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

Hantai Kim; Moo Kyun Park; Shi Nae Park; Hyong Ho Cho; Jae Young Choi; Chi Kyou Lee; Il Woo Lee; Il Joon Moon; Jae Yun Jung; Jinsei Jung; Kyu Yup Lee; Jeong Hoon Oh; Hong Ju Park; Jae Hyun Seo; Jae Jin Song; Jungho Ha; Jeong Hun Jang; Yun Hoon Choung

doi:10.1002/ohn.520

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

Hantai Kim, Moo Kyun Park, Shi Nae Park, Hyong Ho Cho, Jae Young Choi, Chi Kyou Lee, Il Woo Lee, Il Joon Moon, Jae Yun Jung, Jinsei Jung, Kyu Yup Lee, Jeong Hoon Oh, Hong Ju Park, Jae Hyun Seo, Jae Jin Song, Jungho Ha, Jeong Hun Jang, Yun Hoon Choung

Department of Otorhinolaryngology

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

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.

Original language	English
Pages (from-to)	490-504
Number of pages	15
Journal	Otolaryngology - Head and Neck Surgery
Volume	170
Issue number	2
DOIs	https://doi.org/10.1002/ohn.520
State	Published - Feb 2024

Bibliographical note

Publisher Copyright:
© 2023 American Academy of Otolaryngology–Head and Neck Surgery Foundation.

Keywords

active transcutaneous bone conduction implant
bone conduction implant
bonebridge
single-sided deafness

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10.1002/ohn.520

Cite this

Kim, H., Park, M. K., Park, S. N., Cho, H. H., Choi, J. Y., Lee, C. K., Lee, I. W., Moon, I. J., Jung, J. Y., Jung, J., Lee, K. Y., Oh, J. H., Park, H. J., Seo, J. H., Song, J. J., Ha, J., Jang, J. H., & Choung, Y. H. (2024). Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study. Otolaryngology - Head and Neck Surgery, 170(2), 490-504. https://doi.org/10.1002/ohn.520

@article{dace8113dd0e46cc8152b33db6e7771a,

title = "Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study",

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.",

keywords = "active transcutaneous bone conduction implant, bone conduction implant, bonebridge, single-sided deafness",

author = "Hantai Kim and Park, {Moo Kyun} and Park, {Shi Nae} and Cho, {Hyong Ho} and Choi, {Jae Young} and Lee, {Chi Kyou} and Lee, {Il Woo} and Moon, {Il Joon} and Jung, {Jae Yun} and Jinsei Jung and Lee, {Kyu Yup} and Oh, {Jeong Hoon} and Park, {Hong Ju} and Seo, {Jae Hyun} and Song, {Jae Jin} and Jungho Ha and Jang, {Jeong Hun} and Choung, {Yun Hoon}",

note = "Publisher Copyright: {\textcopyright} 2023 American Academy of Otolaryngology–Head and Neck Surgery Foundation.",

year = "2024",

month = feb,

doi = "10.1002/ohn.520",

language = "English",

volume = "170",

pages = "490--504",

journal = "Otolaryngology - Head and Neck Surgery",

issn = "0194-5998",

publisher = "John Wiley and Sons Inc.",

number = "2",

}

Kim, H, Park, MK, Park, SN, Cho, HH, Choi, JY, Lee, CK, Lee, IW, Moon, IJ, Jung, JY, Jung, J, Lee, KY, Oh, JH, Park, HJ, Seo, JH, Song, JJ, Ha, J, Jang, JH & Choung, YH 2024, 'Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study', Otolaryngology - Head and Neck Surgery, vol. 170, no. 2, pp. 490-504. https://doi.org/10.1002/ohn.520

TY - JOUR

T1 - Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness

T2 - A Prospective Multicenter Study

AU - Kim, Hantai

AU - Park, Moo Kyun

AU - Park, Shi Nae

AU - Cho, Hyong Ho

AU - Choi, Jae Young

AU - Lee, Chi Kyou

AU - Lee, Il Woo

AU - Moon, Il Joon

AU - Jung, Jae Yun

AU - Jung, Jinsei

AU - Lee, Kyu Yup

AU - Oh, Jeong Hoon

AU - Park, Hong Ju

AU - Seo, Jae Hyun

AU - Song, Jae Jin

AU - Ha, Jungho

AU - Jang, Jeong Hun

AU - Choung, Yun Hoon

PY - 2024/2

Y1 - 2024/2

N2 - 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.

AB - 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.

KW - active transcutaneous bone conduction implant

KW - bone conduction implant

KW - bonebridge

KW - single-sided deafness

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DO - 10.1002/ohn.520

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C2 - 37811702

AN - SCOPUS:85173910159

SN - 0194-5998

VL - 170

SP - 490

EP - 504

JO - Otolaryngology - Head and Neck Surgery

JF - Otolaryngology - Head and Neck Surgery

IS - 2

ER -

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

Abstract

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Keywords

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