Abstract
PURPOSE: We aimed to investigate the surgical outcomes and clinical performance of an active osseointegration implant system that uses piezoelectric technology. METHODS: This national, multicenter, prospective, repeated measures study was approved by the Ethics Committee (opinion no. CEISH 0559-2019). The sample included patients with conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided deafness (SSD) who were eligible for osseointegrated implant surgery. Surgical parameters were assessed, along with functional and effective gain (FG and EG) and self-perception of benefits, which were evaluated between 3 and 6 months after activation. Participants also completed the Client Oriented Scale of Improvement (COSI) questionnaire to subjectively report expected and perceived benefits. RESULTS: A total of 580 participants aged 5 to 73 years were included in the study between June 2020 and April 2023. Most participants were diagnosed with CHL (58.8%), followed by MHL (28.8%) and SSD. 11.4% of the surgeries involved conversion of other devices to the piezoelectric system. The mean surgery duration was 54 min, and the mean skin thickness was 5.6 mm. Soft tissue reduction was required for 4% of the participants, while 21.2% required bone polishing. The mean PTA (pure tone average) FG was 38.6 dB for participants with CHL, 44.4 dB for those with MHL, and 66.1 dB for those with SSD. CONCLUSION: These results confirmed the clinical safety, performance, and benefits of an innovative active transcutaneous bone conduction implant with a piezoelectric transducer design for patients with CHL, MHL, or SSD.