The evaluation of a surgery and the short-term benefits of a new active bone conduction hearing implant - the Osia®

Gawęcki, Wojciech; Gibasiewicz, Renata; Marszał, Joanna; Błaszczyk, Magdalena; Gawłowska, Maria Bratumiła; Wierzbicka, Małgorzata

doi:10.1016/j.bjorl.2020.05.021

Cited by 19 publications

(25 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…There was no significant difference in operative length when comparing the standard technique to the minimally invasive technique previously described (10). This duration is comparable with that reported in Goldstein et al's CMR data, where a mean length of surgery of 52 minutes was reported across 44 procedures; other studies have reported operative times for device insertion of 71 to 119 minutes (7–9).…”

Section: Discussionsupporting

confidence: 85%

“…Piezoelectricity relies on the properties of certain crystals, ceramics, and polymers to bend under compressive and tensive forces in converting mechanical energy to electrical current or vice versa. To date, only a limited number of studies of the novel active transcutaneous piezoelectric BC implant have been published (7–9). The present study expands on this existing literature by examining audiometric and surgical outcomes among 23 subjects who have been implanted with the device.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Audiometric and Surgical Outcomes of a Novel Bone-Conduction Hearing Aid

Quimby¹,

Park²,

Brant³

et al. 2022

Otol Neurotol

View full text Add to dashboard Cite

Objective: To report the audiometric and surgical outcomes of a series of patients having undergone implantation of a novel transcutaneous bone conduction implant (t-BCI). Study Design: Retrospective case series. Setting: Single academic tertiary referral center. Patients: Adults (≥18 yr) implanted between December 1, 2019, and August 1, 2021, with audiometric data available before and after device implantation and a minimum of 4 weeks follow-up. Interventions: Surgical t-BCI. Main Outcome Measures: Change in aided pure tone average (PTA) after implantation. Secondary outcomes include average operative time, and adverse events. Results: Twenty-three patients underwent implantation of the t-BCI via either a conventional or minimally invasive surgical approach. The most common indication for implantation was unilateral conductive hearing loss with a history of chronic otitis media. The mean operative time was 59 minutes. The mean preimplantation unaided air conduction PTA was 65 dB, and mean postimplantation was 27.2 dB. The mean change in PTA was 37.8 dB, which was significant ( p < 0.0001). There were 30.4% of the patients that suffered from adverse events, the most common of which were pain (8.7%) and device-related complications (13%). One major adverse event occurred, involving magnet displacement that impaired device activation and required reoperation for replacement. Conclusion: Forming the largest series of patients implanted with this t-BCI in the published literature, our data demonstrate that implantation of the device is feasible via either a traditional or minimally invasive surgical approach, with good audiometric benefit and a favorable safety profile.

show abstract

Section: Discussionsupporting

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Audiometric and Surgical Outcomes of a Novel Bone-Conduction Hearing Aid

Quimby¹,

Park²,

Brant³

et al. 2022

Otol Neurotol

View full text Add to dashboard Cite

show abstract

“…Osia does also provide a benefit for speech recognition in noise [ 4 , 8 ]. Subjective evaluation using the SSQ, APHAB, and HUI showed benefit for Osia recipients [ 8 , 11 – 13 ], and our long-term data revealed the largest benefit at > 36 months of Osia experience.…”

Section: Discussionmentioning

confidence: 67%

“…Gawecki et al (2020) showed higher speech recognition scores as well as larger self-reported QoL with the Osia compared to the Baha Attract [ 11 ], while Pla-Gil et al (2021) compared a control group of ten patients using a Baha 5 Power Connect with a group of 10 Osia 1 patients and found a comparable hearing performance in terms of both audiological and subjective outcomes [ 13 ]. As a consequence, Osia can be regarded as similarly effective treatment to other percutaneous BAHS with the highest audiological output, and as superior to other transcutaneous bone conduction devices (Ellsperman et al (2021) provided an overview [ 14 ]).…”

