Safety and performance of the new med-el total ossicular replacement prostheses.

PURPOSE: This multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP). METHODS: Patients underwent tympanoplasty with mXACT Total Prosthesis Center, mXACT Total Prosthesis Offcenter or mXACT PRO Total Prosthesis. The clinical data were retrospectively analyzed. Follow-up examination included access to the medical record (for adverse events) of the patients, ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. RESULTS: 103 patients were implanted with a TORP. 102 (88 adults, 14 children; 37 CHL, 64 MHL, 1 not specified) patients were analyzed for safety and 92 (79 adults, 13 children) patients for performance of the prostheses. ADVERSE EVENTS RESULTS (N = 102): In 1 patient (child, mXACT Total Prosthesis Offcenter) a prosthesis dislocation was reported, which lead to a revision surgery. No prosthesis extrusion or migration was reported. AUDIOLOGICAL RESULTS (N = 92): 49 (53.3%) of the 92 patients had a PTA4 ABG of ≤ 20 dB and therefore a successful rehabilitation. The mean post-operative PTA4 ABG of all 92 patients was 21.0 ± 9.7 dB. The first endpoint, improvement in post-operative PTA4 ABG of ≤ 20 dB by ≥ 25% of the patients was achieved. The individual Δ BC PTA4 (post-operative minus pre-operative BC PTA4) thresholds were stable (within ± 5 dB HL) in 91 (98.9%) patients. 1 patient had a BC PTA4 deterioration of 11.3 dB HL. CONCLUSION: The MED-EL TORPs are safe and effective for middle ear reconstruction. Trial registration number NCT05565339, September 09, 2022, retrospectively registered.

International Consensus Statements on Intraoperative Testing for Cochlear Implantation Surgery.

OBJECTIVES: A wide variety of intraoperative tests are available in cochlear implantation. However, no consensus exists on which tests constitute the minimum necessary battery. We assembled an international panel of clinical experts to develop, refine, and vote upon a set of core consensus statements. DESIGN: A literature review was used to identify intraoperative tests currently used in the field and draft a set of provisional statements. For statement evaluation and refinement, we used a modified Delphi consensus panel structure. Multiple interactive rounds of voting, evaluation, and feedback were conducted to achieve convergence. RESULTS: Twenty-nine provisional statements were included in the original draft. In the first voting round, consensus was reached on 15 statements. Of the 14 statements that did not reach consensus, 12 were revised based on feedback provided by the expert practitioners, and 2 were eliminated. In the second voting round, 10 of the 12 revised statements reached a consensus. The two statements which did not achieve consensus were further revised and subjected to a third voting round. However, both statements failed to achieve consensus in the third round. In addition, during the final revision, one more statement was decided to be deleted due to overlap with another modified statement. CONCLUSIONS: A final core set of 24 consensus statements was generated, covering wide areas of intraoperative testing during CI surgery. These statements may provide utility as evidence-based guidelines to improve quality and achieve uniformity of surgical practice.

Short-term safety and effectiveness of the mCLIP partial prosthesis.

PURPOSE: This multicentric, retrospective study aimed to analyze the short-term safety and effectiveness of the mCLIP Partial Prosthesis. METHODS: Patients underwent tympanoplasty with implantation of a mCLIP Partial Prosthesis. Follow-up examination included ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. Thus, the follow-up times of each study center were different, which resulted in different follow-up times for the audiological analysis and for adverse events (AE). RESULTS: 72 (66 adults, 6 children) patients were implanted with the mCLIP Partial Prosthesis. 68 (62 adults, 6 children) patients underwent audiological examination; all 72 patients were examined for adverse events. All patients (N = 68): 72.1% of the patients showed a PTA4 ABG of ≤ 20 dB. Individual post-operative bone conduction (BC) PTA4 thresholds were stable in 67 patients. The mean post-operative follow-up time was 78 ± 46 days. Children (N = 6): 5 out of 6 children showed a PTA4 ABG of ≤ 20 dB. None of the children reported a BC PTA4 deterioration of > 10 dB HL after the implantation. The mean post-operative follow-up time was 101 ± 45 days. Adverse events (all patients, N = 72): 15 (14 adults, 1 child) patients had AEs (27 AEs and 2 Follow-Ups). The mean post-operative follow-up time was 375 days. CONCLUSION: Clinical data show satisfactory audiological parameters after implantation of the mCLIP Partial Prosthesis. The prosthesis is safe and effective for implantation in children and adults. TRIAL REGISTRATION NUMBER: NCT05565339, 09 September 2022, retrospectively registered.

