Outcomes of Cochlear Implantation Using FLEX26 Electrode: Audiological Results and Quality of Life after 12 Months.

INTRODUCTION: The electrode length is one of the many factors impacted on results of cochlear implantation. Among lateral wall flexible electrode arrays the latest one is FLEX26 (MED-EL GmbH, Innsbruck, Austria). The main aim of the study was to evaluate the preservation of residual hearing, the level of speech understanding, and quality of life after cochlear implantation with FLEX26 electrode array. METHODS: The study was conducted in a tertiary referral centre. Fifty-two patients implanted unilaterally with FLEX26, including 10 EAS patients (electric acoustic stimulation) and 42 ES patients (electric stimulation). The intervention was minimally invasive cochlear implantation via the round window. Pure-tone audiometry (0.125-8 kHz) was performed preoperatively and at 1, 6, and 12 months postoperatively. Twelve-month hearing preservation was established using HEARRING group formula. Quality of life was measured with AQoL-8D (Assessment of Quality of Life-8 Dimensions) pre- and postoperatively. RESULTS: Residual hearing was preserved in 88.8% EAS patients. Quality of life was significantly better postoperatively in comparison to preoperative period (the effect size for overall quality of life was 0.49). Especially, it increased in relationships and senses dimensions (the effect sizes 0.47 and 0.44, respectively). CONCLUSION: Preservation of residual hearing can be achieved in the majority of patients implanted with FLEX26. Improvement of quality of life was also documented. FLEX26 seems to be an option for surgeons who seek an electrode providing sufficient cochlear coverage.

Can an individual with low frequency hearing in the candidate ear benefit from a cochlear implant even if they have normal hearing in the other ear?

PURPOSE: To determine hearing preservation and subjective benefit after cochlear implant (CI) surgery in patients with low frequency hearing in the ear to be implanted (i.e., they have partial deafness, PD) and close to normal hearing in the other. METHODS: There were two study groups. The test group was made up of 12 adult patients (mean age 43.4 years; SD 13.6) with normal hearing or mild hearing loss in one ear, and with PD in the ear to be implanted. The reference group consisted of 12 adult patients (mean age 44.5 years; SD 14.1) who had PD in both ears and who underwent unilateral implantation in their worse ear. Hearing preservation was assessed 1 and 14 months after CI surgery using the Skarzynski Hearing Preservation Classification System. The APHAB questionnaire was used to evaluate the benefit from the CI. RESULTS: The differences in HP% between the groups were not significant: mean hearing preservation (HP%) in the test group was 82% one month after CI surgery and 75% some 14 months after implantation; corresponding results in the reference group were 71% and 69%. However, on the APHAB background noise subscale, the benefit in the test group was significantly larger than in the reference group. CONCLUSION: To a large extent it was possible to preserve low-frequency hearing in the implanted ear. This means that individuals with low frequency hearing in the implanted ear (partial deafness) and with normal hearing in the other generally received more benefits from cochlear implantation than did patients with partial deafness in both ears. We conclude that residual low frequency hearing in the ear to be implanted should not be considered a contraindication for a CI in a patient with single-sided deafness.

New technology can benefit established middle ear implant users: Samba 2 vs previous models of audio processors for Vibrant Soundbridge.

INTRODUCTION: The Vibrant Soundbridge (VSB) is a semi-implantable hearing aid for patients with various types of hearing loss and has been available for over 25 years. Recently, new audio processors with advanced signal processing, noise reduction, and multi-microphone technology have appeared. The aim of this study is to compare the benefits of using the newest Samba 2 processor to the previous generation processors in a group of experienced VSB users. METHODS: There were 22 experienced VSB users (mean time of using VSB was 9 years, SD = 2) who had their processor (D404 or Amadé) upgraded to the newest model (Samba 2). The mean age of the subjects was 56 years (SD = 20). Assessments were made by free-field audiometry, speech reception in quiet and noise, and Patient-Reported Outcome Measures (PROMs). RESULTS: Hearing tests in free field showed statistically significant improvements in hearing sensitivity and speech discrimination in quiet and noise with the Samba 2 audio processor compared to the earlier technology. PROMs confirmed the benefits of using the newest audio processor and there was more satisfaction in terms of usability. CONCLUSIONS: Access to modern technology for VSB patients provides measurable benefits.

