hearing preservation

听力保护
  • 文章类型: Journal Article
    目标:梅尼埃病(MD),内耳的紊乱,提出了许多治疗挑战,鼓室内(IT)庆大霉素已被建议用于难治性病例。然而,关于剂量和方法的争议仍然存在。这项研究的目的是使用基于临床症状学的方法评估低剂量IT庆大霉素对MD眩晕发作的疗效和安全性。其中仅在眩晕发作复发时重复给药,注射间隔2周。
    方法:本研究纳入88例单侧难治性MD患者。所有患者均接受1至5次IT注射,其中0.5ml10mg庆大霉素(80mg/2ml),两次注射间隔为2周。在治疗前后对眩晕发作进行评估,并根据2015年平衡委员会标准将其分为A-F类。前庭听觉评估,包括纯音测听法和前庭眼反射评估,被执行了。
    结果:治疗前,患者平均有4.4眩晕发作/月;治疗后,这一平均值下降到0.52。大多数患者(57%)通过五次或更少的庆大霉素注射达到A类或B类眩晕控制。VOR增益在健康侧受到轻微影响,在受影响侧明显减少。在任何接受治疗的患者中均未发现听力恶化。
    结论:根据临床症状给予小剂量庆大霉素治疗可对治疗后的眩晕发作产生满意的控制。这个方案主要影响前庭功能,如受影响侧VOR增益显着降低所示,同时避免耳蜗损伤。缺乏不良事件和听力的保留强调了该方法的安全性和有效性。这些发现具有重要的临床意义,表明低剂量,基于临床症状学的庆大霉素治疗方案可能是治疗更大人群中单侧梅尼埃病的有效和安全的策略.
    OBJECTIVE: Meniere\'s disease (MD), a disorder of the inner ear, presents numerous therapeutic challenges, and intratympanic (IT) gentamicin has been proposed for intractable cases. However, controversy regarding dosage and method persists. The purpose of this study was to assess the efficacy and safety of low-dose IT gentamicin on vertigo attacks in MD using a clinical symptomatology-based method, wherein administration was repeated only if vertigo attacks recurred, with a 2-week interval between injections.
    METHODS: This study included 88 patients with unilateral intractable MD. All patients received one to five IT injections with 0.5 ml of 10 mg of gentamicin (80 mg/2 ml) with an interval of 2 weeks between injections. Vertigo attacks were evaluated before and after therapy and categorized into classes A-F according to the 2015 Equilibrium Committee criteria. Audiovestibular assessments, including Pure Tone Audiometry and Vestibulo-Ocular Reflex evaluations, were performed.
    RESULTS: Before treatment, patients had an average of 4.4 vertigo attacks/month; after treatment, this average decreased to 0.52. The majority of patients (57 %) reached Class A or B vertigo control with five or fewer gentamicin injections. VOR gain was slightly affected on the healthy side and significantly reduced on the affected side. No hearing deterioration was found in any of the treated patients.
    CONCLUSIONS: Low-dose IT gentamicin administration based on clinical symptomatology can produce a satisfactory control of vertigo attacks after treatment. This protocol primarily affected the vestibular function, as demonstrated by the significant reduction in VOR gain on the affected side, while avoiding cochlear damage. The lack of adverse events and preservation of hearing underscore the safety and efficacy of this method. These findings have significant clinical implications, suggesting that a low-dose, clinical symptomatology-based gentamicin treatment regimen could be an effective and safe strategy for managing unilateral Meniere\'s disease in a larger population.
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  • 文章类型: Multicenter Study
    目的:立体定向放射外科(SRS)是一种完善的前庭神经鞘瘤(VS)治疗方法。听力损失仍然是VS及其治疗的主要发病率,包括SRS。SRS的辐射参数对听力的影响仍然未知。这项研究的目的是确定肿瘤体积的影响,患者人口统计学,预处理听力状态,耳蜗辐射剂量,肿瘤总辐射剂量,分馏,和其他放射治疗参数对听力恶化。
    方法:多中心回顾性分析了1990-2020年因VS接受SRS治疗并有治疗前后听力图的611例患者。
    结果:在12-60个月时,治疗后耳朵的纯音平均值(PTAs)增加,单词识别得分(WRS)降低,而未治疗的耳朵保持稳定。较高的基线PTA,更高的肿瘤辐射剂量,较高的最大耳蜗剂量,单部分的使用导致较高的辐射后PTA;WRS仅由基线WRS和年龄预测。较高的基线PTA,单级处理,更高的肿瘤辐射剂量,较高的最大耳蜗剂量导致PTA的更快恶化。在3Gy的最大耳蜗剂量以下,PTA或WRS无统计学显著变化.
