Long-Term Safety and Quality of Life after Vibroplasty in Sensorineural Hearing Loss: Short/Long Incus Process Coupler.

OBJECTIVE: The study shows the long-term effectiveness, safety, and quality of life after Vibrant Soundbridge (VSB) implantation in sensorineural hearing loss (SNHL) using the short process coupler (SP) or the long process coupler (LP). METHODS: This retrospective study evaluated 77 VSB cases. Follow-up (F/U) time-dependent objective measurements (audiological outcomes), subjective data collection (quality-of-life questionnaire), and safety measures are presented. RESULTS: Sixty-two ears were included in the analysis with up to 116 months of postsurgical F/U data (mean 32.15 ± 37.97 months LP and SP coupler). Fifty-three ears (13 bilateral cases) received the LP coupler and 9 subjects the SP coupler. The post-operative bone conduction thresholds remained stable and, in both groups, <10 dB. The benefit in word recognition scores measured at 65 dB SPL and 80 dB SPL showed no significant difference between the couplers (p = 0.559 and p = 0.088, respectively). The functional gain was not significantly different (p > 0.05) with a mean of 20.91 ± 9.77 and 17.19 ± 5.75 for LP and SP coupler, respectively. The utility score deciphered from the Assessment of Quality-of-life Questionnaire-8 dimensions revealed a mean score of 0.75 ± 0.16 which is not significantly different to the age- and sex-matched healthy control group with 0.81 ± 0.02 (p = 0.3547). CONCLUSION: The Incus Vibroplasty utilizing both couplers is a safe and effective method to treat mild-to-severe SNHL. Both fixation methods of the floating mass transducer exhibit good clinical and audiological outcomes with high patient quality of life. The SP coupling method can be a good alternative when the long process is anatomically inaccessible, or the approach is limited due to anatomical reasons.

Minimal Reporting Standards for Active Middle Ear Hearing Implants.

There is currently no standardized method for reporting audiological, surgical and subjective outcome measures in clinical trials with active middle ear implants (AMEIs). It is often difficult to compare studies due to data incompatibility and to perform meta-analyses across different centres is almost impossible. A committee of ENT and audiological experts from Germany, Austria and Switzerland decided to address this issue by developing new minimal standards for reporting the outcomes of AMEI clinical trials. The consensus presented here aims to provide a recommendation to enable better inter-study comparability.

Towards a Unified Testing Framework for Single-Sided Deafness Studies: A Consensus Paper.

BACKGROUND: While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL. METHODS: This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada. RESULTS: A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable. CONCLUSION: A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options.

Bilateral use of active middle ear implants: speech discrimination results in noise.

Binaural sound reception has advantages over unilateral perception, including better localization and sound quality as well as speech and tone reception in both quiet and noisy environments. Up to now, most active middle ear implant (AMEI) users have been unilaterally implanted, but patient demand for an implant on the other side is increasing. Ten bilaterally-AMEI implanted native German-speaking adults were included in the study. The Oldenburg sentence test was used to measure speech reception thresholds in noise. The subject's signal-to-noise ratio (SNR) at a speech reception score of 50 % was calculated for different noise conditions. SRT was measured as a function of noise condition (nc) and listening condition (lc)-for example, SRT (lc, nc), with nc from S0N0, S0N-90, or S0N90 and lc from left, right or both. For each noise condition, the squelch effect and the binaural summation effect were calculated. Patients in this study demonstrated improvement with bilateral AMEIs compared to right or left AMEI only in all three tested listening conditions. Statistical significance was found in the S0N0 condition to favor usage of bilateral AMI versus either the right or left side only. The benefits of binaural hearing are well known, also in normal-hearing individuals. In the future every bilateral implantation should be a part of the clinical routine. Bilateral implantation can help to reduce problems in background noise and restore directional hearing.

(68)Ga-DOTATOC PET/CT provides accurate tumour extent in patients with extraadrenal paraganglioma compared to (123)I-MIBG SPECT/CT.

