Product Classification

• Device: masker, tinnitus
• Regulation Description: Tinnitus masker.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Product Code: KLW
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 874.3400
• 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 ANSI ASA S3.1-1999 (Reaffirmed 2023)
  American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
• 4-162 ASA ANSI 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 2019)
  American National Standard Methods for Manual Pure-Tone Threshold Audiometry
• 4-173 ANSI ASA S3.44-1996 (Reaffirmed 2006)
  American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
• 4-228 ANSI ASA S3.20-2015 (Reaffirmed 2020)
  American National Standard Bioacoustical Terminology
• 4-260 ANSI ASA S12.2-2019
  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