title: Active Middle Ear Implantation: Long-term Medical and Technical Follow-up, Implant Survival, and Complications.
abstract: To evaluate the long-term medical and technical results, implant survival, and complications of the semi-implantable vibrant soundbridge (VSB), otologics middle ear transducer (MET), and the otologics fully implantable ossicular stimulator (FIMOS).
  
  
  
  Retrospective cohort study.
  
  
  
  Patients with chronic external otitis and either moderate to severe sensorineural or conductive/mixed hearing loss.
  
  
  
  Tertiary referral center.
  
  
  
  Implantation with the VSB, MET, or FIMOS.
  
  
  
  Medical complications, number of reimplantations, and explantations.
  
  
  
  Ninety-four patients were implanted, 12 patients with a round window or stapes application. 28 patients were lost to follow-up. The average follow-up duration was 4.4 years (range, 1 month-15 years). 128 devices were evaluated: (92 VSB, 32 MET, 4 FIMOS). 36 devices (28%) have been explanted or replaced (18 VSB, 14 MET, 4 FIMOS). Device failure was 7% for VSB, 28% for MET, and 100% for FIMOS. In 16 patients (17%) revision surgery (n = 20) was performed. Twenty patients (21%) suffered any medical complication.
  
  
  
  Medical and technical complications and device failures have mostly occurred in the initial period of active middle ear implants (AMEI) implementation and during clinical trials or experimental procedures. All four FIMOS had technical difficulties. An important decrease in the occurrence of both medical and technical complications was observed. Application in more recent years did not show any complications and the recent device failure rates are acceptable. Magnetic resonance imaging (MRI) incompatibility should be taken into account when indicating AMEI.
authors.affiliation: Department of Otorhinolaryngology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Joost W
authors.initials: JW
authors.lastname: Zwartenkot
authors.forename: Jef J S
authors.initials: JJ
authors.lastname: Mulder
authors.forename: Ad F M
authors.initials: AF
authors.lastname: Snik
authors.forename: Cor W R J
authors.initials: CW
authors.lastname: Cremers
authors.forename: Emmanuel A M
authors.initials: EA
authors.lastname: Mylanus
mesh_terms: D000368:Aged; D015331:Cohort Studies; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006314:Hearing Loss, Conductive / Q000601:surgery*; D006801:Humans; D008875:Middle Aged; D009998:Ossicular Prosthesis; D013506:Otologic Surgical Procedures / Q000295:instrumentation*; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000453:epidemiology*; D012189:Retrospective Studies; D012405:Round Window, Ear / Q000601:surgery; D016896:Treatment Outcome