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Aim: This European multicentric study aimed to prove safety and performance of the Bonebridge BCI 602 in children and adults suffering from either conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided sensorineural deafness (SSD)., Methods: 33 patients (13 adults and 10 children with either CHL or MHL and 10 patients with SSD) in three study groups were included. Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 3-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements., Results: The Bonebridge BCI 602 significantly improved SF thresholds (+ 25.5 dB CHL/MHL/SSD), speech intelligibility in WRS (+ 68.0% CHL/MHL) and SRT in quiet (- 16.5 dB C/MHL) and in noise (- 3.51 dB SNR SSD). Air conduction (AC) and bone conduction (BC) thresholds remained stable over time. All adverse events were resolved, with none unanticipated. Mean audio processor wearing times in hours [h] per day for the CHL/MHL group were ~ 13 h for adults, ~ 11 h for paediatrics and ~ 6 h for the SSD group. The average surgical length was 57 min for the CHL/MHL group and 42 min for the SSD group. The versatility of the BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows for treatment of normal, pre-operated and malformed anatomies. All audiological endpoints were reached., Conclusions: The Bonebridge BCI 602 significantly improved hearing thresholds and speech understanding. Since implant placement follows the patient's anatomy instead of the shape of the device and the duration of surgery is shorter than with its predecessor, implantation is easier with the BCI 602. Performance and safety were proven for adults and children as well as for the CHL/MHL and SSD indications 3 months post-operatively., (© 2023. The Author(s).)

Background: The aim of this study was to find out how candidacy criteria have evolved differently across the globe., Methods: Candidacy criteria and outcome measurements applied in 19 HEARRING clinics were analyzed., Results: Candidacy criteria vary between clinics. Overall, both bilateral implantation and cochlear implantation in patients with single-sided deafness are becoming more frequent., Conclusion: Standardized outcome measurement instruments need to be applied to provide access to the hearing world to all patients with hearing loss who would benefit from cochlear implantation.

Objective: To compare audiologic outcomes, quality-of-life (QoL) and usage-of-device (UoD) between case-matched, otosclerotic patients with mixed hearing loss (MHL) which received (a) stapedotomy and postoperative amplification with hearing aids (SDT+HA) or (b) short-incudial process coupled active middle ear implant with simultaneous stapedotomy (mPP)., Study Design, Setting, and Patients: Prospective, matched case-control, follow-up study conducted at two tertiary otologic referral centers. Eligible were all otosclerotic patients with MHL, which received mPP at either of the two institutions. A case-matched-cohort of SDT+HA-patients was generated from the hospitals database based on preoperative audiologic findings., Main Outcome Measures: For sound- and speech perception, primary outcome parameters were the mean postoperative, aided air-conduction pure tone average (mpa-AC-PTA) and word recognition score at 80 dB speech level (mpa-WRS), for QoL the mean Nijmegen-Cochlear-Implant-Questionnaire (NCIQ) total-score, and for UoD the mean score rated on a 10-point Likert-scale., Results: A total of 28 patients were included; 14 received mPP; mpa-AC-PTA and mpa-WRS significantly improved from 47.1 dB-HL to 34.3 dB-HL (-12.8 dB-HL; p < 0.001) and from 75.0% to 93.2% (+18.2%; p = 0.002) compared to 46.5 dB-HL to 31.9 dB-HL (-14.8 dB-HL; p < 0.008) and 75.0% to 93.2% (+18.2%; p = 0.002) for SDT+HA. No significant difference between groups was observed (all p > 0.1). NCIQ total-score between groups did not significantly differ (70.4 vs. 69.9; p = 0.93). UoD for mPP was significantly higher (6.1 vs. 3.0; p < 0.001)., Conclusions: If medical/technical problems prevent usage of HA in otosclerosis with MHL, mPP can be considered as effective treatment option with similar audiological outcome and QoL. A significantly higher UoD for mPP was observed., Competing Interests: Joachim Schmutzhard is currently receiving a research grant from MedEl (Innsbruck, Austria). None of the other authors named in the submitted work have any conflict of interest including financial, consultant, institutional and or personal relationships that inappropriately bias his or her actions within 3 years of the work beginning. The open access charges have been covered by MED-EL Medical Electronics. The authors disclose no conflicts of interest., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of Otology & Neurotology, Inc.)

