Cochlear's unique electrode portfolio now and in the future.

OBJECTIVES: To review Cochlear's electrode portfolio and discuss the merits of current and future straight and perimodiolar electrode arrays. To present an update on implant reliability. METHODS: Performance and hearing preservation data from studies involving the Slim Straight (CI422), Hybrid L24 and Contour Advance electrode array were reviewed. RESULTS: While several studies in past found little difference in performance outcomes between subjects implanted with perimodiolar and straight arrays, recent studies demonstrated that proximity to the modiolus is correlated with better performance. Hearing threshold increase was lowest with the Hybrid L24, closely followed by the slim straight array and was largest with the Contour Advance array. The CI24RE receiver-stimulator used for the three arrays had a cumulative survival of 99% at eight years post implantation. CONCLUSIONS: Combining the hearing preservation benefits of slim straight arrays with perimodiolar proximity is the design objective of Cochlear's next generation electrodes.

Performance and preference for ACE stimulation rates obtained with nucleus RP 8 and freedom system.

Cochlear recently released the Nucleus Freedom System which has been based on the Nucleus Research Platform 8. Both systems make use of the same implant, the CI24RE, which includes expanded total stimulation rates up to 32 kHz. In this study the performance of the ACE strategy at 500, 1200 and 3500 pps/channel was investigated using an ABC-CBA design. At the end of each period speech tests were performed. In the CBA phase the patients completed a comparative questionnaire to determine the subjective rate preference. Preliminary results in 13 recipients indicate no differences in for the ACE strategy at rates ranging from 500 pps to 3500 pps/channel.

Influence of ionizing radiation on nucleus 24 cochlear implants.

HYPOTHESIS: To evaluate the influence of conventional or hyperfractionated radiotherapy on Nucleus CI24M or CI24R(CS) implant systems. BACKGROUND: As a consequence of more than 70,000 cochlear implant recipients worldwide, the potential need for radiotherapy is an issue requiring consideration by both implantees and implantation centers. Conditions requiring radiotherapy of the head may include head, neck, or brain tumors. METHODS: The study examines the effect of ionizing radiation on cochlear implant function. The implanted devices examined were the Nucleus CI24M and Nucleus CI24R(CS). In a modeled study, two implants of each type were treated with fraction schemes most frequently used in clinical routine (e.g., conventional fractionation [total dose, 120 Gy] and hyperfractionation [total dose, 116 Gy]). Parameters quantified were the implant output amplitude changes at high and low current level (current levels 255 and 100, respectively), the charge balance of the biphasic pulse, and the accuracy of the impedance telemetry function. RESULTS: Within the clinically relevant dose range (< 80 Gy), implant function in all four devices was normal. Failure occurred in one Nucleus CI24R(CS) device treated with hyperfractionation. A dramatic drop in the output amplitude at 106 Gy was observed, and the impedance measurement failed at a total dose of 111 Gy. CONCLUSION: The results suggest that conventional or hyperfractionated radiotherapy can be applied safely at Nucleus CI24M or CI24R(CS) implant systems in a patient-like setting. Therefore, the authors propose that the results of the study can be applicable in clinical practice.

Normative findings of electrically evoked compound action potential measurements using the neural response telemetry of the Nucleus CI24M cochlear implant system.

One hundred and forty-seven adult recipients of the Nucleus 24 cochlear implant system, from 13 different European countries, were tested using neural response telemetry to measure the electrically evoked compound action potential (ECAP), according to a standardised postoperative measurement procedure. Recordings were obtained in 96% of these subjects with this standardised procedure. The group results are presented in terms of peak amplitude and latency, slope of the amplitude growth function and ECAP threshold. The effects of aetiological factors and the duration of deafness on the ECAP were also studied. While large intersubject variability and intrasubject variability (across electrodes) were found, results fell within a consistent pattern and a normative range of peak amplitudes and latencies was established. The aetiological factors had little effect on the ECAP characteristics. However, age affected ECAP amplitude and slope of the amplitude growth function significantly; i.e., the amplitude is higher in the lowest age category (15-30 years). Principal component analysis of the ECAP thresholds shows that the thresholds across 5 electrodes can be described by two factors accounting for 92% of the total variance. The two factors represent the overall level of the threshold profiles ('shift') and their slopes across the electrode array ('tilt'). Correlation between these two factors and the same factors describing the T- and C-levels appeared to be moderate, in the range of 0.5-0.6.

