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U.S. Department of Health and Human Services

Product Classification

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Device hybrid cochlear implant
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 Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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