PURPOSE: The aim of this study was to compare the accuracy of (123)I-MIBG SPECT/CT with that of (68)Ga-DOTATOC PET/CT for staging extraadrenal paragangliomas (PGL) using both functional and anatomical images (i.e. combined cross-sectional imaging) as the reference standards. METHODS: The study included three men and seven women (age range 26 to 73 years) with anatomical and/or histologically proven disease. Three patients had either metastatic head and neck PGL (HNPGL) or multifocal extraadrenal PGL, and seven patients had nonmetastatic extraadrenal disease. Comparative evaluation included morphological imaging with CT, functional imaging with (68)Ga-DOTATOC PET, and (123)I-MIBG imaging. The imaging results were analysed on a per-patient and on a per-lesion basis. RESULTS: On a per-patient basis, the detection rate of (68)Ga-DOTATOC PET was 100 %, whereas that of planar (123)I-MIBG imaging was 10.0 % and with SPECT/CT 20.0 % for both nonmetastatic and metastatic/multifocal extraadrenal PGL. On a per-lesion basis, the overall sensitivity of (68)Ga-DOTATOC PET was 100 % (McNemar p < 0.5), that of planar (123)I-MIBG imaging was 3.4 % (McNemar p < 0.001) and that of SPECT/CT was 6.9 % (McNemar p < 0.001). Both (68)Ga-DOTATOC PET and anatomical imaging identified 27 lesions. Planar (123)I-MIBG imaging identified only one lesion, and SPECT/CT two lesions. Two additional lesions were detected by (68)Ga-DOTATOC PET but not by either (123)I-MIBG or CT imaging. CONCLUSION: Our analysis in this patient cohort indicated that (68)Ga-DOTATOC PET/CT is superior to (123)I-MIBG SPECT/CT, particularly in head and neck and bone lesions, and provides valuable information for staging extraadrenal PGL, particularly in patients with surgically inoperable tumours or multifocal/malignant disease.

A retrospective comparison between 68Ga-DOTA-TOC PET/CT and 18F-DOPA PET/CT in patients with extra-adrenal paraganglioma.

PURPOSE: (18)F-Fluoro-L-dihydroxyphenylalanine ((18)F-DOPA) PET offers high sensitivity and specificity in the imaging of nonmetastatic extra-adrenal paragangliomas (PGL) but lower sensitivity in metastatic or multifocal disease. These tumours are of neuroendocrine origin and can be detected by (68)Ga-DOTA-Tyr(3)-octreotide ((68)Ga-DOTA-TOC) PET. Therefore, we compared (68)Ga-DOTA-TOC and (18)F-DOPA as radiolabels for PET/CT imaging for the diagnosis and staging of extra-adrenal PGL. Combined cross-sectional imaging was the reference standard. METHODS: A total of 5 men and 15 women (age range 22 to 73 years) with anatomical and/or histologically proven extra-adrenal PGL were included in this study. Of these patients, 5 had metastatic or multifocal lesions and 15 had single sites of disease. Comparative evaluation included morphological imaging with CT and functional imaging with (68)Ga-DOTA-TOC PET and (18)F-DOPA PET. The imaging results were analysed on a per-patient and a per-lesion basis. The maximum standardized uptake value (SUVmax) of each functional imaging modality in concordant tumour lesions was measured. RESULTS: Compared with anatomical imaging, (68)Ga-DOTA-TOC PET and (18)F-DOPA PET each had a per-patient and per-lesion detection rate of 100% in nonmetastatic extra-adrenal PGL. However, in metastatic or multifocal disease, the per-lesion detection rate of (68)Ga-DOTA-TOC was 100% and that of (18)F-DOPA PET was 56.0%. Overall, (68)Ga-DOTA-TOC PET identified 45 lesions; anatomical imaging identified 43 lesions, and (18)F-DOPA PET identified 32 lesions. The overall per-lesion detection rate of (68)Ga-DOTA-TOC PET was 100% (McNemar, P < 0.5), and that of (18)F-DOPA PET was 71.1% (McNemar, P < 0.001). The SUVmax (mean ± SD) of all 32 concordant lesions was 67.9 ± 61.5 for (68)Ga-DOTA-TOC PET and 11.8 ± 7.9 for (18)F-DOPA PET (Mann-Whitney U test, P < 0.0001). CONCLUSION: (68)Ga-DOTA-TOC PET may be superior to (18)F-DOPA PET and diagnostic CT in providing valuable information for pretherapeutic staging of extra-adrenal PGL, particularly in surgically inoperable tumours and metastatic or multifocal disease.

