title: Evolution of the reliability of the fully implantable middle ear transducer over successive generations.
abstract: OBJECTIVE
  To describe the reliability of the fully implantable middle ear transducer after successive technological changes.
  
  
  METHODS
  Prospective, observational, multicenter study.
  
  
  METHODS
  Eight tertiary referral centers.
  
  
  METHODS
  One hundred twenty-three adults were implanted with one of the five successive versions of the fully implantable middle ear implant between September 2005 and July 2012.
  
  
  METHODS
  The reliability of each generation 2 years after implantation or at the maximal lifetime was reported by means of survival curves. Only technological failures were considered; non-technological failures were excluded from the analysis of reliability.
  
  
  RESULTS
  One hundred fifty-seven devices were implanted during the period of study. Fifteen explantations were related to non-technological problems (e.g., infections, extrusions, etc.). One hundred forty-two implants were followed in the analysis of reliability. We observed 32 technical failures at 2 years. At the maximal lifetime of follow-up, 46 implants failed. The end of the follow-up was the first of November 2012. Survival rates at 2 years were 0%, 76.1%, 84.2%, 81.8%, and 100% for each of the successive available versions, respectively.
  
  
  CONCLUSIONS
  The reliability of the fully implantable middle ear implant improved over generations thanks to successive technological modifications that corrected the observed failures. The latest generation seems to be a reliable fully implantable middle ear implant system up to 22 months after implantation. The need to know the reliability of these active middle ear implants incites the creation of a follow-up register including patient's data and device failures to improve patient management.
authors: *Department of Otolaryngology, Hôpital E. Herriot, Université Lyon 1, Lyon, France; †Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche, Unité de Recherche Clinique, Lyon, France; ‡Université de Lyon, RECIF, EAM Santé Individu Société 4128, Lyon, France; §Université Lyon 1, Lyon, France; ∥Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Département d'Oto-neurochirurgie, Pierre-Bénite, France; ¶Department of Otolaryngology, University Hospital Nord, Assistance Publique Hôpitaux de Marseille and Laboratory of Applied Biomechanics, IFSTTAR UMR T24, Aix Marseille Universités, Marseille, France; #Service ORL et Chirurgie Cervico-Faciale CHU Gabriel Montpied et laboratoire de Biophysique Neurosensorielle, INSERM UMR 1107-63000, Clermont-Ferrand, France; **ENT and Skull Base Surgery Department, Hôpital Pellegrin, Bordeaux Cedex, France; ††University of Bordeaux, Bordeaux, France; and ‡‡Lyon Neuroscience Research Center, Brain Dynamics and Cognition Team, CRNL, INSERM U1028, CNRS UMR 5292, Lyon, France.
authors: Mathilde
authors: M
authors: Debeaupte
authors: Evelyne
authors: E
authors: Decullier
authors: Stephane
authors: S
authors: Tringali
authors: Arnaud
authors: A
authors: Devèze
authors: Thierry
authors: T
authors: Mom
authors: Vincent
authors: V
authors: Darrouzet
authors: Eric
authors: E
authors: Truy
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004432:Ear, Middle; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D034381:Hearing Loss / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009998:Ossicular Prosthesis; D011446:Prospective Studies; D015203:Reproducibility of Results; D014159:Transducers