Dataset Information

Clinical Validation of a Sound Processor Upgrade in Direct Acoustic Cochlear Implant Subjects.

ABSTRACT: The objectives of the investigation were to evaluate the effect of a sound processor upgrade on the speech reception threshold in noise and to collect long-term safety and efficacy data after 2½ to 5 years of device use of direct acoustic cochlear implant (DACI) recipients.The study was designed as a mono-centric, prospective clinical trial.Tertiary referral center.Fifteen patients implanted with a direct acoustic cochlear implant.Upgrade with a newer generation of sound processor.Speech recognition test in quiet and in noise, pure tone thresholds, subject-reported outcome measures.The speech recognition in quiet and in noise is superior after the sound processor upgrade and stable after long-term use of the direct acoustic cochlear implant. The bone conduction thresholds did not decrease significantly after long-term high level stimulation.The new sound processor for the DACI system provides significant benefits for DACI users for speech recognition in both quiet and noise. Especially the noise program with the use of directional microphones (Zoom) allows DACI patients to have much less difficulty when having conversations in noisy environments. Furthermore, the study confirms that the benefits of the sound processor upgrade are available to the DACI recipients even after several years of experience with a legacy sound processor. Finally, our study demonstrates that the DACI system is a safe and effective long-term therapy.

SUBMITTER: Kludt E

PROVIDER: S-EPMC5426695 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Clinical Validation of a Sound Processor Upgrade in Direct Acoustic Cochlear Implant Subjects.

Kludt Eugen E D'hondt Christiane C Lenarz Thomas T Maier Hannes H

Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 20170601 5

<h4>Objective</h4>The objectives of the investigation were to evaluate the effect of a sound processor upgrade on the speech reception threshold in noise and to collect long-term safety and efficacy data after 2½ to 5 years of device use of direct acoustic cochlear implant (DACI) recipients.<h4>Study design</h4>The study was designed as a mono-centric, prospective clinical trial.<h4>Setting</h4>Tertiary referral center.<h4>Patients</h4>Fifteen patients implanted with a direct acoustic cochlear i ...[more]

PMID: 28406848

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Project description:Objectives The SONNET 2 audio processor features ambient noise reduction (ANR), transient-noise reduction (TNR), and adaptive intelligence (AI). The primary aim of this study was to evaluate if using these features improves speech perception in noise, subjective listening effort, and sound quality. Design In this prospective longitudinal study, twenty adult SONNET users were fitted with the SONNET 2 audio processor, configured either as a default SONNET (no ANR/TNR/AI), with mild ANR/TNR, with strong ANR/TNR, with mild AI, and with strong AI. Speech perception in noise was assessed in speech and stationary noise from the front (S0N0); speech, stationary noise, and transient noise from the front (S0N0T0); and speech from the front in spatially-distributed stationary noise (S0N±45N±135). Listening effort, subjective sound quality, and device/setup preference were assessed. Results In the S0N0 setup, speech perception in noise was significantly better with the SONNET 2 when using ANR/TNR in the mild setup than with the SONNET or the SONNET 2 in the default SONNET configuration. In the S0N±45N±135 setup, speech understanding was significantly better in all four SONNET 2 configurations than with the SONNET or the SONNET 2 in the default SONNET configuration (a 1.26–2.55 dB SRT80 benefit). Subjects tolerated consistently lower signal-to-noise values with the SONNET 2 configurations using ANR/TNR than with the default SONNET configuration in all listening effort categories. All SONNET 2 configurations using ANR/TNR were preferred and better rated in speech in stationary and/or transient noise compared to the default SONNET configuration. Sound quality and pleasantness were better in those SONNET 2 configurations. Subjects strongly preferred the SONNET 2 configurations over the SONNET configuration. Conclusions The new front-end features implemented in the SONNET 2 audio processor objectively improve speech perception in noise. Subjects preferred the SONNET 2, over the SONNET, in the presence of stationary and transient noise.

Project description:The aim of this study was to assess the frequency-position function resulting from electric stimulation of electrodes in cochlear implant subjects with significant residual hearing in their nonimplanted ear. Six cochlear implant users compared the pitch of the auditory sensation produced by stimulation of an intracochlear electrode to the pitch of acoustic pure tones presented to their contralateral nonimplanted ear. Subjects were implanted with different Clarion electrode arrays, designed to lie close to the inner wall of the cochlea. High-resolution radiographs were used to determine the electrode positions in the cochlea. Four out of six subjects presented electrode insertions deeper than 450 degrees . We used a two-interval (one acoustic, one electric), two-alternative forced choice protocol (2I-2AFC), asking the subject to indicate which stimulus sounded the highest in pitch. Pure tones were used as acoustic stimuli. Electric stimuli consisted of trains of biphasic pulses presented at relatively high rates [higher than 700 pulses per second (pps)]. First, all electric stimuli were balanced in loudness across electrodes. Second, acoustic pure tones, chosen to approximate roughly the pitch sensation produced by each electrode, were balanced in loudness to electric stimuli. When electrode insertion lengths were used to describe electrode positions, the pitch sensations produced by electric stimulation were found to be more than two octaves lower than predicted by Greenwood's frequency-position function. When insertion angles were used to describe electrode positions, the pitch sensations were found about one octave lower than the frequency-position function of a normal ear. The difference found between both descriptions is because of the fact that these electrode arrays were designed to lie close to the modiolus. As a consequence, the site of excitation produced at the level of the organ of Corti corresponds to a longer length than the electrode insertion length, which is used in Greenwood's function. Although exact measurements of the round window position as well as the length of the cochlea could explain the remaining one octave difference found when insertion angles were used, physiological phenomena (e.g., stimulation of the spiral ganglion cells) could also create this difference. From these data, analysis filters could be determined in sound coding strategies to match the pitch percepts elicited by electrode stimulation. This step might be of main importance for music perception and for the fitting of bilateral cochlear implants.