    结论:SRS后VS患者一年听力下降与最大耳蜗剂量直接相关,单次治疗与3分治疗相比,肿瘤总辐射剂量,和基线听力水平。一年内保存心脏克罗布的最大安全耳蜗剂量为3Gy,使用3个分数代替一个分数在保持听力方面更好。
    Stereotactic radiosurgery (SRS) is a well-established treatment for vestibular schwannomas (VS). Hearing loss remains a main morbidity of VS and its treatments, including SRS. The effects of radiation parameters of SRS on hearing remain unknown. The goal of this study is to determine the effect of tumor volume, patient demographics, pretreatment hearing status, cochlear radiation dose, total tumor radiation dose, fractionation, and other radiotherapy parameters on hearing deterioration.
    Multicenter retrospective analysis of 611 patients who underwent SRS for VS from 1990-2020 and had pre- and post-treatment audiograms.
    Pure tone averages (PTAs) increased and word recognition scores (WRSs) decreased in treated ears at 12-60 months while remaining stable in untreated ears. Higher baseline PTA, higher tumor radiation dose, higher maximum cochlear dose, and usage of single fraction resulted in higher post radiation PTA; WRS was only predicted by baseline WRS and age. Higher baseline PTA, single fraction treatment, higher tumor radiation dose, and higher maximum cochlear dose resulted in a faster deterioration in PTA. Below a maximum cochlear dose of 3 Gy, there were no statistically significant changes in PTA or WRS.
    Decline of hearing at one year in VS patients after SRS is directly related to maximum cochlear dose, single versus 3-fraction treatment, total tumor radiation dose, and baseline hearing level. The maximum safe cochlear dose for hearingtbrowd preservation at one year is 3 Gy, and the use of 3 fractions instead of one fraction was better at preserving hearing.
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  • 文章类型: Journal Article
    目的:评估DX和HA对猫模式下人工耳蜗植入的听力保护和组织反应的影响。
    方法:11只猫双侧植入Nurotron电极。根据治疗的不同,22只耳朵被细分为以下四组:仅电极(E),电极+HA(E+H),电极+DX(E+DX),和电极+HA+DX(E+H+DX)。手术前和手术后3个月记录听性脑干反应(ABR)阈值。人工耳蜗植入3个月后,对所有耳蜗进行组织病理学评估。
    结果:在低频,在用E+H+DX治疗的动物中,平均ABR阈值偏移显示出统计学上的显著差异.E+H+DX组耳蜗显示纤维组织和新骨形成的比例为50%,E+DX组66.7%,E+H组83.3%,E组100%。
    结论:联合HA和DX局部给药可以在低频阈值下提供更好的听力损失保护,可以更有效地减少与电极插入相关的创伤和电极周围纤维组织的形成。
    OBJECTIVE: To evaluate the effects of DX and HA on hearing preservation and tissue response with cochlear implantation in a cat mode.
    METHODS: 11 cats were bilaterally implanted with Nurotron electrode. According to the different treatment, 22 ears were subdivided into four following groups: Electrode (E) only, Electrode +HA (E+H), Electrode + DX (E+DX), and Electrode +HA +DX (E+H+DX). Auditory brainstem responses (ABR) thresholds were recorded before and 3 months after surgery. After 3 months of cochlear implantation histopathological assessment of all cochleae were performed .
    RESULTS: At low frequencies, the mean ABR thresholds shift in animals treated with E+H+DX demonstrated a statistically significant difference. The proportion of cochleae showing fibrous tissue and new bone formation was 50% in E+H+DX group, 66.7% in E+DX group, 83.3% in E+H group and 100% in E group.
