Thomas Zahnert1, Robert Mlynski2,3, Hubert Löwenheim4, Dirk Beutner5, Rudolf Hagen2, Arneborg Ernst6, Thorsten Zehlicke3, Hilke Kühne7, Natascha Friese4, Anke Tropitzsch4, Jan Christoffer Luers5, Ingo Todt6, Karl-Bernd Hüttenbrink5. 1. Department of Medicine, Clinic of Otorhinolaryngology, Head and Neck Surgery, Technical University of Dresden, Dresden, Germany, Thomas.Zahnert@uniklinikum-dresden.de. 2. Department of Otorhinolaryngology, Plastic, Aesthetic and Reconstructive Head and Neck Surgery, Comprehensive Hearing Center, University of Würzburg, Würzburg, Germany. 3. Department of Otorhinolaryngology, Head and Neck Surgery, Rostock University Medical Center, Rostock, Germany. 4. Department of Otorhinolaryngology, Head and Neck Surgery, Hearing Research Center, University of Tübingen Medical Center, Tübingen, Germany. 5. Department of Otorhinolaryngology, Head and Neck Surgery, Medical Faculty, University of Cologne, Cologne, Germany. 6. Department of Otolaryngology at UKB, Hospital of the University of Berlin, Charité Medical School, Berlin, Germany. 7. Department of Medicine, Clinic of Otorhinolaryngology, Head and Neck Surgery, Technical University of Dresden, Dresden, Germany.
Abstract
OBJECTIVE: To evaluate the long-term safety and performance of four different vibroplasty couplers (round window, oval window, CliP and Bell coupler) in combination with an active middle ear implant. METHODS: This was a multicentre, prospective, long-term study including 5 German hospitals. Thirty adult subjects suffering from conductive or mixed hearing loss were initially enrolled for the study, 24 of these were included in the final analysis with up to 36 months of postsurgical follow-up data. Bone conduction and air conduction were measured pre- and postoperatively to evalu ate safety. Postoperative aided sound field thresholds and Freiburger monosyllable word recognition scores were compared to unaided pre-implantation results to confirm performance. Additional speech tests compared postoperative unaided with aided results. To determine patient satisfaction, an established quality-of-life questionnaire developed for conventional hearing aid usage was administered to all subjects. RESULTS: Mean postoperative bone conduction thresholds remained stable throughout the whole study period. Mean functional gain for all couplers investigated was 38.5 ± 11.4 dB HL (12 months) and 38.8 ± 12.5 dB HL (36 months). Mean word recognition scores at 65 dB SPL increased from 2.9% in the unaided by 64.2% to 67.1% in the aided situation. The mean postoperative speech reception in quiet (or 50% understanding of words in sentences) shows a speech intelligibility improvement at 36 months of 17.8 ± 12.4 dB SPL over the unaided condition. The signal-to-noise ratio (SNR) improved by 5.9 ± 7.2 dB SNR over the unaided condition. High subjective device satisfaction was reflected by the International Inventory for Hearing Aids scored very positively. CONCLUSION: A significant improvement was seen with all couplers, and audiological performance did not significantly differ between 12 and 36 months after surgery.
OBJECTIVE: To evaluate the long-term safety and performance of four different vibroplasty couplers (round window, oval window, CliP and Bell coupler) in combination with an active middle ear implant. METHODS: This was a multicentre, prospective, long-term study including 5 German hospitals. Thirty adult subjects suffering from conductive or mixed hearing loss were initially enrolled for the study, 24 of these were included in the final analysis with up to 36 months of postsurgical follow-up data. Bone conduction and air conduction were measured pre- and postoperatively to evalu ate safety. Postoperative aided sound field thresholds and Freiburger monosyllable word recognition scores were compared to unaided pre-implantation results to confirm performance. Additional speech tests compared postoperative unaided with aided results. To determine patient satisfaction, an established quality-of-life questionnaire developed for conventional hearing aid usage was administered to all subjects. RESULTS: Mean postoperative bone conduction thresholds remained stable throughout the whole study period. Mean functional gain for all couplers investigated was 38.5 ± 11.4 dB HL (12 months) and 38.8 ± 12.5 dB HL (36 months). Mean word recognition scores at 65 dB SPL increased from 2.9% in the unaided by 64.2% to 67.1% in the aided situation. The mean postoperative speech reception in quiet (or 50% understanding of words in sentences) shows a speech intelligibility improvement at 36 months of 17.8 ± 12.4 dB SPL over the unaided condition. The signal-to-noise ratio (SNR) improved by 5.9 ± 7.2 dB SNR over the unaided condition. High subjective device satisfaction was reflected by the International Inventory for Hearing Aids scored very positively. CONCLUSION: A significant improvement was seen with all couplers, and audiological performance did not significantly differ between 12 and 36 months after surgery.
Authors: Laura Fröhlich; Alexander Müller; Miriam H Kropp; Parwis Mir-Salim; Oliver Dziemba; Tobias Oberhoffner; Stefan K Plontke; Torsten Rahne Journal: Front Neurol Date: 2022-01-20 Impact factor: 4.003
Authors: Nora M Weiss; David Bächinger; Adrian Rrahmani; Hans E Bernd; Alexander Huber; Robert Mlynski; Christof Röösli Journal: Eur Arch Otorhinolaryngol Date: 2020-05-05 Impact factor: 2.503
Authors: Chan Il Song; Hyong-Ho Cho; Byung Yoon Choi; Jae Young Choi; Jin Woong Choi; Yun-Hoon Choung; Jong Woo Chung; Won-Ho Chung; Sung Hwa Hong; Yehree Kim; Byung Don Lee; Il-Woo Lee; Jong Dae Lee; Jun Ho Lee; Kyu-Yup Lee; Il Joon Moon; In Seok Moon; Seung-Ha Oh; Hong Ju Park; Shi Nae Park; Ji Won Seo Journal: Clin Exp Otorhinolaryngol Date: 2021-04-09 Impact factor: 3.372