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Effects of Hyperbaric Exposure on the Integrity of the Internal Components of Commercially Available Cochlear Implant Systems

Hypothesis 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. Background 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. Methods 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. Results 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. Conclusion 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.