Objective: If mixed-hearing-loss (MHL) occurs in otosclerosis, hearing-aids (HA) in addition to conventional-stapedotomy (SDT) may be necessary. If otosclerosis progresses or technical or medical problems prevent use of HA, combining active-middle-ear-implants (AMEI) with SDT ("power-piston") may be considered. Previously, AMEI-coupling to the long-incudial-process was suggested. Here, a "modified-power-piston" surgery (mPP) coupling to the short-incudial-process was proposed, so no coupling over the positioned stapes-piston is required. We questioned whether mPP is as safe and effective as SDT., Methods: Otosclerotic patients with MHL and limited satisfaction with previously worn HA receiving mPP were retrospectively reviewed at two Austrian tertiary otologic referral centers. Patients, receiving stapedotomy, were case-matched for preoperative pure-tone averages (PTA), bone-conduction (BC-PTA), air-conduction (AC-PTA), and air-bone gap (ABG-PTA). Postoperative changes in BC-PTA and in AC-PTA and ABG-PTA were defined as safety- and as efficacy outcome parameter., Results: Of 160 patients, 14 received mPP and 14 stapedotomy. Preoperative findings were comparable (all p = 1.000). BC-PTA improved from 38.0 to 36.7 and from 37.1 to 36.9 dB-HL for mPP and SDT, respectively (Δ -1.3 versus -0.2 dB-HL; p = 0.077). AC-PTA improved from 66.8 to 47.1 and from 66.3 to 46.5 dB-HL for mPP and SDT, respectively (Δ -19.6 versus -19.7 dB-HL; p = 0.991). ABG-PTA improved from 28.8 to 10.4 and from 29.1 to 9.6 dB-HL for mPP and SDT, respectively (Δ -18.3 versus -19.5 dB-HL; p = 0.771)., Conclusion: In otosclerosis with MHL and limited satisfaction with HA, mPP appeared as safe and effective as SDT and may be considered a treatment alternative in these patients.

Background/aims: Calcium-binding proteins in neurons buffer intracellular free Ca2+ ions, which interact with proteins controlling enzymatic and ion channel activity. The heterogeneous distribution of calretinin, calbindin, and parvalbumin influences calcium homeostasis, and calcium-related neuronal processes play an important role in neuronal aging and degeneration. This study evaluated age-related changes in calretinin, calbindin, and parvalbumin immune reactivity in spiral ganglion cells., Methods: A total of 16 C57BL/6J and 16 129/SvJ mice at different ages (2, 4, 7, and 12 months) were included in the study. Hearing thresholds were assessed using auditory brainstem response before inner ears were excised for further evaluation. Semiquantitative immunohistochemistry for the aforementioned calcium-binding proteins was performed at the cellular level., Results: The hearing thresholds of C57BL/6J and 129/SvJ mice increased significantly by 7 months of age. The average immune reactivity of calbin-din as well as the relative number of positive cells increased significantly with aging, but no significant alterations in calretinin or parvalbumin were observed., Conclusions: Upregulation of calbindin could serve as a protection to compensate for functional deficits that occur with aging. Expression of both calretinin and parvalbumin seem to be stabilizing factors in murine inner ears up to the age of 12 months in C57BL/6J and 129/SvJ mice., (© 2019 S. Karger AG, Basel.)

