Novel Coding Strategies for Children With Cochlear Implants

OTHER

Single-Electrode Pulse Train

AIM 2 - Stimuli will be presented on one of three electrodes (apical, middle, and basal) at an amplitude between 10 and 100% dynamic range in µAs in 10% dynamic range steps. Stimulation will be delivered at a rate of 1000 pps. The process will be repeated in random order until 20 loudness estimates are obtained for each stimulus (3 electrodes x 2 rates x 10 amplitudes) for each subject. The dynamic range will be determined by measuring the maximum acceptable loudness (MAL) and threshold for each of the stimuli. MAL will be measured by slowly raising the current level for each stimulus until the subject reports that it is as loud as they are willing to accept without becoming uncomfortably loud.

OTHER

Modulation Detection Threshold (MDT) and Gap Detection Tasks

AIM 1 - MDT will be set at 150 Hz. Testing will be conducted in soundfield in a sound booth at 60 dB Sound Pressure Level (SPL) while the participant listens with both implants adjusted to user setting.

OTHER

Sound coding strategy.

Aim3 - Spectral-temporally modulated ripple test (SMRT), Quick Spectral Modulation Detection (QSMD), Modulation Detection, Gap Detection. CNC words will be set in quiet and Az-Bio/BabyBio sentences in quiet and multi-talker babble (+10 and +5 dB SNR) using both the subject's clinical map and the new reduced channels map. Tests will be presented in the soundfield at 60 dB SPL

OTHER

Electric-only spectral resolution

Aim 1- Spectral resolution will be tested using frequency allocations consisting of the full default clinical range as well as the subject's clinical frequency allocation if they differ. For Hybrid electrode users in which electrode contacts are closer in proximity in the cochlea, maps with a frequency allocation of 938-7938 Hz will also be tested in that it will closely approximate the frequency spacing of a Nucleus Contour Advance electrode array. Spectral resolution will be measured with three repetitions of the SMRT and one repetition of the QSMD test. Testing will be presented at 60 dB SPL in the soundfield with the acoustic ear plugged and muffed.

Change in loudness growth in Cochlear Implant participants

Time frame: Baseline Visit (Day 1) , Visit week 10

Power functions will be fit for each of the loudness growth curves. Data will be analyzed using a mixed-design ANOVA with the two groups as the between-subjects factor and electrode and rate as within-subject factors.

Change in temporal resolution in Cochlear implant participants

Time frame: Baseline Visit (Day 1) , Visit week 10

A mixed-effect ANOVA will be conducted to determine if there is an effect of age group (children vs adults) and hearing condition (CI vs NH) for both modulation detection and gap detection tasks. Post-hoc two-sample t-tests will compare differences between NH and CI children as well as NH and CI adults. Post-hoc paired t-tests will compare differences between adults and children for both the NH and the CI populations.

Change in spectral resolution in Cochlear implant participants

Time frame: Baseline Visit (Day 1) , Visit week 10

A one-way ANOVA will be used to calculate the differences between the four groups. If significant, post-hoc t-tests will be performed using Rom's modified Bonferroni Type I error correction.

Difference in performance between the reduced channel map and the full map

Time frame: Baseline Visit (Day 1) , Visit week 10

A mixed-design ANOVA will be conducted for each of the tests with subject population as the between-subjects factor and sound coding strategy as the within-subjects factor

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Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.