Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use

Sébastien Schmerber, O. Deguine, M. Marx, P. Van de Heyning, O. Sterkers, I. Mosnier, P. Garin, B. Godey, C. Vincent, F. Venail, M. Mondain, A. Deveze, J. P. Lavieille, A. Karkas

Research output: Contribution to journalArticle

Abstract

The objective of this study is to evaluate the safety and efficacy of a new transcutaneous bone-conduction implant (BCI BB) in patients with conductive and mixed hearing loss or with single-sided deafness (SSD), 1 year after surgical implantation. The study design is multicentric prospective, intra-subject measurements. Each subject is his/her own control. The setting is nine university hospitals: 7 French and 2 Belgian. Sixteen subjects with conductive or mixed hearing loss with bone-conduction hearing thresholds under the upper limit of 45 dB HL for each frequency from 500 to 4000 Hz, and 12 subjects with SSD (contralateral hearing within normal range) were enrolled in the study. All subjects were older than 18 years. The intervention is rehabilitative. The main outcome measure is the evaluation of skin safety, audiological measurements, benefit, and satisfaction questionnaires with a 1-year follow up. Skin safety was rated as good or very good. For the mixed or conductive hearing loss groups, the average functional gain (at 500 Hz, 1, 2, 4 kHz) was 26.1 dB HL (SD 13.7), and mean percentage of speech recognition in quiet at 65 dB was 95 % (vs 74 % unaided). In 5/6 SSD subjects, values of SRT in noise were lower with BB. Questionnaires revealed patient benefit and satisfaction. The transcutaneous BCI is very well tolerated at 1-year follow up, improves audiometric thresholds and intelligibility for speech in quiet and noise, and gives satisfaction to both patients with mixed and conductive hearing loss and patients with SSD.

Original languageEnglish
Pages (from-to)1835-1851
Number of pages17
JournalEuropean Archives of Oto-Rhino-Laryngology
Volume274
Issue number4
DOIs
Publication statusPublished - 1 Apr 2017
Externally publishedYes

Fingerprint

Mixed Conductive-Sensorineural Hearing Loss
Bone Conduction
Conductive Hearing Loss
Deafness
Safety
Equipment and Supplies
Noise
Speech Intelligibility
Skin
Patient Satisfaction
Hearing
Reference Values
Outcome Assessment (Health Care)
Drive

Keywords

  • Bonebridge
  • Conductive and mixed hearing loss
  • Direct-drive
  • Percutaneous
  • Questionnaires
  • Single-sided deafness
  • Transcutaneous bone-conduction implant

Cite this

Schmerber, Sébastien ; Deguine, O. ; Marx, M. ; Van de Heyning, P. ; Sterkers, O. ; Mosnier, I. ; Garin, P. ; Godey, B. ; Vincent, C. ; Venail, F. ; Mondain, M. ; Deveze, A. ; Lavieille, J. P. ; Karkas, A. / Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use. In: European Archives of Oto-Rhino-Laryngology. 2017 ; Vol. 274, No. 4. pp. 1835-1851.
@article{12a23b9ad7914e91a63fddfd32b3aadf,
title = "Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use",
abstract = "The objective of this study is to evaluate the safety and efficacy of a new transcutaneous bone-conduction implant (BCI BB) in patients with conductive and mixed hearing loss or with single-sided deafness (SSD), 1 year after surgical implantation. The study design is multicentric prospective, intra-subject measurements. Each subject is his/her own control. The setting is nine university hospitals: 7 French and 2 Belgian. Sixteen subjects with conductive or mixed hearing loss with bone-conduction hearing thresholds under the upper limit of 45 dB HL for each frequency from 500 to 4000 Hz, and 12 subjects with SSD (contralateral hearing within normal range) were enrolled in the study. All subjects were older than 18 years. The intervention is rehabilitative. The main outcome measure is the evaluation of skin safety, audiological measurements, benefit, and satisfaction questionnaires with a 1-year follow up. Skin safety was rated as good or very good. For the mixed or conductive hearing loss groups, the average functional gain (at 500 Hz, 1, 2, 4 kHz) was 26.1 dB HL (SD 13.7), and mean percentage of speech recognition in quiet at 65 dB was 95 {\%} (vs 74 {\%} unaided). In 5/6 SSD subjects, values of SRT in noise were lower with BB. Questionnaires revealed patient benefit and satisfaction. The transcutaneous BCI is very well tolerated at 1-year follow up, improves audiometric thresholds and intelligibility for speech in quiet and noise, and gives satisfaction to both patients with mixed and conductive hearing loss and patients with SSD.",
keywords = "Bonebridge, Conductive and mixed hearing loss, Direct-drive, Percutaneous, Questionnaires, Single-sided deafness, Transcutaneous bone-conduction implant",
author = "S{\'e}bastien Schmerber and O. Deguine and M. Marx and {Van de Heyning}, P. and O. Sterkers and I. Mosnier and P. Garin and B. Godey and C. Vincent and F. Venail and M. Mondain and A. Deveze and Lavieille, {J. P.} and A. Karkas",
year = "2017",
month = "4",
day = "1",
doi = "10.1007/s00405-016-4228-6",
language = "English",
volume = "274",
pages = "1835--1851",
journal = "European Archives of Oto-Rhino-Laryngology",
issn = "0937-4477",
publisher = "Springer Verlag",
number = "4",