Systematic Literature Review of Hearing Preservation Rates in Cochlear Implantation Associated With Medium- and Longer-Length Flexible Lateral Wall Electrode Arrays.

Background: The last two decades have demonstrated that preoperative functional acoustic hearing (residual hearing) can be preserved during cochlear implant (CI) surgery. However, the relationship between the electrode array length and postoperative hearing preservation (HP) with lateral wall flexible electrode variants is still under debate. Aims/Objectives: This is a systematic literature review that aims to analyze the HP rates of patients with residual hearing for medium-length and longer-length lateral wall electrodes. Method: A systematic literature review methodology was applied following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) recommendations to evaluate the HP rates of medium-length and longer-length lateral wall electrodes from one CI manufacturer (medium length FLEX 24, longer length FLEX 28 and FLEX SOFT, MED-EL, Innsbruck, Austria). A search using search engine PubMed (https://www.ncbi.nlm.nih.gov/pubmed/) was performed using the search terms "hearing preservation" or "residual hearing" and "cochlear implant" in "All fields." Articles published only in English between January 01, 2009 and December 31, 2020 were included in the search. Results: The HP rate was similar between medium-length (93.4%-93.5%) and longer (92.1%-86.8%) electrodes at 4 months (p = 0.689) and 12 months (p = 0.219). In the medium-length electrode group, patients under the age of 45 years had better HP than patients above the age of 45 years. Conclusions: Both medium-length and longer electrode arrays showed high hearing preservation rates. Considering the hearing deterioration over time, implanting a longer electrode at primary surgery should be considered, thus preventing the need for future reimplantation.

Implantation of two generations of Bonebridge after mastoid obliteration with bioactive glass S53P4.

PURPOSE: After radical surgery for chronic cholesteatoma (CWD mastoidectomy), patients have the option to have the posterior wall of their external auditory canal surgically reconstructed with S53P4 bioactive glass. The procedure eliminates some of the restrictions related to having a postoperative cavity and extends the options for a hearing prosthesis. If classic reconstruction is not possible and a hearing aid is not used, we suggest use of a Bonebridge implant. METHODS: This study describes, over 18 months of follow-up, 16 patients after a two-stage surgical procedure: obliteration of the mastoid cavity with bioactive glass followed by Bonebridge implantation. There were 7 patients who received the first generation implant (BCI 601) and 9 who used the second (BCI 602). Before and after implantation, pure tone audiometry, sound field thresholds, and free-field audiometry were performed. Speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. Subjective assessment of benefits was done using the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. RESULTS: During the observation period, no serious complications were found. The study demonstrated the safety and validity of the procedures and confirmed the safety of using S53P4 bioactive glass in otosurgery (antibacterial effect, nonrecurrence of cholesteatoma, and no effect on the inner ear). The audiological benefits expected from using the Bonebridge implant processor were also confirmed. CONCLUSION: It is concluded that, after reconstructing the posterior wall of the external auditory canal with bioactive glass, two-stage implantation of a Bonebridge implant in a typical site is a safe solution for patients who have difficult anatomical conditions following their CWD mastoidectomy.

Suitable Electrode Choice for Robotic-Assisted Cochlear Implant Surgery: A Systematic Literature Review of Manual Electrode Insertion Adverse Events.

