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Product Classification

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Device

implant, cochlear

Review Panel

Ear Nose & Throat

Product Code

MCM

Submission Type

PMA

Device Class

3

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

ANSI S3.20 Bioacoustical Terminology
ANSI S3.21 Methods for Manual Pure-Tone Threshold Audiometry
ANSI S3.1 Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
ANSI S3.4-2007 Procedure for the Computation of Loudness of Steady Sounds
S3.5-1997 Revision of ANSI S3.5-1969 (R1969) Reaffirmed by ANSI May 18, 2007 American National Standard Methods for Calculation of the Speech Intelligibility Index
ASA S12.65-2006 (Revision of ANSI S3.14-1977) American National Standard For Rating Noise with Respect to Speech Interference
ASA S12.2-2008 (Revision of ANSI S12.2-1995) American National Standard Criteria for Evaluating Room Noise

Third Party Review

Not Third Party Eligible

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