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# Expanded Use Cleared for Robotic Cochlear Implant Insertion
- URL: https://www.fdaweb.com/expanded-use-cleared-for-robotic-cochlear-implant-insertion/
- Published: 2026-01-14T12:00:00.000Z
- Updated: 2026-09-14T15:30:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160494

FDA has cleared an iotaMotion 510(k) for an expanded pediatric indication for its iotaSOFT robotic-assisted cochlear implant insertion system, allowing its use in children as young as four years old. The device is designed to standardize and precisely control the insertion of cochlear implant electrodes, a step surgeons describe as one of the most delicate parts of the procedure, according to the company.

The company says the iotaSOFT system uses robotic assistance to deliver slow, consistent electrode insertion intended to reduce variability associated with manual techniques and help preserve delicate cochlear structures. Clinical evidence supporting robotic-assisted insertion is beginning to emerge, according to the company. A 2025 cohort study published in *The Laryngoscope* reported that 85% of patients receiving robotic-assisted insertion maintained hearing preservation at one year, compared with 71% of patients who underwent manual insertion, according to the study’s authors.

iotaMotion executives say the expanded pediatric clearance could help address hearing preservation concerns by offering a more standardized surgical approach, while also positioning children to benefit from future advances in hearing care, including gene-based and regenerative therapies that may depend on atraumatic cochlear implant placement early in life.