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.
authors.affiliation: Department of Otorhinolaryngology, Michallon University Hospital, Grenoble, France. SSchmerber@chu-grenoble.fr.
authors.forename: Sébastien
authors.identifier: http://orcid.org/0000-0003-0189-5574
authors.initials: S
authors.lastname: Schmerber
authors.affiliation: Department of Otorhinolaryngology, Purpan University Hospital, Toulouse, France.
authors.forename: O
authors.initials: O
authors.lastname: Deguine
authors.affiliation: Department of Otorhinolaryngology, Purpan University Hospital, Toulouse, France.
authors.forename: M
authors.initials: M
authors.lastname: Marx
authors.affiliation: Department of Otorhinolaryngology, Antwerp University Hospital, Antwerp, Belgium.
authors.forename: P
authors.initials: P
authors.lastname: Van de Heyning
authors.affiliation: Department of Otorhinolaryngology, Hôpital La Pitié Salpêtrière (AP-HP), Paris, France.
authors.forename: O
authors.initials: O
authors.lastname: Sterkers
authors.affiliation: Department of Otorhinolaryngology, Hôpital La Pitié Salpêtrière (AP-HP), Paris, France.
authors.forename: I
authors.initials: I
authors.lastname: Mosnier
authors.affiliation: Department of Otorhinolaryngology, Mont-Godinne University Hospital, Yvoir, Belgium.
authors.forename: P
authors.initials: P
authors.lastname: Garin
authors.affiliation: Department of Otorhinolaryngology, Pontchaillou University Hospital, Rennes, France.
authors.forename: B
authors.initials: B
authors.lastname: Godey
authors.affiliation: Department of Otorhinolaryngology, Salengro University Hospital, Lille, France.
authors.forename: C
authors.initials: C
authors.lastname: Vincent
authors.affiliation: Department of Otorhinolaryngology, University Hospital, Montpellier, France.
authors.forename: F
authors.initials: F
authors.lastname: Venail
authors.affiliation: Department of Otorhinolaryngology, University Hospital, Montpellier, France.
authors.forename: M
authors.initials: M
authors.lastname: Mondain
authors.affiliation: Department of Otorhinolaryngology, Nord University Hospital, Marseille, France.
authors.forename: A
authors.initials: A
authors.lastname: Deveze
authors.affiliation: Department of Otorhinolaryngology, Nord University Hospital, Marseille, France.
authors.forename: J P
authors.initials: JP
authors.lastname: Lavieille
authors.affiliation: Department of Otorhinolaryngology, University Hospital, Saint Etienne, France.
authors.forename: A
authors.initials: A
authors.lastname: Karkas
mesh_terms: D000328:Adult; D001299:Audiometry; D001844:Bone Conduction; D005260:Female; D006310:Hearing Aids; D006314:Hearing Loss, Conductive / Q000601:surgery*; D046089:Hearing Loss, Mixed Conductive-Sensorineural / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D019736:Prostheses and Implants; D013067:Speech Perception; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Bonebridge; Conductive and mixed hearing loss; Direct-drive; Percutaneous; Questionnaires; Single-sided deafness; Transcutaneous bone-conduction implant