Shohet Jack A, Kraus Eric M, Catalano Peter J, Toh Elizabeth
Shohet Ear Associates, Newport Beach, California, U.S.A.
Ear Center of Greensboro, Greensboro, North Carolina, U.S.A.
Laryngoscope. 2018 Jan;128(1):210-216. doi: 10.1002/lary.26602. Epub 2017 Apr 13.
OBJECTIVES/HYPOTHESIS: 1) To provide long-term hearing outcome measures of a totally implantable hearing system (implant) and compare to the baseline unaided (BLU) and baseline aided (BLA) conditions, and 2) discuss relevant safety measures.
Prospective, nonrandomized, multicenter, single-subject-as-own-control design.
Fifty-one subjects with mild to severe sensorineural hearing loss were implanted between 2008 and 2009 and enrolled in this postmarket approval study in the setting of private and hospital-based practices. Forty-nine of these subjects completed the 5-year study, which included annual follow-ups. Primary effectiveness endpoints were speech reception threshold (SRT) and word recognition scores at 50 dB (WRS50s). Secondary effectiveness endpoints were WRSs and the Abbreviated Profile of Hearing Aid Benefit (APHAB) scores. Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) reported during the study period and a comparison of bone conduction scores are submitted as safety measures.
Compared to the BLA condition, 1) SRT scores were improved at every annual follow-up; 2) WRS50s were better in 49%, and the same in 41% at the 5-year follow-up; 3) WRSs were improved by 17% at the 5-year follow-up; and 4) APHAB scores were improved in most subscales at every annual follow-up. There were three SADEs in three subjects and 15 ADEs in 11 subjects. Bone conduction scores increased by 3.7 dB at the 5-year follow-up. Average battery life was 4.9 years.
The implant compared favorably to the subjects' hearing aid throughout the 5-year period in all of the areas measured and was found to be safe.
2b. Laryngoscope, 128:210-216, 2018.
目的/假设：1）提供完全植入式听力系统（植入物）的长期听力结果测量，并与基线未助听（BLU）和基线助听（BLA）情况进行比较，以及2）讨论相关安全措施。
前瞻性、非随机、多中心、单受试者自身对照设计。
2008年至2009年间，51名轻度至重度感音神经性听力损失患者接受了植入，并在私人诊所和医院环境中参加了这项上市后批准研究。其中49名受试者完成了为期5年的研究，包括年度随访。主要有效性终点是言语接受阈值（SRT）和50 dB时的单词识别分数（WRS50s）。次要有效性终点是WRS和助听器益处简表（APHAB）分数。研究期间报告的不良器械效应（ADE）和严重不良器械效应（SADE）以及骨传导分数的比较作为安全措施提交。
与BLA情况相比，1）每年随访时SRT分数均有所改善；2）5年随访时，49%的患者WRS50s更好，41%相同；3）5年随访时WRS提高了17%；4）每年随访时，大多数子量表的APHAB分数均有所改善。3名受试者出现3例SADE，11名受试者出现15例ADE。5年随访时骨传导分数增加了3.7 dB。平均电池寿命为4.9年。
在测量的所有领域中，该植入物在整个5年期间与受试者的助听器相比表现良好，且被发现是安全的。
2b。《喉镜》，2018年，第128卷，第210 - 216页。
