Product Classification

• Device: implant, auditory brainstem
• Review Panel: Ear Nose & Throat
• Product Code: MHE
• 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: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 4-160 ASA ANSI S3.1-1999 (Reaffirmed 2023)
  American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
• 4-162 ANSI ASA S3.4-2007 (Reaffirmed 2020)
  American National Standard Procedure for the Computation of Loudness of Steady Sounds
• 4-167 ASA ANSI S3.21-2004 (Reaffirmed 2023)
  American National Standard Methods for Manual Pure-Tone Threshold Audiometry
• 4-177 ANSI ASA S12.65-2006 (Reaffirmed 2020)
  American National Standard For Rating Noise with Respect to Speech Interference
• 4-228 ANSI ASA S3.20-2015 (Reaffirmed 2020)
  American National Standard Bioacoustical Terminology
• 4-260 ANSI ASA S12.2-2019 (Reaffirmed 2023)
  American National Standard for Criteria for Evaluating Room Noise

Third Party Review

Not Third Party Eligible