Cochlear Implant Surgery Device iotaSoft Earns FDA Clearance

Early-stage medical technology company iotaMotion, known for developing advanced cochlear implant surgery solutions, has scored De Novo classification from the FDA for its new surgical system. The open-platform, minimalist iotaSoft system is markedly more precise than the human hand when planting electrode arrays within the inner ear, and does away with the need for the cumbersome hardware often used in hearing loss procedures. The single-use device latches onto a patient's skull and helps the surgeon maneuver with unvarying pressure and speed.

By giving surgeons better control over procedures, iotaSoft mitigates collateral damage to the cochlea and increases the likelihood of preserving a patient's remaining hearing capabilities. Research has shown perfectly consistent force is very difficult to maintain during manual insertion of electrodes. iotaMotion says that between 15% and 50% of cochlear implant wearers self-attest to additional loss of natural hearing.

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"There are clear opportunities to improve outcomes, optimize preservation of existing function, and support consistent results for surgeons and patients in the U.S. and around the world," said iotaMotion’s medical director Marlan Hansen, M.D. The thumb-sized iotaSoft is bound to take the hearing loss procedure space by storm, as it is compatible with a huge variety of existing cochlear implants. A controlled commercialization schedule will see the device become available to providers and patients in a matter of months.