title: Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results.
abstract: To evaluate the safety and effectiveness of round window (RW), oval window (OW), CliP and Bell couplers for use with an active middle ear implant.
  
  
  
  This is a multicenter, long-term, prospective trial with consecutive enrollment, involving 6 university hospitals in Germany. Bone conduction, air conduction, implant-aided warble-tone thresholds and Freiburger monosyllable word recognition scores were compared with unaided preimplantation results in 28 moderate-to-profound hearing-impaired patients after 12 months of follow-up. All patients had previously undergone failed reconstruction surgeries (up to 5 or more). In a subset of patients, additional speech tests at 12 months postoperatively were used to compare the aided with the unaided condition after implantation with the processor switched off. An established quality-of-life questionnaire for hearing aids was used to determine patient satisfaction.
  
  
  
  Postoperative bone conduction remained stable. Mean functional gain for all couplers was 37 dB HL (RW = 42 dB, OW = 35 dB, Bell = 38 dB, CliP = 27 dB). The mean postoperative Freiburger monosyllable score was 71% at 65 dB SPL. The postimplantation mean SRT50 (speech reception in quiet for 50% understanding of words in sentences) improved on average by 23 dB over unaided testing and signal-to-noise ratios also improved in all patients. The International Outcome Inventory for Hearing Aids (IOI-HA)quality-of-life questionnaire was scored very positively by all patients.
  
  
  
  A significant improvement was seen with all couplers, and patients were satisfied with the device at 12 months postoperatively. These results demonstrate that an active implant is an advantage in achieving good hearing benefit in patients with prior failed reconstruction surgery.
authors.affiliation: Department of Medicine, Clinic of Otorhinolaryngology, Head and Neck Surgery, Technical University of Dresden, Dresden, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zahnert
authors.forename: Hubert
authors.initials: H
authors.lastname: Löwenheim
authors.forename: Dirk
authors.initials: D
authors.lastname: Beutner
authors.forename: Rudolf
authors.initials: R
authors.lastname: Hagen
authors.forename: Arneborg
authors.initials: A
authors.lastname: Ernst
authors.forename: Hans-Wilhelm
authors.initials: HW
authors.lastname: Pau
authors.forename: Thorsten
authors.initials: T
authors.lastname: Zehlicke
authors.forename: Hilke
authors.initials: H
authors.lastname: Kühne
authors.forename: Natascha
authors.initials: N
authors.lastname: Friese
authors.forename: Anke
authors.initials: A
authors.lastname: Tropitzsch
authors.forename: Jan-Christoffer
authors.initials: JC
authors.lastname: Lüers
authors.forename: Robert
authors.initials: R
authors.lastname: Mlynski
authors.forename: Ingo
authors.initials: I
authors.lastname: Todt
authors.forename: Karl-Bernd
authors.initials: KB
authors.lastname: Hüttenbrink
mesh_terms: D000328:Adult; D000368:Aged; D001844:Bone Conduction; D004432:Ear, Middle; D005260:Female; D005858:Germany; D006309:Hearing; D006310:Hearing Aids; D006314:Hearing Loss, Conductive / Q000534:rehabilitation*; D046089:Hearing Loss, Mixed Conductive-Sensorineural / Q000534:rehabilitation*; D006320:Hearing Tests; D006801:Humans; D008297:Male; D008875:Middle Aged; D009998:Ossicular Prosthesis; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D012405:Round Window, Ear; D059629:Signal-To-Noise Ratio; D013067:Speech Perception; D011795:Surveys and Questionnaires; D016896:Treatment Outcome