Efficacy of the Bonebridge BCI602 for Adult Patients with Single‐sided Deafness: A Prospective Multicenter Study

Author:

Kim Hantai1ORCID,Park Moo Kyun2ORCID,Park Shi Nae3ORCID,Cho Hyong‐Ho4ORCID,Choi Jae Young5ORCID,Lee Chi Kyou6ORCID,Lee Il‐Woo7,Moon Il Joon8ORCID,Jung Jae Yun9ORCID,Jung Jinsei5ORCID,Lee Kyu‐Yup10,Oh Jeong‐Hoon11,Park Hong Ju12ORCID,Seo Jae‐Hyun3ORCID,Song Jae‐Jin13ORCID,Ha Jungho14ORCID,Jang Jeong Hun14ORCID,Choung Yun‐Hoon14ORCID

Affiliation:

1. Department of Otorhinolaryngology–Head and Neck Surgery Konyang University College of Medicine Daejeon Korea

2. Department of Otorhinolaryngology–Head and Neck Surgery Seoul National University College of Medicine Seoul Korea

3. Department of Otorhinolaryngology–Head and Neck Surgery, Seoul St. Mary's Hospital, College of Medicine The Catholic University of Korea Seoul Korea

4. Department of Otolaryngology–Head and Neck Surgery Chonnam National University Medical School and Chonnam National University Hospital Gwangju Korea

5. Department of Otorhinolaryngology Yonsei University College of Medicine Seoul Korea

6. Department of Otorhinolaryngology–Head and Neck Surgery Soonchunhyang University College of Medicine, Seoul Hospital Seoul Korea

7. Department of Otorhinolaryngology–Head and Neck Surgery Pusan National University College of Medicine, Pusan National University Yangsan Hospital Yangsan Korea

8. Department of Otorhinolaryngology–Head and Neck Surgery, Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea

9. Department of Otolaryngology–Head and Neck Surgery Dankook University College of Medicine Cheonan Korea

10. Department of Otorhinolaryngology–Head and Neck Surgery, School of Medicine Kyungpook National University Daegu Korea

11. Department of Otorhinolaryngology–Head and Neck Surgery, Bucheon St. Mary's Hospital, College of Medicine The Catholic University of Korea Bucheon Korea

12. Department of Otorhinolaryngology–Head and Neck Surgery, Asan Medical Center University of Ulsan College of Medicine Seoul Korea

13. Department of Otorhinolaryngology–Head and Neck Surgery Seoul National University Bundang Hospital Seongnam Korea

14. Department of Otolaryngology Ajou University School of Medicine Suwon Korea

Abstract

AbstractObjectiveTo investigate the safety and efficacy of a novel active transcutaneous bone conduction implant (BCI) device for patients with single‐sided deafness (SSD).Study DesignProspective cohort study.SettingTertiary referral hospitals.MethodsThis 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.ResultsThe 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).ConclusionThe 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.

Publisher

Wiley

Subject

Otorhinolaryngology,Surgery

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