Management of conductive hearing loss with implantable bone conduction devices

To summarize available peer-reviewed literature to describe the range and rate of complications related to osseointegrated hearing aids in adult and pediatric patients. We searched PubMed using the terms bone-anchored hearing aid for articles published in English between 2000 and 2011. We included all articles reporting complications rates, except those that were case reports, general review (not systematic review), or commentary, as well as those that did not include patient outcomes, that reported outcomes associated with nonstandard implantation (e.g., 8.5-mm abutment) or were of poor study or reporting quality. After excluding articles that did not meet criteria, 20 articles were identified, comprising 2,134 patients who underwent a total of 2,310 osseoimplants. Complications reported in the literature were typically minor in nature. Skin reactions from Holgers Grade 2 to 4 ranged from 2.4% to 38.1%. Failure of osseointegration ranged from 0% to 18% in adult and mixed populations, and 0% to 14.3% in pediatric populations. The rate of revision surgery ranges from 1.7% to 34.5% in adult and mixed populations and 0.0% to 44.4% in pediatric patients, whereas the total rate of implant loss ranged from 1.6% to 17.4% in adult and mixed populations and from 0.0% to 25% in pediatric patients. Overall, the quality of large scale and/or prospective studies reporting the incidence of complications after osseointegrated hearing aid surgery is poor and lacks uniformity. However, based on available data, which shows a lack of major complications, osseointegrated implantation is a safe procedure in both adult and pediatric populations. Well-designed, prospective studies with uniform reporting standards would allow greater comparison between techniques and more reliable analysis of complications of osseointegration surgery of the temporal bone for cochlear stimulation. Show more

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). Show more

After more than 25 years of clinical experience, the BAHA (bone-anchored hearing aid) system is a well-established treatment for hearing-impaired patients with conductive or mixed hearing loss. Owing to its success, the use of the BAHA system has spread and the indications for application have gradually become broader. New indications, as well as clinical applications, were discussed during scientific roundtable meetings in 2004 by experts in the field, and the outcomes of these discussions are presented in the form of statements. The issues that were discussed concerned BAHA surgery, the fitting range of the BAHA system, the BAHA system compared to conventional devices, bilateral application, the BAHA system in children, the BAHA system in patients with single-sided deafness, and, finally, the BAHA system in patients with unilateral conductive hearing loss. Show more