Background and Objective: The cochlear implant (CI) electrode insertion process is a key step in CI surgery. One of the aims of advances in robotic-assisted CI surgery (RACIS) is to realize better cochlear structure preservation and to precisely control insertion. The aim of this literature review is to gain insight into electrode selection for RACIS by acquiring a thorough knowledge of electrode insertion and related complications from classic CI surgery involving a manual electrode insertion process. Methods: A systematic electronic search of the literature was carried out using PubMed, Scopus, Cochrane, and Web of Science to find relevant literature on electrode tip fold over (ETFO), electrode scalar deviation (ESD), and electrode migration (EM) from both pre-shaped and straight electrode types. Results: A total of 82 studies that include 8,603 ears implanted with a CI, i.e., pre-shaped (4,869) and straight electrodes (3,734), were evaluated. The rate of ETFO (25 studies, 2,335 ears), ESD (39 studies, 3,073 ears), and EM (18 studies, 3,195 ears) was determined. An incidence rate (±95% CI) of 5.38% (4.4-6.6%) of ETFO, 28.6% (26.6-30.6%) of ESD, and 0.53% (0.2-1.1%) of EM is associated with pre-shaped electrodes, whereas with straight electrodes it was 0.51% (0.1-1.3%), 11% (9.2-13.0%), and 3.2% (2.5-3.95%), respectively. The differences between the pre-shaped and straight electrode types are highly significant (p < 0.001). Laboratory experiments show evidence that robotic insertions of electrodes are less traumatic than manual insertions. The influence of round window (RW) vs. cochleostomy (Coch) was not assessed. Conclusion: Considering the current electrode designs available and the reported incidence of insertion complications, the use of straight electrodes in RACIS and conventional CI surgery (and manual insertion) appears to be less traumatic to intracochlear structures compared with pre-shaped electrodes. However, EM of straight electrodes should be anticipated. RACIS has the potential to reduce these complications.

The Application of P300-Long-Latency Auditory-Evoked Potential in Parkinson Disease

Abstract Introduction Parkinson disease (PD) is a degenerative and progressive neurological disorder characterized by resting tremor, stiffness, bradykinesia, and postural instability. Despite the motor symptoms, PD patients also consistently show cognitive impairment or executive dysfunction. The auditory event-related potential P300 has been described as the best indicator of mental function, being highly dependent on cognitive skills, including attention and discrimination. Objective To review the literature on the application and findings of P300 as an indicator of PD. Data Analysis The samples ranged from 7 to 166 individuals. Young adult and elderly male patients composed most study samples. The Mini-Mental State Examination test, the Unified Parkinson Disease Rating Scale, and the Hoehn and Yahr Scale were used to assess neurological and cognitive function. In terms of testing hearing function, few studies have focused on parameters other than the P300. The factors we focused on were how the P300 was modified by cognitive effects, its correlation with different PD scales, the effect of performing dual tasks, the effect of fatigue, and the influence of drug treatments. Conclusion The use of the P300 appears to be an effective assessment tool in patients with PD. This event-related potential seems to correlate well with other neurocognitive tests that measure key features of the disease.

Evaluation of the Bonebridge BCI 602 active bone conductive implant in adults: efficacy and stability of audiological, surgical, and functional outcomes.

