Systematic Review and Meta-Analysis of a New Active Transcutaneous Bone Conduction Implant.

Objective: This review aims to quantify the pooled functional gain (FG) in different types of hearing loss with the transcutaneous hearing device, Osia (Cochlear, Sydney, Australia) in comparison with the unaided state. Secondary outcomes are patient-reported outcomes measures (PROMs) and complication rates.

Data Sources: Medline, Embase, SCOPUS, Cochrane CENTRAL, PROSPERO and Cochrane Library.

Review Methods: Systematic review and meta-analysis of indexed search terms relating to "Osia," "Osseointegration," "Cochlear Implant," and "Bone-Anchored Prosthesis" was performed from database inception to September 20, 2022.

Results: Of the 168 studies identified, 14 studies with 15 patient cohorts (n = 314) met inclusion criteria for meta-analysis. Pooled overall mean FG for all types of hearing loss was 35.0 dB sound pressure level (SPL) (95% confidence interval [CI] 29.12-40.97) compared against unaided hearing. Pooled FG for conductive/mixed hearing loss was 37.7 dB SPL (95% CI 26.1-49.3). Pooled single-sided deafness (SSD) FG could not be calculated due to the small patient cohort for whom SSD data was reported. There is a trend toward improvements in speech receptiveness threshold, signal to noise ratio, and some PROMs compared with baseline hearing. Early complication rates demonstrate risks similar to other transcutaneous implants, with a low predicted explantation (0.11%, 95% CI 0.00%-1.90%) and wound infection rate (1.92% [95% CI 0.00%-6.17%]). No articles directly comparing transcutaneous devices were identified.

Conclusion: The Osia devices demonstrate clear audiologic benefits and a good safety profile for the included patient population. Our study results indicate that frequency-specific gain, PROMs, and the audiological benefit in single-sided deafness may be areas for future prospective research. Laryngoscope, 134:1531-1539, 2024.