OBJECTIVE: To clinically evaluate the performance of a titanium percutaneous bone-anchored hearing implant (BAHI) using a 3-week healing period. Short-term implant survival, stability changes, and skin reactions are evaluated from the initial implantation to 6 months postimplantation. METHODS: Thirty patients eligible for a BAHI were included in an open, prospective clinical investigation. Implant stability quotient (ISQ) values were recorded using resonance frequency analysis (RFA) at the time of implantation and at 10 days; at 3, 6, and 12 weeks; and at 6 months after placement of the implant. Sound processor fitting was performed 3 weeks after implantation. Skin reactions were evaluated according to the Holgers classification. RESULTS: One implant was lost 3 days after implantation because of poor bone quality. No implant loss occurred in the remaining 29 patients (96.7%). The mean ISQ value at the time of implantation was 67.1 (range, 44-71). Compared with baseline, there was a significant dip of -2.2 ISQ units at 10 days (mean, 65.7; p = 0.0093). There was a positive change in mean ISQ compared with baseline over the subsequent visits. No reduction in mean ISQ values was observed after implant loading. Skin reactions were observed incidentally (mean over all visits, 9.7%) and were generally mild (Holgers Grade 1; mean 9.0%). An adverse skin reaction (Holgers Grade 2) was observed only once (mean, 0.7%). CONCLUSION: The current study suggests that loading the implant and 6-mm abutment with the sound processor at 3 weeks is safe. The stability of the implant as measured by ISQ values had reached its baseline value within 3 weeks after implantation. The degree of stability was not affected by implant loading. Only mild skin reactions were observed incidentally. This study supports the use of early loading at 3 weeks as current practice in healthy adults with good bone quality; thus, these adults can benefit from the rehabilitation of their hearing at an earlier stage.
OBJECTIVE: To clinically evaluate the performance of a titanium percutaneous bone-anchored hearing implant (BAHI) using a 3-week healing period. Short-term implant survival, stability changes, and skin reactions are evaluated from the initial implantation to 6 months postimplantation. METHODS: Thirty patients eligible for a BAHI were included in an open, prospective clinical investigation. Implant stability quotient (ISQ) values were recorded using resonance frequency analysis (RFA) at the time of implantation and at 10 days; at 3, 6, and 12 weeks; and at 6 months after placement of the implant. Sound processor fitting was performed 3 weeks after implantation. Skin reactions were evaluated according to the Holgers classification. RESULTS: One implant was lost 3 days after implantation because of poor bone quality. No implant loss occurred in the remaining 29 patients (96.7%). The mean ISQ value at the time of implantation was 67.1 (range, 44-71). Compared with baseline, there was a significant dip of -2.2 ISQ units at 10 days (mean, 65.7; p = 0.0093). There was a positive change in mean ISQ compared with baseline over the subsequent visits. No reduction in mean ISQ values was observed after implant loading. Skin reactions were observed incidentally (mean over all visits, 9.7%) and were generally mild (Holgers Grade 1; mean 9.0%). An adverse skin reaction (Holgers Grade 2) was observed only once (mean, 0.7%). CONCLUSION: The current study suggests that loading the implant and 6-mm abutment with the sound processor at 3 weeks is safe. The stability of the implant as measured by ISQ values had reached its baseline value within 3 weeks after implantation. The degree of stability was not affected by implant loading. Only mild skin reactions were observed incidentally. This study supports the use of early loading at 3 weeks as current practice in healthy adults with good bone quality; thus, these adults can benefit from the rehabilitation of their hearing at an earlier stage.
Authors: Rik C Nelissen; Emmanuel A M Mylanus; Henricus P M Kunst; Ronald J E Pennings; Ad F M Snik; Myrthe K S Hol Journal: Eur Arch Otorhinolaryngol Date: 2013-01-29 Impact factor: 2.503
Authors: Rik C Nelissen; Christine A den Besten; Hubert T Faber; Catharina A J Dun; Emmanuel A M Mylanus; Myrthe K S Hol Journal: Eur Arch Otorhinolaryngol Date: 2015-08-14 Impact factor: 2.503
Authors: Rik C Nelissen; Christine A den Besten; Emmanuel A M Mylanus; Myrthe K S Hol Journal: Eur Arch Otorhinolaryngol Date: 2015-03-20 Impact factor: 2.503
Authors: Christine A den Besten; Joacim Stalfors; Stina Wigren; Johan Ivarsson Blechert; Mark Flynn; Måns Eeg-Olofsson; Rohini Aggarwal; Kevin Green; Rik C Nelissen; Emmanuel A M Mylanus; Myrthe K S Hol Journal: Otol Neurotol Date: 2016-09 Impact factor: 2.311
Authors: Tim G A Calon; Marc van Hoof; Herbert van den Berge; Arthur J G de Bruijn; Joost van Tongeren; Janny R Hof; Jan Wouter Brunings; Sofia Jonhede; Lucien J C Anteunis; Miranda Janssen; Manuela A Joore; Marcus Holmberg; Martin L Johansson; Robert J Stokroos Journal: Trials Date: 2016-11-09 Impact factor: 2.279