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Clinical and Experimental Otorhinolaryngology > Accepted Articles
doi: https://doi.org/10.21053/ceo.2020.01851    [Accepted]
Results of the Active Middle Ear Implantation in Patients With Mixed Hearing Loss After the Middle Ear Surgery: Prospective Multicenter Study (ROMEO Study)
Chan Il Song1, Hyong-Ho Cho2, Byung Yoon Choi3, Jae Young Choi1 , Jin Woong Choi4 , Yun-Hoon Choung5, Jong Woo Chung6 , Won-Ho Chung7, Sung Hwa Hong8, Yehree Kim6 , Byung Don Lee9, Il-Woo Lee10, Jong Dae Lee11, Jun Ho Lee12, Kyu-Yup Lee13, Il Joon Moon7 , In Seok Moon1 , Seung-Ha Oh12, Hong Ju Park6 , Shi Nae Park14 , Ji Won Seo8
1Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Korea
2Department of Otolaryngology-Head and Neck Surgery, Chonnam National University Medical School and Chonnam National University Hospital, Gwangju, Korea
3Department of Otorhinolaryngology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
4Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, Chungnam National University, Daejeon, Korea
5Department of Otolaryngology, Ajou University School of Medicine, Suwon, Korea
6Department of Otorhinolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
7Department of Otorhinolaryngology-Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
8Department of Otorhinolaryngology-Head and Neck Surgery, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea
9Department of Otorhinolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine, Seoul, Korea
10Department of Otorhinolaryngology-Head and Neck Surgery, Pusan National University School of Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea
11Department of Otorhinolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine, Bucheon, Korea
12Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea
13Department of Otorhinolaryngology-Head and Neck Surgery, School of Medicine, Kyungpook National University Hospital, Kyungpook National University, Daegu, Korea
14Department of Otorhinolaryngology-Head and Neck Surgery, The Catholic University of Korea College of Medicine, Seoul, Korea
Correspondence  Jong Woo Chung ,Tel: +82-2-3010-3718 , Fax: +82-2-489-2773, Email: jwchung@amc.seoul.kr
Received: September 8, 2020; Revised: March 9, 2021   Accepted: April 8, 2021.  Published online: April 9, 2021.
ABSTRACT
Objectives.
To evaluate the user satisfaction, efficacy, and safety of round window (RW) vibroplasty using the Vibrant Soundbridge (VSB) in patients with persistent mixed hearing loss after mastoidectomy.
Method.
The study included twenty-seven patients (mean age, 58.7 years; age range, 28–76 years; 11 men and 16 women) with mixed hearing loss after mastoidectomy surgery from 15 tertiary referral centers in Korea. The VSB was implanted at the RW. The Korean translation of the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire and the Korean version of the International Outcome Inventory for Hearing Aids (K-IOI-HA) questionnaire were used to evaluate user satisfaction as the primary outcome. Secondary outcome measures were audiological test results and complication rates.
Results.
The mean scores on the Ease of Communication (61.3% → 29.7% → 30.2%), Reverberation (62.1% → 43.1% → 37.4%), and Background Noise (63.3% → 37.7% → 34.3%) subscales of the APHAB questionnaire were significantly reduced after VSB surgery. Mean K-IOI-HA scores at 3 and 6 months after surgery were significantly higher than the mean preoperative score (18.6 → 26.8 → 28.0). Postoperative VSB-aided thresholds were significantly lower than preoperative unaided and hearing aid (HA)-aided thresholds. There was no significant difference between preoperative unaided, preoperative HA-aided, and postoperative VSB-aided maximum phonetically balanced word-recognition scores. None of the 27 patients experienced a change in postoperative bone conduction pure tone average (PTA). One patient developed temporary facial palsy and two developed surgical wound infections.
Conclusion.
RW vibroplasty resulted in improved satisfaction and audiological test results in patients with mixed hearing loss after mastoidectomy surgery, and the complication rate was tolerable.
Keywords: Active Middle Ear Implant; Mixed Hearing Loss; Round Window; Vibroplasty; Vibrant Soundbridge
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