Totally implantable active middle ear implant: Hearing and safety results in a large series.

Objectives: To evaluate hearing performance and safety measures in a large group of totally implantable active middle ear implant (AMEI) wearers.

Methods: Retrospective case review of 172 ears (166 patients) with sensorineural hearing loss undergoing implantation of a totally implantable AMEI. Pure-tone air and bone thresholds, pure-tone average, speech reception threshold (SRT), and word recognition scores (WRS) at phonetically balanced maximum and at 50 dB (WRS50) were assessed at baseline unaided, with a hearing aid (baseline aided [BLA]), with the implant at activation, and for best implant postoperative measurement. Adverse events were reviewed.

Results: Mean length of follow-up was 35.7 months. Compared to unaided, the implant provided significant gain at all frequencies through 6 kHz. Amount of gain was significantly better with the implant than BLA at 1,500 and 2,000 Hz (P ≤ .001). Implant SRT was also significantly improved compared to BLA (29.9 dB vs. 38.5 dB, P ≤ .001). At a 50-dB presentation level, WRS was significantly better with the implant than BLA (65.6% vs. 45.5%, P ≤ .001). Bone conduction thresholds were not affected by the implant. The most common adverse event was taste disturbance, which occurred in 39.1%. In subjects with preimplant tinnitus, 56.1% experienced resolution of their tinnitus. Revision surgery was required in 15.7%, and 4% were ultimately explanted.

Conclusion: The implant provided significant hearing benefit compared to unaided and to the subjects' own hearing aids in most test categories, with minimal adverse events. Many subjects experienced complete resolution of their tinnitus after implantation.

Level Of Evidence: 4 Laryngoscope, 128:2872-2878, 2018.