NeoCoil’s Wireless MRI Headphones Get FDA Green Light

Medical device imaging manufacturer NeoCoil said Thursday that the FDA granted 510(k) clearance for the NeoCoil Wireless 2-Way Audio System, a patient communication and entertainment system for use during magnetic resonance imaging exams.

The first headphones will become available for GE musculoskeletal scanners in the next four to six weeks, said Steve Nichols, a spokesman for the Pewauklee, Wis., company. Additional headphones will be released as they are made compatible with other MRI machines.

The stand-alone wireless headphones and patient alert system offer a new alternative for patients skittish about having an MRI by doing away with the long plastic tubes that are features of standard pneumatic headphones, the company says. The MRI-compatible battery allows for continuous use without the need to recharge between patients.

The system allows patients to hear the technologist more clearly to listen to a customized music playlist while undergoing the procedure. The headphones incorporate a directional microphone that allows for clear 2-way communication, even during the loudest MRI scans, NeoCoil says. A “push-to-talk” button allows the patient to interrupt the music to communicate with the technologist, and a wireless hand-held alert lets the patient signal them without having to speak. — Kellen Owings

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