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

Abstract

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.

Keywords: Active Middle Ear Implant; Mixed Hearing Loss; Round Window; Vibrant Soundbridge; Vibroplasty.

Fig. 1.

Scores on the Korean translation of the Abbreviated Profile of Hearing Aid Benefit questionnaire, assessed preoperatively and at 3 and 6 months postoperatively. (A) Ease of communication subscale. (B) Reverberation subscale. (C) Background noise subscale. (D) Aversiveness subscale. Preop, preoperative; VSB, Vibrant Soundbridge; VSB 3 mo, VSB-aided thresholds at 3 months after surgery; VSB 6 mo, VSB-aided thresholds at 6 months after surgery.

Fig. 2.

Scores on the Korean version of the International Outcome Inventory for Hearing Aids (K-IOI-HA) questionnaire assessed at three different time points: preoperatively and at 3 and 6 months postoperatively. The K-IOI-HA questionnaire was completed before and 3 and 6 months after round window (RW) vibroplasty by 16 patients who used hearing aids before RW vibroplasty. HA, hearing aid; HA (preop), preoperative HA-aided thresholds; VSB, Vibrant Soundbridge; VSB 3 mo, VSB-aided thresholds at 3 months after surgery; VSB 6 mo, VSB-aided thresholds at 6 months after surgery.

Fig. 3.

Pure tone average measured preoperatively and 1 month postoperatively. There was no significant difference between mean preoperative (Preop BC) and postoperative bone conduction thresholds (Postop BC 1 mo) (P=0.444). A comparison between preoperative (Preop AC) and 1-month postoperative air conduction thresholds (Postop AC 1 mo) revealed no significant difference (P=0.232). AC, air conduction; BC, bone conduction.

Fig. 4.

Mean sound field thresholds for ears treated with round window vibroplasty, assessed using warble tones at frequencies between 250 Hz and 4k Hz. (A) Comparison between preoperative unaided thresholds and postoperative VSB-aided thresholds (n=27). (B) Comparison between preoperative HA-aided thresholds and postoperative VSB-aided thresholds (n=16). AC, air conduction; Preop AC, preoperative unaided thresholds; VSB, Vibrant Soundbridge; VSB 1 mo, VSB-aided thresholds at 1 month after surgery; VSB 3 mo, VSB-aided thresholds at 3 months after surgery; VSB 6 mo, VSB-aided thresholds at 6 months after surgery; HA, hearing aids; HA (preop), preoperative HA-aided thresholds.