The first results of a totally implanted active middle ear device.

Purpose: The aim of this study was to assess the first outcomes of a fully implantable active middle ear device.

Methods: Retrospective observational nonrandomized group study.

Settings: Private hospital. Fifteen patients underwent device implantation between December 2014 and June 2017. The pre-operative and post-operative air conduction (AC) and bone conduction (BC) thresholds were evaluated. The functional gain, speech perception in silence and in noise, and localization abilities were also analyzed.

Results: Sixteen active middle ear implantations were performed. Post-operatively, the mean pure tone thresholds were 50.5 dB ( ± 12.64) for BC and 64.9 dB ( ± 15.36) for AC. No differences were found between the post-operative and pre-operative audiometric thresholds before activating the system (p > 0.05). Post-operatively, the mean thresholds in the free field after the device was activated were 46.8 dB, 45.75 dB, 42.6 dB, and 43.38 dB at 1, 3, 6, and 12 months, respectively. The global results of speech understanding in silence were 50.7 dB, 47.18 dB, 42 dB, and 42 dB for 1, 3, 6, and 12 months, respectively. Patients with mixed hearing loss had better results than those with sensorineural hearing loss. Speech discrimination in noise and localization was improved.

Conclusions: Despite the small number of patients, our results confirmed that this fully implantable active middle ear device is a viable treatment for patients with moderate-to-severe sensorineural hearing loss who cannot or do not want to use traditional hearing aids for clinical or cosmetic reasons.