Project description:Multielectrode cochlear implants rely on differential stimulation of the cochlear nerve for presenting the brain with the spectral and timing information required to understand speech. In implant patients, the degree of overlap among cochlear nerve fibers stimulated by the different electrodes constitutes the electrode interaction. Electrode interaction degrades the spectral resolution of the implant's stimulus. We sought to define electrode interaction in a cohort of pediatric cochlear implant subjects as a function of both stimulus intensity and electrode location along the array. The 27 pediatric subjects that completed the study were implanted with either the Clarion Hi-Focus array with or without positioner, the Nucleus 24 Contour array, or the Nucleus 24 Straight array. All but two of the patients had congenital hearing loss, and none of the patients had meningitis prior to the onset of deafness. The cochlear nerve response was measured with the electrically evoked compound action potential (ECAP). A forward masking protocol was used such that a probe stimulus electrode remained fixed while a preceding masker was moved across the array. Electrode interaction was estimated by measuring the unmasked probe response minus the masked probe response. Three probe locations and three probe intensities were examined for each subject. At all probe locations, electrode interaction increased as probe intensity increased (p < 0.05). Interaction at the basal probe was less than that at either the middle or apical probe locations (p < 0.05), and significant correlation found between probe distance from the basal end of the array and electrode interaction (p < 0.001). These results demonstrate that in this cohort of pediatric subjects, electrode interaction depended on both stimulus intensity and probe location. Implications of these findings on future implant array design and current implant fitting strategies are discussed. The impact of electrode interaction on implant performance is yet to be elucidated.

Project description:Objectivesto characterize differences in wideband power reflectance for ears with and without cochlear implants (CIs), to describe electrically evoked stapedial reflex (eSR)-induced changes in reflectance, and to evaluate the benefit of a broadband probe for reflex threshold determination for CI recipients. It was hypothesized that reflectance patterns in ears with CIs would be consistent with increased middle ear stiffness and that reflex thresholds measured with a broadband probe would be lower compared with thresholds obtained with a single-frequency probe.DesignEleven CI recipients participated in both wideband reflectance and eSR testing. Ipsilateral reflexes were measured with three probes: a broadband chirp (swept from 200 to 8000 Hz), a 226 Hz tone, and a 678 Hz tone. Wideband reflectance measures acquired from 28 adults without CIs and with normal middle ear function served as a normative data set for comparison.ResultsConsidering the group data, average reflectance was significantly greater for ears with CIs across 250 to 891 Hz and 4238 to 4490 Hz compared with the normative data set, although individual reflectance curves were variable. Some CI recipients also had low 226 Hz admittance, which contributed to the group finding, considering the control group had clinically normal 226 Hz admittance by design. Electrically evoked stapedial reflexes were measurable in nine of 14 ears (64.3%) and in 24 of 46 electrodes (52.5%) tested. Reflex-induced changes in reflectance patterns were unique to the participant/ear, but similar across activators (electrodes) within a given ear. In addition, reflectance values at or above 1000 Hz were affected most by activating the stapedial reflex, even in ears with clinically normal 226 Hz admittance. This is a higher-frequency range than has been reported for acoustically evoked reflex-induced reflectance changes and is consistent with increased middle ear stiffness at rest. Electrically evoked reflexes could be measured more often with the 678 Hz or the broadband probe compared with the 226 Hz probe tone. Although reflex thresholds were lower with the broadband probe compared with the 678 Hz probe in 16 of 24 conditions, this was not a statistically significant finding (Wilcoxon signed-rank test; p = 0.072).ConclusionsThe applications of wideband acoustic immittance measurements (reflectance and reflexes) should also be considered for ears with CIs. Further work is needed to describe changes across time in ears with CIs to more fully understand the reflectance pattern indicating increased middle ear stiffness and to optimize measuring eSRs with a broadband probe.

Dataset Information

Clinical Validation of a Sound Processor Upgrade in Direct Acoustic Cochlear Implant Subjects.

Publications

Clinical Validation of a Sound Processor Upgrade in Direct Acoustic Cochlear Implant Subjects.

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