Device, Assistive Listening

Device Code: 1608

Product Code(s): LZI

Device Classification Information

• Device Type ID: 1608
• Device Name: Device, Assistive Listening
• Regulation Description: Group Hearing Aid Or Group Auditory Trainer.
• Regulation Medical Specialty: Ear Nose & Throat
• 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: 510(K) Exempt
• CFR Regulation Number: 874.3320 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LZI
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 4-183 ANSI S3.2-2009 (Reaffirmed 2014)
  American National Standard Method For Measuring The Intelligibility Of Speech Over Communication Systems
• 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: 1608
• Device: Device, Assistive Listening
• Product Code: LZI
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Group Hearing Aid Or Group Auditory Trainer.
• CFR Regulation Number: 874.3320 [🔎]

TPLC Last Update: 2019-04-02 19:56:30