Aims To report safety and performance outcomes 24 months after implantation of a novel active transcutaneous bone conduction device in adults with conductive/mixed hearing loss (CHL/MHL) or single-sided deafness (SSD). Methods Prospective, open-label, multicenter investigation with follow-up at 3, 6, 12, and 24 months. Outcomes included surgical parameters, audiological performance, and patient-reported benefits and quality of life. Results Fifty-one participants (mean age 50 years; range 24–77) were implanted for CHL (51%), MHL (25%), or SSD (24%). Mean surgery time was 58 min (range 23–85); general anesthesia was used in 96%, only local in 4%. Preoperative imaging was not performed in 55%. At 24 months, aided thresholds (PTA4) improved to 26.2 dB HL (SD4.3) [preliminary], yielding a functional gain of 32.8 (SD 8.4) dB [preliminary]. Speech recognition in quiet increased from 46.2% (SD 36.2) unaided to 97.9% (SD) [preliminary] aided. Quality of life improved (GBI total score 28.4 ± 15.7); SSQ12 mean total score increased by 2.62 (SD 1.28) [preliminary]. No device-related serious adverse events occurred. Conclusion After 24 months, the device demonstrated stable performance and safety. Patients reported significant functional and quality-of-life improvements. These results support its use in adults with CHL, MHL, or SSD.