PURPOSE: (1) To assess the effectiveness and safety of a bone-conduction implant, the Bonebridge BCI 602, in adults with conductive or mixed hearing loss. (2) To investigate whether the Bonebridge BCI 602 is at least as effective as the Bonebridge BCI 601 in such patients. METHODS: The study group included 42 adults who had either conductive or mixed hearing loss. All patients underwent Bonebridge BCI 602 implant surgery. Before and after implantation, pure-tone audiometry, speech recognition tests (in quiet and noise), and free-field audiometry were performed. Word recognition scores were evaluated using the Polish Monosyllabic Word Test. Speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. Subjective assessment of benefits was done using the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. RESULTS: The APHAB questionnaire showed that difficulties in hearing decreased after BCI 602 implantation. Both word recognition in quiet and speech reception threshold in noise were significantly better after BCI 602 implantation and remained stable for at least 12 months. A significant advantage of the device is a reduced time for surgery while maintaining safety. In this study, the mean time for BCI 602 implantation was 28.3 min ± 9.4. CONCLUSIONS: The second-generation Bonebridge BCI 602 implant is an effective hearing rehabilitation device for patients with conductive or mixed hearing loss. Patient satisfaction and audiological results confirm its efficacy and safety. Its new shape and dimensions allow it to be used in patients previously excluded due to insufficient or difficult anatomical conditions. The new BCI 602 implant is as effective as its predecessor, the BCI 601.

Effectiveness of Various Treatments for Sudden Sensorineural Hearing Loss-A Retrospective Study.

(1) Background: A retrospective clinical study was conducted to compare the effectiveness of different pharmacological and non-pharmacological regimens for treating sudden sensorineural hearing loss (SSNHL). (2) Methods: Adult patients (n = 130) diagnosed with sudden sensorineural hearing loss (SSNHL) and hospitalized between 2015 and 2020 were enrolled in this study. Depending on the treatment regimen applied, patients were divided into five groups. Inclusion criteria were as follows: (i) hearing loss of sudden onset; (ii) hearing loss of at least 30 dB at three consecutive frequencies; (iii) unilateral hearing loss; (iv) age above 18 years. Exclusion criteria were as follows: (i) no follow-up audiogram; (ii) bilateral hearing loss; (iii) recognized alternative diagnosis such as tumor, disorder of inner ear fluids, infection or inflammation, autoimmune disease, malformation, hematological disease, dialysis-dependent renal failure, postdural puncture syndrome, gene-related syndrome, mitochondrial disease; and (iv) age below 18 years. (3) Results: Complete recovery was found in 14% of patients (18/130) and marked improvement was found in 6% (8/130), giving an overall success rate of 20%. The best results were obtained in the second group (i.e., patients given intratympanic glucocorticoid + prolonged orally administered glucocorticoid) where the success rate was 28%. In general, the older the patient, the smaller the improvement in hearing, a correlation that was statistically significant. (4) Conclusions: In treating SSNHL, the highest rate of hearing recovery-28%-was in the group of patients given intratympanic corticoid plus prolonged treatment with orally administered glucocorticoid.

Auditory processing in normally hearing individuals with and without tinnitus: assessment with four psychoacoustic tests.

PURPOSE: In most cases, tinnitus co-exists with hearing loss, suggesting that poorer speech understanding is simply due to a lack of acoustic information reaching the central nervous system (CNS). However, it also happens that patients with tinnitus who have normal hearing also report problems with speech understanding, and it is possible to suppose that tinnitus is to blame for difficulties in perceptual processing of auditory information. The purpose of the study was to evaluate the auditory processing abilities of normally hearing subjects with and without tinnitus. METHODS: The study group comprised 97 adults, 54 of whom had normal hearing and chronic tinnitus (the study group) and 43 who had normal hearing and no tinnitus (the control group). The audiological assessment comprised pure-tone audiometry and high-frequency pure-tone audiometry, impedance audiometry, and distortion product oto-acoustic emission assessment. To evaluate possible auditory processing deficits, the Frequency Pattern Test (FPT), Duration Pattern Test (DPT), Dichotic Listening Test (DLT), and Gap Detection Threshold (GDT) tests were performed. RESULTS: The tinnitus subjects had significantly lower scores than the controls in the gap detection test (p < 0.01) and in the dichotic listening test (p < 0.001), but only for the right ear. The results for both groups were similar in the temporal ordering tests (FPT and DPT). Right-ear advantage (REA) was found for the controls, but not for the tinnitus subjects. CONCLUSION: In normally hearing patients, the presence of tinnitus may be accompanied with auditory processing difficulties.

