QQH — Powered Insertion System For A Cochlear Implant Electrode Array Class II

FDA Device Classification

Classification Details

Product Code: QQH
Device Class: Class II
Regulation Number: 874.4450
Submission Type
Review Panel: EN
Medical Specialty: Ear, Nose, Throat
Implant: No

Definition

A powered insertion system for a cochlear implant electrode array is a prescription device used to assist in placing an electrode array into the cochlea.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K252339	iotamotion	iotaSOFT® Insertion System	January 9, 2026
DEN190055	iotamotion	iotaSOFT Insertion System - Drive Unit, Controller and Accessories	October 1, 2021