Robustness and lifetime of the bone conduction implant - a pilot study
Journal article, 2019

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.

bone conduction audiometry

audiology

electromagnetic transducer

electro-acoustics

Author

Karl-Johan Fredén Jansson

Chalmers, Electrical Engineering, Signalbehandling och medicinsk teknik, Biomedical Signals and Systems

Bo Håkansson

Chalmers, Electrical Engineering, Signalbehandling och medicinsk teknik, Biomedical Signals and Systems

Cristina Rigato

Chalmers, Electrical Engineering, Signalbehandling och medicinsk teknik, Biomedical Signals and Systems

Mans Eeg-Olofsson

University of Gothenburg

Sabine Reinfeldt

Chalmers, Electrical Engineering, Signalbehandling och medicinsk teknik, Biomedical Signals and Systems

Medical Devices: Evidence and Research

1179-1470 (ISSN)

Vol. 12 89-100

Subject Categories

Dermatology and Venereal Diseases

Geotechnical Engineering

Medical Equipment Engineering

DOI

10.2147/MDER.S192860

PubMed

30881150

More information

Latest update

8/20/2019