The Clinical Effects of Steroids Therapy in the Preserving Residual Hearing after Cochlear Implantation with the OTICON Neuro Zti EVO.

BACKGROUND: A prospective clinical study was conducted to investigate whether two different pharmacotherapy strategies of steroid administration impact hearing preservation in adult patients who underwent cochlear implantation with the Oticon Medical Neuro cochlear implant system. METHODS: Twenty nine adult participants were included. Pure tone audiometry was performed before implantation, during processor activation and 12 months after activation. There were three treatment groups: (1) intravenous steroid therapy (standard steroid therapy with dexamethasone administrated intravenously at the dose 0.1 mg/kg body mass twice a day); (2) combined oral and intravenous steroid therapy (extended steroid therapy with dexamethasone administrated intravenously at the dose 0.1 mg/kg b.m. twice a day and prednisone (orally) at the dose 1 mg/kg body mass/24 h), and (3) no steroid therapy (a control group). Patients' hearing thresholds before implantation were on average 103 dB HL, 89 dB HL, and 93 dB HL, respectively. RESULTS: Deterioration of hearing thresholds was observed in all three patients' groups. Twelve months after surgery the patients with and without steroid therapy had similar hearing thresholds. CONCLUSIONS: The steroid regimen used in this study did not play a significant role in patients with non-functional residual hearing, who underwent cochlear implantation with the Oticon Medical Neuro cochlear implant system.

Vestibular status in partial deafness / Condição vestibular na surdez parcial

Abstract Introduction The hair cells of the cochlea and the vestibulum are closely connected and may be susceptible to the same noxious factors. The relationship between their function has been a continuing field of investigation. The indications for cochlear implantation have been broadened and now include the patients with partial deafness. This raises the question of their vestibular status. Objective The aim of the study was to investigate whether there is any difference between the vestibular function of patients with low frequency residual hearing and those with totally deaf ears. Methods A total of 360 ears with profound sensorineural hearing loss were analysed before cochlear implantation. The patients were divided into four groups, according to their low frequency residual hearing (Group 1 ‒ normal or slightly elevated low frequency residual hearing; Group 2 ‒ elevated threshold but still usable hearing at low frequencies; Group 3 - non-functional residual hearing; Group 4 ‒ no detectable hearing threshold within the limits of the audiometer). The patients underwent vestibular tests: cervical vestibular evoked myogenic potential, ocular vestibular evoked myogenic potential, caloric test and video-head impulse test. Results The rates of elicited responses in cervical vestibular evoked myogenic potential were as follows: in Group 1 (59.3 %); Group 2 (57.5 %); Group 3 (35.2 %); Group 4 (7.7 %). For ocular vestibular evoked myogenic potential the percentage of correct outcomes was: Group 1 (70.8 %); Group 2 (56.0 %); Group 3 (40.0 %); Group 4 (14.3 %). For the caloric test we counted normal responses in 88.9 % of Group 1; 81.6 % of Group 2; 57.9 % of Group 3; 53.3 % of Group 4. For video-head impulse test we also found markedly better results in Group1, followed by Group 2, and much worse in Group 3 and 4. Conclusion Patients with partial deafness not only have a better cochlea but also better vestibular function, which needs to be protected. In summary, the better the low frequency residual hearing, the better the vestibular status.