Tumor cell and carcinoma-associated fibroblast interaction regulates matrix metalloproteinases and their inhibitors in oral squamous cell carcinoma.

Co-culture of periodontal ligament (PDL) fibroblasts and SCC-25 oral squamous carcinoma cells (OSCC), results in conversion of PDLs into carcinoma-associated fibroblasts (CAFs). Paracrin circuits between CAFs and OSCC cells were hypothesized to regulate the gene expression of matrix remodeling enzymes in their co-culture, which was performed for 7days, followed by analysis of the mRNA/protein expression and activity of metalloproteinases (MMPs), their tissue inhibitors (TIMPs) and other relevant genes. Interleukin1-ß, transforming growth factor-ß1, fibronectin and αvß6 integrin have shown to be involved in the regulation of the MMP and TIMP gene expression in co-culture of CAFs and tumor cells. In addition, these cells also cooperated in activation of MMP pro-enzymes. It is particularly interesting that the fibroblast-produced inactive MMP-2 has been activated by the tumor-cell-produced membrane-type 1 matrix metalloproteinase (MT1-MMP). The crosstalk between cancer- and the surrounding fibroblast stromal-cells is essential for the fine tuning of cancer cells invasivity.

Bilateral vocal fold paresis and glottal bridge synechia in COVID-19.

Key Clinical Message: Bilateral vocal fold paresis (BVFP) is a rare complication in COVID-19 and should be considered as differential diagnosis in COVID-19-patients presenting with dyspnea and stridor. High-dose intravenous corticosteroids can be useful treating COVID-19-related laryngeal edema and vocal fold paresis. This case shows the complexity of laryngeal complications in COVID-19 requiring surgeries and functional therapies. Abstract: Although COVID-19 is known to affect peripheral as well as cranial nerves, there is a paucity of reports on vocal fold paresis in COVID-19, bilateral vocal fold paresis (BVFP) in particular. We describe a case of BVFP and glottal bridge synechia following COVID-19-pneumonia discussing pathomechanisms and treatment options.

Effects of Auditory Training on Speech Recognition in Children with Single-Sided Deafness and Cochlea Implants Using a Direct Streaming Device: A Pilot Study.

Treating individuals with single-sided deafness (SSD) with a cochlear implant (CI) offers significant benefits for speech perception in complex spatial listening environments. After implantation, training without involvement of the normal-hearing ear is essential. Therefore, the AudioLink streaming device (MED-EL GmbH, Austria) can be used to connect the externally worn audio processor to media devices; thus, the auditory stimuli are directly streamed to the implanted ear. The aim was to test whether children with SSD, aged 5-12 years, accept this training method and whether auditory training, streamed directly via AudioLink using the Tiptoi device (Ravensburger GmbH., Ravensburg, Germany), improves speech recognition. A total of 12 children with SSD and implanted with a CI received Tiptoi training via AudioLink and were asked to practice daily for 10 min over a period of one month. All participants completed the training. The measurements employed to assess improvement included speech audiometry, speech, spatial, and quality of hearing scale for parents (SSQ P), and specially designed tasks crafted for this study. Daily training of 9.93 min was reported. The word recognition score (WRS) at 65 dB and 80 dB in aided condition significantly improved and the WRS streamed via AudioLink was significantly better after training. The speech, spatial, and qualities of hearing scale for parents (SSQ P questionnaire) showed significant improvement in the dimension of quality of hearing and overall gain. The outcomes of the Tiptoi tasks resulted in a significant benefit in both categories of the "recognition of sounds" and "understanding of sentences". The results are very encouraging and do not only show the positive uptake of daily training at home but also how this resulted in a significant improvement in subjective and objective measures for this rather short training period of one month only.

Magnetic Resonance Imaging with Active Implantable Hearing Devices: Reports from the Daily Radiological Routine in an Outpatient MR Center.

