Roland J Thomas, Gantz Bruce J, Waltzman Susan B, Parkinson Aaron J
Department of Otolaryngology-Head and Neck Surgery, New York University, New York, New York.
Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.
Laryngoscope. 2016 Jan;126(1):175-81. doi: 10.1002/lary.25451. Epub 2015 Jul 7.
OBJECTIVES/HYPOTHESIS: To evaluate the safety and efficacy of acoustic and electric sound processing for individuals with significant residual low-frequency hearing and severe-to-profound high-frequency sensorineural hearing loss.
Prospective, single-arm repeated measures, single-subject design.
Fifty individuals, ≥ 18 years old, with low-frequency hearing and severe high-frequency loss were implanted with the Cochlear Nucleus Hybrid L24 implant at 10 investigational sites. Preoperatively, subjects demonstrated consonant-nucleus-consonant word scores of 10% through 60% in the ear to be implanted. Subjects were assessed prospectively, preoperatively, and postoperatively on coprimary endpoints of consonant-nucleus-consonant words, AzBio sentences in noise, and self-assessment measures.
Significant mean improvements were observed for coprimary endpoints: consonant-nucleus-consonant words (35.8 percentage points) and AzBio sentences in noise (32.0 percentage points), both at P < 0.001. Ninety-six percent of subjects performed equal or better on speech in quiet and 90% in noise. Eighty-two percent of subjects showed improved performance on speech in quiet and 74% in noise. Self-assessments were positive, corroborating speech perception results.
The Nucleus Hybrid System provides significant improvements in speech intelligibility in quiet and noise for individuals with severe high-frequency loss and some low-frequency hearing. This device expands indications to hearing-impaired individuals who perform poorly with amplification due to bilateral high-frequency hearing loss and who previously were not implant candidates.
目的/假设：评估声学和电声音处理对低频听力显著残留且高频感音神经性听力损失严重至极重度的个体的安全性和有效性。
前瞻性、单臂重复测量、单受试者设计。
50名年龄≥18岁、有低频听力且高频重度损失的个体在10个研究地点植入了科利耳Nucleus Hybrid L24植入物。术前，受试者在拟植入耳中的辅音-核-辅音单词得分在10%至60%之间。对受试者进行前瞻性评估，在术前和术后评估辅音-核-辅音单词、噪声中的AzBio句子以及自我评估措施等共同主要终点。
共同主要终点有显著的平均改善：辅音-核-辅音单词（35.8个百分点）和噪声中的AzBio句子（32.0个百分点），P均<0.001。96%的受试者在安静环境下的言语表现相同或更好，在噪声环境下为90%。82%的受试者在安静环境下的言语表现有所改善，在噪声环境下为74%。自我评估为阳性，证实了言语感知结果。
Nucleus Hybrid系统为高频重度损失且有一定低频听力的个体在安静和噪声环境下的言语可懂度提供了显著改善。该设备将适应症扩展到因双侧高频听力损失而使用放大装置效果不佳且以前不符合植入条件的听力受损个体。