Resumo Introdução As células ciliadas da cóclea e do vestíbulo estão intimamente ligadas e podem ser suscetíveis aos mesmos fatores nocivos. A relação entre suas funções tem sido um campo de investigação há muito tempo. As indicações para implante coclear foram ampliadas e agora incluem os pacientes com surdez parcial. Isso levanta a questão de sua condição vestibular. Objetivo Investigar se existe alguma diferença entre a função vestibular de pacientes com audição residual de baixa frequência e aqueles com surdez total. Método Foram analisadas antes do implante coclear 360 orelhas com perda auditiva neurossensorial profunda. Os pacientes foram divididos em quatro grupos, de acordo com a audição residual de baixa frequência (Grupo 1 - audição residual de baixa frequência normal ou levemente elevada; Grupo 2 - limiar auditivo elevado, mas ainda usável em baixas frequências; Grupo 3 - audição residual não funcional; Grupo 4 - sem limiar auditivo detectável dentro dos limites do audiômetro). Os pacientes foram submetidos a testes vestibulares: potencial evocado miogênico vestibular cervical, potencial evocado miogênico vestibular ocular, prova calórica e teste do impulso cefálico com vídeo. Resultados As taxas de respostas obtidas no potencial evocado miogênico vestibular cervical foram as seguintes: no Grupo 1 (59,3%); Grupo 2 (57,5%); Grupo 3 (35,2%); Grupo 4 (7,7%). Para o potencial evocado miogênico vestibular ocular, o percentual de resultados corretos foi: Grupo 1 (70,8%); Grupo 2 (56,0%); Grupo 3 (40,0%); Grupo 4 (14,3%). Para a prova calórica, contamos respostas normais em 88,9% do Grupo 1; 81,6% do grupo 2; 57,9% do Grupo 3; 53,3% do Grupo 4. Para o teste do impulso cefálico com vídeo, também encontramos resultados significativamente melhores no Grupo 1, seguidos pelo Grupo 2, e muito piores nos Grupos 3 e 4. Conclusão Pacientes com surdez parcial não só apresentam uma função coclear melhor, mas também melhor função vestibular, que precisa ser protegida. Em resumo, quanto melhor for a audição residual de baixa frequência, melhor a condição vestibular.

Can preoperative results predict the need for future reintervention following injection laryngoplasty for unilateral vocal fold paralysis?

PURPOSE: The objective was to investigate whether a patient's preoperative test results can predict the need for future reoperation in unilateral vocal fold paralysis (UVFP). METHODS: A single-centre retrospective study was performed. The study group consisted of 18 patients with UVFP who had been treated with injection laryngoplasty but who required further treatment and were augmentated again within 36 months. The control group consisted of 33 injected patients who had not required reintervention up to 36 months later. RESULTS: Only glottal gap was associated with a relative risk for reinjection. Glottal gap was found to be severe in 77.8% of the patients from the study group compared to 42.4% of the controls, and the difference was statistically significant. The kind of injected material (calcium hydroxylapatite or hyaluronic acid), age, and voice assessment (perceptual, objective, or subjective) did not seem to affect the likelihood of reoperation being needed. There were no between-group statistically significant differences in individual aspects of the GRBAS scale. The global score was slightly higher in the study group, but it did not reach statistical significance (U = 198.5; p = 0.09). A comparison of VHI scores did not yield statistically significant differences between the study and control groups. No significant differences in objective acoustic voice parameters were observed between the groups. CONCLUSION: Only glottal gap occurred to be associated with a relative risk for reinjection. A kind of injected material (CaHA or HA), age, perceptual, objective and subjective voice assessment do not seem to impact the likelihood of reoperation in patients with UVFP.

The Listening Network and Cochlear Implant Benefits in Hearing-Impaired Adults.

