Long-Term, Multicenter Results With the First Transcutaneous Bone Conduction Implant

Georg Sprinzl, Thomas Lenarz, Rudolf Hagen, Wolf Dieter Baumgartner, Thomas Keintzel, Tilmann Keck, Herbert Riechelmann, Astrid Magele, Rolf Salcher, Hannes Maier, Robert Mlynski, Andreas Radeloff, Kristen Rak, Dominik Riss, Rudolfs Liepins, Sasan Hamzavi, Thomas Rasse, Peter Potzinger, Joachim Schmutzhard, Patrick ZorowkaPhilipp Mittmann, Klaus Böheim, Ingo Todt

Publikation: Beitrag in Fachzeitschrift (peer-reviewed)Artikel in Fachzeitschrift

11 Zitate (Scopus)

Abstract

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.

OriginalspracheEnglisch
Seiten (von - bis)858-866
Seitenumfang9
FachzeitschriftOtology and Neurotology
Jahrgang42
Ausgabenummer6
DOIs
PublikationsstatusVeröffentlicht - 01 Juli 2021

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