← Product Code [KLW](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLW) · K963838

# STARKEY TM AIR CONDUCTION TINNITUS MASKER (K963838)

_Starkey Laboratories, Inc. · KLW · Nov 26, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLW/K963838

## Device Facts

- **Applicant:** Starkey Laboratories, Inc.
- **Product Code:** [KLW](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLW.md)
- **Decision Date:** Nov 26, 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 and transmit a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)

## Device Story

Custom-fit air conduction tinnitus masker; generates/transmits white noise stimulus to mask tinnitus. Device features adjustable volume and frequency controls; color-coded for left/right ear. Assembled from standard hearing aid components; powered by size 13 (ITE) or 312 (ITC) batteries. Used by patients to manage tinnitus symptoms; provides relief via sound masking. Clinician adjusts frequency response based on patient needs.

## Clinical Evidence

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

## Technological Characteristics

Air conduction tinnitus masker; standard hearing aid components; ANSI S3.22-1987 compliant. Frequency response adjustable per patient; SSPL tolerance ± 4 dB. Controls: potentiometers/switches. Power: size 13 or 312 batteries.

## 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)

> 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.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

NOV 26 1996 K963838

# SAFETY AND EFFECTIVENESS SUMMARY - STARKEY TM

**NAME OF DEVICE:** Starkey TM air conduction tinnitus masker.

**TYPE OF DEVICE:** Custom fit air conduction Tinnitus Masker -- Substantially equivalent to the Starkey CE-8 TML/TMC, K940667

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

**FEATURES:** Adjustable adjustable masker volume control, control for adjusting the masker frequency, color coding for left and right instruments.

**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

**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 hearing aid battery, size 13 for ITE and size 312 for ITC

9/10/96

---

**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLW/K963838](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KLW/K963838)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com