Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2025
A Prospective, Multicenter Clinical Investigation on the Safety and Performance of a New Active Transcutaneous Bone-Anchored Implant System.
Clinical StudyСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Hol Myrthe Karianne Sophie, Aukema Tjerk Winus, Ubbink Sander Wilhelmus Johannes, Lindholm Dennis, Holmberg Marcus, Arndt Susan, Wolf Stefanie, Monksfield Peter, Marwa Mihalache, Lenarz Thomas, Busch Susan, Tysome James, Asher Abi, Kok Herman, Mylanus Emmanuel Antonius Maria
Аннотация
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.
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.