Nucleus 22-channel cochlear implant: preliminary observations.

A carefully designed study was undertaken in 1982 to evaluate the performance of individuals who received the Nucleus 22-channel cochlear implant. All patients were profound-totally deaf, adults with a postlingual onset of impairment. The preoperative evaluation, prosthesis fitting, training, and postoperative testing were consistent across clinics. Single-subject studies, where each patient acted as his/her own control, revealed that of the 37 subjects, 16-24 obtained significant improvement (P less than or equal to 0.001) on unpracticed, unfamiliar recorded speech tests from the Minimal Auditory Capabilities (MAC) Battery, when using hearing alone (no lipreading). In addition, virtually all patients showed improvement in recognition of speech material with lipreading. The data support the efficacy of a feature extraction coding system where specific formant and amplitude information are transmitted via direct electrical stimulation to the cochlea.

Histological evaluation of porous titanium cardiac pacemaker electrode tips.

An investigation of the tissue reaction to five porous titanium alloy pacemaker electrode tips inserted in sheep hearts was made. Attachment of the electrode tips to the endocardial wall was facilitated by fibrous tissue ingrowth into the porous material. Vascularized fibrocollagenous tissue was found within the pores of the tips. One tip was found to be infected. The presence of occasional multinucleated foreign-body giant cells within the porosity was related to the particulate features of the porous tip. The electrode tips had a reduced sensing impedance compared with conventional solid platinum tips. The present findings are consistent with previous observations relating to porous cobalt-chromium alloy and porous platinum-iridium alloy tips and suggest that porous titanium alloy may be a suitable pacemaker electrode tip material.

Implanted material tolerance studies for a multiple-channel cochlear prosthesis.

We have performed a number of temporal bone and animal studies in order to evaluate the histopathological effects of intracochlear electrode implantation and chronic electrical stimulation. Our results indicate that (a) the insertion of a free-fit scala tympani array results in minimal damage to the membranous labyrinth; (b) the materials used in the electrode array evoke mild tissue reactions when implanted subcutaneously, in muscle, or within the scala tympani; (c) intracochlear electrical stimulation for periods of 500 to 2000 hours, using carefully controlled biphasic pulses, does not adversely affect the population or neural activity of the primary auditory neurones; (d) labyrinthine infection severely reduces the number of viable spiral ganglion cells; (e) an adequate fibrous tissue seal of the round window can prevent the spread of infection from the bulla to the implanted cochlea in cats, following inoculation of the bulla cavity with bacteria; (f) bone growth is not associated with electrical stimulation per se; (g) the electrode arrays show minimal platinum dissolution and no apparent degradation of the Silastic carrier following periods of long-term intracochlear electrical stimulation.

Characteristics of advanced porous and textured surface pacemaker electrodes.

Reduced stimulation thresholds, improved sensing and better attachment have been claimed for totally porous and porous surfaced electrodes. In this study, the potential for clinical use of two new types of porous electrodes and a non-porous, textured high microsurface area electrode, has been evaluated by comparison with equivalent sized, smooth non-porous controls. Eighteen sintered and seven laser drilled porous electrodes, seven-non-porous textured electrodes, and sixteen controls, were implanted singly in the right ventricles of sheep. Measurements of threshold, pacing, sensing and bulk impedances were taken at regular intervals for up 180 days. At sacrifice, only three of the thirteen non-porous controls were attached. All laser porous electrodes, apart from two which were dislodged, were attached, as were eleven of fifteen sintered porous, and five of seven textured non-porous electrodes. Tissue ingrowth was found for both porous electrode types. Stimulation thresholds were not statistically different for all electrode types (p less than 0.05). Pacing and bulk impedances of the two porous and surface textured electrodes were significantly higher (p less than 0.10, p less than 0.05, respectively) than those of controls. The three new electrodes exhibited similar chronic sensing impedance values, 30% less than equivalent non-porous electrodes. The similar sensing performance of the porous and high microsurface area non-porous electrodes indicates that the nature of the external surface, rather than internal porosity, determines sensing impedance. All three new electrode types showed improved attachment and sensing compared with similar smooth electrodes. The laser porous electrode, which permits fixation by tissue ingrowth and maintains simplicity of construction, is promising for routine clinical use.

Screening of solid and porous materials for pacemaker electrodes.

Several different materials, including one which was porous, were studied to assess their properties as pacemaker electrode tips. Leads were implanted in sheep for periods up to one year. Electrical measurements were made during the implant period and histopathological examination performed after sacrifice. Although titanium vapor-deposited carbon, and silver did not lower the chronic stimulation threshold below that of platinum, their electrical characteristics were within generally acceptable limits. Zinc evoked a severe tissue reactions and a high threshold. Porous titanium alloy electrodes demonstrated reduced dislodgement, more frequent attachment and a lower sensing impedance than other electrodes.