The nucleus double array cochlear implant: a new concept for the obliterated cochlea.

OBJECTIVE: To increase the number of intracochlear electrodes that may be inserted into a totally obliterated cochlea, a special implant has been developed in collaboration with Cochlear Limited. This implant features two separate electrode carriers containing 11 and 10 active electrodes, respectively, as well as a reference electrode located on the receiver-stimulator package. The potential stimulation modes available with this device therefore include monopolar and bipolar stimulation, and stimulation between both arrays. SURGICAL TECHNIQUE: A cochleostomy anterior to the round window provides access to the basal turn (both the scala tympani and the scala vestibuli), and new built connective tissue and bone can be removed until the anterior wall of the basal turn is approached. A second cochleostomy is performed at the second turn caudal of the cochleariform process and 2 mm anterior of the oval window after removal of the incus. New tissue should also be removed if necessary. The two electrode carriers are then placed into the scala tympani of the basal and the scala vestibuli of the second turn, respectively. The remaining surgical procedure is identical with that used for cochlear implantation in patients without obliterated cochleas. PATIENTS: In this clinical study, 10 patients aged 32 to 66 years with an obliterated cochlea each received a double array cochlear implant. All patients had total obliteration of the basal turn either on preoperative imaging or during surgery. Intraoperatively, the second turn was not obliterated in only 4 of 10 patients. Postoperatively, a standard audiologic test battery was used to determine auditory improvement over time. POSTOPERATIVE RESULTS: All patients achieved significantly improved speech understanding when the additional apical electrode array was used, compared with the use of each electrode array independently. No complications occurred. CONCLUSION: In patients with a totally obliterated cochlea, the number of intracochlear electrodes can be increased by use of the Nucleus double array implant. As a result, patients achieve significantly better auditory results.

[The Nucleus Double Array Cochlear Implant: a new concept in obliterated cochlea]. / Das Nucleus Double Array Cochlear Implant: Ein neues Konzept bei obliterierter Cochlea.

AIM: In order to increase the number of intracochlear electrodes to be inserted into a totally obliterated cochlea a special implant has been developed in collaboration with Cochlear Ltd. The implant features two separate electrode carriers containing 11 and 10 active electrodes, respectively, and a reference electrode on the receiver stimulator package. The potential stimulation modes include monopolar and bipolar stimulation as well as stimulation between both arrays. SURGICAL TECHNIQUE: A cochleostomy at the round window provides access to the scala tympani. Newly formed bone is removed as far as the anterior portion of the basal turn. Care is taken to identify and preserve the osseous border of the cochlea. A second cochleostomy is performed immediately caudal to the cochleariform process after removal of the incus. New tissue can be removed here in the same way. The two electrode carriers are then placed into the first and the second turn respectively. The remaining procedure corresponds to the procedure for cochlear implantation in cases in which the cochlea is not obliterated. PATIENTS: For the purpose of a clinical study n = 10 patients aged between 32-66 years with an obliterated cochlea were fitted with a double array cochlear implant. All patients showed signs of total obliteration of the basal turn either in preoperative imaging or during surgery. Intraoperative inspection revealed that the second turn was not obliterated in 4 of 10 patients. POSTOPERATIVE RESULTS: Postoperatively, a standard test battery was used to determine auditory performance over a period of time. All patients achieved significantly better speech understanding due to the additional apical electrode array. No complications occurred. CONCLUSION: In cases involving an obliterated cochlea, the number of intracochlear electrodes can be increased with the double array implant. As a result, the patients achieve significantly better auditory results.