The COVID-19 pandemic and upgrades of CI speech processors for children: part II-hearing outcomes.

PURPOSE: To gauge the benefits to children of upgrading speech processors during the COVID-19 pandemic. METHODS: The study involved 297 children, aged from 7.3 to 18.0 years, whose processors were upgraded to either Nucleus 7 or Kanso 2, or to Sonnet 2 or Rondo 3. To document the benefits of the upgrades, a speech-in-noise discrimination test and Patient Reported Outcome Measures (PROMs) were used. RESULTS: There was a significant benefit from the newer processors in terms of speech discrimination in noise. Patient Reported Outcome Measures (PROMs) indicated less hearing disability, a higher level of functioning in everyday life situations, and more satisfaction with the new speech processor in social situations. CONCLUSION: There is a measurable improvement in performance when the devices are upgraded to the new technology.

The COVID-19 pandemic and upgrades of CI speech processors for children: part I-procedure of speech processor upgrade.

PURPOSE: To demonstrate the feasibility of upgrading speech processors during the COVID-19 pandemic. METHODS: Adopting concepts from "lean thinking", we optimized hospital workflows to allow speech processors to be upgraded despite the obstacles arising from national guidelines for COVID-19 prevention. The study involved 297 children, aged from 7.3 to 18.0 years, whose processors were upgraded on five consecutive Saturdays during a time of peak COVID-19 in Poland. RESULTS: The optimized workflow allowed us to conduct speech processor upgrades during a time of peak COVID-19 in Poland. The upgrades were conducted as scheduled, patient flow was smooth, appropriate social distancing was kept, and no reports of COVID-19 infection in our patients in the 2 weeks after their visit were received. CONCLUSION: Upgrading of speech processors in children is still feasible under coronavirus conditions.

Validation of AQoL-8D: a health-related quality of life questionnaire for adult patients referred for otolaryngology.

PURPOSE: The purpose of the study was to validate the AQoL-8D questionnaire in the adult population of patients referred to an otolaryngology clinic. METHODS: AQoL-8D was translated into Polish. 463 patients (age18-80 years) with otolaryngological conditions were assessed with the AQoL-8D, SF-6D, and SWLS questionnaires. We investigated the item content-relevance, factor structure by means of Confirmatory Factor Analysis, corrected item-total correlations, Cronbach's alpha, Pearson correlation of the AQoL-8D scores with results from SF-6D and from the SWLS questionnaires. Finally, ANOVA was used to test the AQoL-8D ability to group the HRQoL of patients in terms of their otolaryngological management type. RESULTS: The median score of item content-relevance was 5.0 for all AQoL-8D items. Confirmatory Factor Analysis revealed the following fit indices: Comparative Fit Index = 0.81; Tucker-Lewis Index = 0.80; and Root Mean Square Error of Approximation = 0.07. Cronbach's alpha for AQoL-8D dimensions ranged from 0.48 to 0.79. Mean item-total correlations over all dimensions, super dimensions, and the instrument overall were higher than 0.3. There was a significant Pearson correlation between the results obtained with AQoL-8D and SF-6D (r = 0.68), and with AQoL-8D and SWLS (r = 0.43). A one-way ANOVA showed a significant effect of management type on HRQoL as measured by AQoL-8D [F(4,458) = 6.12, p < 0.001] CONCLUSION: AQoL-8D provides valid and reliable measures of HRQoL in patients undergoing otolaryngological treatment. Because it is a generic questionnaire, it is possible to make general comparisons of otolaryngology outcomes with those from other subspecialties.

Resumption of Cochlear Implant Surgery under COVID-19 Pandemic Conditions.

(1) Background: The novel coronavirus COVID-19 has been recognized by the World Health Organization as a public health emergency of international concern and has caused cancellation of elective cochlear implantation in many countries. This article sets out our experience with resuming cochlear implant (CI) surgery under COVID-19 conditions over a period of 3 months. In addition, early results of hearing preservation (HP) after CI surgery are presented; (2) Methods: We adopted epidemic management policies and procedures according to the National Consultant for Infectious Diseases recommendations. During preoperative visits, all patients were tested for COVID-19 with a RT-PCR test. One month postoperatively, HP values in the Partial Deafness Treatment (PDT) group of patients was established using the HEARRING group formula; (3) Results: Between January and March 2021, we performed 312 CI procedures in adult and pediatric patients. Of these, none were subsequently re-admitted to hospital and found to be COVID-19 positive. Postoperative audiometric results showed that complete or partial HP was achieved in more than half the PDT patients; (4) Conclusion: Cochlear implantation during the coronavirus disease pandemic is essential and, with careful planning, is perfectly feasible.