    CONCLUSIONS: United HA and DX local delivery could provide better protection against hearing loss at low-frequency threshold and could more effectively reduce the trauma related to electrode insertion and the fibrous tissue formation around the electrode.
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  • 文章类型: Journal Article
    目的伽玛刀立体定向放射外科(SRS)治疗的前庭神经鞘瘤(VS)通常在50%等剂量线(IDL50)进行;然而,IDL变异对结局的影响知之甚少.本研究旨在比较40%(IDL40)和50%(IDL50)治疗之间的肿瘤对照(TC)和毒性。方法纳入接受SRS剂量12至14Gy和处方等剂量≤10cm3治疗的散发性/单侧VS患者。将倾向评分匹配应用于IDL40队列以生成IDL50同伴队列,调整年龄和处方剂量。排除术后随访<24个月的患者,IDL40和IDL50队列中有30和28名患者,分别。结果中位随访时间为96个月(24~225个月)。在5年和10年时,精算和影像学TC率为91.8%,临床TC为96.2%。IDL40队列中TC较高,但不显着(96.4与86.7%;p=0.243)。5年和10年的听力保留率(HP)分别为71.9%和39.2%,在IDL40队列中,HP的发生率明显较高(83.3vs.5年间隔57.1%;62.5vs.10年间隔为11.4%;p=0.017)。两名患者发生永久性面神经病变,两者均来自IDL50队列(3.5%)。在IDL50患者中,SRS后类固醇治疗或分流术治疗脑积水的比率略高(6.9vs.17.9%;p=0.208和3.3vs.7.1%;p=0.532)。结论SRS治疗VS,IDL40或IDL50的剂量处方可提供出色的长期TC和毒性特征。IDL40可以与改善的长期HP相关联。
    Objective  Vestibular schwannoma (VS) treated with Gamma Knife stereotactic radiosurgery (SRS) was typically performed at 50% isodose line (IDL50); however, the impact of IDL variation on outcomes is poorly understood. This study aimed to compare tumor control (TC) and toxicities between treatment at 40% (IDL40) and 50% (IDL50). Methods  Sporadic/unilateral VS patients treated with SRS dose 12 to 14 Gy and prescription isodose volume ≤10cm 3 were included. Propensity score matching was applied to IDL40 cohort to generate an IDL50 companion cohort, adjusting for age and prescription isodose volume. After exclusion of patients with follow-up <24 months, there were 30 and 28 patients in IDL40 and IDL50 cohorts, respectively. Results  Median follow-up time was 96 months (24-225 months). Actuarial and radiographic TC rates were 91.8% and clinical TC was 96.2% both at 5 and 10 years. TC was higher in IDL40 cohort but not significant (96.4 vs. 86.7%; p  = 0.243). Hearing preservation (HP) rates were 71.9 and 39.2% at 5- and 10-year intervals, with significantly higher rates of HP noted in IDL40 cohort (83.3 vs. 57.1% at 5-year interval; 62.5 vs. 11.4% at 10-year interval; p  = 0.017). Permanent facial neuropathy occurred in two patients, both from the IDL50 cohort (3.5%). Rates of post-SRS steroid treatment or shunt placement for hydrocephalus were slightly higher in IDL50 patients (6.9 vs. 17.9%; p  = 0.208 and 3.3 vs. 7.1%; p  = 0.532). Conclusion  For treatment of VS with SRS, dose prescription at IDL40 or IDL50 provides excellent long-term TC and toxicity profiles. IDL40 may be associated with improved long-term HP.
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  • 文章类型: Journal Article
    目的研究国家人工耳蜗植入中心的听力保留率和听力保留候选人的结果。使用了听力标准。
    包括具有保留的低频纯音平均值(PTA)的所有耳蜗植入物候选物。所有患者均使用标准的“软手术”技术进行人工耳蜗植入。PTA在开机时进行评估,术后3、6、9和12个月。主要结果是在12个月时保留听力。
    在2015年至2020年期间,66名患者被纳入研究。植入了71只耳朵,包括33名成人和33名儿童,共进行了5次双侧植入。术前平均PTA为74.8dB(范围52.3-92dB),术后平均PTA为95.3dB,平均移位为20.5dB.在成年人口中,HP率如下:完全HP为13%,部分HP为39.1%,最低HP为30.4%,听力损失为17.4%。在儿科人群中:完全HP为20.7%,部分HP为51.7%,最低HP为13.8%,听力损失为13.8%。术后初次移位后,在3~12个月的随访期间,残余听力没有显著恶化.听力保留没有明显的预后因素。
    描述了使用HEARRING标准的听力保持率。这项研究将有助于有资格进行人工耳蜗植入并保留听力的患者的咨询和决策。需要进一步的研究来评估电刺激和电声刺激的性能和结果。
    To study the rate of hearing preservation and outcomes of hearing preservation candidates in a national cochlear implant centre. The HEARRING criteria was used.
