A Systematic Review of Surgical Characteristics and Adverse Events of an Active, Transcutaneous Bone Conduction Device.

Autor:	Jukic A; University of Arizona College of Medicine-Phoenix, Phoenix, AZ, USA., Munhall CC; Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA., Stevens SM; Department of Otolaryngology and Skull Base Surgery-Barrow Neurological Institute, Phoenix, AZ, USA.
Jazyk:	angličtina
Zdroj:	The Annals of otology, rhinology, and laryngology [Ann Otol Rhinol Laryngol] 2024 Nov; Vol. 133 (11), pp. 956-966. Date of Electronic Publication: 2024 Sep 22.
DOI:	10.1177/00034894241283269
Abstrakt:	Objective: A new, active transcutaneous bone conduction device (BCD) was FDA-approved in 2019 in the USA. This systematic review sought to evaluate early outcomes associated with Osia implantation. Methods: A systematic review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Four databases were reviewed: PubMed, Scopus, Cochrane CENTRAL, and CINAHL. Studies were included if they described audiometric, surgical characteristics/complications, or adverse events associated with the Osia BCD. Exclusion criteria: non-English language studies, animal investigations, reviews/meta-analyses, case reports, database studies. Results: Eighteen studies with 336 patients were included. Mean age at implantation was 37.9 years. About 79.5% of patients had MHL/CHL and 19.5% had SSD/SHL. Mean operative time was 71.6 minutes. Mean PTA gain from unaided conditions was 35.4 dB. Mean functional gain at high frequency (6 kHz and above) from aided conditions was 16.1 dB. Mean improvement in speech recognition thresholds was 19.1 dB from unaided conditions. Adverse events (all types) were reported in 20.1% of cases. Across all studies, the postoperative infection rate was 5%. About 2% of patients reported magnet retention issues. About 1.65% of cases were complicated by hematomas. Conclusions: Under systematic literature review, the Osia BCD has been associated with low complication rates, relatively short operative times, and good audiometric and speech outcomes, notably high frequency gain >6 kHz. More advanced audiometric outcome reporting remains limited and audiometric data and patient reported outcome measures were reported heterogeneously. Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Shawn M. Stevens, MD: Cochlear Americas. Consultant. Speaker Honorarium. There was no direct or indirect conflict of interest or interaction with this entity regarding conduct of this investigation. No funding or other renumeration was received in association/support of this research. Zeiss. Consultant. Stryker Corporation. Consultant. Alcon Medical. Consultant.
Databáze:	MEDLINE
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