Original Title: Implante auditivo de conducción ósea activo piezoeléctrico

Authors' objectives: To assess the efficacy/effectiveness, safety and surgical characteristics of the Osia® active bone conduction hearing implant in patients with conductive hearing loss (CHL), mixed hearing loss (MHL) or single-sided deafness (SSD) both adults and children.

Authors' results and conclusions: A total of 17 studies were included: 2 systematic reviews and 15 individual studies, most of which were observational. Overall, the size of the effect and consistency of the results varied by type of hearing loss, with results being more consistent in CHL and MHL, and less so in SSD. Improvements were particularly marked for mid and high frequencies; sounds associated with speech understanding. In adults, the functional gain reported after implantation of the Osia® system ranges from 25 to 47 dB HL, with improvements in speech understanding under both quiet and noisy conditions. Some comparative studies suggest similar or potentially better audiological results than other bone conduction devices at certain frequencies, although the evidence remains limited. In children, the available studies show hearing improvements similar to those observed in adults, with significant functional gains and improvements in speech recognition tests and hearing‑related quality of life questionnaires. PROMs indicate improvements in auditory perception, communication, and quality of life following device implantation. The complications reported were generally uncommon and mild, mainly skin irritation and discomfort at the magnet site, while serious adverse events were rare. The surgical procedure lasts 45 to 70 minutes and is associated with a low rate of intraoperative complications. Regarding organisational and ethical implications, the implantation of the Osia® system requires multidisciplinary assessment in specialised clinics and coordination with patients and families, particularly in the case of children. Moreover, organisational factors such as the availability of implant centres may influence access to this technology, raising concerns related to equity of access across the Spanish National Health System. In this context, clear information on alternative treatment options may facilitate shared decisionmaking between health professionals, patients and their relatives. Although no specific systematic search was conducted to identify research on economic implications, some of the studies retrieved suggest that this system is potentially cost‑effective in the long term, according to international thresholds, although these results cannot be extrapolated directly to the context of the Spanish National Health System. CONCLUSIONS - The available evidence suggests that the Osia® active bone conduction hearing implant is associated with improvements in hearing and patientperceived benefits in people with CHL and MHL, both adults and children, while the benefits are more variable in patients with SSD. Nonetheless, the evidence is mainly from observational studies with methodological limitations and findings are heterogeneous across studies. Therefore, the overall certainty of the evidence is low and the results should be interpreted with caution.

Authors' methods: A systematic review was conducted of the literature in Medline (PubMed), Embase (OvidWeb), Cochrane Library, Web of Science and Scopus. The initial search was performed in October 2024, and the results were updated in June and October 2025. Studies were included if they involved patients aged ≥5 years with CHL, MHL or SSD treated with an Osia® implant. The outcomes of interest were audiological measures (functional gain and speech audiometry), patientreported outcome measures (PROMs), safety and surgical parameters. The quality of the studies was assessed using the AMSTAR 2 tool and the critical appraisal tool FLC 3.0, developed by the Basque Office for Health Technology Assessment (OSTEBA). Given the heterogeneity of the studies, the evidence was synthesised narratively. No specific searches were conducted to identify research on economic, ethical or organisational implications. These issues were analysed based on information available from the included studies, as well as institutional documentation and relevant legislation.

Project Status: Completed

Year Published: 2026

URL for published report: https://www.euskadi.eus/contenidos/informacion/osteba_publicacion/es_def/adjuntos/Implante_auditivo_de_conduccion_osea_activo_.pdf

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>