    All cochlear implant candidates with preserved low frequency pure tone average (PTA) were included. All patients underwent cochlear implantation using a standard \'soft-surgery\' technique. PTA was assessed at switch-on, 3, 6, 9 and 12 months postoperatively. The primary outcome was hearing preservation at 12 months.
    Sixty six patients were included in the study between 2015 and 2020. Seventy one ears were implanted including 33 adults and 33 children with 5 bilateral implantations. Mean preoperative PTA was 74.8 dB (range 52.3-92 dB), mean postoperative PTA was 95.3 dB corresponding to a mean shift of 20.5 dB. In the adult population, HP rates were as follows: complete HP in 13%, partial HP in 39.1%, minimal HP in 30.4%, loss of hearing in 17.4%. In the paediatric population: complete HP in 20.7%, partial HP in 51.7%, minimal HP in 13.8% and loss of hearing in 13.8%. After the initial postoperative shift, there was no significant worsening of residual hearing during follow-up between 3 and 12 months. There were no significant prognostic factors for hearing preservation.
    Hearing preservation rates using the HEARRING criteria are described. This study will help counselling and decision making in patients eligible for cochlear implantation with hearing preservation. Further studies are required to assess the performances and outcomes of electronatural and electroacoustic stimulation.
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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Clinical Trial Protocol
    背景:先前对112名受试者进行了III期试验,研究了尼莫地平在前庭神经鞘瘤(VS)手术中的预防性治疗,对保留面部和耳蜗神经功能没有明显的有益作用,尽管应考虑保护面神经功能是主要结果。然而,与对照组相比,尼莫地平组术后听力损失的风险降低了一半(OR0.49;95%CI0.18~1.30;p=0.15).因此,这项III期扩展试验研究了VS手术中预防性使用尼莫地平保护听力的有效性和安全性.
    方法:这是一个随机的,多中心,双臂,开放标签III期试验,专家审查盲法和中期分析两阶段.将136名具有显微手术切除VS(KoosI-IV)和可使用的术前听力(Gardner-Robertson量表(GR)1-3)适应症的成年人分配给治疗(静脉注射尼莫地平1-2mg/h从手术前一天到术后第五天和标准护理)或对照组(仅手术和标准护理)。试验的主要终点是根据GR1-3和GR4-5(二元)在出院前测量的术后耳蜗神经功能。听力功能将通过带有言语辨别的术前和术后测听来确定,这将由盲目的专家审阅者进行评估。此外,将使用标准化问卷分析患者报告的结局.
    结论:预防性胃肠外尼莫地平治疗可能对VS手术中的听力保护有积极作用,并将改善患者的生活质量。计划进行进一步的二次分析。除了剂量依赖性低血压,尼莫地平被认为是一种安全的药物。在未来,预防性尼莫地平治疗可作为VS手术的常规药物。VS可以被认为是临床评估神经保护的理想模型,因为听力结果可以通过公认的标准进行分类。尼莫地平的有益效果可能会转移到其他具有神经风险的外科手术中,并可能对基础研究产生影响。
    背景:EudraCT2019-002317-19,DRKS00019107。2020年5月8日。
    BACKGROUND: A previously performed phase III trial on 112 subjects investigating prophylactic nimodipine treatment in vestibular schwannoma (VS) surgery showed no clear beneficial effects on preservation of facial and cochlear nerve functions, though it should be considered that protection of facial nerve function was the primary outcome. However, the risk for postoperative hearing loss was halved in the nimodipine group compared to the control group (OR 0.49; 95% CI 0.18-1.30; p = 0.15). Accordingly, this phase III extension trial investigates the efficacy and safety of prophylactic nimodipine for hearing preservation in VS surgery.
