Abstract
Objective:
To evaluate the audiological outcomes and safety profile of the Vibrant Soundbridge middle ear implant in patients with moderate-to-severe sensorineural hearing loss. Databases reviewed: PubMed, Embase, Google Scholar, and the enrolled papers’ reference lists.
Methods:
A systematic literature review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The database search yielded 194 articles, of which 48 underwent full-text review. The extracted data included age, sex, length of follow-up period and functional hearing gain.
Results:
Twenty-three studies (917 ears) were included in the qualitative synthesis, of which 16 (648 ears) were suitable for quantitative meta-analysis. The mean (SD) preoperative pure-tone average was 56.69 (4.27) dB hearing level. The pooled mean functional gain was 24.29 dB (95% CI: 20.09-28.49;
P
I
²=99%). The overall complication rate over a mean follow-up period of 23.2 months was 8.3%, and the revision surgery rate over the same follow-up period was 6.2%. Internal device failure occurred in 1.7% (n=7/413) cases.
Conclusion:
The Vibrant Soundbridge provided significant functional hearing gain and demonstrated a favorable safety profile in patients with moderate-to-severe sensorineural hearing loss. It affords a promising alternative for individuals who do not benefit from conventional hearing aids.