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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
Regulation Description Tympanic membrane 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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 874.3315
Device Class 2
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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