Benefits of Binaural Integration in Cochlear Implant Patients with Single-Sided Deafness and Residual Hearing in the Implanted Ear.

The purpose of the study is to gauge the benefits of binaural integration effects (redundancy and squelch) due to preserved low-frequency residual hearing in the implanted ear of cochlear implant users with single-sided deafness. There were 11 cochlear implant users (age 18-61 years old) who had preserved low-frequency hearing in the implanted ear; they had a normal hearing or mild hearing loss in the contralateral ear. Patients were tested with monosyllabic words, under different spatial locations of speech and noise and with the cochlear implant activated and deactivated, in two listening configurations-one in which low frequencies in the implanted ear were masked and another in which they were unmasked. We also investigated how cochlear implant benefit due to binaural integration depended on unaided sound localization ability. Patients benefited from the binaural integration effects of redundancy and squelch only in the unmasked condition. Pearson correlations between binaural integration effects and unaided sound localization error showed significance only for squelch (r = -0.67; p = 0.02). Hearing preservation after cochlear implantation has considerable benefits because the preserved low-frequency hearing in the implanted ear contributes to binaural integration, presumably through the preserved temporal fine structure.

Functional Polymorphism of MMP9 and BDNF as Potential Biomarker of Auditory Neuroplasticity in Prelingual Deafness Treatment With Cochlear Implantation-A Retrospective Cohort Analysis.

Genetic biomarkers of neuroplasticity in deaf children treated with cochlear implantation (CI) might facilitate their clinical management, especially giving them better chances of developing proficient spoken language. We investigated whether carrying certain variants of the genes encoding matrix metalloproteinase MMP9 and neurotrophin brain-derived neurotrophic factor (BDNF), involved in synaptic plasticity, can be taken as prognostic markers of how well auditory skills might be acquired. Association analysis of functional MMP9 rs3918242 and BDNF rs6265 variants and the child's auditory development measured at CI activation and 1, 5, 9, 14, and 24 months post CI activation with LittlEARS Questionnaire (LEAQ) was conducted in a group of 100 children diagnosed with DFNB1-related deafness, unilaterally implanted before the age of 2 years. Statistical analysis in the subgroup implanted after 1 year of life (n = 53) showed significant association between MMP9 rs3918242 and LEAQ scores at 1 month (p = .01), at 5 months (p = .01), at 9 months (p = .01), and at 24 months (p = .01) after CI activation. No significant associations in the subgroup implanted before 1 year of life were observed. No significant associations between the BDNF rs6265 and LEAQ score were found. Multiple regression analysis (R2 = .73) in the subgroup implanted after 1 year of life revealed that MMP9 rs3918242 was a significant predictor of treatment outcome. In conclusion, C/C rs3918242 MMP9 predisposes their deaf carriers to better CI outcomes, especially when implanted after the first birthday, than carriers of C/T rs3918242MMP9.

Cochlear Implantation Outcome in Children with DFNB1 locus Pathogenic Variants.

Almost 60% of children with profound prelingual hearing loss (HL) have a genetic determinant of deafness, most frequently two DFNB1 locus (GJB2/GJB6 genes) recessive pathogenic variants. Only few studies combine HL etiology with cochlear implantation (CI) outcome. Patients with profound prelingual HL who received a cochlear implant before 24 months of age and had completed DFNB1 genetic testing were enrolled in the study (n = 196). LittlEARS questionnaire scores were used to assess auditory development. Our data show that children with DFNB1-related HL (n = 149) had good outcome from the CI (6.85, 22.24, and 28 scores at 0, 5, and 9 months post-CI, respectively). A better auditory development was achieved in patients who receive cochlear implants before 12 months of age. Children without residual hearing presented a higher rate of auditory development than children with responses in hearing aids over a wide frequency range prior to CI, but both groups reached a similar level of auditory development after 9 months post-CI. Our data shed light upon the benefits of CI in the homogenous group of patients with HL due to DFNB1 locus pathogenic variants and clearly demonstrate that very early CI is the most effective treatment method in this group of patients.

