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Safety and efficacy of the mAXIS stapes prosthesis.
Bevis, Nicholas; Hüser, Marc A; Oestreicher, David; Beutner, Dirk.
Afiliación
  • Bevis N; Department of Otorhinolaryngology, Head and Neck Surgery, Nicholas Bevis, University Medical Center Goettingen, Robert-Koch- Straße 40, 37075, Goettingen, Germany. nicholas.bevis@med.uni-goettingen.de.
  • Hüser MA; Department of Otorhinolaryngology, Head and Neck Surgery, Nicholas Bevis, University Medical Center Goettingen, Robert-Koch- Straße 40, 37075, Goettingen, Germany.
  • Oestreicher D; Department of Otorhinolaryngology, Head and Neck Surgery, Nicholas Bevis, University Medical Center Goettingen, Robert-Koch- Straße 40, 37075, Goettingen, Germany.
  • Beutner D; Department of Otorhinolaryngology, Head and Neck Surgery, Nicholas Bevis, University Medical Center Goettingen, Robert-Koch- Straße 40, 37075, Goettingen, Germany.
Eur Arch Otorhinolaryngol ; 2024 Jul 28.
Article en En | MEDLINE | ID: mdl-39069576
ABSTRACT

PURPOSE:

Otosclerosis leads to a fixed stapes footplate and thus to hearing loss. The predominant treatment method is surgery, with various types of stapes prostheses available. The aim of this study was to investigate the safety and efficacy of the new mAXIS Stapes Prosthesis.

METHODS:

34 cases of otosclerosis were implanted with the new mAXIS Stapes Prosthesis. Comprehensive clinical assessments, including pre- and postoperative pure tone audiometry was performed at short-term (ST) follow-up at 25 (± 15) days and mid-term (MT) follow-up at 181 (± 107) days. The pure tone average of 0.5, 1, 2 and 3 kHz (PTA4) was calculated.

RESULTS:

In all cases, the application of the prosthesis was successful and straightforward. The postoperative PTA4 air-bone gap was 10.7 ± 5.2 dB at ST follow-up (n = 34) and 8.3 ± 4.1 dB at MT follow-up (n = 18). In 61% of cases, the ABG-closure was within 10 dB and in 100% of cases within 20 dB at MT follow-up.

CONCLUSION:

Findings of this study support that the mAXIS Stapes Prosthesis is safe for implantation and shows promising audiological outcome. Future investigations will contribute its long-term efficacy and safety profile.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Eur Arch Otorhinolaryngol Asunto de la revista: OTORRINOLARINGOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Alemania 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 Idioma: En Revista: Eur Arch Otorhinolaryngol Asunto de la revista: OTORRINOLARINGOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Alemania