Objectives: To provide multidisciplinary cochlear implant teams with a current consensus statement to support hearing preservation cochlear implantation (HPCI) in children, including those children with symptomatic partial deafness (PD) where the intention is to use electric-acoustic stimulation (EAS). The main objectives are to provide guidelines on who is a candidate, how to assess these children and when to implant if Med-El Flex electrode arrays are chosen for implantation., Methods: The HEARRING group reviewed the current evidence and practice regarding the management of children to be considered for HPCI surgery emphasizing the assessment needed prior to implantation in order to demonstrate the benefits in these children over time. The consensus statement addresses following three key questions: (1) Should these children be treated? (2) How to identify these children? (3) How to manage these children?, Summary: The HEARRING group concludes that irrespective of the degree of residual hearing present, the concepts of hearing and structure preservation should be applied in every child undergoing cochlear implantation and that HPCI is a safe and reliable treatment option. Early detection and multidisciplinary assessment are key to the identification of children with symptomatic PD, these children should undergo HPCI as early as possible.

Background: Severe malaria may influence inner ear function, although this possibility has not been examined prospectively. In a retrospective analysis, hearing impairment was found in 9 of 23 patients with cerebral malaria. An objective method to quickly evaluate the function of the inner ear are the otoacoustic emissions. Negative transient otoacoustic emissions are associated with a threshold shift of 20 dB and above., Methods: This prospective multicenter study analyses otoacoustic emissions in patients with severe malaria up to the age of 10 years. In three study sites (Ghana, Gabon, Kenya) 144 patients with severe malaria and 108 control children were included. All malaria patients were treated with parental artesunate., Results: In the control group, 92.6 % (n = 108, 95 % confidence interval 86.19-6.2 %) passed otoacoustic emission screening. In malaria patients, 58.5 % (n = 94, malaria vs controls p < 0.001, 95 % confidence interval 48.4-67.9 %) passed otoacoustic emission screening at the baseline measurement. The value increased to 65.2 % (n = 66, p < 0.001, 95 % confidence interval 53.1-75.5 %) at follow up 14-28 days after diagnosis of malaria. The study population was divided into severe non-cerebral malaria and severe malaria with neurological symptoms (cerebral malaria). Whereas otoacoustic emissions in severe malaria improved to a passing percentage of 72.9 % (n = 48, 95 % confidence interval 59-83.4 %) at follow-up, the patients with cerebral malaria showed a drop in the passing percentage to 33 % (n = 18) 3-7 days after diagnosis. This shows a significant impairment in the cerebral malaria group (p = 0.012 at days 3-7, 95 % confidence interval 16.3-56.3 %; p = 0.031 at day 14-28, 95 % confidence interval 24.5-66.3 %)., Conclusion: The presented data show that 40 % of children have involvement of the inner ear early in severe malaria. In children, audiological screening after severe malaria infection is not currently recommended, but is worth investigating in larger studies.

Hearing loss is frequent in intensive care patients and can be due to several causes. However, sepsis has not been examined as a possible cause. The aim of this study is to assess the influence of experimental sepsis on hearing thresholds and to evaluate pathological changes in the cochlea. The cecal ligation puncture technique was used to induce sepsis in 18 mice. Results were compared with those from 13 sham-operated and 13 untreated control mice. The hearing thresholds of the animals were evaluated with auditory evoked brainstem responses prior to the induction of sepsis and again at the peak of the disease. Immediately after the second measurement, the mice were sacrificed and the inner ears harvested and prepared for further evaluation. The cochleae were examined with light microscopy, electron microscopy and immunohistochemistry for Bax, cleaved caspase-3 and Bcl-2. The mice with sepsis showed a significant hearing loss but not the control groups. Induction of apoptosis could be shown in the supporting cells of the organ of Corti. Furthermore, excitotoxicity could be shown at the basal pole of the inner hair cells. In this murine model, sepsis leads to significant hearing impairment. The physiological alteration could be linked to apoptosis in the supporting cells of the organ of Corti and to a disturbance of the synapses of the inner hair cells.