Cochlear Microphonics in Hearing Preservation Cochlear Implantees.

OBJECTIVES: The intracochlear electrocochleography (ECoG) could be recorded directly from the cochlear implant (CI) electrode in CI recipients with residual hearing. The primary objective of this study is to identify the most sensitive frequency to record cochlear microphonics (CM) in CI users with a wide degree of hearing abilities and deep electrode insertion. The secondary objective is to identify the optimum location within the cochlea to record intracochlear potentials. MATERIALS AND METHODS: CMs were recorded from the CI electrodes in eight females and eight males implanted with CIs Pulsar, Concerto, or Sonata, Med-El Corp. RESULTS: Among the tone pips of various frequencies, 1k or 500 Hz were the most sensitive for CI users. The most sensitive place in the cochlea to record the CM potentials depended on the tone frequency used. The deeper into the cochlea the mean maximum CM peak-to-peak amplitude was measured, the lower the stimulating tone frequency was. CONCLUSION: The most optimal recording parameters identified for intracochlear CM recording can be useful for intraoperative and postoperative monitoring of cochlear health in CI users with residual hearing.

Binaural advantages in using a cochlear implant for adults with profound unilateral hearing loss.

BACKGROUND: Recent studies of cochlear implants (CIs) in profound unilateral hearing loss (UHL) patients have demonstrated a restoration of some binaural hearing. AIMS/OBJECTIVES: The objective was to evaluate three possible advantages of binaural hearing in CIs adult users with UHL including single-side deafness (SSD) and asymmetric hearing loss (AHL) subgroups. MATERIAL AND METHODS: A prospective study was conducted that included 70 sequentially implanted patients. Subgroups of these subjects included 64 with a postlingual onset of a profound hearing loss on the implanted side and 6 with a prelingual onset of that loss. Three binaural effects - redundancy, head shadow, and squelch - were evaluated. RESULTS: Significant differences between the 'CI on' and 'CI off' conditions were found for all three binaural effects for the study group as a whole and for the postlingual subgroup. However, results for the subjects in the prelingual subgroup did not demonstrate any of the binaural advantages. CONCLUSION AND SIGNIFICANCE: Patients with a postlingual onset of a profound hearing loss in one ear and normal hearing or only a moderate loss in the other ear are able to make the effective use of a CI in the profound-loss ear in conjunction with acoustic stimulation of the other ear.

The hearing benefit of cochlear implantation for individuals with unilateral hearing loss, but no tinnitus.

CONCLUSION: Cochlear implants improve the hearing abilities of individuals with unilateral hearing loss and no tinnitus. The benefit is no different from that seen in patients with unilateral hearing loss and incapacitating tinnitus. OBJECTIVE: To evaluate hearing outcomes after cochlear implantation in individuals with unilateral hearing loss and no tinnitus and compare them to those obtained in a similar group who had incapacitating tinnitus. METHODS: Six cases who did not experience tinnitus before operation and 15 subjects with pre-operative tinnitus were evaluated with a structured interview, a monosyllabic word test under difficult listening situations, a sound localization test, and an APHAB (abbreviated profile of hearing aid benefit) questionnaire. RESULTS: All subjects used their cochlear implant more than 8 hours a day, 7 days a week. In 'no tinnitus' patients, mean benefit of cochlear implantation was 19% for quiet speech, 15% for speech in noise (with the same signal-to-noise ratio in the implanted and non-implanted ear), and 16% for a more favourable signal-to-noise ratio at the implanted ear. Sound localization error improved by an average of 19°. The global score of APHAB improved by 16%. The benefits across all evaluations did not differ significantly between the 'no tinnitus' and 'tinnitus' groups.

Validation of the LittlEARS Auditory Questionnaire in cochlear implanted infants and toddlers.

