Systematic Review and Meta‐Analysis of a New Active Transcutaneous Bone Conduction Implant

Key, Seraphina; Mohamed, Nusrat; Da Cruz, Melville; Kong, Kelvin; Hasan, Zubair

doi:10.1002/lary.31053

Cited by 3 publications

(3 citation statements)

References 28 publications

(343 reference statements)

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“…The surgical outcome revealed no major complications, aligning with the results from the recent published systematic review by Key et al [3], comprising 14 studies on Osia devices, which indicated a risk profile similar to that of other transcutaneous devices, with a low infection and explantation rate.…”

Section: Surgical Efficacysupporting

confidence: 85%

“…The significance of bone conduction hearing implants (BCHIs) has grown considerably in recent years, particularly for patients with conductive or mixed hearing loss, as well as those with single-sided deafness (SSD) [ 1 ]. BCHIs are currently categorized into passive percutaneous, passive transcutaneous and active transcutaneous devices [ 2 , 3 ]. For a significant period, passive bone conducting systems, which comprise an external sound processor and a transducer positioned behind the ear, have dominated the field.…”

Section: Introductionmentioning

confidence: 99%

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Piezoelectric Bone Conduction Hearing Implant: A Case Series of Audiological, Surgical and Patient-Reported Outcomes

Vagle,

Bille,

Gordon Jensen

2024

JCM

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Objective: To examine the surgical, audiological and patient-reported outcomes of the Osia 2 implant. Methods: Data from 14 consecutive subjects undergoing implantation between April 2022 and November 2023 were reviewed. Ten subjects had conductive hearing loss, three had mixed hearing loss and one had single-sided deafness (SSD). Warble tone thresholds, Pure Tone Average (PTA4) and Speech Discrimination Score (SDS) in quiet and in noise were determined unaided and aided. The subjective outcome was determined from two standardized questionnaires: (1) International Outcome Inventory for Hearing Aids (IOI-HA) and (2) Speech, Spatial and Qualities of Hearing Scale 12 (SSQ12b). Results: Unexpected postoperative pain was found in four cases. The warble tone thresholds exhibited a consistent reduction across all frequencies, contributing to a mean decrease of 27 dB in the aided PTA4. SDS demonstrated notable improvements, with a 57.3% increase at 50 dB and a 55.6% increase at 65 dB. In noise, SDS exhibited a 43.9% improvement. The mean IOI-HA Score was 3.8, and the mean overall score for SSQ12b was 6.6, with consistent findings across the subgroups. Conclusions: The Osia device emerges as a promising recommendation for individuals with conductive or mixed hearing loss, possibly also for those with SSD. Its safety and efficacy profile aligns with the broader category of active transcutaneous devices, demonstrating a reduced risk of wound infection compared to percutaneous alternatives. Both audiological assessments and subjective evaluations revealed positive outcomes.

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Section: Surgical Efficacysupporting

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Piezoelectric Bone Conduction Hearing Implant: A Case Series of Audiological, Surgical and Patient-Reported Outcomes

Vagle,

Bille,

Gordon Jensen

2024

JCM

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“…A recent review focusing on the Osia systems reported an overall complication rate of 2.61%, demonstrating a commendable safety profile. 48 Additionally, while data on pediatric patients remain limited, recent studies highlight acceptable surgical and audiological outcomes in this population. 49,50 In cases of more limited bone availability, the use of lifts remains a viable option.…”

Section: Surgical Outcomesmentioning

confidence: 99%

Early Results With the New Active Bone‐Conduction Hearing Implant: A Systematic Review and Meta‐Analysis

Lein,

Baumgartner,

Riss

et al. 2024

Otolaryngol.--head neck surg.

