Long-Term, Multicenter Results With the First Transcutaneous Bone Conduction Implant.
Journal
Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology
ISSN: 1537-4505
Titre abrégé: Otol Neurotol
Pays: United States
ID NLM: 100961504
Informations de publication
Date de publication:
01 07 2021
01 07 2021
Historique:
pubmed:
15
5
2021
medline:
13
7
2021
entrez:
14
5
2021
Statut:
ppublish
Résumé
Investigation of long-term safety and performance of an active, transcutaneous bone conduction implant in adults and children up to 36 months post-implantation. Prospective, single-subject repeated-measures design. Otolaryngology departments of eight German and Austrian hospitals.∗†‡§||¶#∗∗†† Affiliations listed above that did not participate in the study.‡‡§§||||¶¶. Fifty seven German-speaking patients (49 adults and eight children) suffering from conductive or mixed hearing loss, with an upper bone conduction threshold limit of 45 dB HL at frequencies between 500 and 3000 Hz. Implantation of the Bonebridge transcutaneous bone conduction hearing implant (tBCI). Patients' audiometric pure tone averages (PTA4) (0.5, 1, 2, 4 kHz) thresholds (air conduction, bone conduction, and sound field) and speech perception (word recognition scores [WRS] and speech reception thresholds [SRT50%]) were tested preoperatively and up to 36 months postoperatively. Patients were also monitored for adverse events and administered quality-of-life questionnaires. Speech perception (WRS: pre-op: 17.60%, initial activation [IA]: 74.23%, 3M: 83.65%, 12M: 83.46%, 24M: 84.23%, 36M: 84.42%; SRT50%: pre-op: 65.56 dB SPL, IA: 47.67 dB SPL, 3M: 42.61 dB SPL, 12M: 41.11 dB SPL, 24M: 41.74 dB SPL, 36M: 42.43 dB SPL) and sound field thresholds (pre-op: 57.66 dB HL, IA: 33.82 dB HL, 3M: 29.86 dB HL, 12M: 28.40 dB HL, 24M: 28.22 dB HL, 36M: 28.52 dB HL) improved significantly at all aided postoperative visits. Air and bone conduction thresholds showed no significant changes, confirming preservation of patients' residual unaided hearing. All adverse events were resolved by the end of the study. Safety and performance of the tBCI was demonstrated in children and adults 36 months postoperatively.
Identifiants
pubmed: 33989254
doi: 10.1097/MAO.0000000000003159
pii: 00129492-202107000-00018
doi:
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
858-866Informations de copyright
Copyright © 2021, Otology & Neurotology, Inc.
Déclaration de conflit d'intérêts
The authors disclose no conflicts of interest.
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