PURPOSE: For people with hearing implants (HI), magnetic resonance imaging (MRI) still presents some difficulties due to the built-in magnet. Radiologists often have concerns regarding complications associated with HIs. The aim of this study was to record the experiences of HI users during and after MRI examinations. METHOD: A survey including 15 questions regarding MRI specifics, namely changes in hearing ability, hearing/sound impressions, pain, uncomfortable feelings, etc., were mailed to our patients. RESULTS: Overall, 79 patients with HI had a total of 159 MR examinations in our institute. A total of 45 HI recipients reported back: 35% stated that they had been rejected by an MRI Institute because of their HI. Their feelings/impression ratings during the measurements were not present and therefore were not rated for the majority (49%), 42% of the HI users rated the pain with 0 (no pain), 2% with 1 (very light pain), 4% with 5 (acceptable pain), and 2% rated the pain with 7, which is between acceptable and strong pain. One examination resulted in a dislocation of the magnet of a cochlear implant (CI 512 Cochlear Limited). No adverse events were reported for MED-EL HI users in the survey (none of the contacted AB users answered the questionnaire). The reported mean daily wearing time was 11.6 ± 4.6 h per day for 6.3 ± 1.7 days per week. CONCLUSIONS: Based on these results and our experience we conclude that MRI examinations with HI are safe given that the measurements are performed according to the safety policies and procedures released by the manufacturers.

A Novel Representation of Audiological and Subjective Findings for Acoustical, Bone Conduction and Direct Drive Hearing Solutions.

BACKGROUND: The benefit of hearing rehabilitation is often measured using audiological tests or subjective questionnaires/interviews. It is important to consider both aspects in order to evaluate the overall benefits. Currently, there is no standardized method for reporting combined audiological and patient reported subjective outcome measures in clinical practice. Therefore, this study focuses on showing the patient's audiological, as well as subjective outcomes in one graph using data from an existing study. METHOD: The present paper illustrated a graph presenting data on four quadrants with audiological and subjective findings. These quadrants represented speech comprehension in quiet (unaided vs. aided) as WRS% at 65 dB SPL, speech recognition in noise (unaided vs. aided) as SRT dB SNR, sound field threshold (unaided vs. aided) as PTA4 in dB HL, wearing time and patient satisfaction questionnaire results. RESULTS: As an example, the HEARRING graph in this paper represented audiological and subjective datasets on a single patient level or a cohort of patients for an active bone conduction hearing implant solution. The graph offered the option to follow the user's performance in time. CONCLUSION: The HEARRING graph allowed representation of a combination of audiological measures with patient reported outcomes in one single graph, indicating the overall benefit of the intervention. In addition, the correlation and consistency between some results (e.g., aided threshold and aided WRS) can be better visualized. Those users who lacked performance benefits on one or more parameters and called for further insight could be visually identified.

Tumor-produced, active interleukin-1ß regulates gene expression in carcinoma-associated fibroblasts.

Recently we described a co-culture model of periodontal ligament (PDL) fibroblasts and SCC-25 lingual squamous carcinoma cells, which resulted in conversion of normal fibroblasts into carcinoma-associated fibroblasts (CAFs), and in epithelial-mesenchymal transition (EMT) of SCC-25 cells. We have found a constitutive high interleukin-1ß (IL1-ß) expression in SCC-25 cells in normal and in co-cultured conditions. In our hypothesis a constitutive IL1-ß expression in SCC-25 regulates gene expression in fibroblasts during co-culture. Co-cultures were performed between PDL fibroblasts and SCC-25 cells with and without dexamethasone (DEX) treatment; IL1-ß processing was investigated in SCC-25 cells, tumor cells and PDL fibroblasts were treated with IL1-ß. IL1-ß signaling was investigated by western blot and immunocytochemistry. IL1-ß-regulated genes were analyzed by real-time qPCR. SCC-25 cells produced 16kD active IL1-ß, its receptor was upregulated in PDL fibroblasts during co-culture, which induced phosphorylation of interleukin-1 receptor-associated kinase-1 (IRAK-1), and nuclear translocalization of NFκBα. Several genes, including interferon regulatory factor 1 (IRF1) interleukin-6 (IL-6) and prostaglandin-endoperoxide synthase 2 (COX-2) were induced in CAFs during co-culture. The most enhanced induction was found for IL-6 and COX-2. Treatment of PDL fibroblasts with IL1-ß reproduced a time- and dose-dependent upregulation of IL1-receptor, IL-6 and COX-2. A further proof was achieved by DEX inhibition for IL1-ß-stimulated IL-6 and COX-2 gene expression. Constitutive expression of IL1-ß in the tumor cells leads to IL1-ß-stimulated gene expression changes in tumor-associated fibroblasts, which are involved in tumor progression.

