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U.S. Department of Health and Human Services

Product Classification
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Device implant, hearing, active, middle ear, totally implanted
Definition Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%.
Physical State All components: microphone, sensor, electronics, audio processor, battery and driver are hermetically sealed inside the housing and implanted. Programming accessories are separate.
Technical Method surgically implanted
Target Area Mastoid bone
Review Panel Ear Nose & Throat
Product CodeOAF
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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