}

Schmerber, S, Deguine, O, Marx, M, Van de Heyning, P, Sterkers, O, Mosnier, I, Garin, P, Godey, B, Vincent, C, Venail, F, Mondain, M, Deveze, A, Lavieille, JP & Karkas, A 2017, 'Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use', European Archives of Oto-Rhino-Laryngology, vol. 274, no. 4, pp. 1835-1851. https://doi.org/10.1007/s00405-016-4228-6

Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use. / Schmerber, Sébastien; Deguine, O.; Marx, M.; Van de Heyning, P.; Sterkers, O.; Mosnier, I.; Garin, P.; Godey, B.; Vincent, C.; Venail, F.; Mondain, M.; Deveze, A.; Lavieille, J. P.; Karkas, A.

In: European Archives of Oto-Rhino-Laryngology, Vol. 274, No. 4, 01.04.2017, p. 1835-1851.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use

AU - Schmerber, Sébastien

AU - Deguine, O.

AU - Marx, M.

AU - Van de Heyning, P.

AU - Sterkers, O.

AU - Mosnier, I.

AU - Garin, P.

AU - Godey, B.

AU - Vincent, C.

AU - Venail, F.

AU - Mondain, M.

AU - Deveze, A.

AU - Lavieille, J. P.

AU - Karkas, A.

PY - 2017/4/1

Y1 - 2017/4/1

N2 - The objective of this study is to evaluate the safety and efficacy of a new transcutaneous bone-conduction implant (BCI BB) in patients with conductive and mixed hearing loss or with single-sided deafness (SSD), 1 year after surgical implantation. The study design is multicentric prospective, intra-subject measurements. Each subject is his/her own control. The setting is nine university hospitals: 7 French and 2 Belgian. Sixteen subjects with conductive or mixed hearing loss with bone-conduction hearing thresholds under the upper limit of 45 dB HL for each frequency from 500 to 4000 Hz, and 12 subjects with SSD (contralateral hearing within normal range) were enrolled in the study. All subjects were older than 18 years. The intervention is rehabilitative. The main outcome measure is the evaluation of skin safety, audiological measurements, benefit, and satisfaction questionnaires with a 1-year follow up. Skin safety was rated as good or very good. For the mixed or conductive hearing loss groups, the average functional gain (at 500 Hz, 1, 2, 4 kHz) was 26.1 dB HL (SD 13.7), and mean percentage of speech recognition in quiet at 65 dB was 95 % (vs 74 % unaided). In 5/6 SSD subjects, values of SRT in noise were lower with BB. Questionnaires revealed patient benefit and satisfaction. The transcutaneous BCI is very well tolerated at 1-year follow up, improves audiometric thresholds and intelligibility for speech in quiet and noise, and gives satisfaction to both patients with mixed and conductive hearing loss and patients with SSD.

AB - The objective of this study is to evaluate the safety and efficacy of a new transcutaneous bone-conduction implant (BCI BB) in patients with conductive and mixed hearing loss or with single-sided deafness (SSD), 1 year after surgical implantation. The study design is multicentric prospective, intra-subject measurements. Each subject is his/her own control. The setting is nine university hospitals: 7 French and 2 Belgian. Sixteen subjects with conductive or mixed hearing loss with bone-conduction hearing thresholds under the upper limit of 45 dB HL for each frequency from 500 to 4000 Hz, and 12 subjects with SSD (contralateral hearing within normal range) were enrolled in the study. All subjects were older than 18 years. The intervention is rehabilitative. The main outcome measure is the evaluation of skin safety, audiological measurements, benefit, and satisfaction questionnaires with a 1-year follow up. Skin safety was rated as good or very good. For the mixed or conductive hearing loss groups, the average functional gain (at 500 Hz, 1, 2, 4 kHz) was 26.1 dB HL (SD 13.7), and mean percentage of speech recognition in quiet at 65 dB was 95 % (vs 74 % unaided). In 5/6 SSD subjects, values of SRT in noise were lower with BB. Questionnaires revealed patient benefit and satisfaction. The transcutaneous BCI is very well tolerated at 1-year follow up, improves audiometric thresholds and intelligibility for speech in quiet and noise, and gives satisfaction to both patients with mixed and conductive hearing loss and patients with SSD.

KW - Bonebridge

KW - Conductive and mixed hearing loss

KW - Direct-drive

KW - Percutaneous

KW - Questionnaires

KW - Single-sided deafness

KW - Transcutaneous bone-conduction implant

UR - http://www.scopus.com/inward/record.url?scp=84980027574&partnerID=8YFLogxK

U2 - 10.1007/s00405-016-4228-6

DO - 10.1007/s00405-016-4228-6

M3 - Article

VL - 274

SP - 1835

EP - 1851

JO - European Archives of Oto-Rhino-Laryngology

JF - European Archives of Oto-Rhino-Laryngology

SN - 0937-4477

IS - 4

ER -