Personalized Medicine in Otolaryngology: Special Topic Otology.

Globally, more than 1.5 billion people experience some degree of hearing loss [...].

Clinical feasibility of a novel test setup for objective measurements using the VIBRANT SOUNDBRIDGE.

Objectives: The VIBRANT SOUNDBRIDGE is a widely used active middle ear implant to treat hearing loss. The floating mass transducer is surgically coupled to the ossicles, the round or oval window. A reliable method to monitor the coupling efficiency intraoperatively is highly desired. Research groups have developed several methods, but limitations remain. This study aims to evaluate the clinical feasibility of a new research setup for auditory brainstem response measurement to evaluate the coupling efficiency. Method: In 14 subjects, the new tool was used to record VSB-evoked ABR thresholds during surgery. The intra-op ABR thresholds were compared to pre-op bone conduction (BC) thresholds and post-op vibrogram thresholds to evaluate the feasibility of the method as a tool to monitor coupling efficiency. Results: The mean pre-op BC threshold average at 1, 2, and 4 kHz (PTA3) was 47 dB HL, the mean intra-op ABR threshold was 54 dB nHL, and the mean post-op vibrogram PTA3 was 60 dB HLeq. ABR was measurable in all subjects using the new tool. Correlation between pre-op BC thresholds and intra-op ABR thresholds was statistically significant; however, one outlier was present. Conclusion: Intra-op hearing threshold detection through ABR and direct stimulation of the VSB implant was reliable using this new tool. Despite some individual variability, first results correlate well with pre-op BC and post-op vibrogram thresholds.

Improved Music Perception after Music Therapy following Cochlear Implantation in the Elderly Population.

BACKGROUND: Cochlear implantation (CI) and the accompanying rehabilitation has become a routine procedure in hearing restoration. Literature is sparse on elderly CI recipients focusing on the issue of age and their inclined auditory resolution, taking their diminished cognitive function into account, which requires adaptation of rehabilitation programs to overcome habituation. OBJECTIVE: This study aims to show that a few adjustments in the therapy program towards age, mental, physical and auditory condition significantly improve music perception and overall auditory benefit, hence normal communication and social interactions can be found. METHODS: Subjects implanted with a CI 65 years or older were compared to age-matched normal hearing subjects. Questionnaires were administered before and after ten music therapy sessions, to evaluate the participant's music habits, the perception of sound quality and self-awareness and hearing implant satisfaction. RESULTS: The greatest benefit was seen in participants' gain in self-confidence and enjoyable music perception. Not only did the amount of listening to music increase, but also the impression of sound quality changed from poor up to good/very good sound quality. CONCLUSIONS: The music therapy was well accepted and resulted in beneficial subjective as well as objective outcomes towards hearing and music impression, hence improved quality of life.

Minimally Traumatic Cochlear Implant Surgery: Expert Opinion in 2010 and 2020.

This study aimed to discover expert opinion on the surgical techniques and materials most likely to achieve maximum postoperative residual hearing preservation in cochlear implant (CI) surgery and to determine how these opinions have changed since 2010. A previously published questionnaire used in a study published in 2010 was adapted and expanded. The questionnaire was distributed to an international group of experienced CI surgeons. Present results were compared, via descriptive statistics, to those from the 2010 survey. Eighteen surgeons completed the questionnaire. Respondents clearly favored the following: round window insertion, slow array insertion, and the peri- and postoperative use of systematic antibiotics. Insertion depth was regarded as important, and electrode arrays less likely to induce trauma were preferred. The usefulness of dedicated soft-surgery training was also recognized. A lack of agreement was found on whether the middle ear cavity should be flushed with a non-aminoglycoside antibiotic solution or whether a sheath or insertion tube should be used to avoid contaminating the array with blood or bone dust. In conclusion, this paper demonstrates how beliefs about CI soft surgery have changed since 2010 and shows areas of current consensus and disagreement.

