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 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.

Keywords:
Conductive hearing loss, Mixed hearing loss, Vibroplasty, Couplers, Middle ear implant
1.
Ball GR: The Vibrant Soundbridge: design and development. Adv Otorhinolaryngol 2010;69:1-13.
2.
Baumgartner WD, Böheim K, Hagen R, Muller J, Lenarz T, Reiss S, Schlogel M, Mlynski R, Mojallal H, Colletti V, Opie J: The Vibrant Soundbridge for conductive and mixed hearing losses: European multicenter study results. Adv Otorhinolaryngol 2010;69:38-50.
3.
Beleites T, Neudert M, Beutner D, Hüttenbrink KB, Zahnert T: Experience with vibroplasty couplers at the stapes head and footplate. Otol Neurotol 2011;32:1468-1472.
4.
Beltrame AM, Todt I, Sprinzl G, Profant M, Schwab B: consensus statement on round window vibroplasty. Ann Otol Rhinol Laryngol 2014;123(10):734.
5.
Bernardeschi D, Hoffman C, Benchaa T, Labassi S, Beliaeff M, Sterkers O, Grayeli AB: Functional results of Vibrant Soundbridge middle ear implants in conductive and mixed hearing losses. Audiol Neurotol 2011;16:381-387.
6.
Böheim K, Mlynski R, Lenarz T, Schlogel M, Hagen R: Round window vibroplasty: long-term results. Acta Otolaryngol 2012;132:1042-1048.
7.
Colletti L, Mandala M, Colletti V: Long-term outcome of round window Vibrant Soundbridge implantation in extensive ossicular chain defects. Otolaryngol Head Neck Surg 2013;149:134-141.
8.
Colletti V, Fiorino FG, Sittoni V: Minisculptured ossicle grafts versus implants: long-term results. Am J Otol 1987;8:553-559.
9.
Colletti V, Soli SD, Carner M, Colletti L: Treatment of mixed hearing losses via implantation of a vibratory transducer on the round window. Int J Audiol 2006;45:600-608.
10.
Cox R, Stephens D, Kramer S: Translations of the International Outcome Inventory for Hearing Aids (IOI-HA). Int J Audiol 2002;41:3-26.
11.
Heuermann H, Kinkel M, Tchorz J: Comparison of psychometric properties of the International Outcome Inventory for Hearing Aids (IOI-HA) in various studies. Int J Audiol 2005;44:102-109.
12.
Huber AM, Ball GR, Veraguth D, Dillier N, Bodmer D, Sequeira D: A new implantable middle ear hearing device for mixed hearing loss: a feasibility study in human temporal bones. Otol Neurotol 2006;27:1104-1109.
13.
Hüttenbrink KB, Beutner D, Bornitz M, Luers JC, Zahnert T: Clip vibroplasty: experimental evaluation and first clinical results. Otol Neurotol 2011;32:650-653.
14.
Hüttenbrink KB, Beutner D, Zahnert T: Clinical results with an active middle ear implant in the oval window. Adv Otorhinolaryngol 2010;69:27-31.
15.
Hüttenbrink KB, Zahnert T, Bornitz M, Beutner D: TORP-vibroplasty: a new alternative for the chronically disabled middle ear. Otol Neurotol 2008;29:965-971.
16.
Iwasaki S, Suzuki H, Moteki H, Miyagawa M, Takumi Y, Usami S: Experience with the Vibrant Soundbridge RW-coupler for round window vibroplasty with tympanosclerosis. Acta Otolaryngol 2012;132:676-682.
17.
Kapur TR, Jayaramchandran S: Long-term results of total ossicular chain reconstruction using autografts. J Laryngol Otol 1992;106:688-691.
18.
Lüers JC, Hüttenbrink KB: Vibrant Soundbridge rehabilitation of conductive and mixed hearing loss. Otolaryngol Clin North Am 2014;47:915-926.
19.
Lüers JC, Hüttenbrink KB, Zahnert T, Bornitz M, Beutner D: Vibroplasty for mixed and conductive hearing loss. Otol Neurotol 2013;34:1005-1012.
20.
Maier H, Hinze AL, Gerdes T, Busch S, Salcher R, Schwab B, Lenarz T: Long-term results of incus vibroplasty in patients with moderate-to-severe sensorineural hearing loss. Audiol Neurotol 2015;20:136-146.
21.
Schwab B, Grigoleit S, Teschner M: Do we really need a coupler for the round window application of an AMEI? Otol Neurotol 2013;34:1181-1185.
22.
Shinohara T, Gyo K, Saiki T, Yanagihara N: Ossiculoplasty using hydroxyapatite prostheses: long-term results. Clin Otolaryngol Allied Sci 2000;25:287-292.
23.
Skarzynski H, Olszewski L, Skarzynski PH, Lorens A, Piotrowska A, Porowski M, Mrowka M, Pilka A: Direct round window stimulation with the MED-EL Vibrant Soundbridge: 5 years of experience using a technique without interposed fascia. Eur Arch Otorhinolaryngol 2014;271:477-482.
24.
Zahnert T, Bornitz M, Hüttenbrink KB: Experiments on the coupling of an active middle ear implant to the stapes footplate. Adv Otorhinolaryngol 2010;69:32-37.
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2016
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