title: Long-term Stability of the Active Middle-ear Implant with Floating-mass Transducer Technology: A Single-center Study.
abstract: OBJECTIVE
  To examine the long-term results of an active middle-ear implant (AMEI) with floating-mass transducer (FMT) technology.
  
  
  METHODS
  Prospective cohort study of German-speaking patients implanted with an AMEI between 2006 and 2013.
  
  
  METHODS
  Single-center study.
  
  
  METHODS
  Eighty-three patients.
  
  
  METHODS
  AMEI with FMT technology implantation.
  
  
  METHODS
  Long-term outcome (27 mo; range, 12-84 mo) for FMT position in correlation with pure-tone audiometry, auditory thresholds for frequency-modulated (warble) tones, vibroplasty thresholds for pure tones, and speech audiometry in quiet and noise.
  
  
  RESULTS
  In 15.6% of patients, a revision surgery was necessary to improve functional performance of the AMEI, and the highest revision rate was found with FMT coupling to the round window not using couplers. A peak number of revision surgeries were observed 3 years after the initial surgery. Stable audiological results (pure-tone audiometry and speech audiometry in quiet and noise) were observed up to 84-month post-surgery. Incus vibroplasty (classic indication) showed a significantly lower functional gain compared with oval and round window vibroplasty. Vibroplasty in combined or conductive hearing loss showed no functional difference between forward and reverse stimulation of the cochlea; however, significantly lower vibroplasty thresholds were detected when using a coupler.
  
  
  CONCLUSIONS
  The AMEI with FMT technology can be safely used in treatment of patients with mild-to-severe sensorineural, conductive, or mixed hearing loss. Optimized coupling, especially in incus vibroplasty, has to be developed to achieve enhanced audiological results.
authors.affiliation: *Department of Oto-Rhino-Laryngology, Plastic, Aesthetic and Reconstructive Head and Neck Surgery, Comprehensive Hearing Center, University of Wuerzburg, Würzburg †Department of Oto-Rhino-Laryngology, Head and Neck Surgery "Otto Körner," University Medical Center Rostock, Rostock, Germany.
authors.forename: Sebastian P
authors.initials: SP
authors.lastname: Schraven
authors.forename: Wilma
authors.initials: W
authors.lastname: Gromann
authors.forename: Kristen
authors.initials: K
authors.lastname: Rak
authors.forename: Wafaa
authors.initials: W
authors.lastname: Shehata-Dieler
authors.forename: Rudolf
authors.initials: R
authors.lastname: Hagen
authors.forename: Robert
authors.initials: R
authors.lastname: Mlynski
mesh_terms: D001309:Auditory Threshold / Q000502:physiology; D005260:Female; D034381:Hearing Loss / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009998:Ossicular Prosthesis; D011446:Prospective Studies; D012086:Reoperation; D014159:Transducers; D016896:Treatment Outcome; D055815:Young Adult