Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study
- Authors
- Kim, Hantai; Park, Moo Kyun; Park, Shi Nae; Cho, Hyong-Ho; Choi, Jae Young; Lee, Chi Kyou; Lee, Il-Woo; Moon, Il Joon; Jung, Jae Yun; Jung, Jinsei; Lee, Kyu-Yup; Oh, Jeong-Hoon; Park, Hong Ju; Seo, Jae-Hyun; Song, Jae-Jin; Ha, Jungho; Jang, Jeong Hun; Choung, Yun-Hoon
- Issue Date
- Oct-2023
- Publisher
- WILEY
- Keywords
- active transcutaneous bone conduction implant; bone conduction implant; bonebridge; single-sided deafness
- Citation
- OTOLARYNGOLOGY-HEAD AND NECK SURGERY
- Journal Title
- OTOLARYNGOLOGY-HEAD AND NECK SURGERY
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/25587
- DOI
- 10.1002/ohn.520
- ISSN
- 0194-5998
1097-6817
- Abstract
- Objective. To investigate the safety and efficacy of a novel active transcutaneous bone conduction implant (BCI) device for patients with single-sided deafness (SSD).Study Design. Prospective cohort study.Setting. Tertiary referral hospitals.Methods. This prospective multicenter study was conducted at 15 institutions nationwide. Thirty adult (aged >= 19 years) SSD patients were recruited. They underwent implantation of an active transcutaneous BCI device (Bonebridge BCI602). Objective outcomes included aided pure-tone thresholds, aided speech discrimination scores (SDSs), and the Hearing in Noise Test (HINT) and sound localization test results. The Bern Benefit in Single-Sided Deafness (BBSS) questionnaire, the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, and the Tinnitus Handicap Inventory (THI) were used to measure subjective benefits.Results. The mean aided pure-tone threshold was 34.2 (11.3), mean (SD), dB HL at 500 to 4000 Hz. The mean total BBSS score was 27.5 (13.8). All APHAB questionnaire domain scores showed significant improvements: ease of communication, 33.6 (23.2) versus 22.6 (21.3), P = .025; reverberation, 44.8 (16.6) versus 32.8 (15.9), P = .002; background noise, 55.5 (23.6) versus 35.2 (18.1), P < .001; and aversiveness, 36.7 (22.8) versus 25.8 (21.4), P = .028. Moreover, the THI scores were significantly reduced [47.4 (30.1) versus 31.1 (27.0), P = .003]. Congenital SSD was a significant factor of subjective benefit (-11.643; 95% confidence interval: -21.946 to -1.340).Conclusion. The BCI602 active transcutaneous BCI device can provide functional hearing gain without any adverse effects and is a feasible option for acquired SSD patients with long-term deafness.
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