TY  - JOUR
A1  - Zahnert, Thomas
A1  - Löwenheim, Hubert
A1  - Beutner, Dirk
A1  - Hagen, Rudolf
A1  - Ernst, Arneborg
A1  - Pau, Hans-Wilhelm
A1  - Zehlicke, Thorsten
A1  - Kühne, Hilke
A1  - Friese, Natascha
A1  - Tropitzsch, Anke
A1  - Lüers, Jan-Christoffer
A1  - Mlynski, Robert
A1  - Todt, Ingo
A1  - Hüttenbrink, Karl-Bernd
T1  - Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results
JF  - Audiology and Neurotology
N2  - Objective: 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. Methods: 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. Results: 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 SRT<sub>50</sub> (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. Conclusion: 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.
KW  - conductive hearing loss
KW  - mixed hearing loss
KW  - vibroplasty
KW  - couplers
KW  - middle ear implant
Y1  - 2016
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-199129
SN  - 1420-3030
SN  - 1421-9700
N1  - This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively.
VL  - 21
IS  - 4
ER  -