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U.S. Department of Health and Human Services

Product Classification

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Device hearing aid, bone conduction, implanted
Regulation Description Hearing Aid.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeMAH
Premarket Review ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 874.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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