Controlled comparative clinical trial of hearing benefit outcomes for users of the Cochlear™ Nucleus® 7 Sound Processor with mobile connectivity.

OBJECTIVES: To assess subjective benefits and objective speech recognition performance following a take-home trial with the new Cochlear™ Nucleus® 7 Sound Processor (SP), in experienced users of compatible cochlear implants from Cochlear Limited. METHODS: A total of 37 adult participants were fitted with the Nucleus 7 SP and used the device for up to one year. Baseline speech recognition was assessed at the initial fitting session, using each participant's own SP, and Client Oriented Scale of Improvement (COSI) goals were identified. Speech recognition was measured after 3 months of device use and outcomes of the COSI and a non-validated Processor Comparison Questionnaire (PCQ) were collected. After 11 months, a subset of subjects were tested on speech recognition delivered via direct wireless streaming from an Apple® smartphone to the SP and compatible hearing aid on the opposite side (if worn). RESULTS: The COSI and PCQ instruments both indicated significant improvement in perceived subjective benefits in comparison to the participants' previous SPs. Direct streaming via an Apple mobile phone showed improvements when compared with the acoustic alone condition. Standard speech recognition in quiet and noise was equivalent to that obtained using a previous generation SP which uses the same basic processing as the Nucleus 7 Sound Processor. CONCLUSIONS: The incremental refinements provided by the Nucleus 7 Sound Processor provide real-world benefits in key areas such as upgraded wireless connectivity. The COSI proved to be an effective tool for individualized assessment of specific benefits that may not be addressed by more standardized instruments.

Clinical outcomes with the Kanso™ off-the-ear cochlear implant sound processor.

OBJECTIVE: To investigate clinical outcomes and subjective ratings of the Kanso™ off-the-ear (OTE) cochlear implant sound processor. DESIGN: Prospective, within-subject design investigating outcomes with a range of single and dual-microphone programmes for Kanso compared to conventional behind-the-ear (BTE) sound processors. STUDY SAMPLE: Twenty post-lingually hearing-impaired cochlear implant recipients who were experienced Nucleus® 5 or Nucleus® 6 BTE users. RESULTS: No significant difference in performance was found for words in quiet or sentences in co-located noise between the Kanso and Nucleus 6 devices. For the moderately directional Standard programme, no significant difference was found for sentences in spatially separated noise between the Kanso and Nucleus 6 devices, but a performance decrement between 1.4 and 2.0 dB was found in highly directional and adaptive directional programmes. The default Kanso programme, SCAN, provided improvements of 6.9 dB over a single-microphone programme and 2.3 dB over the Standard programme in spatially separated noise. Participants rated Kanso significantly better than their own BTE processor on measures of comfort, look and feel, ease of use, music and overall hearing performance. CONCLUSION: Dual-microphone directional processing provides significant benefit over a single microphone for OTE processors. This study demonstrates clinical outcomes and acceptance of the Kanso OTE sound processor.

A multicentre clinical evaluation of paediatric cochlear implant users upgrading to the Nucleus(®) 6 system.

OBJECTIVES: The aim of this study was to investigate whether experienced paediatric cochlear implant users could show benefits to speech perception outcomes from the introduction of noise reduction and automated scene classification technologies as implemented in the Nucleus(®) 6 sound processor. Previous research with adult cochlear implant users had shown significant improvements in speech intelligibility for listening in noisy conditions and good user acceptance for upgrading to the Nucleus 6 processor. In adults, these improvements for listening in noise were primarily attributed to the use of a range of new input processing technologies including noise reduction, as well as introduction of automatic scene classification technology. METHODS: Experienced paediatric cochlear implant users (n=25) were recruited from four clinics located in three countries. Research participants were evaluated on three occasions, an initial session using their Nucleus 5 sound processor; a second session in which participants used the Nucleus 6 processor programmed with the same technologies as were used in their Nucleus 5 sound processor; and a final session in which participants used the Nucleus 6 processor programmed with the default technologies including automatic scene classification (SCAN) which automatically selects the microphone directionality, noise reduction (SNR-NR), and wind noise reduction (WNR) technologies. Prior to both the second and third evaluations, research participants had approximately two weeks take-home experience with the new system. Speech perception performances on monosyllabic word tests presented in quiet and in noise, and a sentence test presented in noise, were compared across the three processor conditions. Acceptance of the Nucleus 6 default settings was assessed in a final session. RESULTS: No group mean difference in performance was found for monosyllabic words in quiet. A significant improvement in speech perception was found for both monosyllabic words and sentences in noise with the default Nucleus 6 program condition as compared with the Nucleus 5 condition. No acceptance issues were noted for any of the children. CONCLUSIONS: Experienced paediatric cochlear implant users showed a significant improvement in speech perception in listening in noise when upgraded to the Nucleus 6 sound processor primarily due to the introduction of a noise reduction technology, and all children accepted the default program. These findings suggest that school-aged children may benefit from upgrading to the Nucleus 6 sound processor using the default program.

