Affiliation:
1. Faculty of Medicine and Health University of Sydney Camperdown New South Wales Australia
2. Department of Otolaryngology Head and Neck Surgery Canterbury Hospital Campsie New South Wales Australia
3. Department of Otolaryngology—Head and Neck Surgery Westmead Hospital Sydney New South Wales Australia
4. Department of Otolaryngology—Head and Neck Surgery John Hunter Hospital New Lambton Heights New South Wales Australia
5. School of Medicine and Public Health The University of Newcastle Callaghan New South Wales Australia
6. Faculty of Medicine Macquarie University Macquarie Park New South Wales Australia
7. Department of Otolaryngology—Head and Neck Surgery The Royal Children's Hospital Parkville Victoria Australia
Abstract
ObjectiveThis 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 SourcesMedline, Embase, SCOPUS, Cochrane CENTRAL, PROSPERO and Cochrane Library.Review MethodsSystematic 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.ResultsOf 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.ConclusionThe 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, 2023