BACKGROUND: In July 2018 the active transcutaneous bone conduction hearing implant received FDA approval in the US (for patients 12 years and older with conductive and/or mixed hearing loss or single-sided deafness), reflecting the current trend of moving away from percutaneous hearing solutions towards intact skin systems.
OBJECTIVES: To critically assess the current literature on safety, efficacy and subjective benefit after implantation with an active transcutaneous bone conduction hearing device.
DATA SOURCES: Literature investigation was performed by electronic database search including PubMed and Cochrane Central Register of Controlled Trials, and manual search of relevant journals and reference lists of included studies.
STUDY ELIGIBILITY CRITERIA: Randomized controlled trials, clinical controlled trials and cohort studies, case series and case reports investigating subjective and objective outcomes.
STUDY APPRAISAL AND SYNTHESIS METHODS: Retrieved literature was screened and extracted by two reviewers independently. Subgroup analysis of indications (conductive and/or mixed hearing loss, single-sided deafness) and participant ages (pediatric vs. adults) was conducted on patients with active transcutaneous bone conduction devices. Sensitivity analysis was performed to test the stability of the results in meta-analysis.
RESULTS: 39 citations reporting on pre- and postoperative audiological results, speech performance in quiet and in noise, localization testing as well as subjective outcomes were included in this systematic review. Functional gain as well as word recognition score outcomes could be further investigated via meta-analysis. All outcomes reported and summarized here reflect beneficial audiological performance and high patient satisfaction, accompanied with a low complications rate (minor event incidence rate: 9.9 person-years; major incidence rate: 148.9 person-years) for the indications of conductive and mixed hearing loss as well as in individuals suffering from single-sided deafness for all age groups of subjects who underwent active transcutaneous bone conduction hearing device implantation.
LIMITATIONS: A limiting factor of this systematic review was the Level of Evidence of the reviewed literature, comprising 2a/3a studies (cohort studies and case-control studies). Furthermore, the reporting standards, especially in outcomes such as word recognition scores in quiet and in noise, vary across study cites from various countries, which impedes comparisons. Last but not least, no other comparable other device was retrieved as the active transcutaneous bone conduction hearing device is the only available at the moment.
CONCLUSION: The device's transcutaneous technology results in a minor event incidence rate of one in 9.9 person-years and a major incidence rate of one in 148.9 person-years. Based on the audiological outcomes, high patient satisfaction as well as the low complication rate, the authors recommend the active transcutaneous bone conduction hearing device as a safe and effective treatment for patients suffering from hearing loss within the device's indication criteria (conductive and/or mixed hearing loss or single-sided deafness).