Surgical Experience and Early Audiological Outcomes With New Active Transcutaneous Bone Conduction Implant.

OBJECTIVES: Our objective was to report the very first surgical experiences, audiologic benefits, and satisfaction with the new active transcutaneous bone conduction implant, generation 602 (BCI602), in patients with mixed/conductive hearing loss (M/CHL) and single-sided deafness. METHODS: A retrospective chart review from patients who underwent BCI602 surgery was performed. RESULTS: Twelve subjects were implanted (mean age 33.17 ±â€Š21.67 yrs). Mean surgery time was 29.89 ±â€Š8.59 minutes, with the longest being a difficult passive-BCI explantation due to excessive osseointegration. No surgical nor post-surgical complications occurred. No pre-operative surgical planning for device placement was necessary, no BCI-lifts were used and complete transmastoid implantation was possible. The mean functional gain in the M/CHL cohort significantly increased after 3 months (ρ < .0001). The mean word recognition score (%) in quiet for the M/CHL group significantly improved at activation and 3 months post-surgery (ρ = .0002; ρ < .0001). At the 3 months follow-up the subjects reported high satisfaction with the device accompanied with a mean wearing time of 10.13 hours per day (range 18-6 h/d) resulting in a reported battery change of every 8.29 ±â€Š0.49 days. CONCLUSIONS: These early results of the new BCI602 showed significantly improved audiological performance, no limitations during surgery (youngest subject 2 yrs at surgery), no prior surgical planning necessary, accompanied by high patient satisfaction and increased wearing time. Based on these results, the BCI602 can be highly recommended and especially for difficult anatomical and surgical cases and the given indication for children older than 5 years should probably be revaluated.Level of Evidence: Level 4.

Long-Term Stability and Safety of the Soundbridge Coupled to the Round Window.

OBJECTIVE: The objective of the study was to demonstrate the long-term outcomes of patients implanted with the active middle ear implant (AMEI) Vibrant Soundbridge (VSB) through coupling the floating mass transducer (FMT) to the round window (RW). METHODS: This retrospective study evaluated the short- and long-term clinical performance (audiological outcomes) and safety (revisions/explantations) of the VSB coupled to the RW between 2013 and 2019 at the St. Pölten University Hospital, Austria. For the outcome analysis, the sample was divided into a short-term examination group followed up for less than 12 months (<12 months) and a long-term examination group followed up for more than 12 months (>12 months). Cumulative survival outcomes were separately analyzed for subjects with and without cholesteatoma. RESULTS: 46 patients with an average long-term follow-up period of 31.43 months (13-75 months) were investigated. Complications requiring revision surgery were reported in total in seven patients with cholesteatoma (15.2%) and none in subjects without cholesteatoma (0%). Residual hearing was not affected by VSB surgery. Word understanding on the Freiburger monosyllabic speech test improved significantly at 65 dB (P < .0001) and 80 dB (P < .0001), and these outcomes were stable for long-term follow up. CONCLUSION: The VSB coupled to the RW is a safe implantation method for patients with conductive or mixed hearing loss. Hearing improvement was stable for the long-term follow-up up to 74 months. The revision rates are directly related to the underlying pathology of cholesteatoma (with radical cavity); thus, this special cohort requires additional counseling on potential complications. LEVEL OF EVIDENCE: 4 (Case-series) Laryngoscope, 131:E1434-E1442, 2021.

Long-term Hearing Preservation in Electric Acoustic Cochlear Implant Candidates.

