Dataset Information

Long-term Outcomes of Bone Conduction Hearing Implants in Patients With Bilateral Microtia-atresia.

ABSTRACT:

Objectives

To evaluate the long-term outcomes of three different types of bone conduction hearing implants (BCHI)-BAHA, Ponto, and Bonebridge-in Mandarin-speaking patients with bilateral microtia-atresia.

Methods

This cohort study enrolled 59 patients affected by bilateral microtia-atresia, with an upper bone conduction threshold limit of 30?dB HL at frequencies of 0.5 to 4?kHz. All subjects underwent unilateral BCHI surgery, including 26 (18 males, 8 females, of mean age 8.7?±?1.9 yr) implanted with BAHA devices; 10 (7 males, 3 females, of mean age 11.7?±?2.8 yr) implanted with Ponto devices; and 23 (14 males, 9 females, of mean age 9.0?±?1.8 yr) implanted with Bonebridge devices. The main outcome measures included long-term audiological benefits, patient satisfaction, and complications. Each subject acted as his or her own control.

Results

Two years after BCHI surgery, the mean hearing thresholds in the BAHA, Ponto, and Bonebridge groups had improved to 22.6?±?1.6?dB HL, 21.6?±?1.2?dB HL, and 22.5?±?1.5?dB HL, respectively. The mean percentages of subjects in these three groups recognizing speech at 65?dB SPL under quiet conditions were 97.7?±?4.2%, 96.3?±?1.1%, and 94.4?±?9.4%, respectively, whereas the mean percentages recognizing speech under noise conditions (signal:noise ratio +5) were 87.0?±?1.8%, 89.3?±?9.3%, and 85.3?±?4.7%, respectively. Questionnaires revealed patients' benefits and satisfaction with this surgery. Three (11.5%) of 26 patients in the BAHA group and 1 (10%) of 10 in the Ponto group experienced skin irritation, but all recovered after local treatment. Five (19.2%) patients in the BAHA group and two (20%) in the Ponto experienced abutment extrusion about 6 months postoperatively, with all achieving good results after revision surgery to replace the abutment. One (3.8%) patient in the BAHA group experienced local chronic inflammation and underwent surgery to replace the BAHA with a Bonebridge implant. One (4.3%) patient in the Bonebridge group developed a local infection 3 months postoperatively and underwent implant removal.

Conclusions

All three BCHIs were well tolerated after long-term follow-up, and all improved audiometric thresholds and the intelligibility of speech in the presence of both quiet and noise. These implants should be considered valid and safe options for the functional rehabilitation of patients with bilateral microtia-atresia.

SUBMITTER: Fan X

PROVIDER: S-EPMC6733601 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Publications

Long-term Outcomes of Bone Conduction Hearing Implants in Patients With Bilateral Microtia-atresia.

Fan Xinmiao X Yang Tengyu T Niu Xiaomin X Wang Yibei Y Fan Yue Y Chen Xiaowei X

Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 20190901 8

<h4>Objectives</h4>To evaluate the long-term outcomes of three different types of bone conduction hearing implants (BCHI)-BAHA, Ponto, and Bonebridge-in Mandarin-speaking patients with bilateral microtia-atresia.<h4>Methods</h4>This cohort study enrolled 59 patients affected by bilateral microtia-atresia, with an upper bone conduction threshold limit of 30 dB HL at frequencies of 0.5 to 4 kHz. All subjects underwent unilateral BCHI surgery, including 26 (18 males, 8 females, of mean age 8.7 ± 1. ...[more]

PMID: 31318785

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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).

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:To compare implant stability, survival, and soft tissue reactions for a novel (test) and previous generation (control) percutaneous auditory osseointegrated implant for bone conduction hearing at long-term follow-up of 5 years.Single follow-up visit of a previously completed multicenter, randomized, controlled trial.Fifty-seven of the 77 participants of a completed randomized controlled trial on a new auditory osseointegrated implant underwent a single follow-up visit 5 years after implantation, which comprised implant stability measurements and collection of Holgers scores. Additionally, implant survival was recorded for all 77 patients from the original trial.The test implant showed significantly higher implant stability quotient (ISQ) values compared with the control implant throughout the 5-year follow-up. Mean area under the curve of ISQ high from baseline to 5 years was 71.6 (standard deviation [SD] ±2.0) and 66.7 (SD ±3.4) for the test and control implant, respectively (p?<?0.0001). For both implants, the mean ISQ value recorded at 5 years was higher compared with implantation (test group +2.03 [SD ±2.55, within group p?<?0.0001] and control group +2.25 [SD ±4.95, within group p?=?0.12]). No difference was noticed in increase from baseline between groups (p?=?0.64). Furthermore, evaluation of soft tissue reactions continued to show superiority of the test implant. At the 5-year follow-up visit, one patient (2.5%) presented with a Holgers grade 2 in the test group, compared with four patients (23.5%) in the control group (p?=?0.048); no patient presented with more severe soft tissue reactions. Excluding explantations, the survival rate was 95.8% for the test group and 95.0% for the control group. The corresponding rates including explantations were 93.9 and 90.0%.The test implant showed superiority in terms of higher mean ISQ values and less adverse soft tissue reactions, both at the single 5-year follow-up visit and during the complete follow-up. In addition, both implants showed an equally high implant survival.

Dataset Information

Long-term Outcomes of Bone Conduction Hearing Implants in Patients With Bilateral Microtia-atresia.

Objectives

Methods

Results

Conclusions

Publications

Long-term Outcomes of Bone Conduction Hearing Implants in Patients With Bilateral Microtia-atresia.

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