Section: Discussionmentioning

confidence: 99%

Long-term data of the new transcutaneous partially implantable bone conduction hearing system Osia®

Rauch

Wesarg

Aschendorff

et al. 2021

Eur Arch Otorhinolaryngol

View full text Add to dashboard Cite

Purpose The new active transcutaneous partially implantable osseointegrated system Cochlear™ Osia® System is indicated in case of conductive or mixed hearing loss (CHL/MHL) with a maximum average bone conduction hearing loss of 55 dB, or in single-sided deafness (SSD). The implant directly stimulates the bone via a piezoelectric transducer and is directed by an external sound processor. We conducted a monocentric retrospective longitudinal within-subject clinical study at our tertiary academic referral center. The aim was to investigate long-term data (2017–2021) on audiological outcomes and hearing-related quality of life for the Osia system. Methods Between 2017 and 2020, 22 adults (18: CHL/MHL; 3: SSD) were implanted with the Osia100 implant; seven received bilateral implants. As of 10/2020, the sound processor was upgraded to Osia 2. Results Mean Osia system use by 04/2021 was 30.9 ± 8.6 months (range 17–40 months). Unaided bone conduction thresholds were unchanged postoperatively. One patient had to be explanted because of prolonged wound infection. Aided hearing thresholds were significantly lower compared to the unaided thresholds preoperatively, along with a marked increase in speech recognition in quiet. Speech processor upgrade resulted in a stable benefit. Patients with CHL/MHL and SSD showed a similar improvement in self-rated hearing performance revealed by SSQ, APHAB, and HUI questionnaires. Conclusion The Osia system is a safe, effective and sustainable option for treatment of conductive and mixed hearing loss or single-sided deafness.

show abstract

“…Second generation Vistafix implants (dimensions: full implant length 5.35 mm, bone embedded length 4 mm, and diameter 4.475 mm; the diameter of the collar at its widest point 5.2 mm [10]) are implanted in the bones of the skull, most often in the temporal bone, zygomatic bone, frontal bone, maxilla [3,8,10,42]. According to the literature on the anatomy and surgery of laryngological hearing implant implantation, it appears that the thickness of the temporal bone in places of implantation is at least 5.55 ± 1.46 mm on average, and it even reaches 11.15 ± 1.86 mm [43][44][45][46]. Therefore, following the anatomy of the skull and the dimensions of the implant itself, the selected model allows you to freely create a hole for the VXI300 implant (without damaging the side walls of the cube) and the entire surface.…”

Section: Evaluation Of the Printout Of Calibration Models And The Cou...mentioning

confidence: 99%

Surgery Training System Supported by Organic Materials

et al. 2022

Self Cite

View full text Add to dashboard Cite

The aim of the study was the qualitative assessment of new materials based on a polycarbonate matrix in terms of its use in 3D printing and its processing and geometric modification (cutting). Filaments made of the new material doped with talc in five different proportions were visually inspected with a microscope. The calibration and test models were made using the FFF (fused filament fabrication) technique. In addition, its susceptibility to the drill and the behavior of the shavings were assessed and the temperature changing during drilling was measured. The implant was inserted to measure its resonance stability in each of the holes made and translated into the value of the implant stability quotient (ISQ) ranging from 1 to 100. The results were compared to those obtained for the training model of the skull bone. The amount of filler has been shown to affect the composite. Moreover, due to the properties of talc, a compatibilizer (polyol) was used. Differences were observed between the model made of the commercial material, the model made of the dried, tested material, and the model made of the undried material. It was confirmed that the presence of water in the material during its processing is important.

show abstract

The evaluation of a surgery and the short-term benefits of a new active bone conduction hearing implant - the Osia®

Cited by 19 publications

References 14 publications

Audiometric and Surgical Outcomes of a Novel Bone-Conduction Hearing Aid

Audiometric and Surgical Outcomes of a Novel Bone-Conduction Hearing Aid

Long-term data of the new transcutaneous partially implantable bone conduction hearing system Osia®

Surgery Training System Supported by Organic Materials

Contact Info

Product

Resources

About