Hearing Aid, Bone Conduction

Device Code: 1604

Product Code(s): LXB

Device Classification Information

• Device Type ID: 1604
• Device Name: Hearing Aid, Bone Conduction
• Regulation Description: Hearing Aid.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Ear, Nose, And Throat Devices Branch (ENTB)
• Submission Type: 510(k)
• CFR Regulation Number: 874.3300 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LXB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized 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
• 4-186 ANSI ASA S12.2-2008 (Revision Of ANSI S12.2-1995)
  American National Standard Criteria For Evaluating Room Noise
• 4-204 ANSI ASA IEC S3.42-2012/Part 2/ IEC 60118-15:2012
  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

Total Product Life Cycle

• Device Type ID: 1604
• Device: Hearing Aid, Bone Conduction
• Product Code: LXB
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hearing Aid.
• CFR Regulation Number: 874.3300 [🔎]

Premarket Reviews
Manufacturer	Decision
COCHLEAR AMERICAS
	SUBSTANTIALLY EQUIVALENT	5
MED-EL
	SUBSTANTIALLY EQUIVALENT	1
WILLIAM DEMANT HOLDING A/S
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Appropriate Term/Code Not Available	1427
Loss Of Osseointegration	346
Insufficient Information	30
Magnet	24
Extrusion	16
Adverse Event Without Identified Device Or Use Problem	13
Osseointegration Problem	9
Failure To Osseointegrate	7
Missing Value Reason	4
Migration Or Expulsion Of Device	3
Improper Or Incorrect Procedure Or Method	3
Battery	2
Material Integrity Problem	2
Migration	2
Use Of Device Problem	2
Expulsion	2
Device Handling Problem	1
Device Issue	1
Unintended Movement	1
Battery Problem	1
Total Device Problems	1896

Recalls
Manufacturer		Recall Class	Date Posted
1	Cochlear Americas Inc.	II	Jun-02-2014

TPLC Last Update: 2019-04-02 19:56:26