OBJECTIVES: The LittlEARS Auditory Questionnaire (LEAQ) has so far been validated to assess auditory development in groups of normal-hearing children in over 20 different languages. Considering the huge variability in auditory development of CI children, especially since candidacy criteria have been relaxed, additional evidence to validate the use of LEAQ scores in this particular population is needed. The aim of this study is to provide evidence for the reliability and validity of LEAQ scores for assessing the auditory development of CI infants and toddlers based on an evaluation of LEAQ's internal structure and its relation to other variables. METHODS: The study was prospective, with sequential enrolment and within-subject repeated measures. It included 122 children with profound bilateral sensorineural hearing loss implanted at 6-22 months of age. All children were evaluated with the Polish version of LEAQ on the first day of CI activation and at each of four follow-up visits related to sound processor fitting. The study was undertaken in the light of current psychometric thinking about how assessment instruments should be validated. The main aim of the study was to obtain evidence for the validity of interpreting LEAQ measures from CI children in terms of auditory development. First, in order to collect evidence for score reliability and validity based on LEAQ's internal structure, the psychometric properties of LEAQ scores from CI children were determined. A second step was to confirm validity by investigating the effect of concomitant variables on LEAQ scores. Correlations between LEAQ score and duration of hearing aid (HA) use, and between LEAQ score and duration of CI use, were investigated. Additionally, group differences in LEAQ scores between: 1) early and late implanted children; 2) children with long and short HA experience prior to implantation; and 3) children who showed responses over a wide frequency range from using their HAs (prior to implantation) vs those who did not. RESULTS: On each of the five administrations of LEAQ, the item difficulty indices increased (meaning the items became easier) and over the series they progressively increased with a range of: 0.01-0.62, 0.03-0.92, 0.09-1.00, 0.26-1.00, and 0.52-1.00. At the same time, item-total correlations were in the ranges: 0.09-0.77, 0.26-0.62, 0.00-0.65, 0.00-0.65, and 0.00-0.67. Cronbach's alpha values were above 0.80 for all administrations. A positive correlation between LEAQ score and duration of HA use, and subsequent duration of CI use (hearing experience) was found. When the children were stratified into groups according to age at cochlear implantation, duration of HA use before implantation, and audibility provided by HAs prior to implantation, the differences between the groups were reflected in both their rate of auditory development and their LEAQ score. CONCLUSION: The interpretation of LEAQ scores from CI children in terms of auditory development was supported by the validity evidence of internal structure and from a logical relationship to other variables. (1) Psychometric properties - item difficulty, item-total correlations, and Cronbach's alpha values - indicate that LEAQ measures are highly consistent and reliably gauge the level of a CI child's auditory development. (2) There was a positive correlation between LEAQ scores and the duration of hearing experience with HAs and a later CI; similarly, there were significant differences between groups of children stratified according to the age at cochlear implantation, duration of HA use before implantation, and audibility provided by HAs prior to implantation, all of which demonstrate the expected relation between LEAQ score and concomitant variables.

Fine Structure Processing improves speech perception as well as objective and subjective benefits in pediatric MED-EL COMBI 40+ users.

OBJECTIVES: Presently, there are only few studies examining the benefits of fine structure information in coding strategies. Against this background, this study aims to assess the objective and subjective performance of children experienced with the C40+ cochlear implant using the CIS+ coding strategy who were upgraded to the OPUS 2 processor using FSP and HDCIS. METHODS: In this prospective study, 60 children with more than 3.5 years of experience with the C40+ cochlear implant were upgraded to the OPUS 2 processor and fit and tested with HDCIS (Interval I). After 3 months of experience with HDCIS, they were fit with the FSP coding strategy (Interval II) and tested with all strategies (FSP, HDCIS, CIS+). After an additional 3-4 months, they were assessed on all three strategies and asked to choose their take-home strategy (Interval III). The children were tested using the Adaptive Auditory Speech Test which measures speech reception threshold (SRT) in quiet and noise at each test interval. The children were also asked to rate on a Visual Analogue Scale their satisfaction and coding strategy preference when listening to speech and a pop song. However, since not all tests could be performed at one single visit, some children were not able complete all tests at all intervals. RESULTS: At the study endpoint, speech in quiet showed a significant difference in SRT of 1.0 dB between FSP and HDCIS, with FSP performing better. FSP proved a better strategy compared with CIS+, showing lower SRT results of 5.2 dB. Speech in noise tests showed FSP to be significantly better than CIS+ by 0.7 dB, and HDCIS to be significantly better than CIS+ by 0.8 dB. Both satisfaction and coding strategy preference ratings also revealed that FSP and HDCIS strategies were better than CIS+ strategy when listening to speech and music. FSP was better than HDCIS when listening to speech. CONCLUSIONS: This study demonstrates that long-term pediatric users of the COMBI 40+ are able to upgrade to a newer processor and coding strategy without compromising their listening performance and even improving their performance with FSP after a short time of experience.