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U.S. Department of Health and Human Services

Product Classification
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Device electronic media, hyperacusis
Definition To improve sound tolerances.
Physical State compact disc
Technical Method Compact disc containing broadband pink noise.
Target Area brain
Review Panel Ear Nose & Throat
Product CodeOAQ
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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