Background: Experimental murine malaria has been shown to result in significant hearing impairment. Microscopic evaluation of the temporal bones of these animals has revealed regular morphology of the cochlea duct. Furthermore, the known vascular pathologic changes being associated with malaria could not be found. Immunohistochemistry for ICAM1 showed a strong marking in the stria vascularis, indicating a disturbance of the endocochlear potential. The aim of this study was to evaluate the role of apoptosis and the disturbance of the blood labyrinth barrier in the murine malaria associated hearing impairment., Methods: The temporal bones of seven mice with cerebral malaria-four with hearing impairment, three without hearing impairment-were evaluated with immunohistochemistry for cleaved caspase 3 to detect apoptosis and connexin 26, a gap junction protein being a cornerstone in the endocochlear potassium recirculation. Furthermore five animals with cerebral malaria were treated with Evans blue prior to sacrification to detect disturbances of the blood labyrinth barrier., Results: Cleaved caspase 3 could clearly be detected by immunohistochemistry in the fibrocytes of the spiral ligament, more intensively in animals with hearing impairment, less intensively in those without. Apoptosis signal was equally distributed in the spiral ligament as was the connexin 26 gap junction protein. The Evans blue testing revealed a strong signal in the malaria animals and no signal in the healthy control animals., Conclusion: Malfunction of the fibrocytes type 1 in the spiral ligament and disruption of the blood labyrinth barrier, resulting in a breakdown of the endocochlear potential, are major causes for hearing impairment in murine cerebral malaria.

Objective: To evaluate the pathophysiologic changes in the inner ear during the course of severe cerebral malaria in an established animal model, C57 BL/6J mice., Methods: This study aims to examine the hearing threshold, the histological changes and ICAM-1 expression in the murine cochlea., Results: Four of seven mice showed an expected hearing loss of 20 dB or more. The light microscopy of the inner ear did not show any morphologic alterations. The immunohistochemical analysis for ICAM-1 showed intensive staining in the stria vascularis of sick animals and hardly any reaction in healthy controls., Conclusion: The up-regulation of ICAM-1 in the stria vascularis - generating the endocochlear potential - suggests its involvement in plasmodial infection., (© 2011 Blackwell Publishing Ltd.)

Hypothesis: The aim of this investigation was to define the expression of neurotrophic receptors within the developing inner ear of different postnatal ages., Background: Pattern of differential expression of neurotrophic receptors provide molecular target sites for multifunctional nanoparticle-based cell-specific therapeutics delivery to treat hearing diseases., Methods: Protein expression of neurotrophic receptors was studied by immune-histochemistry, quantitative polymerase chain reaction, in situ hybridization, Western blot, in early and late postnatal, adult, and aging mice., Results: There was a high correlation between results obtained at ribonucleic acid and protein levels. TrkB and TrkC gene expression increased during the first 2 weeks and also after the onset of hearing in adult mice. At the onset of hearing, TrkB-immunopositive staining occurred in inner hair cells and in cell bodies of spiral ganglion neurons. TrkC was detected in nerve endings beneath inner and outer hair cells and in supporting cells. Root cells within the spiral ligament and spiral ganglion neurons in the Rosenthal's canal showed high level of TrkC expression. p75NTR was found in organ of Corti similar to TrkC, and scattered neurons showed strong immunoreactivity in the Rosenthal's canal. PD540 mice, a model of age-related hearing loss, showed a complete spiral ganglion cell loss in the basal turn. Although TrkB and TrkC were completely lacking in this region of the Rosenthal's canal, remaining nerve fibers were p75NTR immunopositive., Conclusion: We found differential expression pattern of TrkB, TrkC, and p75NTR receptors in the inner ear and could make a receptor expression data base. These findings, in turn, will help to design a study on receptor-specific drug targeting of the mice model of auditory development and aging.

Background: Plasmodium falciparum malaria has been suspected to cause hearing loss. Developmental, cognitive and language disorders have been observed in children, surviving cerebral malaria. This prospective study aims to evaluate whether malaria influences hearing in mice., Methods: Twenty mice were included in a standardized murine cerebral malaria model. Auditory evoked brainstem responses were assessed before infection and at the peak of the illness., Results: A significant hearing impairment could be demonstrated in mice with malaria, especially the cerebral form. The control group did not show any alterations. No therapy was used., Conclusion: This suggests that malaria itself leads to a hearing impairment in mice.

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