The FDA has granted 510(k) clearance for iotaSOFT®, a robotic-assisted cochlear implant insertion system, for pediatric use.

• Expanded Indication: The clearance allows the system to be used for patients aged four years and older.
• Clinical Benefit: The system is designed to help preserve delicate cochlear structures and residual hearing during surgery.

This summary is based on a press release issued by iotaMotion.