Product Classification

• Device: calibrator, hearing aid / earphone and analysis systems
• Regulation Description: Hearing aid calibrator and analysis system.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Product Code: ETW
• Submission Type: 510(k)
• Regulation Number: 874.3310
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ANSI S3.22:2009 American National Standard Specification of Hearing Aid Characteristics
• ANSI

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

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