Implant, Auditory Brainstem

Device Code: 1660

Product Code(s): MHE

Device Classification Information

• Device Type ID: 1660
• Device Name: Implant, Auditory Brainstem
• Review Panel: Ear Nose & Throat
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Ear, Nose, And Throat Devices Branch (ENTB)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: MHE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 4-160 ANSI S3.1 (Reaffirmed 2013)
  American National Standard Maximum Permissible Ambient Noise Levels For Audiometric Test Rooms
• 4-162 ANSI S3.4-2007 (Reaffirmed 2017)
  American National Standard Procedure For The Computation Of Loudness Of Steady Sounds
• 4-167 ANSI S3.21-2004 (Reaffirmed 2009)
  American National Standard Methods For Manual Pure-Tone Threshold Audiometry
• 4-177 ANSI ASA S12.65-2006 (Reaffirmed 2011)
  American National Standard For Rating Noise With Respect To Speech Interference
• 4-186 ANSI ASA S12.2-2008 (Revision Of ANSI S12.2-1995)
  American National Standard Criteria For Evaluating Room Noise
• 4-228 ANSI ASA S3.20-2015 (Revision Of ANSI S3.20-1995)
  American National Standard Bioacoustical Terminology

Total Product Life Cycle

• Device Type ID: 1660
• Device: Implant, Auditory Brainstem
• Product Code: MHE
• FDA Device Classification: Class 3 Medical Device

Device Problems
Appropriate Term/Code Not Available	11
Migration Or Expulsion Of Device	4
Receiver Stimulator Unit	3
No Device Output	3
Insufficient Information	2
Magnet	2
Electrode	2
Total Device Problems	27

TPLC Last Update: 2019-04-02 19:57:22