The safety and effectiveness of an implanted electromagnetic hearing device

The records of 184 patients implanted with the XOMED Audiant Bone Conductor (XOMED Inc, Jacksonville, Fla) prior to March 1988 were reviewed retrospectively to determine the safety of this device. Complications were few and minor in nature. Effectiveness was judged from the audiometric data obtained from the 96 patients in the hearing part of this study, all of whom had improved hearing with the device. The mean preoperative pure-tone air-conduction three-frequency average threshold +/- SD in the implanted ear was 55.8 +/- 10.7-dB hearing level; postoperative average aided warble-tone threshold was 19.9 +/- 8.5-dB hearing level. The average improvement in threshold was 36.0 +/- 13.3 dB. Ninety-three percent of patients achieved socially adequate hearing, ie, mean aided sound-field thresholds of at least 30-dB hearing level, and 81% had thresholds of at least 25-dB hearing level. We conclude that the XOMED Audiant Bone Conductor is a safe and effective device for the surgical correction of conductive hearing loss.