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A Comparative Study of a Novel Adhesive Bone Conduction Device and Conventional Treatment Options for Conductive Hearing Loss.

ABSTRACT: OBJECTIVE:To compare the audiological performance with the novel adhesive bone conduction hearing device (ADHEAR) to that with a passive bone conduction (BC) implant and to that with a bone conduction device (BCD) on a softband. STUDY DESIGN:Prospective study in an acute setting, single-subject repeated measure in three situations: unaided, with conventional BCDs (passive implant or on softband), and with the ADHEAR. SETTING:Tertiary referral center. PATIENTS:Ten subjects with conductive hearing loss were evaluated with the ADHEAR. Five of these were users of a passive BC implant (Baha Attract with Baha4); five received a BCD (Baha4) on a softband for test purposes. INTERVENTION:Use of non-invasive adhesive bone conduction system for the treatment of conductive hearing loss. MAIN OUTCOME MEASURES:Air and bone conduction thresholds, sound field thresholds, word recognition scores in quiet, and speech recognition thresholds in quiet and noise were assessed. RESULTS:Users of the passive BC implant received comparable hearing benefit with the ADHEAR. The mean aided thresholds in sound field measurements and speech understanding in quiet and noise were similar, when subjects were evaluated either with the ADHEAR or the passive BC implant. The audiological outcomes for the non-implanted group were also comparable between the ADHEAR and the BCD on softband. CONCLUSIONS:Based on our initial data, the ADHEAR seems to be a suitable alternative for patients who need a hearing solution for conductive hearing loss but for medical reasons cannot or do not want to undergo surgery for a passive BC implant.

SUBMITTER: Skarzynski PH

PROVIDER: S-EPMC6641089 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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A Comparative Study of a Novel Adhesive Bone Conduction Device and Conventional Treatment Options for Conductive Hearing Loss.

Skarzynski Piotr H PH Ratuszniak Anna A Osinska Kamila K Koziel Magdalena M Krol Bartlomiej B Cywka Katarzyna B KB Skarzynski Henryk H

Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 20190801 7

<h4>Objective</h4>To compare the audiological performance with the novel adhesive bone conduction hearing device (ADHEAR) to that with a passive bone conduction (BC) implant and to that with a bone conduction device (BCD) on a softband.<h4>Study design</h4>Prospective study in an acute setting, single-subject repeated measure in three situations: unaided, with conventional BCDs (passive implant or on softband), and with the ADHEAR.<h4>Setting</h4>Tertiary referral center.<h4>Patients</h4>Ten sub ...[more]

PMID: 31295197

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Project description:ObjectivesThis study aims to characterize lateralization of sounds and localization of sounds in children with bilateral conductive hearing loss (BCHL) when listening with either one or two percutaneous bone conduction devices (BCDs).DesignSound lateralization was measured with the minimum audible angle test in which children were asked to indicate from which of the two visible speakers the sound originated. Sound localization was measured with a test in which stimuli were presented from speakers that were not visible to the children. In the sound localization test, 150 ms broadband noise bursts were presented, and sound level was roved over a 20-dB range. Because speakers were not visible the localization response was not affected by any visual cue. The sound localization test provides a clear distinction between lateralization and localization of sounds. Ten children with congenital BCHL and one child with acquired BCHL participated.ResultsBoth lateralization and sound localization were better with bilateral BCDs compared with the unilaterally aided conditions. In the bilateral BCD condition, lateralization was close to normal in nearly all the children. The localization test demonstrated lateralization rather than sound localization behavior when listening with bilateral BCDs. Furthermore, in the unilateral aided condition, stimuli presented at different sound levels were mainly perceived at the same location.ConclusionsThis study demonstrates that, in contrast to listening with two BCDs, children demonstrated difficulties in lateralization of sounds and in sound localization when listening with just one BCD (i.e., one BCD turned off). Because both lateralization and sound localization behavior were tested, it could be demonstrated that these children are more able to lateralize than localize sounds when listening with bilateral BCDs. The present study provides insight in (sub-optimal) sound localization capabilities of children with congenital BCHL in the unilateral-aided and bilateral-aided condition. Despite the sub-optimal results on sound localization, this study underlines the merits of bilateral application of BCDs in such children.

Project description:BackgroundIn 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.ObjectivesTo critically assess the current literature on safety, efficacy and subjective benefit after implantation with an active transcutaneous bone conduction hearing device.Data sourcesLiterature 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 criteriaRandomized controlled trials, clinical controlled trials and cohort studies, case series and case reports investigating subjective and objective outcomes.Study appraisal and synthesis methodsRetrieved 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.Results39 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.LimitationsA 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.ConclusionThe 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).

Dataset Information

A Comparative Study of a Novel Adhesive Bone Conduction Device and Conventional Treatment Options for Conductive Hearing Loss.

Publications

A Comparative Study of a Novel Adhesive Bone Conduction Device and Conventional Treatment Options for Conductive Hearing Loss.

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