Benefits of Adaptive Signal Processing in a Commercially Available Cochlear Implant Sound Processor.

OBJECTIVE: Cochlear implant recipients often experience difficulty understanding speech in noise. The primary objective of this study was to evaluate the potential improvement in speech recognition in noise provided by an adaptive, commercially available sound processor that performs acoustic scene classification and automatically adjusts input signal processing to maximize performance in noise. RESEARCH DESIGN: Within-subjects, repeated-measures design. SETTING: This multicenter study was conducted across five sites in the U.S.A. and Australia. PATIENTS: Ninety-three adults and children with Nucleus Freedom, CI422, and CI512 cochlear implants. INTERVENTION: Subjects (previous users of the Nucleus 5 sound processor) were fitted with the Nucleus 6 sound processor. Performance was assessed while these subjects used each sound processor in the manufacturer's recommended default program (standard directionality, ASC + ADRO for the Nucleus 5 processor and ASC + ADRO and SNR-NR with SCAN for the Nucleus 6 sound processor). The subjects were also evaluated with the Nucleus 6 with standard directionality, ASC + ADRO and SNR-NR enabled but SCAN disabled. MAIN OUTCOME MEASURES: Speech recognition in noise was assessed with AzBio sentences. RESULTS: Sentence recognition in noise was significantly better with the Nucleus 6 sound processor when used with the default input processing (ASC + ADRO, SNR-NR, and SCAN) compared to performance with the Nucleus 5 sound processor and default input processing (standard directionality, ASC + ADRO). Specifically, use of the Nucleus 6 at default settings resulted in a mean improvement in sentence recognition in noise of 27 percentage points relative to performance with the Nucleus 5 sound processor. Use of the Nucleus 6 sound processor using standard directionality, ASC + ADRO and SNR-NR (SCAN disabled) resulted in a mean improvement of 9 percentage points in sentence recognition in noise compared to performance with the Nucleus 5. CONCLUSION: The results of this study suggest that the Nucleus 6 sound processor with acoustic scene classification, automatic, adaptive directionality, and speech enhancement in noise processing provides significantly better speech recognition in noise when compared to performance with the Nucleus 5 processor.

The history of Cochlear™ Nucleus® sound processor upgrades: 30 years and counting.

To review developments in sound processors over the past 30 years that have resulted in significant improvements in outcomes for Nucleus® recipients.

Clinical evaluation of the Nucleus 6 cochlear implant system: performance improvements with SmartSound iQ.

OBJECTIVE: This paper provides a detailed description of the Nucleus 6 system, and clinically evaluates user performance compared to the previous Nucleus 5 system in cochlear implant recipients. Additionally, it clinically evaluates a range of Nucleus 6 and Nucleus 5 programs to determine the performance benefits provided by new input processing technologies available in SmartSound iQ. DESIGN: Speech understanding tests were used to clinically validate the default Nucleus 6 program, by comparing performance outcomes against up to five custom Nucleus 5 or Nucleus 6 programs in a range of listening environments. Clinical comparisons between programs were conducted across the following listening environments; quiet, speech weighted noise (co-located and spatially separated noise), and 4-talker babble (co-located and spatially separated noise). STUDY SAMPLE: Twenty-one adult cochlear implant recipients participated. RESULTS: Significant speech understanding benefits were found with the default Nucleus 6 program compared to the participants' preferred program using their Nucleus 5 processor and compared to a range of custom Nucleus 6 programs. All participants successfully accepted and upgraded to the new default Nucleus 6 SmartSound iQ program. CONCLUSION: This study demonstrates the acceptance and clinical benefits of the Nucleus 6 cochlear implant system and SmartSound iQ.

Clinical evaluation of higher stimulation rates in the nucleus research platform 8 system.