Experience with the cochlear miniature speech processor in adults and children together with a comparison of unipolar and bipolar modes.

Following the experience with nearly 150 patients with the Nucleus cochlear implant, a more sophisticated and lighter speech processor was tested successfully in terms of better speech understanding. In order to prepare further miniaturization, the standard bipolar stimulation mode was compared with an unipolar mode. It was found that unipolar stimulation needs less energy, without decreasing speech understanding. Preconditions for supplying very young children with a cochlear implant were the use of electrically elicited stapedius reflex thresholds, obtained intraoperatively, for the fitting of the speech processor and the setup of a special rehabilitation center, where children together with their mothers could be trained in hearing and understanding by special teachers and engineers for 12 weeks, distributed over the 1st postoperative year.

Comparative speech recognition results in eight subjects using two different coding strategies with the Nucleus 22 channel cochlear implant.

This study was designed to compare the results of several speech tests administered to eight subjects who used two types of speech-coding strategies with the Nucleus 22 channel cochlear implant. The subjects had an average experience of 40 months with the F0F1F2 coding strategy implemented in their previous wearable speech processor. Three subjects were good performers (showing significant open-set understanding without lip-reading) and five were moderate performers (not able to do speech-tracking by auditory means alone). All subjects were evaluated again after 1 month and 6 months of experience with the MULTIPEAK coding strategy of the miniature speech processor. The test materials included vowel and consonant identification, monosyllabic words, everyday sentences and numbers in noise. All eight subjects showed an improvement on more than three of five measures. The group of moderate performers showed a larger improvement in vowel (+16%) and consonant (+17%) identification scores than the group of good performers. For the open-set sentence test, the better patients were able to increase their score from 52% to 80% correct; two of the moderate performers did not improve. Six subjects achieved significantly higher scores at moderate signal-to-noise ratios (up to 10 dB S/N) in the (Freiburger) number test. Results of information transmission analysis are also discussed.

Initial results with simultaneous analog and pulsatile stimulation of the cochlea.

An improved method has been developed for the coding of speech information into adequate signals for the stimulation of the auditory nerve. It combines the periodicity principle, which has been applied in single-channel analog stimulation in the Austrian cochlear prosthesis, with the place principle by simultaneous analog stimulation on one channel and pulsatile stimulation on other channels. The second formant frequency determines the place of stimulation for the pulsatile signals. Simultaneous stimulation of several channels can cause the currents emerging from different electrodes to interact because the fluid impedance in the cochlea is small. Therefore, an important aspect of the multichannel strategy is to maintain the temporal pattern transmitted via the analog channel by adequate repetition rates and phase relationships of the pulsatile signals. The signals were processed with finite impulse response digital filters. Vowel identification tests were performed with 6 patients implanted with a 4-channel intracochlear electrode. The test material was spoken by male and female speakers. With proper timing of the pulses the improvement over the single-channel stimulation was significant at the 1% level and this difference was due to a significant increase in second formant recognition.

Initial Results with Simultaneous Analog and Pulsatile Stimulation of the Cochlea.

An improved method has been developed for the coding of speech information into adequate signals for the stimulation of the auditory nerve. It combines the periodicity principle, which has been applied in single-channel analog stimulation in the Austrian cochlear prosthesis, with the place principle by simultaneous analog stimulation on one channel and pulsatile stimulation on other channels. The second formant frequency determines the place of stimulation for the pulsatile signals. Simultaneous stimulation of several channels can cause the currents emerging from different electrodes to interact because the fluid impedance in the cochlea is small. Therefore, an important aspect of the multichannel strategy is to maintain the temporal pattern transmitted via the analog channel by adequate repetition rates and phase relationships of the pulsatile signals. The signals were processed with finite impulse response digital filters. Vowel identification tests were performed with 6 patients implanted with a 4-channel intracochlear electrode. The test material was spoken by male and female speakers. With proper timing of the pulses the improvement over the single-channel stimulation was significant at the 1% level and this difference was due to a significant increase in second formant recognition.