Backous Douglas D, Dunford Richard G, Segel Phil, Muhlocker Mag Christine, Carter Paul, Hampson Neil B
The Listen for Life Center at Virginia Mason, Virginia Mason Medical Center, 1100 Ninth Avenue, X10-0N, Seattle, WA 98111, U.S.A.
Otol Neurotol. 2002 Jul;23(4):463-7; discussion 467. doi: 10.1097/00129492-200207000-00012.
This study investigated whether pressure changes common to scuba diving and to hyperbaric oxygen therapy would not cause crush damage or leakage from critical seals in commercially available cochlear implants.
The implanted packages of cochlear implants are susceptible to electrical failure caused by leakage from critical seals and to crush injury when exposed to changing barometric pressures encountered in recreational diving and in hyperbaric oxygen therapy.
Six Clarion 1.2, eight MED-EL Combi-40+, six Nucleus CI22M, and six Nucleus CI24M cochlear implants underwent three exposures at 165 feet of seawater (FSW) (6 ata abs), 99 FSW (4 ata abs), and 60 FSW (2.8 ata abs), simulating rates in accordance with U.S. Navy dive tables for nondecompression dives. Dives to 45 FSW (2.4 ata abs) simulated wound therapy. Before each dive began, after each dive, and after completion of the dive protocol, each device underwent telemetry and electrical integrity checks. All implants were returned to their respective factories for final electrical and quality control testing.
All 26 devices completed the dive protocol. One Nucleus CI24M implant had a fault recorded at electrode lead 18 on predive and final product testing, which was absent during interval dive measurements. All 26 devices passed final electrical and quality control testing. In addition, the six Clarion units passed repeat helium leak testing.
The implanted components of the Clarion 1.2, MED-EL Combi-40+, and Nucleus CI22M and CI24M were safely subjected to repeated pressure changes up to 6 atm abs, equivalent to 165 feet of seawater, without electrical failure from leakage at critical seals or crush damage.
本研究调查了水肺潜水和高压氧治疗中常见的压力变化是否不会导致市售人工耳蜗关键密封处出现挤压损坏或泄漏。
人工耳蜗的植入组件在休闲潜水和高压氧治疗中遇到气压变化时，容易因关键密封处泄漏而导致电气故障以及受到挤压损伤。
六台Clarion 1.2、八台MED-EL Combi-40+、六台Nucleus CI22M和六台Nucleus CI24M人工耳蜗在165英尺海水深度（FSW）（6绝对大气压）、99 FSW（4绝对大气压）和60 FSW（2.8绝对大气压）下进行了三次暴露，模拟符合美国海军非减压潜水潜水表的速率。潜水至45 FSW（2.4绝对大气压）模拟伤口治疗。在每次潜水开始前（原文“before each dive began”翻译为“在每次潜水开始前”更符合中文表达习惯）、每次潜水后以及潜水方案完成后，对每个设备进行遥测和电气完整性检查。所有植入物都返回各自的工厂进行最终电气和质量控制测试。
所有26个设备均完成了潜水方案。一台Nucleus CI24M植入物在潜水前和最终产品测试时电极导线18处记录到故障，而在间隔潜水测量期间未出现该故障。所有26个设备均通过了最终电气和质量控制测试。此外，六台Clarion装置通过了重复氦气泄漏测试。
Clarion 1. – 2、MED-EL Combi-40+以及Nucleus CI22M和CI24M的植入组件在高达6绝对大气压（相当于165英尺海水深度）的反复压力变化下安全无恙，关键密封处未因泄漏出现电气故障，也未受到挤压损坏。
