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

Abstract

------------e-pub(22.1.13)---- 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.

Methods: 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.