COMFORTAID HEARING AID

K964680 · Ethical Hearing Instruments · ESD · Jan 24, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K964680
• Device Name: COMFORTAID HEARING AID
• Applicant: Ethical Hearing Instruments
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Jan 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1

Device Story

Hearing aid device; traditional principles of operation; user controls and methods similar to existing marketed hearing aids; intended for hearing assistance; operated by patient; performance meets ANSI S3.2-1987 requirements.

Clinical Evidence

Bench testing only; performance meets ANSI S3.2-1987 requirements.

Technological Characteristics

Traditional hearing aid design; performance meets ANSI S3.2-1987.

Regulatory Classification

Identification

An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.

Submission Summary (Full Text)

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# Ethical Hearing Instruments, Inc.

90 Fleet Street Portsmouth, NH 03801
603-430-1024 603-436-3220 (fax)

K964680

JAN 24 1997

## Safety and Effectiveness

### DRAERD 510 (k) Summary/Statement Certification for Ethical ComfortAid Hearing Aid.

The summary of information, new product to present products demonstrates substantial equivalence as required by the “Safe Medical Devices Act (SMDA)” of 1990. The design follows traditional principles of operation for Hearing Aids. The device is manufactured and assembled with equivalent manufacturing practices and performance guidelines. Performance of this instrument meets requirements specified by ANSI S3.2-1987. User controls and methods are similar to others currently being marketed.