| 1. |
- den Besten, C. A., et al.
(författare)
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Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing: Long-Term Follow-Up of a Randomized Controlled Trial
- 2016
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Ingår i: Otology & Neurotology. - : Ovid Technologies (Wolters Kluwer Health). - 1531-7129. ; 37:8, s. 1077-1083
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Tidskriftsartikel (refereegranskat)abstract
- Objective: 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. Study Design: Single follow-up visit of a previously completed multicenter, randomized, controlled trial. Patients: 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. Results: 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%. Conclusion: 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.
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| 2. |
- Eeg-Olofsson, Måns, 1967, et al.
(författare)
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BCI-bone conduction implant.
- 2013
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Ingår i: The Fourth International Symposium on Bone Conduction Hearing – Craniofacial Osseointegration. Newcastle, UK.
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)
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| 5. |
- Eeg-Olofsson, Måns, 1967, et al.
(författare)
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Evaluation of bone tissue formation in a flat surface attachment of a Bone Conduction Implant - A pilot study in a sheep model
- 2014
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Ingår i: Audiology & Neurotology Extra. - : S. Karger AG. - 1664-5537. ; 4:3, s. 62-76
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Tidskriftsartikel (refereegranskat)abstract
- The Bone Conduction Implant (BCI) is a new bone conduction hearing device implanted under intact skin. The transducer has a flat direct contact to the mastoid part of the temporal bone and no screws are used. The sound signal is transmitted from the external audio processor to the implant by means of magnetic induction. In this study, osseointegration of a flat passive BCI transducer dummy in sheep skulls was assessed using quantitative and qualitative histology as well as Cone Beam Computed Tomography (CBCT) and Computed Tomography (CT). The histology results were also related to the mechanical properties of the bone to implant interface. Eight months after the surgical implantation, histology sections of the bone close to the implant showed bone remodelling, compact bone and some degree of osseointegration. The histological findings corresponded well to the mechanical measurements indicating stiffer bone close to the implant, and unaffected skull vibration transmission. Neither CBCT nor CT had enough resolution to visualize the bone to implant interface in detail. In this study, using an animal model, it is shown that a flat implant in contact with bone, can be a feasible method for efficient vibration transmission to the skull bone.
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| 6. |
- Eeg-Olofsson, Måns, 1967, et al.
(författare)
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Implications for contralateral bone-conducted transmission as measured by cochlear vibrations.
- 2011
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Ingår i: Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology. - : LWW. - 1537-4505 .- 1531-7129. ; 32:2, s. 192-8
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Tidskriftsartikel (refereegranskat)abstract
- The velocity response at the contralateral cochlea from bone-conducted (BC) stimulation depends on the stimulation position.
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