title: Stability, survival, and tolerability of a novel baha implant system: six-month data from a multicenter clinical investigation.
abstract: OBJECTIVE
  Determination of the difference in implant stability between a novel Baha implant system (test) and the previous-generation implant system (control).
  
  
  METHODS
  In an open, randomized, prospective multicenter clinical investigation, 77 adult patients with Baha implants were included. Test and control implants were randomly assigned in proportions of 2:1. Implant stability quotient (ISQ) values were recorded using resonance frequency analysis at the time of implantation and at 10 days, at 4, 6, 8, and 12 weeks, and at 6 months after surgery. Skin reactions were evaluated according to the Holgers classification. Sound processor fitting was performed from 6 weeks after implantation.
  
  
  RESULTS
  Significantly higher mean ISQ values, measured between 0 and 6 months, were obtained for test compared to control implants (70.4 versus 65.4, p < 0.0001). Statistically significant differences were obtained for the study population as a whole and for the subgroup of patients loaded at 6 ± 1 weeks after implant surgery (63.6% of patients). Up to 12 weeks, Holgers rates were comparable, whereas at 6 months, more skin reactions (Grades 1 and 2) were observed in the control implant group. No reduction in mean ISQ values was observed after implant loading.
  
  
  CONCLUSIONS
  The test implant showed higher mean ISQ values at the time of placement and over time. The level of osseointegration reached with the implants in adults as early as 6 weeks after implantation was sufficient to support the sound processor. The test implant system is expected to provide additional benefits related to the improvement of the degree of osseointegration, especially for patients with thin or compromised bone.
authors: Department of Otorhinolaryngology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre Nijmegen, The Netherlands.
authors: Catharina A J
authors: CA
authors: Dun
authors: Maarten J F
authors: MJ
authors: de Wolf
authors: Myrthe K S
authors: MK
authors: Hol
authors: Stina
authors: S
authors: Wigren
authors: Mans
authors: M
authors: Eeg-Olofsson
authors: Kevin
authors: K
authors: Green
authors: Anneli
authors: A
authors: Karlsmo
authors: Mark C
authors: MC
authors: Flynn
authors: Joacim
authors: J
authors: Stalfors
authors: Mike
authors: M
authors: Rothera
authors: Emmanuel A M
authors: EA
authors: Mylanus
authors: Cor W R J
authors: CW
authors: Cremers
mesh_terms: D000328:Adult; D000368:Aged; D001844:Bone Conduction; D005260:Female; D034381:Hearing Loss / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016348:Osseointegration; D009998:Ossicular Prosthesis / Q000009:adverse effects*; D011446:Prospective Studies; D016896:Treatment Outcome