OBJECTIVES: To evaluate long-term stability and residual hearing preservation after cochlear implantation with electric acoustic stimulation (EAS). STUDY DESIGN: Retrospective chart-analysis. SETTING: University clinic. METHODS: Long- and short-term hearing preservation (HP) of 18 EAS subjects (21 ears) was evaluated. Short-term was defined as follow-ups less than 12 months after surgery versus long-term outcomes longer than 12 months postsurgery. RESULTS: Mean period of observation in the short-term group was 4 ±â€Š3.0 months (range 0-7). In the long-term group the mean follow-up was 28.4 ±â€Š15.0 months (range 12-58). Full insertion was possible in all 18 implanted subjects. In the short-term group, complete HP was achieved in 50%, partial HP in 33.3%, and minimal HP in 8.3% of the investigated subjects. One subject lost hearing completely. In the long-term group, complete HP was achieved in 50%, partial HP was observed in 40%, and minimal HP in 10% of the ears. No subject lost hearing completely. Subjects using EAS showed better word recognition scores after surgery (mean at 65 dB 55.3 ±â€Š18.4; mean at 80 dB 68.1 ±â€Š12.2) than subjects using electric stimulation only (mean at 65 dB 38.3 ±â€Š18.1; mean at 80 dB 60.0 ±â€Š16.4) with nonfunctional low-frequency hearing. CONCLUSION: The study confirms that hearing can be preserved to a large extent. As a result, most subjects benefitted from EAS. Subjects with postoperative functional low-frequency hearing showed greater benefit in word speech tests. Furthermore, the outcomes show that EAS implantation is a safe, effective, and most importantly stable treatment option (longest follow-up with 58 mo).

Active transcutaneous bone conduction hearing implants: Systematic review and meta-analysis.

BACKGROUND: In July 2018 the active transcutaneous bone conduction hearing implant received FDA approval in the US (for patients 12 years and older with conductive and/or mixed hearing loss or single-sided deafness), reflecting the current trend of moving away from percutaneous hearing solutions towards intact skin systems. OBJECTIVES: To critically assess the current literature on safety, efficacy and subjective benefit after implantation with an active transcutaneous bone conduction hearing device. DATA SOURCES: Literature investigation was performed by electronic database search including PubMed and Cochrane Central Register of Controlled Trials, and manual search of relevant journals and reference lists of included studies. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials, clinical controlled trials and cohort studies, case series and case reports investigating subjective and objective outcomes. STUDY APPRAISAL AND SYNTHESIS METHODS: Retrieved literature was screened and extracted by two reviewers independently. Subgroup analysis of indications (conductive and/or mixed hearing loss, single-sided deafness) and participant ages (pediatric vs. adults) was conducted on patients with active transcutaneous bone conduction devices. Sensitivity analysis was performed to test the stability of the results in meta-analysis. RESULTS: 39 citations reporting on pre- and postoperative audiological results, speech performance in quiet and in noise, localization testing as well as subjective outcomes were included in this systematic review. Functional gain as well as word recognition score outcomes could be further investigated via meta-analysis. All outcomes reported and summarized here reflect beneficial audiological performance and high patient satisfaction, accompanied with a low complications rate (minor event incidence rate: 9.9 person-years; major incidence rate: 148.9 person-years) for the indications of conductive and mixed hearing loss as well as in individuals suffering from single-sided deafness for all age groups of subjects who underwent active transcutaneous bone conduction hearing device implantation. LIMITATIONS: A limiting factor of this systematic review was the Level of Evidence of the reviewed literature, comprising 2a/3a studies (cohort studies and case-control studies). Furthermore, the reporting standards, especially in outcomes such as word recognition scores in quiet and in noise, vary across study cites from various countries, which impedes comparisons. Last but not least, no other comparable other device was retrieved as the active transcutaneous bone conduction hearing device is the only available at the moment. CONCLUSION: The device's transcutaneous technology results in a minor event incidence rate of one in 9.9 person-years and a major incidence rate of one in 148.9 person-years. Based on the audiological outcomes, high patient satisfaction as well as the low complication rate, the authors recommend the active transcutaneous bone conduction hearing device as a safe and effective treatment for patients suffering from hearing loss within the device's indication criteria (conductive and/or mixed hearing loss or single-sided deafness).