Envoy Medical’s Esteem middle ear implant has received approval from the US Food and Drug Administration (FDA) for magnetic resonance (MR) conditional labelling.
A device’s compatibility with MRI is enquired with surgeons and audiologists who work closely with hearing implants.
It has been seen as a limitation of middle ear implants that all of them were contraindicated for “high-resolution” 3.0 Tesla (T) scans, and all but one were also contraindicated for 1.5 T.
Following the receipt of the approval, patients with Esteem Hearing Implant can now be safely scanned in both 1.5 and 3.0 (T) scanning environments.
Envoy Medical chief executive officer Brent Lucas said: “MR-conditional approval at both 1.5 and 3.0 Tesla gives Esteem patients the peace of mind that they can safely undergo certain MRIs without having to endure the additional surgeries, hassles, and costs to have the device partially or fully removed beforehand.”
The fully implantable hearing device is designed to alleviate moderate to severe sensorineural hearing loss in adults.
The device uses the natural ear to pick-up sounds, bypasses a portion of the middle ear, and then directly drives the inner ear.
Ear Associates Medical Group California MD Jack Shohet said: “MRI compatibility is an important consideration when thinking about any implanted hearing solution. The news about the Esteem – that we now have a middle ear implant that can be safely scanned at both 1.5 and 3.0 Tesla – represents a significant advancement in middle ear implant technology and its applicability to a broader group of patients.”