title: Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing: Long-Term Follow-Up of a Randomized Controlled Trial.
abstract: 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.
  
  
  
  Single follow-up visit of a previously completed multicenter, randomized, controlled trial.
  
  
  
  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.
  
  
  
  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%.
  
  
  
  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.
authors.affiliation: *Department of Otorhinolaryngology, Radboud University Medical Center, Nijmegen, The Netherlands †Department of Otorhinolaryngology, Sahlgrenska University Hospital, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden ‡Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden §Department of Otorhinolaryngology, Salford Royal Hospital, Salford, United Kingdom ||Department of Otorhinolaryngology, Manchester Royal Infirmary, Manchester, United Kingdom.
authors.forename: Christine A
authors.initials: CA
authors.lastname: den Besten
authors.forename: Joacim
authors.initials: J
authors.lastname: Stalfors
authors.forename: Stina
authors.initials: S
authors.lastname: Wigren
authors.forename: Johan Ivarsson
authors.initials: JI
authors.lastname: Blechert
authors.forename: Mark
authors.initials: M
authors.lastname: Flynn
authors.forename: Måns
authors.initials: M
authors.lastname: Eeg-Olofsson
authors.forename: Rohini
authors.initials: R
authors.lastname: Aggarwal
authors.forename: Kevin
authors.initials: K
authors.lastname: Green
authors.forename: Rik C
authors.initials: RC
authors.lastname: Nelissen
authors.forename: Emmanuel A M
authors.initials: EA
authors.lastname: Mylanus
authors.forename: Myrthe K S
authors.initials: MK
authors.lastname: Hol
mesh_terms: D000328:Adult; D000368:Aged; D001844:Bone Conduction; D005260:Female; D005500:Follow-Up Studies; D006310:Hearing Aids; D034381:Hearing Loss; D006801:Humans; D008297:Male; D008875:Middle Aged; D016348:Osseointegration; D011183:Postoperative Complications / Q000453:epidemiology*; D019736:Prostheses and Implants / Q000009:adverse effects; D016896:Treatment Outcome