iS limited to a rather narrow bandwidth which changes with the angle of incidence. Although the elastic parameters are usually frequency independent inthe low MHz range, the interface between the two media is of•n some kind of thin layer with different acoustical properties from both neighboring media, which may result in frequencydependent behavior. To determine the reflection coefficient in aluminum for a particular acoustic load (including the second medium and the separating interface), we compare the level of the output signal with that of one received from an unloaded, i.e., free surface. The calcnlated reflection coefficient and the measured output signal for free surface are shown in Fig. 2. The difference between the two curves is due to such factors as the frequency response of the transducers, changing diffraction efficiency of the grating at different frequencies, and for different orders ofdiffruction, frequencyand distancedependent attenuation due to beam divergence and absorption. All of these factors are constant parameters of the scanner and can be taken into consideration by calibrating the system in the case of free surface (using the calculated, but probably fairly accurate data for aluminum ).

Stand audiological tests were administered to a totally deaf multiple-channel cochlear implant patient with a wearable speech-processor in a monitored sound field under the following conditions: a wearable unit activated alone (WA), lipreading with the wearable unit off (LA), and wearable unit activated in combination with lipreading (WL). Thresholds obtained for narrow-band noise signals indicated that the wearable unit allowed the patient to detect a variety of sounds at different frequencies. The results obtained in closed-set word tests and open-set word and sentence tests showed significant improvements in word and sentence scores from LA to WL. In the open-set (C.I.D.) sentence test, the patient scored 22% for LA and 76% for WL. The WL score of 76% correlates with a satisfactory performance in understanding connected speech. The patient also scored 30% correct in a test involving the recognition of environmental sounds.

The Nucleus 22-channel implantable hearing prosthesis (Cochlear Pty. Ltd., Lane Cove, Sydney, Australia) has been modified by computer programming (MOCO, Inc., Scituate, Mass. USA) into a functional electrical stimulator. Individual or multiple channels can be sequenced and adjusted for their amplitude, width and frequency of the pulse so that activation of single and multiple nerves can be achieved. Sciatic nerve branches (lateral and medial) of anesthetized rabbits were stimulated to produce single contractions or co-contraction at the ankle and simultaneous bilateral joint movements. The spiral (Helix) electrode was also found suitable in these experiments. The external equipment is being re-designed for a wearable ambulation unit to be used in paraplegic subjects.