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U.S. Department of Health and Human Services

Product Classification

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Device tympanic membrane direct contact hearing aid
Definition A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.
Physical State A tympanic membrane contact hearing aid consists of an externally worn audio processor, and a custom fitted tympanic membrane receiver/transducer.
Technical Method A tympanic membrane contact hearing aid is a device worn by the patient that uses an external audio processor to transmit amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane
Target Area A tympanic membrane contact hearing aid provides direct, mechanical vibration of the lateral side of the tympanic membrane.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodePLK
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 510(k)
Regulation Number 874.3315
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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