Product Classification

• Device: hearing aid, air conduction, transcutaneous system
• Regulation Description: Transcutaneous air conduction hearing aid system.
• Definition: The transcutaneous air conduction hearing aid system is a wearable sound-amplifying device that is intended to compensate for impaired hearing.It consists of an air conduction hearing aid attached to a surgically fitted tube system.The tube creates an air channel through the soft tissue between outer ear canal and the post-auricular region of the pinna (ear).The air conduction hearing aid attaches to the post-auricular opening of the tube, thereby transmiting amplified sound to the ear canal without occluding the canal.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Product Code: NIX
• Submission Type: 510(k)
• Regulation Number: 874.3950
• Device Class: 2
• 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
• S3.46-1997 Reaffirmed by ANSI November 13, 2007 American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
• ASA S12.65-2006 (Revision of ANSI S3.14-1977) American National Standard For Rating Noise with Respect to Speech Interference
• S3.2-2009 (Revision of ANSI S3.2-1999) American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
• ASA S12.2-2008 (Revision of ANSI S12.2-1995) American National Standard Criteria for Evaluating Room Noise

Guidance Document

• Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA

Third Party Review

Not Third Party Eligible