Product Classification

• Device: hearing aid, bone conduction
• Regulation Description: Hearing Aid.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Product Code: LXB
• Premarket Review: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
• Submission Type: 510(k)
• Regulation Number: 874.3300
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible

Recognized Consensus Standards

• 4-160 ANSI S3.1 (Reaffirmed 2013)
  American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
• 4-162 ANSI S3.4-2007 (Reaffirmed 2017)
  American National Standard Procedure for the Computation of Loudness of Steady Sounds
• 4-163 ANSI S3.5-1997 (Reaffirmed 2017)
  American National Standard Methods for Calculation of the Speech Intelligibility Index
• 4-165 ANSI S3.13-1987 (Reaffirmed 2012)
  American National Standard Mechanical Coupler for Measurement of Bone Vibrators
• 4-167 ANSI S3.21-2004 (Reaffirmed 2009)
  American National Standard Methods for Manual Pure-Tone Threshold Audiometry
• 4-177 ANSI ASA S12.65-2006 (Reaffirmed 2011)
  American National Standard For Rating Noise with Respect to Speech Interference
• 4-183 ANSI S3.2-2009 (Reaffirmed 2014)
  American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
• 4-204 ANSI ASA S3.42-2012/Part 2/ IEC 60118-15:2012 (R2017)
  American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)
• 4-228 ANSI ASA S3.20-2015 (Revision of ANSI S3.20-1995)
  American National Standard Bioacoustical Terminology
• 4-260 ANSI ASA S12.2-2019
  American National Standard Criteria for Evaluating Room Noise

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• accelerated device approval services
• beanstock ventures
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc