← Product Code [KLW](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLW) · K964216

# STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER (K964216)

_Starkey Laboratories, Inc. · KLW · Dec 6, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLW/K964216

## Device Facts

- **Applicant:** Starkey Laboratories, Inc.
- **Product Code:** [KLW](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLW.md)
- **Decision Date:** Dec 6, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3400
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic

## Indications for Use

To generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)

## Device Story

Starkey TM Series are behind-the-ear (BTE) air conduction tinnitus maskers; generate white noise stimulus to mask tinnitus. Device features adjustable volume control and variable high/low frequency cut potentiometers; tuned by Hearing Health Professional to match patient's specific tinnitus frequency and intensity. Powered by standard 675 hearing aid battery; constructed from standard hearing aid components. Used in clinical settings by professionals to tailor masking response to individual patient needs.

## Clinical Evidence

Bench testing only; compliance with ANSI S3.22-1987 standards for technical specifications and SSPL tolerances maintained within ±4 dB range.

## Technological Characteristics

BTE form factor; standard hearing aid components; 1.4V type 675 battery; analog circuitry with adjustable volume and high/low frequency cut potentiometers; technical specifications comply with ANSI S3.22-1987.

## Regulatory 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](/device/K940667.md))

## Submission Summary (Full Text)

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>
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DEC - 6 1996
K964216

# SUMMARY—STARKEY TM - SERIES SUBSTANTIAL EQUIVALENCE

The Starkey TM air conduction high frequency tinnitus maskers are designed to be behind-the-ear maskers. This form of masker is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly.

The Starkey TMs are substantially equivalent to the masking portion of the Starkey CE-8 TML/TMC (K940667). The Starkey TMs are BTE Tinnitus Maskers with a 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. Variable high and low frequency cut potentiometers can be set by a Dispenser to tune to more specific frequencies. All other aspects of these tinnitus maskers are similar to the masking portion of the Starkey CE-8 TML/TMC.

## Starkey TM Series

- BTE
- 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

10/15/96

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# SAFETY AND EFFECTIVENESS SUMMARY - STARKEY BTE TM SERIES

NAME OF DEVICE: Starkey TM Series air conduction high frequency tinnitus maskers.

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

INTENDED USE: To generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)

FEATURES: Adjustable masker volume controls, control for adjusting the high and low masker frequencies.

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: Masker frequency response varying based on the needs of the patient. Tolerances are maintained to a ±4 dB range for SSPL.

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 675 hearing aid battery.

10/15/96

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLW/K964216](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLW/K964216)

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