Product Classification

• Device: masker, tinnitus
• Regulation Description: Tinnitus masker.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Product Code: KLW
• Submission Type: 510(k)
• Regulation Number: 874.3400
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ANSI S3.20 Bioacoustical Terminology
• ANSI S3.21 Methods for Manual Pure-Tone Threshold Audiometry
• ANSI S3.1 Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
• ANSI S3.4-2007 Procedure for the Computation of Loudness of Steady Sounds
• S3.44-1996 Reaffirmed by ANSI on 27 April 2006 American National Standard Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
• ASA S12.2-2008 (Revision of ANSI S12.2-1995) American National Standard Criteria for Evaluating Room Noise

Guidance Document

• Tinnitus Masker Devices - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.