    METHODS: This is a randomized, multi-center, two-armed, open-label phase III trial with blinded expert review and two-stage with interim analysis. Three hundred thirty-six adults with the indication for microsurgical removal of VS (Koos I-IV) and serviceable preoperative hearing (Gardner-Robertson scale (GR) 1-3) are assigned to either the therapy (intravenous nimodipine 1-2 mg/h from the day before surgery until the fifth postoperative day and standard of care) or the control group (surgery only and standard of care). The primary endpoint of the trial is postoperative cochlear nerve function measured before discharge according to GR 1-3 versus GR 4-5 (binary). Hearing function will be determined by pre- and postoperative audiometry with speech discrimination, which will be evaluated by a blinded expert reviewer. Furthermore, patient-reported outcomes using standardized questionnaires will be analyzed.
    CONCLUSIONS: Prophylactic parenteral nimodipine treatment may have a positive effect on hearing preservation in VS surgery and would improve patient\'s quality of life. Further secondary analyses are planned. Except for dose-depending hypotension, nimodipine is known as a safe drug. In the future, prophylactic nimodipine treatment may be recommended as a routine medication in VS surgery. VS can be considered as an ideal model for clinical evaluation of neuroprotection, since hearing outcome can be classified by well-recognized criteria. The beneficial effect of nimodipine may be transferable to other surgical procedures with nerves at risk and may have impact on basic research.
    BACKGROUND: EudraCT 2019-002317-19, DRKS00019107 . 8th May 2020.
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  • 文章类型: Journal Article
    Cochlear implants (CIs) are commonly used for the rehabilitation of profound bilateral hearing loss. However, patients with substantial residual acoustic hearing are potential CI candidates. Because of both improvements in technology and advancements in surgical techniques, it may be possible to preserve hearing to some extent. For more than a decade, it has been suggested that robots are used to perform middle ear surgery. We evaluated the use of the RobOtol® otologic robot specifically to insert CI electrodes into the inner ear.
    CI surgery with the conventional approach was performed under general anesthesia. The MED-El Flex 24-electrode array was inserted using RobOtol®. Video recordings were used to calculate the speed of insertion. The positions of the electrodes were evaluated using a cone beam CT. All subjects underwent pure-tone audiometry tests before and after surgery, and the pure-tone average (PTA) was calculated from 250 to 4,000 Hz.
    The robot inserted implants in 5 patients, and complete insertion of the electrode array was achieved. The speed of insertion of the electrode array was 0.88 ± 0.12 mm/s. The mean loss of the PTA for 5 frequencies (250, 500, 1,000, 2,000, and 4,000 Hz) was 13.60 ± 7.70 dB. Only 1 patient showed a loss of the PTA by >20 dB. For these 5 patients, the cone beam CT findings showed that all the electrode arrays were in the tympanic ramp and had a grade of 0. The results were compared with those obtained from a cohort of 17 patients who underwent manual implantation of a MED-El Flex 24-electrode array.
    To minimize disturbance to the cochlea while atraumatic electrode arrays are inserted, electrodes can be inserted at a constant, slow speed in the inner ear with the assistance of the RobOtol® robot in a normal clinical surgical setting.
