Jenkins Herman A, Atkins James S, Horlbeck Drew, Hoffer Michael E, Balough Ben, Alexiades George, Garvis William
University of Colorado Denver, Aurora, Colorado 80045, USA.
Otol Neurotol. 2008 Jun;29(4):534-41. doi: 10.1097/MAO.0b013e3181656969.
To assess the safety of the Otologics fully implantable hearing system after 1 year of use in a Phase I clinical trial.
Repeated-measures within-subjects design.
Procedures were performed in a variety of facilities, including a university, military, and private hospital's ambulatory surgical center and outpatient clinical audiologic test facilities.
Adult patients with bilateral moderate to severe sensorineural hearing loss.
INTERVENTION(S): Surgical insertion of this prosthesis included an atticotomy to expose the incus, securing the transducer to the mastoid bone, attaching the transducer tip to the incus via insertion into a laser-drilled hole, and postauricular implantation of the microphone/battery/electronics capsule.
MAIN OUTCOME MEASURE(S): Subjective patient benefit, aided sound field thresholds, and speech discrimination with the subject's own, appropriately fit, walk-in hearing aid(s) and the prosthesis were assessed.
There were no pre-post-implant differences noted for bone conduction: slight differences were noted in the pre-post-implant air conduction results (p < 0.05). These differences were attributed to the healing process and reversed to almost preimplant assessment levels by the third-month evaluation. Pure-tone averages and monaural word recognition scores were slightly better for the walk-in-aided condition (p < 0.05), whereas the patient benefit scales favored the postoperative implant-aided conditions.Adverse effects of the implant were encountered on 14 occasions after the implantation of the 20 subjects. With the exception of partial device extrusions (that occurred later), all were rectified by the time of initial activation. At the 12-month data collection point, problems that had been encountered by subjects included 1) partial device extrusion (3 subjects), necessitating explantation in 2; 2) loss of external communication (2 subjects), resulting in 1 explantation; and 3) increased charging times beyond 1.5 hours (7), resulting in 3 explantations and 2 patients not using their device while awaiting explantation.
Phase I trial results provide evidence that this fully implantable device can provide sound amplification to sensorineural hearing loss patients, with performance results similar to the patients' walk-in hearing aids.
在一项I期临床试验中，评估Otologics完全植入式听力系统使用1年后的安全性。
受试者内重复测量设计。
手术在多种机构进行，包括大学、军队及私立医院的门诊手术中心和门诊临床听力测试机构。
双侧中度至重度感音神经性听力损失的成年患者。
该假体的手术植入包括乳突切开术以暴露砧骨，将换能器固定到乳突骨，通过插入激光钻孔将换能器尖端连接到砧骨，以及在耳后植入麦克风/电池/电子胶囊。
评估患者主观受益情况、助听听阈以及使用患者自己合适的、可直接佩戴的助听器和该假体时的言语辨别能力。
植入前后骨导未发现差异；植入前后气导结果存在轻微差异（p<0.05）。这些差异归因于愈合过程，到第三个月评估时几乎恢复到植入前的评估水平。对于可直接佩戴助听器的情况，纯音平均值和单耳单词识别分数略好（p<0.05），而患者受益量表更倾向于术后植入辅助的情况。20名受试者植入后有14次出现植入相关不良反应。除了部分装置外露（较晚发生）外，所有问题在初次激活时均得到纠正。在12个月数据收集点，受试者遇到的问题包括：1）部分装置外露（3名受试者），其中2名需要取出；2）外部通信丢失（2名受试者），导致1名取出；3）充电时间增加超过1.5小时（7名），导致3名取出，2名患者在等待取出期间未使用其装置。
I期试验结果表明，这种完全植入式装置可为感音神经性听力损失患者提供声音放大，性能结果与患者的可直接佩戴助听器相似。