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ObjectiveThe bone conduction implant (BCI) 602 is a new transcutaneous BCI with smaller dimensions. However, limited patient numbers restrict the statistical power and generalizability of the current studies. The present systematic review and meta‐analysis summarize early audiological and medical outcomes of adult and pediatric patients implanted with the BCI 602 due to mixed or conductive hearing loss.Data SourceFollowing the Preferred Reporting items for Systematic Reviews and Meta‐analyses guidelines, 108 studies were reviewed, and 6 (5.6%) were included in the meta‐analysis.Review MethodThe data on study and patient characteristics, surgical outcomes, and audiological test results were extracted from each article. Meta‐analysis employed the fixed‐effect and random‐effects models to analyze the mean differences (MDs) between pre‐ and postoperative performances.ResultsIn total, 116 patients were evaluated, including 64 (55%) adult and 52 (45%) pediatric patients. No intraoperative adverse events were reported, while postoperative complications were reported in 2 (3.1%) adult and 2 (3.8%) pediatric patients. Studies consistently showed significant improvements in audiological outcomes, quality of life, and sound localization in the aided condition. In the meta‐analysis, we observed a significant difference in the unaided compared to the aided condition in sound field thresholds (n = 112; MD, −27.05 dB; P < 0.01), signal‐to‐noise ratio (n = 96; MD, −6.35 dB; P < 0.01), and word recognition scores (n = 96; MD, 68.89%; P < 0.01).ConclusionThe implantation of the BCI 602 was associated with minimal surgical complications and excellent audiological outcomes for both the pediatric and the adult cohort. Therefore, our analysis indicates a high level of safety and reliability. Further research should focus on direct comparisons with other BCIs and long‐term functional outcomes.

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Clinical Outcomes of an Active, Transcutaneous, Bone Conduction Hearing Device: A Retrospective Study

Jukic,

Cismas,

Flores

et al. 2024

Otolaryngol.--head neck surg.

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ObjectiveThe purpose of this study was to review patient demographics, indications, intraoperative findings, complications/adverse events, and audiological outcomes related to the implantation of the Osia 2 device.Study DesignRetrospective case series.SettingSingle tertiary institutional experience.MethodsPatients who had undergone Osia 2 implantation by the senior author were identified from 2019 to present. Information was extracted from patient charts concerning patient demographics, indications for implantation, surgical findings, audiological outcomes, and adverse events.ResultsSixty patients and 67 implants were included. The median age was 51 years (R: 11‐92). Fifty‐five percent of patients had mixed hearing loss (HL), 30% had single‐sided deafness, and 15% had conductive HL. The mean operative time was 53.9 minutes. Only 4.5% of patients required bone polishing, and 3.0% required tissue thinning. The mean pure‐tone averages 4 gain from unaided conditions was 41.2 dB. Mean gain at 6 and 8 kHz from unaided conditions was 35.42 and 40.67 dB, respectively. Mean improvement in speech recognition threshold and word recognition score was significant in noise and quiet conditions. The all‐cause adverse event/complication rate in our series was 10.4%. The most common complications were infections (4.5%) and poorly controlled postoperative pain (3.0%). Hematomas occurred in 1.5% of patients. Reoperation was required in 4 patients; explant in 1.ConclusionUse of the Osia 2 device in our series has resulted in good hearing outcomes, particularly in terms of high frequency gain. Complication rates were low. To our knowledge, this is the largest study to date reporting on Osia 2 outcomes.

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Systematic Review and Meta‐Analysis of a New Active Transcutaneous Bone Conduction Implant

Cited by 3 publications

References 28 publications

Piezoelectric Bone Conduction Hearing Implant: A Case Series of Audiological, Surgical and Patient-Reported Outcomes

Piezoelectric Bone Conduction Hearing Implant: A Case Series of Audiological, Surgical and Patient-Reported Outcomes

Early Results With the New Active Bone‐Conduction Hearing Implant: A Systematic Review and Meta‐Analysis

Clinical Outcomes of an Active, Transcutaneous, Bone Conduction Hearing Device: A Retrospective Study

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