An observational study in Bone Anchored Devices, Osseo-Integrated Implants and MRI Scans, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational
Bone conduction implants (BCI) are widely used in cases of conductive/ mixed hearing loss or single side deafness when surgical treatment or air hearing aids are not feasible. There are two types of BCI, abutments (which pass through the skin) and magnets (where a subcutaneous magnet is coupled to an external magnet). Pathologies (such as cholesteatoma) leading to the insertion of this hearing implant often require prolonged MRI follow-up. However, both the abutment and the magnet are responsible for imaging artifacts that limit its interpretation. Frequency and extent of these artifacts remain unclear in the literature. In our experience, the magnet, due to its size and composition, produces larger artifacts than the abutment. The main objective of our study is to compare MRI artifacts for each of these device types (abutment and magnet).
The patients included in the study will all have a cerebral MRI as part of the cholesteatoma follow-up or for the assessment of cerebral or inner ear pathology.
ROUTINE SEQUENCES
ADDITIONAL SEQUENCES (approximately 20 minutes of additional acquisition time) :
Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a Baha magnet or abutment hearing implant and having to perform a brain MRI.
Inclusion Criteria Patient over 18 years old Patient with a Baha bone conduction hearing implant, who must perform an MRI examination of the brain, internal auditory canal or middle ear, with or without injection Affiliate or beneficiary of a social security scheme Express consent to participate in the study Exclusion Criteria Patient benefiting from a legal protection measure Pregnant or lactating woman MRI examination not feasible Contraindications to the practice of an MRI: ocular metallic foreign body,certain implanted materials, pacemakers, claustrophobia Contraindications to gadolinium injection, if an MRI is prescribed with gadolinium contrast agent injection allergy, known renal failure: glomerular filtration rate inferior to 30mL by min
The patients included in the study will all have a cerebral MRI as part of the cholesteatoma follow-up or for the assessment of cerebral or inner ear pathology. - ENT evaluation
Artifact size, measured in millimeters, on MRI sequences.
mm
Time frame: baseline
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondation Ophtalmologique Adolphe de Rothschild