First results with the active osseointegrated implant system Osia® in patients with single-sided deafness

Busch, Susan H.; Willenborg, Kerstin; Salcher, R; Lenarz, T; Maier, Hannes

doi:10.1055/s-0041-1728435

Cited by 2 publications

(14 citation statements)

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“…There were six cohort studies, 5,8,9,23,25,26 four case-series, 3,7,27,28 two case-control studies, 12,29 two administrative database studies, 12,30 and one case series abstract 31 included into the systematic review. One study included results for two cohorts and were treated as two separate cohorts: as a database study for complications, and case-control for clinical outcome data.…”

Section: Resultsmentioning

confidence: 99%

“…12 Nine studies were prospective, 3,[7][8][9]23,25,26,28,29 five were retrospective, 5,12,27,30 and one was unclear. 31 There were 308 patients with 327 unique implants. Of studies reporting type of hearing loss, most patients had CMHL (n = 188/236, 79.7%) compared with SSD (n = 48/236, 20.3%).…”

Section: Resultsmentioning

confidence: 99%

“…Audiological outcomes were reported in 12 studies (n = 195 patients, 212 implants). 5,[7][8][9]12,23,[25][26][27][28][29]31 FG was calculated by study authors in 10 studies, utilizing a variety of assessment methods (Supplement 2). 5,[7][8][9]12,23,25,26,28,29 All studies reporting PTA FG utilized 0.5-4 kHz frequencies.…”

Section: Audiological Outcomesmentioning

confidence: 99%

“…9,23 SRT in quiet was reported in 11 studies (n = 158 patients) utilizing an assortment of tests and noise levels. Seven studies used percentages of correct words, 8,9,12,23,28,29,31 and four studies used SRT threshold. 5,7,25,26 8,9 SRT in noise was reported in seven studies (n = 103 patients), wherein SNR for 50% intelligible speech was used in six studies.…”

Section: Audiological Outcomesmentioning

confidence: 99%

“…were collected in nine studies (n = 148). 5,8,9,12,23,25,28,29,31 Common measures were Abbreviated Profile of Hearing Aid Benefit (APHAB) (n = 123, six studies), 8,9,23,28,29,31 Speech, Spatial and Qualities of Hearing Scale-12 (SSQ12) (n = 111, four studies), 5,8,9,23 Health Utilities Index (HUI) (n = 102, three studies), 8,9,23 and Glasgow Benefit Inventory (GBI) (n = 29, three studies). 5,25,29 Some, but not all, studies, demonstrated improvement in quality of life using different PROM.…”

Section: Promsmentioning

confidence: 99%

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

Key,

Mohamed,

Da Cruz

et al. 2023

The Laryngoscope

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ObjectiveThis review aims to quantify the pooled functional gain (FG) in different types of hearing loss with the transcutaneous hearing device, Osia (Cochlear, Sydney, Australia) in comparison with the unaided state. Secondary outcomes are patient‐reported outcomes measures (PROMs) and complication rates.Data SourcesMedline, Embase, SCOPUS, Cochrane CENTRAL, PROSPERO and Cochrane Library.Review MethodsSystematic review and meta‐analysis of indexed search terms relating to “Osia,” “Osseointegration,” “Cochlear Implant,” and “Bone‐Anchored Prosthesis” was performed from database inception to September 20, 2022.ResultsOf the 168 studies identified, 14 studies with 15 patient cohorts (n = 314) met inclusion criteria for meta‐analysis. Pooled overall mean FG for all types of hearing loss was 35.0 dB sound pressure level (SPL) (95% confidence interval [CI] 29.12–40.97) compared against unaided hearing. Pooled FG for conductive/mixed hearing loss was 37.7 dB SPL (95% CI 26.1–49.3). Pooled single‐sided deafness (SSD) FG could not be calculated due to the small patient cohort for whom SSD data was reported. There is a trend toward improvements in speech receptiveness threshold, signal to noise ratio, and some PROMs compared with baseline hearing. Early complication rates demonstrate risks similar to other transcutaneous implants, with a low predicted explantation (0.11%, 95% CI 0.00%–1.90%) and wound infection rate (1.92% [95% CI 0.00%–6.17%]). No articles directly comparing transcutaneous devices were identified.ConclusionThe Osia devices demonstrate clear audiologic benefits and a good safety profile for the included patient population. Our study results indicate that frequency‐specific gain, PROMs, and the audiological benefit in single‐sided deafness may be areas for future prospective research. Laryngoscope, 2023

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Audiological Outcomesmentioning

confidence: 99%

Section: Audiological Outcomesmentioning

confidence: 99%

Section: Promsmentioning

confidence: 99%

See 3 more Smart Citations

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

Key,

Mohamed,

Da Cruz

et al. 2023

The Laryngoscope

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Minimally invasive subperiosteal pocket technique for Osia 2 system- implantation without fixation

Bere,

Nagy,

Posta

et al. 2024

Eur Arch Otorhinolaryngol

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The CochlearTM Osia® 2 is an active transcutaneous implant designed to treat patients with different types of hearing loss. Due to its size, implantation needs appropriate practice since the necessity of extended flap creation and bone work can be an issue in some cases. The goal of our study was to determine whether fixation of the OSI200 implant was necessary for the performance of patients with conductive or mild mixed hearing loss.The vibroacoustic performance of the Osia 2 system, with and without BI300 fixation, was evaluated through tests conducted on a head model. In addition, three patients underwent surgery using the modified minimally invasive subperiosteal pocket technique; the OSI200 implant was placed in a tight subperiosteal pocket without fixing it with the BI300 implant. To evaluate the audiological performance of the non-fixated Osia 2 system, we compared the preoperative unaided pure tone and suprathreshold testing with the Baha 5 sound processor and the non-fixated Osia 2 system aided thresholds.Initial results indicate that omitting fixation does not significantly impair the function of the Osia 2 system. The findings of the clinical assessment support the fact that the Osia 2 system performed better than the Baha 5 system on Softband, both in pure tone and suprathreshold tests.According to our results, we have found that utilizing the subperiosteal pocket method and implanting Osia 2 without BI300 fixation may be a viable option. This approach has shown promising results in terms of improving hearing ability with minimalization of surgery related complications.

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First results with the active osseointegrated implant system Osia® in patients with single-sided deafness

Cited by 2 publications

References 0 publications

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

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

Minimally invasive subperiosteal pocket technique for Osia 2 system- implantation without fixation

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