Product Classification

• Device: implant, hearing, active, middle ear, totally implanted
• Definition: Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%.
• Physical State: All components: microphone, sensor, electronics, audio processor, battery and driver are hermetically sealed inside the housing and implanted. Programming accessories are separate.
• Technical Method: surgically implanted
• Target Area: Mastoid bone
• Review Panel: Ear Nose & Throat
• Product Code: OAF
• Premarket Review: Division of Dental and ENT Devices (DHT1B); 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: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible