prikaz prve stranice dokumenta A MAUDE database analysis on the new generation of active bone conduction hearing implants
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Scientific paper - Original scientific paper
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, no. 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 and Faris F. Brkic. "A MAUDE database analysis on the new generation of active bone conduction hearing implants." Laryngoscope Investigative Otolaryngology 9, no. 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, and sur.. A MAUDE database analysis on the new generation of active bone conduction hearing implants. Laryngoscope Investigative Otolaryngology [Internet]. 2024 September 28 [cited 2025 March 13];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, no. 5, September 2024. [Online]. Available at: https://urn.nsk.hr/urn:nbn:hr:105:262116. [Accessed: 13 March 2025]

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Metadata
Title (english)A MAUDE database analysis on the new generation of active bone conduction hearing implants
AuthorAlexander Lein
AuthorWolf‐Dieter Baumgartner
AuthorLukas D. Landegger
AuthorDominik Riss
AuthorThomas Thurner
AuthorDavid T. Liu
AuthorAndro Košec
AuthorErich Vyskocil
AuthorFaris F. Brkic
Author's institutionUniversity of Zagreb
School of Medicine
(Department of Othorhinolaryngology and Head and Neck Surgery)
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Clinical Medical Sciences
Otorhinolaryngology
Abstract (english)
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.
Keywords (english)
Languageenglish
Publication typeScientific paper - Original scientific paper
Publication statusPublished
Peer reviewPeer review
Publication versionPublished version
Journal titleLaryngoscope Investigative Otolaryngology
Numberingvol. 9, no. 5, e70010
p-ISSN2378-8038
e-ISSN2378-8038
DOIhttps://doi.org/10.1002/lio2.70010
URN:NBNurn:nbn:hr:105:262116
Publication2024-09-28
Document URLhttps://onlinelibrary.wiley.com/doi/10.1002/lio2.70010
Type of resourceText
Access conditionsOpen access
Terms of useLicence Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) icon
Created on2025-03-13 10:13:35