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  • 文章类型: Journal Article
    要评估一个人是否,围手术期,大剂量甲基强的松龙可以改善人工耳蜗植入(CI)后残余听觉的保留。
    这是一项双盲安慰剂对照试验,在三级学术中心演出。假设是甲基强的松龙会改善听力的保存,和较低的电极阻抗。要植入的耳朵中听力为85dB或更好的500Hz的成年患者(18-85岁)被随机分配到任一治疗(甲基强的松龙,在诱导麻醉后静脉内施用1g)或对照(生理盐水输注)。根据标准临床实践,所有患者在麻醉诱导时接受常规剂量的地塞米松(8mg静脉注射).通过圆窗使用细长且柔性的侧壁电极进行植入。手术技术是常规的,坚持软手术原则。主要结果是在500Hz时在20dB内保持听力,人工耳蜗植入后12个月。次要结果包括6周和3个月时的听力保留,单极电极阻抗,术后3个月和12个月的辅音-元音-辅音(CVC)音素评分。
    45例患者被纳入对照组,48例患者接受类固醇治疗。在接受甲基强的松龙治疗的患者和对照组之间,在12个月时达到听力保留的患者人数没有显着差异。植入后6周或3个月,在任何频率下的听力保留均无差异。两组之间的CVC音素评分和电极阻抗均无差异。
    本文表明,在手术中局部注射大剂量类固醇并不能有效防止残余听力损失,改善言语感知,或降低电极阻抗。这些发现与实验文献相反,以及新出现的临床证据表明,从植入电极中的类固醇洗脱会影响人类的耳蜗生物学。我们发现没有证据支持围手术期静脉注射类固醇的广泛做法,试图保持剩余的听力。
    To assess whether a single, peri-operative, high dose of methylprednisolone can improve the preservation of residual acoustic hearing following cochlear implantation (CI).
    This was a double blinded placebo-controlled trial, performed in a tertiary academic centre. The hypothesis was that methylprednisolone would improve the preservation of hearing, and lower electrode impedances. Adult patients (18-85 years) with hearing at 85 dB or better at 500 Hz in the ear to be implanted were randomly allocated to either treatment (methylprednisolone, 1g administered intravenously upon induction of anaesthesia) or control (normal saline infusion). As per standard clinical practice, all patients received a routine dose of dexamethasone (8 mg intravenously) on induction of anaesthesia. Implantation was undertaken with a slim and flexible lateral wall electrode via the round window. Surgical technique was routine, with adherence to soft surgical principles. The primary outcome was hearing preservation within 20 dB at 500 Hz, 12 months following cochlear implantation. Secondary outcomes included hearing preservation at 6 weeks and 3 months, monopolar electrode impedance, and Consonant-Vowel-Consonant (CVC) Phoneme scores at 3 and 12 months after surgery.
    Forty-five patients were enrolled into the control group and 48 patients received the steroid. The number of patients achieving hearing preservation at 12 months did not differ significantly between those receiving methylprednisolone treatment and the controls. There were no differences in hearing preservation at any frequency at either 6 weeks or 3 months after implantation. Neither CVC phoneme scores nor electrode impedances differed between the groups.
    This paper demonstrates that high-dose local steroid injection at surgery was not effective in preventing a loss of residual hearing, improving speech perception, or lowering electrode impedances. The findings were contrary to the experimental literature, and emerging clinical evidence that steroid elution from implant electrodes influences cochlear biology in humans. We found no evidence to support the widely-held practice of administering intravenous steroids in the perioperative period, in an attempt to preserve residual hearing.
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  • 文章类型: Clinical Trial, Phase III
    A 2016 published randomized multicenter phase III trial of prophylactic nimodipine treatment in vestibular schwannoma surgery showed only a tendency for higher hearing preservation rates in the treatment group. Gender was not included in statistical analysis at that time. A retrospective analysis of the trial considering gender, preoperative hearing, and nimodipine treatment was performed. The treatment group received parenteral nimodipine from the day before surgery until the seventh postoperative day. The control group was not treated prophylactically. Cochlear nerve function was determined by pure-tone audiometry with speech discrimination preoperatively, during in-patient care, and 1 year after surgery and classified according to the Gardner-Robertson grading scale (GR). Logistic regression analysis showed a statistically significant effect for higher hearing preservation rates (pre- and postoperative GR 1-4) in 40 men comparing the treatment (n = 21) and the control (n = 19) groups (p = 0.028), but not in 54 women comparing 27 women in both groups (p = 0.077). The results were also statistically significant for preservation of postoperative hearing with pre- and postoperative GR 1-3 (p = 0.024). There were no differences in tumor sizes between the treatment and the control groups in men, whereas statistically significant larger tumors were observed in the female treatment group compared with the female control group. Prophylactic nimodipine is safe, and an effect for hearing preservation in 40 men with preoperative hearing ability of GR 1-4 was shown in this retrospective investigation. The imbalance in tumor size with larger tumors in females of the treatment group may falsely suggest a gender-related effect. Further investigations are recommended to clarify whether gender has impact on nimodipine\'s efficacy.
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