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U.S. Department of Health and Human Services

Product Classification

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Device cochlear implant with combined electrical stimulation and acoustic amplification
Definition Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.
Physical State external sound processor, implant (w/ receiver/stimulator and electrode array), programming software, accessories
Technical Method provide electric stimulation to the mid- to high frequency region of the cochlea via implant and acoustic amplification to the low frequency regions via an external component
Target Area Head: Ear and Cochlea
Review Panel Ear Nose & Throat
Product CodePGQ
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
Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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