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
Indications for 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.
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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
