Results of Active Middle Ear Implantation in Patients With Mixed Hearing Loss After Middle Ear Surgery: A Prospective Multicenter Study (the ROMEO Study)

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 ParkJi Won Seo

Research output: Contribution to journalArticlepeer-review

5 Citations (Scopus)


Objectives. This study was conducted 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. Methods. The study included 27 patients (mean age, 58.7 years; age range, 28–76 years; 11 men and 16 women) with mixed hearing loss after mastoidectomy 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. The secondary outcome measures were audiological test results and complication rates. Results. The mean scores for ease of communication (61.3% to 29.7% to 30.2%), reverberation (62.1% to 43.1% to 37.4%), and background noise (63.3% to 37.7% to 34.3%) subscales of the APHAB questionnaire significantly decreased after VSB surgery. The mean K-IOI-HA scores at 3 and 6 months after surgery were significantly higher than the mean preoperative score (18.6 to 27.2 to 28.1). The postoperative VSB-aided thresholds were significantly lower than the 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. 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, and the complication rate was tolerable.

Original languageEnglish
Pages (from-to)69-76
Number of pages8
JournalClinical and Experimental Otorhinolaryngology
Issue number1
Publication statusPublished - 2022 Feb

Bibliographical note

Publisher Copyright:
© 2022.

All Science Journal Classification (ASJC) codes

  • Surgery
  • Otorhinolaryngology


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