Older adults with mild or no hearing loss make more errors and expend more effort listening to speech. Cochlear implants (CI) restore hearing to deaf patients but with limited fidelity. We hypothesized that patient-reported hearing and health-related quality of life in CI patients may similarly vary according to age. Speech Spatial Qualities (SSQ) of hearing scale and Health Utilities Index Mark III (HUI) questionnaires were administered to 543 unilaterally implanted adults across Europe, South Africa, and South America. Data were acquired before surgery and at 1, 2, and 3 years post-surgery. Data were analyzed using linear mixed models with visit, age group (18-34, 35-44, 45-54, 55-64, and 65+), and side of implant as main factors and adjusted for other covariates. Tinnitus and dizziness prevalence did not vary with age, but older groups had more preoperative hearing. Preoperatively and postoperatively, SSQ scores were significantly higher (Δ0.75-0.82) for those aged <45 compared with those 55+. However, gains in SSQ scores were equivalent across age groups, although postoperative SSQ scores were higher in right-ear implanted subjects. All age groups benefited equally in terms of HUI gain (0.18), with no decrease in scores with age. Overall, younger adults appeared to cope better with a degraded hearing before and after CI, leading to better subjective hearing performance.

Two-phase survey on the frequency of use and safety of MRI for hearing implant recipients.

PURPOSE: Magnetic resonance imaging (MRI) is often used to visualize and diagnose soft tissues. Hearing implant (HI) recipients are likely to require at least one MRI scan during their lifetime. However, the MRI scanner can interact with the implant magnet, resulting in complications for the HI recipient. This survey, which was conducted in two phases, aimed to evaluate the safety and performance of MRI scans for individuals with a HI manufactured by MED-EL (MED-EL GmbH, Innsbruck, Austria). METHODS: A survey was developed and distributed in two phases to HEARRING clinics to obtain information about the use of MRI for recipients of MED-EL devices. Phase 1 focused on how often MRI is used in diagnostic imaging of the head region of the cochlear implant (CI) recipients. Phase 2 collected safety information about MRI scans performed on HI recipients. RESULTS: 106 of the 126 MRI scans reported in this survey were performed at a field strength of 1.5 T, on HI recipients who wore the SYNCHRONY CI or SYNCHRONY ABI. The head and spine were the most frequently imaged regions. 123 of the 126 scans were performed without any complications; two HI recipients experienced discomfort/pain. One recipient required reimplantation after an MRI was performed using a scanner that had not been approved for that implant. There was only one case that required surgical removal of the implant to reduce the imaging artefact. CONCLUSION: Individuals with either a SYNCHRONY CI or SYNCHRONY ABI from MED-EL can safely undergo a 1.5 T MRI when it is performed according to the manufacturer's safety policies and procedures.

Sense of taste in patients after cochlear implantation-preliminary study.

Background: Taste is the leading sense in how we determine the quality of consumed food. Proper gustatory sensation largely determines the well-being and health of an organism, and this affects their quality of life. Objectives: The aim of the present study was to estimate the risk of early taste disorders following implantation surgery. Methods: Twenty patients underwent a taste test before, 1 day after, and 1 month after cochlear implantation. The taste sensations of sweet, sour, salty, and bitter were determined. Results: Statistical analysis showed no significant differences (p > 0.05) between individual tests among the entire study group. After dividing the respondents into smoking (n=6) and non-smoking (n=14) groups, only a weak correlation (p = 0.043) was found between the results of the first and second examination in the smoker group. However, a statistically significant decrease in the number of saline-sensitive (p<0.001) and acid-sensitive (p = 0.042) subjects was observed. Conclusion: These findings suggest that people after a cochlear implant may have transient taste disorders. Taste disorder called dysgeusia may be an early complication after the implantation procedure contributing to deterioration of patients quality of life.

Long-term Effects of Unilateral and Bilateral Otitis Media and Myringotomy on Long-Latency Verbal and Non-Verbal Auditory-Evoked Potentials

