STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS

K964214 · Starkey Laboratories, Inc. · ESD · Nov 27, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K964214
• Device Name: STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
• Applicant: Starkey Laboratories, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Nov 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 into the ear.

Device Story

BTE air conduction hearing aids; amplify sound for hearing loss compensation. Input: ambient sound via microphone; optional audio input. Processing: adjustable gain control; six programmable trimmer options for frequency tuning. Output: amplified sound to ear. Operation: programmed by hearing health professional using Professional Fitting System software with Pro-connect or High-Pro systems; user-operated via volume control and telephone/mic/off switch. Benefit: improved auditory perception for patients with mild to moderate hearing loss.

Clinical Evidence

Bench testing only; compliance with ANSI S3.22-1987 standards for electroacoustic performance. No clinical data provided.

Technological Characteristics

BTE air conduction form factor; standard 1.4V type 13 battery power. Adjustable gain control; six programmable trimmer potentiometers for frequency response tuning. Technical specifications comply with ANSI S3.22-1987. Tolerances: ±4 dB for SSPL and slope; ±4 dB for gain.

Indications for Use

Indicated for patients with mild to moderate conductive and/or sensori-neural hearing loss requiring behind-the-ear (BTE) air conduction amplification.

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

• BOSH Star 42 hearing aid (K942594)

Submission Summary (Full Text)

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NOV 26 1996
K964214

# SUMMARY—STARKEY A-13 PROGRAMMABLES SUBSTANTIAL EQUIVALENCE

The Starkey A-13 air conduction hearing aids are designed to be behind-the-ear 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 A-13s are substantially equivalent to the BOSH Star 42 hearing aid (K942594). Variable high and low frequency cut potentiometers can be set by a Dispenser to tune to more specific frequencies. All other aspects of these A-13s are similar to the BOSH Star 42 hearing aid.

## Starkey A-13 Programmable Sequel / K-AMP

- BTE air conduction
- Adjustable Gain Control
- Six program features
- Programmable using the Professional Fitting System software and Pro-connect or High-Pro Systems.
- Programmable using the PR 3000 or PFS 6000 with PFS software
- Fits mild to moderate hearing losses
- Audio input capabilities
- Telephone/Mic/Off Switch
- 13 or equiv. battery

## Bosh Star 42 Digitally Programmable

- BTE air conduction
- Adjustable Gain Control
- Telephone/Mic/Off Switch
- Digitally programmable using the Starkey Trilogy desktop programmer or the Pro-connect system
- 10 programmable features
- Fits moderate to profound hearing losses
- Audio input capabilities
- 675 or equiv. battery
- Colors: Exchangeable casings available in various colors

10/16/96

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# SAFETY AND EFFECTIVENESS SUMMARY - STARKEY A-13 PROGRAMMABLE HEARING AIDS

NAME OF DEVICE: Starkey A-13 Sequel programmable, A-13 K-AMP programmable air conduction hearing aids.

TYPE OF DEVICE: Standard BTE air conduction hearing aids -- Substantially equivalent to the Bosh Star 42 hearing aid, (K942594)

INTENDED USE: To assist in compensating for hearing loss by amplifying sound as it comes into the ear.

FEATURES: Adjustable hearing aid volume controls, six programmable trimmer options, and telephone switch.

ASSEMBLY: Assembled from standard components that are widely used in hearing aid devices throughout the industry.

TECHNICAL CHARACTERISTICS: Technical specifications comply with ANSI S3.22-1987

FIT: Frequency response varying based on the needs of the patient. Tolerances are maintained to a ±4 dB range for SSPL. and slope, with ±4dB for gain. For conductive and/or sensori-neural hearing loss where BTE type hearing aids are preferred or required.

CONTROLS: Volume controls, similar to those used on other hearing aid devices. Pots or switches are similar to those used in other hearing aid devices.

POWER: Standard 1.4 V type 13 hearing aid battery.

10/16/96