OBJECTIVES: An active middle ear implant (aMEI) was evaluated by the New Health Technology Assessment Committee in Korea in 2012 as a safe and effective technique for sensorineural hearing loss. However, for conductive hearing loss (CHL) and mixed hearing loss (MHL) it was determined a technique requiring further research due to insufficiency evidence. This systematic review aimed to evaluate safety and effectiveness of aMEI in CHL and MHL patients who do not expected achieve sufficient hearing gain with conventional treatment options.

METHODS: Ovid-MEDLINE, Ovid-EMBASE, Cochrane library and five Korean databases were searched on 27 January 2022. The risk of bias was assessed using the SIGN methodology checklist. The entire process was conducted in collaboration with otolaryngology experts.

RESULTS: Of the total 1,270 retrieved articles, 14 articles were selected. Three cohort studies compared aMEI to bone conduction hearing implants (BCHI) and twelve case-crossover studies compared aMEI with cHA in the same patient. The hearing thresholds in the range of 500 to 8000 Hz were significantly lower aMEI than cHA. The meta-analysis result based on five studies showed a significantly greater functional gain in aMEI compared to BCHI or cHA (Mean difference = 9.57 dB, 95% CI = 8.35, 10.78, I² = 0%). In four studies, speech discrimination was significantly better with aMEI compared to cHA. Patient satisfaction was higher with aMEI compared to cHA, but no differences with BCHI. Adverse events such as device dislocation, mild dizziness, wound infection, and facial palsy, were reported. However, these cases were rare and fully recovered with treatment. Additionally, there was no post-operative residual hearing loss.

CONCLUSIONS: aMEI has been proven to be a safe and effective option for hearing rehabilitation in CHL and MHL patients who do not achieve sufficient hearing gain with conventional treatments or unable to use cHA due to anatomical limitations.