A FDA clinical trial was carried out to evaluate the potential benefit of cochlear implant (CI) use for adults with unilateral moderate-to-profound sensorineural hearing loss. Subjects were 20 adults with moderate-to-profound unilateral sensorineural hearing loss and normal or near-normal hearing on the other side. A MED-EL standard electrode was implanted in the impaired ear. Outcome measures included: (a) sound localization on the horizontal plane (11 positions, −90° to 90°), (b) word recognition in quiet with the CI alone, and (c) masked sentence recognition with the target at 0° and the masker at −90°, 0°, or 90°. This battery was completed preoperatively and at 1, 3, 6, 9, and 12 months after CI activation. Normative data were also collected for 20 age-matched control subjects with normal or near-normal hearing bilaterally. The CI improved localization accuracy and reduced side bias. Word recognition with the CI alone was similar to performance of traditional CI recipients. The CI improved masked sentence recognition when the masker was presented from the front or from the side of normal or near-normal hearing. The binaural benefits observed with the CI increased between the 1- and 3-month intervals but appeared stable thereafter. In contrast to previous reports on localization and speech perception in patients with unilateral sensorineural hearing loss, CI benefits were consistently observed across individual subjects, and performance was at asymptote by the 3-month test interval. Cochlear implant settings, consistent CI use, and short duration of deafness could play a role in this result.
Hypotheses Electrocochleography (ECoG) to acoustic stimuli can differentiate relative degrees of cochlear responsiveness across the population of cochlear implant recipients. The magnitude of the ongoing portion of the ECoG, which includes both hair cell and neural contributions, will correlate with speech outcomes as measured by results on CNC word score tests. Background Postoperative speech outcomes with cochlear implants vary from almost no benefit to near normal comprehension. A factor expected to have a high predictive value is the degree of neural survival. However, speech performance with the implant does not correlate with the number and distribution of surviving ganglion cells when measured post-mortem. We will investigate whether ECoG can provide an estimate of cochlear function that helps predict postoperative speech outcomes. Methods An electrode was placed at the ipsilateral round window of the ear about to be implanted during implant surgery. Tone bursts were delivered through an insert earphone. Subjects included children (N=52, 1–18 years) and postlingually hearing impaired adults (N=32). Word scores at six months were available from 21 adult subjects. Results Significant responses to sound were recorded from almost all subjects (80/84 or 95%). The ECoG magnitudes spanned more than 50 dB in both children and adults. The distributions of ECoG magnitudes and frequencies were similar between children and adults. The correlation between the ECoG magnitude and word score accounted for 47% of the variance. Conclusions ECoGs with high signal to noise ratios can be recorded from almost all implant candidates, including both adult and pediatric populations. In post-lingual adults, the ECoG magnitude is more predictive of implant outcomes than other non-surgical variables such as duration of deafness or degree of residual hearing.
Longer electrode insertions (and greater insertion angles) appear to offer better speech perception performance in the early postactivation period when using the same implant system.
The programming of CIs is essential for good performance. However, no Good Clinical Practice guidelines exist. This paper reports on the results of an inventory of the current practice worldwide. A questionnaire was distributed to 47 CI centers. They follow 47600 recipients in 17 countries and 5 continents. The results were discussed during a debate. Sixty-two percent of the results were verified through individual interviews during the following months. Most centers (72%) participated in a cross-sectional study logging 5 consecutive fitting sessions in 5 different recipients. Data indicate that general practice starts with a single switch-on session, followed by three monthly sessions, three quarterly sessions, and then annual sessions, all containing one hour of programming and testing. The main focus lies on setting maximum and, to a lesser extent, minimum current levels per electrode. These levels are often determined on a few electrodes and then extrapolated. They are mainly based on subjective loudness perception by the CI user and, to a lesser extent, on pure tone and speech audiometry. Objective measures play a small role as indication of the global MAP profile. Other MAP parameters are rarely modified. Measurable targets are only defined for pure tone audiometry. Huge variation exists between centers on all aspects of the fitting practice.
Objectives: The spatial position of a cochlear implant (CI) electrode array affects the spectral cues provided to the recipient. Differences in cochlear size and array length lead to substantial variability in angular insertion depth (AID) across and within array types. For CI-alone users, the variability in AID results in varying degrees of frequency-to-place mismatch between the default electric frequency filters and cochlear place of stimulation. For electric-acoustic stimulation (EAS) users, default electric frequency filters also vary as a function of residual acoustic hearing in the implanted ear. The present study aimed to (1) investigate variability in AID associated with lateral wall arrays, (2) determine the subsequent frequency-to-place mismatch for CI-alone and EAS users mapped with default frequency filters, and (3) examine the relationship between early speech perception for CI-alone users and two aspects of electrode position: frequency-to-place mismatch and angular separation between neighboring contacts, a metric associated with spectral selectivity at the periphery. Design: One hundred one adult CI recipients (111 ears) with MED-EL Flex24 (24 mm), Flex28 (28 mm), and FlexSOFT/Standard (31.5 mm) arrays underwent postoperative computed tomography to determine AID. A subsequent comparison was made between AID, predicted spiral ganglion place frequencies, and the default frequency filters for CI-alone (n = 84) and EAS users (n = 27). For CI-alone users with complete insertions who listened with maps fit with the default frequency filters (n = 48), frequency-to-place mismatch was quantified at 1500 Hz and angular separation between neighboring contacts was determined for electrodes in the 1 to 2 kHz region. Multiple linear regression was used to examine how frequency-to-place mismatch and angular separation of contacts influence consonant-nucleus-consonant (CNC) scores through 6 months postactivation. Results: For CI recipients with complete insertions (n = 106, 95.5%), the AID (mean ± standard deviation) of the most apical contact was 428° ± 34.3° for Flex24 (n = 11), 558° ± 65.4° for Flex28 (n = 48), and 636° ± 42.9° for FlexSOFT/Standard (n = 47) arrays. For CI-alone users, default frequency filters aligned closely with the spiral ganglion map for deeply inserted lateral wall arrays. For EAS users, default frequency filters produced a range of mismatches; absolute deviations of ≤ 6 semitones occurred in only 37% of cases. Participants with shallow insertions and minimal or no residual hearing experienced the greatest mismatch. For CI-alone users, both smaller frequency-to-place mismatch and greater angular separation between contacts were associated with better CNC scores during the initial 6 months of device use. Conclusions: There is significant variability in frequency-to-place mismatch among CI-alone and EAS users with default frequency filters, even between individuals implanted with the same array. When using default frequency filters, mismatch can be minimized with longer lateral wall arrays and insertion depths that meet the edge frequency associated with residual hearing for CI-alone and EAS users, respectively. Smaller degrees of frequency-to-place mismatch and decreased peripheral masking due to more widely spaced contacts may independently support better speech perception with longer lateral wall arrays in CI-alone users.
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