Sarah Mowry, Robert Cullen, Sarah Sydlowski, Alejandro Rivas, Joseph Ursick, Erika Woodson, Viral D Tejani, Kristen Lewis, Paul Reinhart
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CT imaging confirmed scala tympani placement for all electrodes, with a mean angular insertion depth of 406.6°.</p><p><strong>Conclusion: </strong>The slim perimodiolar electrode can preserve LF acoustic hearing in adults implanted under expanded indications, supporting meaningful objective and subjective benefit. 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引用次数: 0
摘要
有大量低频(LF)残余听力的成年人越来越多地被认为是人工耳蜗植入术的首选。本研究评估了在扩大适应症下使用窄型磨牙周围电极(CI632)的成人听力保护和语言表现结果。方法:在美国三个三级中心进行的一项前瞻性、开放标签、单臂可行性试验中,10名LF阈值≤50 dB HL (500 Hz)、高频损失倾斜、待植入耳中辅助CNC评分≤60%的成年人接受了CI632装置。参与者在激活后被跟踪了12个月。评估包括空气和骨传导听力学、电极阻抗、安静时单侧和双侧CNC和噪音时AzBio句子、患者报告的结果和术后CT成像。结果:低频纯音平均(125-500 Hz)在激活时平均偏移19.3 dB, 12个月后稳定在22.4 dB。访问期间阻抗稳定。由于保留了声学听力,所有参与者都在植入耳中使用了电声刺激。语音识别在所有测试中都有了显著的提高,根据测试的不同,12个月后的平均提高幅度在22到54个百分点之间。患者报告的结果也有所改善。CT成像证实所有电极均放置鼓室级,平均角度插入深度为406.6°。结论:窄型磨牙周围电极在扩大适应症下植入可保留成人LF听听力,具有明显的客观和主观效益。听力保存的结果在这个队列中超过了通常报道的臼齿周围阵列,并且保存的LF听力对提高噪音下的言语理解有很大的帮助。
Hearing preservation and efficacy outcomes in CI632 recipients with sloping high-frequency hearing loss: Multicenter trial results.
Introduction: Adults with substantial residual low‑frequency (LF) hearing are increasingly considered for cochlear implantation. This study evaluated hearing preservation and speech performance outcomes using a slim perimodiolar electrode (CI632) in adults under expanded indications.
Methods: In a prospective, open label, single arm feasibility trial at three U.S. tertiary centers, ten adults with LF thresholds ≤50 dB HL at 500 Hz, sloping high frequency loss, and aided CNC scores ≤60% in the ear to be implanted received the CI632 device. Participants were followed for 12 months postactivation. Assessments included air and bone conduction audiometry, electrode impedances, unilateral and bilateral CNC in quiet and AzBio sentences in noise, patient reported outcomes, and postoperative CT imaging.
Results: The LF pure tone average (125-500 Hz) showed a mean shift of 19.3 dB at activation and remained stable at 22.4 dB at 12 months. Impedances were stable across visits. Due to preserved acoustic hearing, all participants utilized electric-acoustic stimulation in the implant ear. Speech recognition improved significantly across all measures, with an average improvement at 12 months ranging from 22 to 54 percentage points, depending on the test. Patient reported outcomes also improved. CT imaging confirmed scala tympani placement for all electrodes, with a mean angular insertion depth of 406.6°.
Conclusion: The slim perimodiolar electrode can preserve LF acoustic hearing in adults implanted under expanded indications, supporting meaningful objective and subjective benefit. Hearing preservation outcomes in this cohort exceeded those typically reported for perimodiolar arrays, and preserved LF hearing contributed strongly to improved speech understanding in noise.
期刊介绍:
''Audiology and Neurotology'' provides a forum for the publication of the most-advanced and rigorous scientific research related to the basic science and clinical aspects of the auditory and vestibular system and diseases of the ear. This journal seeks submission of cutting edge research opening up new and innovative fields of study that may improve our understanding and treatment of patients with disorders of the auditory and vestibular systems, their central connections and their perception in the central nervous system. In addition to original papers the journal also offers invited review articles on current topics written by leading experts in the field. The journal is of primary importance for all scientists and practitioners interested in audiology, otology and neurotology, auditory neurosciences and related disciplines.