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A MAUDE database analysis on the new generation of active bone conduction hearing implants
Laryngoscope Investigative Otolaryngology, 9 (2024), 5; e70010. https://doi.org/10.1002/lio2.70010
Lein, Alexander; Baumgartner, Wolf‐Dieter; Landegger, Lukas D.; Riss, Dominik; Thurner, Thomas; Liu, David T.; Košec, Andro; Vyskocil, Erich; Brkic, Faris F.

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Lein, A., Baumgartner, W., Landegger, L. D., Riss, D., Thurner, T., Liu, D. T. ... Brkic, F. F. (2024). A MAUDE database analysis on the new generation of active bone conduction hearing implants. Laryngoscope Investigative Otolaryngology, 9. (5). doi: 10.1002/lio2.70010

Lein, Alexander, et al. "A MAUDE database analysis on the new generation of active bone conduction hearing implants." Laryngoscope Investigative Otolaryngology, vol. 9, br. 5, 2024. https://doi.org/10.1002/lio2.70010

Lein, Alexander, Wolf‐Dieter Baumgartner, Lukas D. Landegger, Dominik Riss, Thomas Thurner, David T. Liu, Andro Košec, Erich Vyskocil i Faris F. Brkic. "A MAUDE database analysis on the new generation of active bone conduction hearing implants." Laryngoscope Investigative Otolaryngology 9, br. 5 (2024). https://doi.org/10.1002/lio2.70010

Lein, A., et al. (2024) 'A MAUDE database analysis on the new generation of active bone conduction hearing implants', Laryngoscope Investigative Otolaryngology, 9(5). doi: 10.1002/lio2.70010

Lein A, Baumgartner W, Landegger LD, Riss D, Thurner T, Liu DT, i sur.. A MAUDE database analysis on the new generation of active bone conduction hearing implants. Laryngoscope Investigative Otolaryngology [Internet]. 28.09.2024. [pristupljeno 14.03.2025.];9(5). doi: 10.1002/lio2.70010

A. Lein, et al., "A MAUDE database analysis on the new generation of active bone conduction hearing implants", Laryngoscope Investigative Otolaryngology, vol. 9, br. 5, Rujan 2024. [Online]. Dostupno na: https://urn.nsk.hr/urn:nbn:hr:105:262116. [Citirano: 14.03.2025.]

Za citiranje koristite ovu mrežnu adresu: https://urn.nsk.hr/urn:nbn:hr:105:262116
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Podaci o radu
Naslov (engleski)A MAUDE database analysis on the new generation of active bone conduction hearing implants
AutorAlexander Lein
AutorWolf‐Dieter Baumgartner
AutorLukas D. Landegger
AutorDominik Riss
AutorThomas Thurner
AutorDavid T. Liu
AutorAndro Košec
AutorErich Vyskocil
AutorFaris F. Brkic
Autorova ustanovaSveučilište u Zagrebu
Medicinski fakultet
(KATEDRA ZA OTORINOLARINGOLOGIJU I KIRURGIJU GLAVE I VRATA)
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Kliničke medicinske znanosti
Otorinolaringologija
Sažetak (engleski)
Objective: To analyze medical device reports (MDR) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events (AEs) in patients implanted with novel active bone conduction hearing implants (BCIs). Methods: We conducted a search of the FDA MAUDE database on the newest generation of BCIs. Data were collected concerning device malfunctions, patient injuries, factors triggering these incidents, and the subsequent actions taken. Results: In total, 93 (16.7%) device malfunctions and 465 (83.3%) patient injuries with 358 subsequent interventions were identified, resulting in 558 AEs. Although the absolute AE number per device cannot be identified, the following trends were detected: Among the 494 AEs associated with OSI200, 55 (11.1%) reported device malfunctions and 454 (88.9%) cited patient injuries. Out of the 64 AEs linked to BCI602, 28 (59.4%) were associated with malfunctions, whereas 26 (40.6%) involved patient injuries. The most frequently reported particular AEs for the OSI200 were infection (n = 171, 34.6%), extrusion of the device (n = 107, 21.7%), and pain (n = 51, 10.3%). Conversely, no device output (n = 20, 31.3%) and loss of osseointegration (n = 7, 10.9%) were the most reported AEs for the BCI602. Various AEs led to 214 explanations and 77 revision surgeries. Sixty-seven AEs reported conservative treatment. Conclusion: The current study provides an overview of the most commonly reported complications with new active BCIs. Although providing an overview, given the limitations of the FDA MAUDE database, our results have to be interpreted with caution.
Ključne riječi (engleski)
Jezikengleski
Vrsta publikacijeZnanstveni rad - Izvorni znanstveni rad
Status objaveObjavljen
Vrsta recenzijeRecenziran
Verzija publikacijeObjavljena verzija rada (izdavačev PDF)
Naslov časopisaLaryngoscope Investigative Otolaryngology
Brojčani podacivol. 9, br. 5, e70010
p-ISSN2378-8038
e-ISSN2378-8038
DOIhttps://doi.org/10.1002/lio2.70010
URN:NBNurn:nbn:hr:105:262116
Datum objave publikacije2024-09-28
URL dokumentahttps://onlinelibrary.wiley.com/doi/10.1002/lio2.70010
Vrsta resursaTekst
Prava pristupaOtvoreni pristup
Uvjeti korištenjaIkona licence Imenovanje-Nekomercijalno-Bez prerada 4.0 međunarodna (CC BY-NC-ND 4.0)
Datum i vrijeme pohrane2025-03-13 10:13:35