Auditory Brainstem Implants: An Analysis of the MAUDE Database

Introduction: Auditory brainstem implants (ABI) were developed as a method of hearing restoration for patients who are not candidates for cochlear implantation (CI). This study examines the Manufacture and User Facility Device Experience (MAUDE) database to characterize and analyze adverse events related to this device.

Methods: The MAUDE database was searched for Medical Device Reports (MDRs) relating to ABIs from January 2012 to December 2022. MDRs were identified using the advanced search term “Implant, Auditory Brainstem” and reviewing all reports with the basic search term “Brainstem Implant”. Reports were individually reviewed and events were categorized with special attention to adverse events.

Results: A total of 265 reports were reviewed, of which 55 reports met inclusion criteria. Reports regarding cessation of use or removal included failure to provide full hearing benefit (n=27), failure of implant/device malfunction (n=10), and non-use of the device (n=6). Postoperative complications included local skin infection (n=3), CSF leak (n=3), pain/headache (n=3), swelling (n=3), and meningitis (n=2). Two patients had dislodged magnets during 1.5 Tesla MRI, one patient had approved head wrapping during this event. There were 35 instances of full explantation of the device and one partial removal. In only 13 of these reports, a new device was reimplanted following explantation.

Conclusions: ABIs demonstrate utility in patients who are not candidates for cochlear implantation or amplification. However, the quality of hearing is vastly different and a common cause for explanation in this database was poor hearing result or nonuse. This information can aid physicians in counseling patients and family members preoperatively and managing expectations.