Product Classification

• Device: cochlear implant with combined electrical stimulation and acoustic amplification
• Definition: Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.
• Physical State: external sound processor, implant (w/ receiver/stimulator and electrode array), programming software, accessories
• Technical Method: provide electric stimulation to the mid- to high frequency region of the cochlea via implant and acoustic amplification to the low frequency regions via an external component
• Target Area: Head: Ear and Cochlea
• Review Panel: Ear Nose & Throat
• Product Code: PGQ
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Dental and ENT Devices (DHT1B)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 4-239 ANSI AAMI CI86:2017
  Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
• 4-308 ISO 14708-7 Second edition 2019-12
  Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems

Third Party Review

Not Third Party Eligible