OBJECTIVE: The effect on speech perception of using higher stimulation rates than the 14.4 kHz available in the Nucleus 24 cochlear implant system was investigated. The study used the Nucleus Research Platform 8 (RP8) system, comprising the CI24RE receiver-stimulator with the Contour electrode array, the L34SP body-worn research speech processor, and the Nucleus Programming Environment (NPE) fitting and Neural Response Telemetry (NRT) software. This system enabled clinical investigation of higher stimulation rates before an implementation in the Freedom cochlear implant system commercially released by Cochlear Limited. DESIGN: Use of higher stimulation rates in the ACE coding strategy was assessed in 15 adult subjects. An ABAB experimental design was used to control for order effects. Program A used a total stimulation rate of between 12 kHz and 14.4 kHz. This program was used for at least the first 3 mo after initial device activation. After evaluation with this program, each subject was provided with two different higher stimulation rate programs: one with a total stimulation rate of 24 kHz and the other with a total stimulation rate of 32 kHz. After a 6-week period of familiarization, each subject identified his/her preferred higher rate program (program B), and this was used for the evaluation. Subjects then repeated their use of program A for 3 wk, then program B for 3 wk, before the second evaluation with each. Speech perception was evaluated by using CNC open-set monosyllabic words presented in quiet and CUNY open-set sentences presented in noise. Preference for stimulation rate program was assessed via a subjective questionnaire. Threshold (T)- and Comfortable (C)-levels, as well as subjective reports of tinnitus, were monitored for each subject throughout the study to determine whether there were any changes that might be associated with the use of higher stimulation rates. RESULTS: No significant mean differences in speech perception results were found for the group between the two programs for tests in either quiet or noise. Analysis of individual subject data showed that five subjects had significant benefit from use of program B for tests administered in quiet and for tests administered in noise. However, only two of these subjects showed benefit in both test conditions. One subject showed significant benefit from use of program A when tested in quiet, whereas another showed benefit with this program in noise. Each subject's preferred program varied. Five subjects reported a preference for program A, eight subjects reported a preference for program B and two reported no overall preference. Preference between the different stimulation rates provided within program B also varied, with 10 subjects preferring 24 kHz and five preferring 32 kHz total stimulation rates. A significant increase in T-levels from baseline measures was observed after three weeks of initial experience with program B, however there was no difference between the baseline levels and those obtained after five weeks of use. No significant change in C-levels was found over the monitoring period. No long-term changes in tinnitus that could be associated with the use of the higher stimulation rates were reported by any of the subjects. CONCLUSIONS: The use of higher stimulation rates may provide benefit to some but not all cochlear implant recipients. It is important to optimize the stimulation rate for an individual to ensure maximal benefit. The absence of any changes in T- and C-levels or in tinnitus suggests that higher stimulation rates are safe for clinical use.

Evaluation of streamlined programming procedures for the Nucleus cochlear implant with the Contour electrode array.

OBJECTIVE: The objective of this study was to evaluate streamlined programming procedures for the Nucleus cochlear implant system with the Contour electrode array. DESIGN: Phase 1 involved an examination of the clinical MAPs for the first 103 recipients implanted with the Contour electrode array in the Melbourne Cochlear Implant Clinic, to examine the ability to predict the entire MAP based on a smaller number of clinically determined T- and/or C-levels. In phase 2, a subset of the streamlined procedures was selected and clinically evaluated, using speech perception and subjective preference measures. In the first study, the clinical MAP was compared with a MAP based on interpolating across three behavioral T-levels and three behavioral C-levels in a group of newly implanted subjects. The second study investigated the use of a single interpolated profile as the basis to creating the entire MAP. Initial evaluation compared the clinical MAP with two streamlined MAPs, one in which the C-level profile was derived from interpolation across a subset of T-levels and one in which the T-level profile was derived from interpolation across a subset of C-levels. In this case, the interpolated profile was based on five behavioral measures. Subsequently, the use of either three or a single T-level measure as the basis for the interpolated T-level profile was evaluated. Eighteen subjects, who were experienced with the clinical MAP before enrollment in the study, participated in the initial evaluation. The subjects were selected to include a group whose RMS deviation from clinical MAP levels, as determined in Phase 1, was greater than that of the wider population. RESULTS: The Phase 1 analysis showed that as expected, larger differences were observed between the clinical and derived MAP levels as interpolation was applied across fewer measured electrodes and that the use of a single interpolated profile to create the entire MAP resulted in the greatest deviation. No significant group mean difference was found in speech perception scores for newly implanted subjects when mapped with the clinical versus the streamlined MAP based on three behavioral T- and three behavioral C-level measures. For some individual subjects, scores were higher with the streamlined MAP. Subjective reports from the comparative performance questionnaire were consistent with these findings. No significant group mean difference in speech perception scores was found in comparing the clinical MAP with the streamlined MAPs based on a single interpolated T- or C-level profile created from five behavioral measures. Individual effects were observed; however, there was no consistent finding across subjects. The use of three rather than five behavioral T-level measures in the procedure did not result in significantly lower group mean scores; however, significantly poorer scores were obtained for three of the 10 individual subjects. The use of a MAP based on a single behavioral measure did result in poorer speech perception scores when compared with the MAP based on five behavioral T-level measures. These findings were consistent with subjective results from the performance questionnaires administered to determine preference for program across a range of listening situations. CONCLUSIONS: Two streamlined programming procedures are recommended for use in the clinical setting: (1) interpolating across three measured T-levels and three measured C-levels and (2) interpolating across five measured T- or C-levels and using the interpolated profile for fitting of the alternative profile.