Product Classification

• Device: tympanometer
• Regulation Description: Auditory impedance tester.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Product Code: NAS
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 874.1090
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• 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
• 4-228 ANSI ASA S3.20-2015 (Reaffirmed 2025)
  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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc