Who is the manufacturer of EUROLINE A-675 SERIS?

Starkey Laboratories, Inc. submitted the Traditional clearance for EUROLINE A-675 SERIS (K963519).

What is the FDA product code for EUROLINE A-675 SERIS?

ESD. It is classified under 21 CFR 874.3300 as a Class 1 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for EUROLINE A-675 SERIS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for EUROLINE A-675 SERIS?

Starkey A-312 Series BTE Hearing Aids (K960494); Starkey Laboratories Euroline A-13 Series BTE Hearing aids.

EUROLINE A-675 SERIS

K963519 · Starkey Laboratories, Inc. · ESD · Sep 27, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K963519
Device Name	EUROLINE A-675 SERIS
Applicant	Starkey Laboratories, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Sep 27, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.3300
Device Class	Class 1
Attributes	Therapeutic

Intended Use

To assist in compensating for hearing loss by amplifying sound as it comes near the ear.

Device Story

Air conduction behind-the-ear (BTE) hearing aids; amplify ambient sound for hearing loss compensation. Operated by patient; fitted by hearing health professional. Features include adjustable volume control, microphone/telephone/off switch, and direct audio input. Powered by standard 675 or equivalent battery. Device utilizes adjustable potentiometers for low frequency, peak clipping, gain, high frequency attenuation, high/low frequency compression, and crossover frequency. Output provided directly to ear canal via air conduction. Benefits include improved auditory perception for users with conductive or sensori-neural impairment.

Clinical Evidence

Bench testing only. Compliance with ANSI S3.22-1987 and IEC 118-0 1983 standards for electroacoustic performance.

Technological Characteristics

BTE air conduction hearing aid; standard electronic components; adjustable potentiometers for gain/frequency shaping; powered by 675 battery. Technical specs: ANSI S3.22-1987, IEC 118-0 1983. No software/digital processing.

Indications for Use

Indicated for patients with conductive and/or sensori-neural hearing loss where behind-the-ear (BTE) hearing aids are preferred or required.

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.

Predicate Devices

Starkey A-312 Series BTE Hearing Aids (K960494)
Starkey Laboratories Euroline A-13 Series BTE Hearing aids

Related Devices

K960494 — EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS · Starkey Laboratories, Inc. · Mar 1, 1996
K964503 — UNITRON MODEL SOUND F/X +4 · Unitron Industries, Inc. · Nov 27, 1996
K964502 — UNITRON MODEL SOUND F/XP +4 · Unitron Industries, Inc. · Nov 27, 1996
K964504 — UNITRON MODEL ICON AOHPL +4 · Unitron Industries, Inc. · Nov 27, 1996
K964511 — UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) · Unitron Industries, Inc. · Nov 27, 1996

Submission Summary (Full Text)

{0} SEP 27 1988 K963519 # SAFETY AND EFFECTIVENESS SUMMARY - Euroline A•675 Series **NAME OF DEVICES:** A•675 TSP, A•675 Sequel **TYPE OF DEVICE:** Air Conduction Behind-the-Ear hearing aids -Substantially equivalent to the Starkey A-312 Series BTE Hearing Aids (K960494) **INTENDED USE:** To assist in compensating for hearing loss by amplifying sound as it comes near the ear. **FEATURES:** Adjustable volume control, Microphone/Telephone/Off switch, direct audio input. **ASSEMBLY:** Assembled from standard components that are widely used in hearing aid devices. **TECHNICAL CHARACTERISTICS:** Technical specifications comply with ANSI S3.22-1987 and IEC 118-0 1983. **FIT:** For conductive and/or sensori-neural hearing loss where BTE type hearing aids are preferred or required. **CONTROLS:** Volume control, Mic/Telephone/Off switch similar to those used on other hearing aid devices. Potentiometers and are incorporated as circuit options require. Any pots or switches are similar to those used in other BTE hearing aid devices. **POWER:** Standard 675 or equivalent hearing aid battery. 8/26/96 {1} # SUMMARY -- Starkey Euroline A 675 Series SUBSTANTIAL EQUIVALENCE The Starkey Euroline A•675 Series BTE Hearing aids are behind-the-ear air conduction hearing aids. This form of hearing aid is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly. The Starkey Euroline A•675 Series BTE Hearing aids are substantially equivalent to the Starkey Laboratories Euroline A-13 Series BTE Hearing aids. ## Euroline A 675 Series - BTE Air conduction - Adjustable Gain Control - Telephone/Mic/Off Switch - Adjustable potentiometers for low frequency, peak clipping, gain, high frequency attenuation, high or low freq compression, and crossover frequency - 675 or equiv Battery - High output, High gain - Colors: Beige or Dark brown ## Euroline A-13 Series - BTE Air conduction - Adjustable Gain Control - Telephone/Mic/Off Switch - Adjustable potentiometers for low frequency, peak clipping or AGC, and high frequency attenuation - 13 or equiv Battery - Miniature size - Colors: Choice of 15 different skin ton 6/26/96