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Adverse events associated with Bonebridge and Osia bone conduction implant devices.

Publication ,  Journal Article
Crowder, HR; Bestourous, DE; Reilly, BK
Published in: American journal of otolaryngology
July 2021

Active transcutaneous Bone Conduction Implants (BCIs) are relatively new to the market and may offer improved outcomes while reducing skin-related complications associated with previous models. The purpose of this study is to examine medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events with the active, transcutaneous BCIs, Bonebridge and Osia.A search of the FDA MAUDE database was conducted using product code "PFO" (for Active Implantable Bone Conduction Hearing System), brand names "Bonebridge" and "Osia." Data was collected on device malfunction, patient injury, inciting events, and subsequent interventions between July 1, 2018 and November 1, 2020.The search query yielded 83 reports that met inclusion criteria, 56 regarding Bonebridge and 27 regarding Osia. A total of 91 adverse events were reported, including 45 device malfunctions and 46 patient injuries. Of all adverse events reported for Bonebridge, 15 (26.3%, 15/57) documented patient injuries, while the majority (73.7%, 42/57) documented device malfunctions. Of all adverse events reported for Osia, 3 (8.8%, 3/34) were reported concerning malfunctions, while 31 (91.2%, 31/34) were reported for patient injuries. The most commonly reported adverse events included lack of conduction or hearing (n = 26, 28.6%), infection (n = 14, 15.4%), and intermittent or reduced conduction or hearing (n = 12, 13.2%). From the MAUDE database reported adverse events and the total number of Osia implants given to us from Cochlear over this 28 month period, we estimate patient injuries to occur in roughly 2.1% of patients.There are limitations to the database which make systemic analysis challenging. This study suggests that patients with transcutaneous, active BCIs may be experiencing fewer soft tissue injuries, but similar device malfunctions as those with previous models.

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Published In

American journal of otolaryngology

DOI

EISSN

1532-818X

ISSN

0196-0709

Publication Date

July 2021

Volume

42

Issue

4

Start / End Page

102968

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Otorhinolaryngology
  • Male
  • Humans
  • Hearing Loss, Conductive
  • Female
  • Equipment Failure
  • Databases, Factual
  • Cochlear Implants
 

Citation

APA
Chicago
ICMJE
MLA
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Crowder, H. R., Bestourous, D. E., & Reilly, B. K. (2021). Adverse events associated with Bonebridge and Osia bone conduction implant devices. American Journal of Otolaryngology, 42(4), 102968. https://doi.org/10.1016/j.amjoto.2021.102968
Crowder, Hannah R., Daniel E. Bestourous, and Brian K. Reilly. “Adverse events associated with Bonebridge and Osia bone conduction implant devices.American Journal of Otolaryngology 42, no. 4 (July 2021): 102968. https://doi.org/10.1016/j.amjoto.2021.102968.
Crowder HR, Bestourous DE, Reilly BK. Adverse events associated with Bonebridge and Osia bone conduction implant devices. American journal of otolaryngology. 2021 Jul;42(4):102968.
Crowder, Hannah R., et al. “Adverse events associated with Bonebridge and Osia bone conduction implant devices.American Journal of Otolaryngology, vol. 42, no. 4, July 2021, p. 102968. Epmc, doi:10.1016/j.amjoto.2021.102968.
Crowder HR, Bestourous DE, Reilly BK. Adverse events associated with Bonebridge and Osia bone conduction implant devices. American journal of otolaryngology. 2021 Jul;42(4):102968.
Journal cover image

Published In

American journal of otolaryngology

DOI

EISSN

1532-818X

ISSN

0196-0709

Publication Date

July 2021

Volume

42

Issue

4

Start / End Page

102968

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Otorhinolaryngology
  • Male
  • Humans
  • Hearing Loss, Conductive
  • Female
  • Equipment Failure
  • Databases, Factual
  • Cochlear Implants