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
• 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: 874.3950
• 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

Recognized Consensus Standards

• 4-160 ASA ANSI S3.1-1999 (Reaffirmed 2023)
  American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
• 4-162 ANSI ASA S3.4-2007 (Reaffirmed 2020)
  American National Standard Procedure for the Computation of Loudness of Steady Sounds
• 4-163 ANSI ASA S3.5-1997 (Reaffirmed 2020)
  American National Standard Methods for Calculation of the Speech Intelligibility Index
• 4-167 ASA ANSI S3.21-2004 (Reaffirmed 2023)
  American National Standard Methods for Manual Pure-Tone Threshold Audiometry
• 4-177 ANSI ASA S12.65-2006 (Reaffirmed 2020)
  American National Standard For Rating Noise with Respect to Speech Interference
• 4-211 ANSI ASA S3.46-2013 (Reaffirmed 2023)
  American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
• 4-228 ANSI ASA S3.20-2015 (Reaffirmed 2020)
  American National Standard Bioacoustical Terminology
• 4-260 ANSI ASA S12.2-2019 (Reaffirmed 2023)
  American National Standard for Criteria for Evaluating Room Noise
• 4-274 ANSI ASA S3.2-2020
  American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems

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