Abstract Introduction Otitis media (OM) is considered one of the most common reasons patients seek medical care in childhood. The fluctuating nature of hearing loss in cases of OM leads to irregular sound stimulation of the central auditory nervous system. Objectives To analyze the long-latency auditory-evoked potential (LLAEP) by verbal and nonverbal sounds in children with a history of OM in the first six years of life. Methods A total of 106 schoolchildren participated in the study, 55 females and 51 males, aged between 8 and 16 years, who were divided into 3 groups: the control group (CG), the bilateral experimental group (BEG), and the unilateral experimental group (UEG). All children underwent a complete audiological evaluation (audiometry, logoaudiometry and immitance testing) and an electrophysiological evaluation (LLAEP with toneburst stimulus - LLAEP-TB, and LLAEP with speech stimulus - LLAEP-S). Results Both study groups (BEG and UEG) presented a statistically lower performance (p < 0.005) when compared with the CG regarding all of the electrophysiological tests with the prolongation of the latency values and decrease in the amplitude values: LLAEP-TB (BEG: latency - N1, P2, N2 [females] and P300, amplitude - N1 and P2), LLAEP-S (BEG: latency - P2 and N2 [females], amplitude - P2 /UEG: latency - P2 and P300, amplitude: N1 and P2). Conclusion Children who had suffered secretory OM in the first six years of life and who had undergone myringotomy for the placement of a ventilation tube, either unilaterally or bilaterally, presented worse performance in their electrophysiological responses to verbal and nonverbal LLAEPs.

Unilateral Cochlear Implants for Severe, Profound, or Moderate Sloping to Profound Bilateral Sensorineural Hearing Loss: A Systematic Review and Consensus Statements.

Importance: Cochlear implants are a treatment option for individuals with severe, profound, or moderate sloping to profound bilateral sensorineural hearing loss (SNHL) who receive little or no benefit from hearing aids; however, cochlear implantation in adults is still not routine. Objective: To develop consensus statements regarding the use of unilateral cochlear implants in adults with severe, profound, or moderate sloping to profound bilateral SNHL. Design, Setting, and Participants: This study was a modified Delphi consensus process that was informed by a systematic review of the literature and clinical expertise. Searches were conducted in the following databases: (1) MEDLINE In-Process & Other Non-Indexed Citations and Ovid MEDLINE, (2) Embase, and (3) the Cochrane Library. Consensus statements on cochlear implantation were developed using the evidence identified. This consensus process was relevant for the use of unilateral cochlear implantation in adults with severe, profound, or moderate sloping to profound bilateral SNHL. The literature searches were conducted on July 18, 2018, and the 3-step Delphi consensus method took place over the subsequent 9-month period up to March 30, 2019. Main Outcomes and Measures: A Delphi consensus panel of 30 international specialists voted on consensus statements about cochlear implantation, informed by an SR of the literature and clinical expertise. This vote resulted in 20 evidence-based consensus statements that are in line with clinical experience. A modified 3-step Delphi consensus method was used to vote on and refine the consensus statements. This method consisted of 2 rounds of email questionnaires and a face-to-face meeting of panel members at the final round. All consensus statements were reviewed, discussed, and finalized at the face-to-face meeting. Results: In total, 6492 articles were identified in the searches of the electronic databases. After removal of duplicate articles, 74 articles fulfilled all of the inclusion criteria and were used to create the 20 evidence-based consensus statements. These 20 consensus statements on the use of unilateral cochlear implantation in adults with SNHL were relevant to the following 7 key areas of interest: level of awareness of cochlear implantation (1 consensus statement); best practice clinical pathway from diagnosis to surgery (3 consensus statements); best practice guidelines for surgery (2 consensus statements); clinical effectiveness of cochlear implantation (4 consensus statements); factors associated with postimplantation outcomes (4 consensus statements); association between hearing loss and depression, cognition, and dementia (5 consensus statements); and cost implications of cochlear implantation (1 consensus statement). Conclusions and Relevance: These consensus statements represent the first step toward the development of international guidelines on best practices for cochlear implantation in adults with SNHL. Further research to develop consensus statements for unilateral cochlear implantation in children, bilateral cochlear implantation, combined electric-acoustic stimulation, unilateral cochlear implantation for single-sided deafness, and asymmetrical hearing loss in children and adults may be beneficial for optimizing hearing and quality of life for these patients.