For assessment of safety, it is necessary to measure the maximum possible force exerted by a bone conduction device coupled to the human head. Calibration of bone conduction hearing aids and vibrators in the audiometric range is based on measurement of acceleration and force using an artificial mastoid. Extending the measurement to the high audio range was accomplished using a live head. To assess safety of the UltraQuiet tinnitus treatment system, as an example, acceleration was measured from 5 to 20 kHz on a live human head as compared with calibrated levels at 6 kHz on an artificial mastoid and the live head. Using head acceleration and anchoring it to established calibration levels is a means of establishing clinical safety. Stimulation in the high audio frequencies at low levels was found to be safe. In contrast, stimulation with ultrasound requires more energy (approximately 75-90 dB re 6 kHz), which may increase the risk of damage to the ear.
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