A Prospective, Multicenter Clinical Investigation on the Safety and Performance of a New Active Transcutaneous Bone-Anchored Implant System

Objective: To evaluate safety and performance of a new active transcutaneous system, 3 and 6 months postoperatively. Study design: An open, prospective, multicenter clinical investigation with 24-month follow-up. Setting: Six European tertiary referral centers from the Netherlands, Germany, and United Kingdom. Patients: Fifty-one adult patients with conductive hearing loss, mixed hearing loss, or single-sided deafness requiring surgical intervention for bone conduction hearing. Intervention: Implantation and fitting of an active transcutaneous device, the Sentio System. Main outcome measure: Performance outcomes included variables related to surgery (eg, surgery time and postoperative wound healing), audiology (eg, sound field thresholds, speech recognition in quiet and noise), and patient-reported outcomes (eg, quality of life, intervention benefit, and patient satisfaction). Moreover, safety was assessed by continuous reporting of adverse events and serious adverse events. Results: Smooth implant installation with no or limited preoperative imaging, and without major events in the postoperative phase was demonstrated. Audiological assessments showed significant improvements in sound field thresholds, with a mean functional gain of 32.8 dB (PTA4) and a mean effective gain of 9.0 dB. Mean aided speech recognition in quiet was 97.9%, and the improvement in speech-noise-ratio compared with a sound processor on softband was -2.98 dB. The patients reported a high perceived quality of life, with 96.1% reporting improvements post-intervention. Safety was confirmed by a limited amount and mild nature of adverse events. Discussion: The Sentio system provides a safe and effective treatment option, showing significant improvements in hearing outcomes, patient benefits, and quality of life for patients.