TY - JOUR
T1 - Long-Term, Multicenter Results With the First Transcutaneous Bone Conduction Implant
AU - Sprinzl, Georg
AU - Lenarz, Thomas
AU - Hagen, Rudolf
AU - Baumgartner, Wolf Dieter
AU - Keintzel, Thomas
AU - Keck, Tilmann
AU - Riechelmann, Herbert
AU - Magele, Astrid
AU - Salcher, Rolf
AU - Maier, Hannes
AU - Mlynski, Robert
AU - Radeloff, Andreas
AU - Rak, Kristen
AU - Riss, Dominik
AU - Liepins, Rudolfs
AU - Hamzavi, Sasan
AU - Rasse, Thomas
AU - Potzinger, Peter
AU - Schmutzhard, Joachim
AU - Zorowka, Patrick
AU - Mittmann, Philipp
AU - Böheim, Klaus
AU - Todt, Ingo
N1 - Publisher Copyright:
© 2021, Otology & Neurotology, Inc.
PY - 2021/7/1
Y1 - 2021/7/1
N2 - OBJECTIVE: Investigation of long-term safety and performance of an active, transcutaneous bone conduction implant in adults and children up to 36 months post-implantation.STUDY DESIGN: Prospective, single-subject repeated-measures design.SETTING: Otolaryngology departments of eight German and Austrian hospitals.∗†‡§||¶#∗∗†† Affiliations listed above that did not participate in the study.‡‡§§||||¶¶.PATIENTS: 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.INTERVENTION: Implantation of the Bonebridge transcutaneous bone conduction hearing implant (tBCI).MAIN OUTCOME MEASURES: 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.RESULTS: 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.CONCLUSIONS: Safety and performance of the tBCI was demonstrated in children and adults 36 months postoperatively.
AB - OBJECTIVE: Investigation of long-term safety and performance of an active, transcutaneous bone conduction implant in adults and children up to 36 months post-implantation.STUDY DESIGN: Prospective, single-subject repeated-measures design.SETTING: Otolaryngology departments of eight German and Austrian hospitals.∗†‡§||¶#∗∗†† Affiliations listed above that did not participate in the study.‡‡§§||||¶¶.PATIENTS: 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.INTERVENTION: Implantation of the Bonebridge transcutaneous bone conduction hearing implant (tBCI).MAIN OUTCOME MEASURES: 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.RESULTS: 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.CONCLUSIONS: Safety and performance of the tBCI was demonstrated in children and adults 36 months postoperatively.
KW - Adult
KW - Auditory Threshold
KW - Bone Conduction
KW - Child
KW - Hearing
KW - Hearing Aids
KW - Hearing Loss, Conductive/surgery
KW - Hearing Tests
KW - Humans
KW - Prospective Studies
KW - Speech Perception
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85108123602&partnerID=8YFLogxK
U2 - 10.1097/MAO.0000000000003159
DO - 10.1097/MAO.0000000000003159
M3 - Journal article
C2 - 33989254
SN - 1531-7129
VL - 42
SP - 858
EP - 866
JO - Otology and Neurotology
JF - Otology and Neurotology
IS - 6
ER -