← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K964214

# 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 · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964214

## Device Facts

- **Applicant:** Starkey Laboratories, Inc.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** Nov 27, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3300
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat
- **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.

## Regulatory 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](/device/K942594.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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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

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964214](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964214)

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