Hearing Aid, Group And Auditory Trainer

Device Code: 1440

Product Code(s): EPF

Device Classification Information

• Device Type ID: 1440
• Device Name: Hearing Aid, Group And Auditory Trainer
• Regulation Description: Group Hearing Aid Or Group Auditory Trainer.
• 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: 874.3320 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: EPF
• 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

• 4-183 ANSI S3.2-2009 (Reaffirmed 2014)
  American National Standard Method For Measuring The Intelligibility Of Speech Over Communication Systems
• 4-220 ANSI ASA S3.22-2014
  American National Standard Specification Of Hearing Aid Characteristics

Total Product Life Cycle

• Device Type ID: 1440
• Device: Hearing Aid, Group And Auditory Trainer
• Product Code: EPF
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Group Hearing Aid Or Group Auditory Trainer.
• CFR Regulation Number: 874.3320 [🔎]

Premarket Reviews
Manufacturer	Decision
HYPERSOUND HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1

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