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U.S. Department of Health and Human Services

Product Classification
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Device hearing aid, air-conduction, prescription
Regulation Description Air-conduction hearing aid.
Definition An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.
Physical State The device is worn behind-the-ear or in-the-canal with audio output into the ear by an ear piece.
Technical Method Air-conduction hearing aids are acoustic amplification devices for hearing impaired users.
Target Area The outer ear and the ear canal
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeESD
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(K) Exempt
Regulation Number 874.3300
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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