Robustness and lifetime of the bone conduction implant - a pilot study

• Objectives: The objective of this study was to develop methods for evaluating the mechanical robustness and estimating the lifetime of the novel bone conduction implant (BCI) that is used in a clinical study. The methods are intended to be applicable to any similar device. Materials and methods: The robustness was evaluated using tests originally developed for cochlear implants comprising a random vibration test, a shock test, a pendulum test, and an impact test. Furthermore, magnetically induced torque and demagnetization during magnetic resonance imaging at 1.5 T were investigated using a dipole electromagnet. To estimate the lifetime of the implant, a long-term age-accelerated test was performed. Results: Out of all the tests, the pendulum and the impact tests had the largest effect on the electro-acoustic performance of the BCI implant, even if the change in performance was within acceptable limits (< 20%). In comparison with baseline data, the lower and higher resonance peaks shifted down in frequency by 13% and 18%, respectively, and with a loss in magnitude of 1.1 and 2.0 dB, respectively, in these tests. Conclusion: A complete series of tests were developed, and the BCI passed all the tests; its lifetime was estimated to be at least 26 years for patients who are using the implant for 12 hours on a daily basis.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Dermatologi och venereologi (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Dermatology and Venereal Diseases (hsv//eng)

TEKNIK OCH TEKNOLOGIER  -- Samhällsbyggnadsteknik -- Geoteknik (hsv//swe)

ENGINEERING AND TECHNOLOGY  -- Civil Engineering -- Geotechnical Engineering (hsv//eng)

TEKNIK OCH TEKNOLOGIER  -- Medicinteknik -- Medicinsk apparatteknik (hsv//swe)

ENGINEERING AND TECHNOLOGY  -- Medical Engineering -- Medical Equipment Engineering (hsv//eng)

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Oto-rhino-laryngologi (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Otorhinolaryngology (hsv//eng)

TEKNIK OCH TEKNOLOGIER  -- Medicinteknik -- Annan medicinteknik (hsv//swe)

ENGINEERING AND TECHNOLOGY  -- Medical Engineering -- Other Medical Engineering (hsv//eng)

Nyckelord

electro-acoustics

electromagnetic transducer

audiology

bone conduction audiometry

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