STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER

K963995 · Starkey Laboratories, Inc. · KLW · Nov 26, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K963995
• Device Name: STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER
• Applicant: Starkey Laboratories, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Nov 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To assist in compensating for hearing loss by amplifying sound as it comes into the ear and to generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)

Device Story

Starkey MA-3 is a behind-the-ear (BTE) air conduction hearing aid with integrated tinnitus masker; device receives ambient sound via microphone, amplifies signal, and generates white noise stimulus; masker frequency and intensity adjustable to match patient tinnitus; hearing aid and masker circuits operate independently or simultaneously; device fitted by hearing health professional; dispenser uses variable high/low frequency cut potentiometers to tailor response to patient needs; output provides sound amplification and tinnitus masking; benefits include improved hearing and tinnitus symptom relief.

Clinical Evidence

Bench testing only; device specifications comply with ANSI S3.22-1987.

Technological Characteristics

BTE form factor; standard hearing aid components; 1.4V type 675 battery; adjustable volume and masker controls; variable high/low frequency cut potentiometers; technical specifications comply with ANSI S3.22-1987; tolerances maintained to ±4 dB for SSPL/slope and ±5 dB for gain.

Indications for Use

Indicated for individuals with hearing loss and tinnitus requiring sound amplification and white noise masking therapy.

Regulatory Classification

Identification

A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.

Special Controls

The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care, (2) Risks, (3) Benefits, (4) Warnings for safe use, and (5) Specifications.

Predicate Devices

• Starkey CE-8 TML/TMC (K940667)

Submission Summary (Full Text)

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NOV 26 1996
Y963995

# SAFETY AND EFFECTIVENESS SUMMARY - STARKEY MA-3

**NAME OF DEVICE:** Starkey MA-3 air conduction combination hearing aid / tinnitus masker.

**TYPE OF DEVICE:** Standard BTE air conduction hearing aid -- Substantially equivalent to the Starkey CE-8 TML/TMC hearing aid, (K940667)

**INTENDED USE:** To assist in compensating for hearing loss by amplifying sound as it comes into the ear and to generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)

**FEATURES:** Adjustable hearing aid volume control, adjustable masker volume controls, control for adjusting the masker frequency.

**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 ±5 dB for gain.

**CONTROLS:** Volume controls, similar to those used on other hearing aid devices. Potentiometers or switches may be incorporated as options require. Any pots or switches are similar to those used in other hearing aid devices.

**POWER:** Standard 1.4 V type 675 hearing aid battery.

10/3/96

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10/3/96

# SUMMARY—STARKEY MA-3 SUBSTANTIAL EQUIVALENCE

The Starkey MA-3 air conduction masker aid is designed to be a behind-the-ear hearing aid. 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 MA-3 is substantially equivalent to the Starkey CE-8 TML/TMC (K940667). The Starkey MA-3 is a Starkey BTE Hearing Aid with an additional white noise generating circuit which can be tuned to match the frequency and intensity of ringing in the patient's ears (head). The patient has a volume control for this circuit. The hearing aid and masker circuits operate independently of each other, and can be used simultaneously, or either can be used alone. Variable high and low frequency cut potentiometers can be set by a Dispenser to tune to more specific frequencies. All other aspects of this hearing aid are similar to the Starkey CE-8 TML/TMC.

## Starkey MA-3

- BTE
- Adjustable Volume Control
- Adjustable Masker Level Control
- Variable Low Frequency Cut (L)
- Variable High Frequency Cut (H)
- Dispenser can tailor to meet individual needs using (L) and (H).
- Made with standard hearing aid parts
- Uses standard hearing aid 675 battery

## Starkey CE-8 TML/TMC

- Custom ITE
- Adjustable Volume Control
- Adjustable Masker Frequency
- Adjustable Masker Level Control
- Color Coded for Left and Right
- Hearing aid response tailored to individual needs
- Made with standard hearing aid parts
- Uses standard hearing aid 13 battery