Your browser doesn't support javascript.
loading
Multicentric study on surgical information and early safety and performance results with the Bonebridge BCI 602: an active transcutaneous bone conduction hearing implant.
Sprinzl, Georg; Toner, Joseph; Koitschev, Assen; Berger, Nadine; Keintzel, Thomas; Rasse, Thomas; Baumgartner, Wolf-Dieter; Honeder, Clemens; Magele, Astrid; Plontke, Stefan; Götze, Gerrit; Schmutzhard, Joachim; Zelger, Philipp; Corkill, Stephanie; Lenarz, Thomas; Salcher, Rolf.
Afiliación
  • Sprinzl G; Hals-Nasen-Ohren-Abteilung, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften und Karl-Landsteiner Institut für Implantierbare Hörsysteme, Universitätsklinikum St. Pölten, Dunant-Platz 1, 3100, St. Pölten, Austria. georg.sprinzl@stpoelten.lknoe.at.
  • Toner J; Regional Auditory Implant Centre, Beech Hall Centre, Belfast, Northern Ireland, UK.
  • Koitschev A; Klinik für HNO-Krankheiten, Plastische Operationen, Klinikum Stuttgart, Olgahospital, Stuttgart, Germany.
  • Berger N; Klinik für HNO-Krankheiten, Plastische Operationen, Klinikum Stuttgart, Olgahospital, Stuttgart, Germany.
  • Keintzel T; Abteilung für Hals-, Nasen-, Ohrenkrankheiten, Klinikum Wels-Grieskirchen, Wels, Austria.
  • Rasse T; Abteilung für Hals-, Nasen-, Ohrenkrankheiten, Klinikum Wels-Grieskirchen, Wels, Austria.
  • Baumgartner WD; Allgemeines Krankenhaus der Stadt Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten, Vienna, Austria.
  • Honeder C; Allgemeines Krankenhaus der Stadt Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten, Vienna, Austria.
  • Magele A; Hals-Nasen-Ohren-Abteilung, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften und Karl-Landsteiner Institut für Implantierbare Hörsysteme, Universitätsklinikum St. Pölten, Dunant-Platz 1, 3100, St. Pölten, Austria.
  • Plontke S; Department of Otorhinolaryngology, Head and Neck Surgery, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
  • Götze G; Department of Otorhinolaryngology, Head and Neck Surgery, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
  • Schmutzhard J; Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde Innsbruck, Medizinische Universität Innsbruck, Innsbruck, Austria.
  • Zelger P; Universitätsklinik für Hör-, Stimm- und Sprachstörungen, Medizinische Universität Innsbruck, Innsbruck, Austria.
  • Corkill S; Regional Auditory Implant Centre, Beech Hall Centre, Belfast, Northern Ireland, UK.
  • Lenarz T; Medizinische Hochschule Hannover, Klinik und Poliklinik für HNO-Heilkunde, Hannover, Germany.
  • Salcher R; Medizinische Hochschule Hannover, Klinik und Poliklinik für HNO-Heilkunde, Hannover, Germany.
Eur Arch Otorhinolaryngol ; 280(4): 1565-1579, 2023 Apr.
Article en En | MEDLINE | ID: mdl-36625869
AIM: This European multicentric study aimed to prove safety and performance of the Bonebridge BCI 602 in children and adults suffering from either conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided sensorineural deafness (SSD). METHODS: 33 patients (13 adults and 10 children with either CHL or MHL and 10 patients with SSD) in three study groups were included. Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 3-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements. RESULTS: The Bonebridge BCI 602 significantly improved SF thresholds (+ 25.5 dB CHL/MHL/SSD), speech intelligibility in WRS (+ 68.0% CHL/MHL) and SRT in quiet (- 16.5 dB C/MHL) and in noise (- 3.51 dB SNR SSD). Air conduction (AC) and bone conduction (BC) thresholds remained stable over time. All adverse events were resolved, with none unanticipated. Mean audio processor wearing times in hours [h] per day for the CHL/MHL group were ~ 13 h for adults, ~ 11 h for paediatrics and ~ 6 h for the SSD group. The average surgical length was 57 min for the CHL/MHL group and 42 min for the SSD group. The versatility of the BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows for treatment of normal, pre-operated and malformed anatomies. All audiological endpoints were reached. CONCLUSIONS: The Bonebridge BCI 602 significantly improved hearing thresholds and speech understanding. Since implant placement follows the patient's anatomy instead of the shape of the device and the duration of surgery is shorter than with its predecessor, implantation is easier with the BCI 602. Performance and safety were proven for adults and children as well as for the CHL/MHL and SSD indications 3 months post-operatively.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Percepción del Habla / Sordera / Perdida Auditiva Conductiva-Sensorineural Mixta / Interfaces Cerebro-Computador / Audífonos / Pérdida Auditiva / Pérdida Auditiva Sensorineural Tipo de estudio: Clinical_trials Límite: Adult / Child / Humans Idioma: En Revista: Eur Arch Otorhinolaryngol Asunto de la revista: OTORRINOLARINGOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Austria Pais de publicación: Alemania
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Percepción del Habla / Sordera / Perdida Auditiva Conductiva-Sensorineural Mixta / Interfaces Cerebro-Computador / Audífonos / Pérdida Auditiva / Pérdida Auditiva Sensorineural Tipo de estudio: Clinical_trials Límite: Adult / Child / Humans Idioma: En Revista: Eur Arch Otorhinolaryngol Asunto de la revista: OTORRINOLARINGOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Austria Pais de publicación: Alemania