OBJECTIVE: To evaluate the audiological efficacy, patient-reported outcomes, and safety of an active middle ear implant (AMEI) in children and adults with distinct coupling options.

STUDY DESIGN: Prospective, longitudinal, multicenter, noninterventional observational study with repeated within-subject measures and a 12-month follow-up.

SETTING: Nine tertiary referral centers in Germany, Austria, and Poland.

PATIENTS: Adults and children with sensorineural, conductive, or mixed hearing loss. Adults were grouped by coupling method: incus long process (LP), incus short process (SP), round window (RW), or stapes head (SH); multiple couplers were used in children.

INTERVENTION: AMEI with coupler.

MAIN OUTCOME MEASURES: The primary outcome was the difference in speech recognition thresholds for 50% speech recognition (SRT50) in quiet between unaided preoperative and aided 12-month postactivation. Secondary outcomes included SRT50 in noise, sound-field thresholds, patient-reported outcomes, air- and bone-conduction thresholds, and adverse events.

RESULTS: Audiological outcomes were evaluated in 67 patients. SRT50 in quiet significantly improved across all subgroups, with large effect sizes (Cohen dz>0.8): 17.9±9.3 dB (LP), 18.3±8.4 dB (SP), 25.3±6.3 dB (RW), 23.1±17.6 dB (SH), and 21.6±9.4 dB in children. SRT50 in noise improved by 4.3 to 9.2 dB, and functional gains ranged from 18.3 to 39.2 dB. Patients reported positive impacts on quality of life and perceived quality of hearing. Two device explantations and 2 revision surgeries occurred. Exploratory analyses showed no statistically detectable differences between coupling approaches.

CONCLUSION: AMEI use was associated with significant audiological and patient‑reported improvements in adults and children. Within the limitations of this observational study, including limited power and baseline heterogeneity, no statistically detectable differences in outcomes were observed between coupling approaches. Coupler selection should therefore remain guided by anatomic and clinical considerations.