Universität zu Köln

Zahnert, Thomas, Loewenheim, Hubert, Beutner, Dirk, Hagen, Rudolf, Ernst, Arneborg, Pau, Hans-Wilhelm, Zehlicke, Thorsten, Kuehne, Hilke, Friese, Natascha, Tropitzsch, Anke, Lueers, Jan-Christoffer, Mlynski, Robert ORCID: 0000-0001-6404-6364, Todt, Ingo and Huettenbrink, Karl-Bernd (2016). Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results. Audiol. Neuro-Otol., 21 (4). S. 212 - 223. BASEL: KARGER. ISSN 1421-9700

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Abstract

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 warbletone 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 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. 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. (C) 2016 S. Karger AG, Basel

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Zahnert, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Loewenheim, Hubert UNSPECIFIED UNSPECIFIED UNSPECIFIED Beutner, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED Hagen, Rudolf UNSPECIFIED UNSPECIFIED UNSPECIFIED Ernst, Arneborg UNSPECIFIED UNSPECIFIED UNSPECIFIED Pau, Hans-Wilhelm UNSPECIFIED UNSPECIFIED UNSPECIFIED Zehlicke, Thorsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuehne, Hilke UNSPECIFIED UNSPECIFIED UNSPECIFIED Friese, Natascha UNSPECIFIED UNSPECIFIED UNSPECIFIED Tropitzsch, Anke UNSPECIFIED UNSPECIFIED UNSPECIFIED Lueers, Jan-Christoffer UNSPECIFIED UNSPECIFIED UNSPECIFIED Mlynski, Robert UNSPECIFIED orcid.org/0000-0001-6404-6364 UNSPECIFIED Todt, Ingo UNSPECIFIED UNSPECIFIED UNSPECIFIED Huettenbrink, Karl-Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-289042
DOI:	10.1159/000444616
Journal or Publication Title:	Audiol. Neuro-Otol.
Volume:	21
Number:	4
Page Range:	S. 212 - 223
Date:	2016
Publisher:	KARGER
Place of Publication:	BASEL
ISSN:	1421-9700
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ROUND WINDOW VIBROPLASTY; INTERNATIONAL OUTCOME INVENTORY; MIDDLE-EAR IMPLANT; AIDS IOI-HA; VIBRANT SOUNDBRIDGE; EXPERIENCE; FOOTPLATE Multiple languages Audiology & Speech-Language Pathology; Neurosciences; Otorhinolaryngology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28904