Audiometer

Device Code: 1472

Product Code(s): EWO

Device Classification Information

• Device Type ID: 1472
• Device Name: Audiometer
• Regulation Description: Audiometer.
• 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) Exempt
• CFR Regulation Number: 874.1050 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: EWO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 4-160 ANSI S3.1 (Reaffirmed 2013)
  American National Standard Maximum Permissible Ambient Noise Levels For Audiometric Test Rooms
• 4-164 ANSI S3.7-1995 (Reaffirmed 2008)
  American National Standard Method For Coupler Calibration Of Earphones
• 4-167 ANSI S3.21-2004 (Reaffirmed 2009)
  American National Standard Methods For Manual Pure-Tone Threshold Audiometry
• 4-186 ANSI ASA S12.2-2008 (Revision Of ANSI S12.2-1995)
  American National Standard Criteria For Evaluating Room Noise
• 4-203 ANSI S3.6-2010 (Revision Of ANSI S3.6-2004)
  American National Standard Specification For Audiometers
• 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: 1472
• Device: Audiometer
• Product Code: EWO
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Audiometer.
• CFR Regulation Number: 874.1050 [🔎]

Premarket Reviews
Manufacturer	Decision
ETYMOTIC RESEARCH, INC.
	SUBSTANTIALLY EQUIVALENT	1
IHEAR MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTERACOUSTICS A/S
	SUBSTANTIALLY EQUIVALENT	1
OTODYNAMICS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
TELEEMG, LLC USA
	SUBSTANTIALLY EQUIVALENT	1
WILLIAM DEMANT HOLDING A/S
	SUBSTANTIALLY EQUIVALENT	2

TPLC Last Update: 2019-04-02 19:54:36