EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS

K960494 · Starkey Laboratories, Inc. · ESD · Mar 1, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K960494
• Device Name: EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS
• Applicant: Starkey Laboratories, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Mar 1, 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

Behind-the-ear (BTE) air conduction hearing aid; amplifies ambient sound for user. Features adjustable volume control, microphone/telephone/off switch, and optional potentiometers for frequency/gain adjustment. Powered by standard 312 battery. Intended for professional fitting by hearing health professionals. Assists patients with conductive or sensori-neural hearing loss by improving sound perception.

Clinical Evidence

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

Technological Characteristics

BTE air conduction hearing aid; standard electronic components; adjustable potentiometers for low frequency, peak clipping, and threshold kneepoint. Powered by 312 battery. Technical specifications comply with ANSI S3.22-1987 and IEC 118-0 1983.

Indications for Use

Indicated for patients with conductive and/or sensori-neural hearing loss where behind-the-ear (BTE) air conduction 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 Euroline A Series BTE Hearing Aids (K940978)

Submission Summary (Full Text)

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MAR - 1 1996

# SAFETY AND EFFECTIVENESS SUMMARY - Euroline A-312 Series

**NAME OF DEVICES:**
A-312 K-Amp, A-312 ISP, A-312 OSP, A-312 Linear.
K-Amp, ISP, OSP, and Linear are the current circuit options available. Other circuit options may be added as a result of consumer demand. These circuit options would not affect the safety or effectiveness of the A-312 Series.

**TYPE OF DEVICE:**
Air Conduction Behind-the-Ear hearing aids - Substantially equivalent to the Starkey Euroline A Series BTE Hearing Aids (K940978)

**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 on all models.

**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 may be incorporated as options require. Any pots or switches are similar to those used in other BTE hearing aid devices.

**POWER:**
Standard 312 or equivalent hearing aid battery.

1/24/96

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1/24/96

# SUMMARY -- Starkey Euroline A-312 Series SUBSTANTIAL EQUIVALENCE

The Starkey Euroline A-312 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-312 Series BTE Hearing aids are substantially equivalent to the Starkey Laboratories Euroline A Series BTE Hearing aids.

## Euroline A-312 Series

- BTE Air conduction
- Adjustable Gain Control
- Telephone/Mic/Off Switch
- Adjustable potentiometers for low frequency, peak clipping, threshold kneepoint
- 312 or equiv Battery
- Miniature size
- Colors: Grey housing and Brown panel or Brown housing and Brown panel

## Euroline A 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 tone shades for the side panels of the case.