Who is the manufacturer of STARKEY TM AIR CONDUCTION TINNITUS MASKER?

Starkey Laboratories, Inc. filed the 510(k) submission for STARKEY TM AIR CONDUCTION TINNITUS MASKER (K963838).

What is the FDA product code for STARKEY TM AIR CONDUCTION TINNITUS MASKER?

KLW. It is classified under 21 CFR 874.3400 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for STARKEY TM AIR CONDUCTION TINNITUS MASKER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like STARKEY TM AIR CONDUCTION TINNITUS MASKER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STARKEY TM AIR CONDUCTION TINNITUS MASKER

Q: What are the predicate devices for STARKEY TM AIR CONDUCTION TINNITUS MASKER?

Starkey CE-8 TML/TMC (K940667).

K963838 · Starkey Laboratories, Inc. · KLW · Nov 26, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K963838
Device Name	STARKEY TM AIR CONDUCTION 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 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.

Indications for Use

Indicated for patients experiencing tinnitus (ringing in the ears) requiring white noise stimulus for masking.

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)

Related Devices

K964216 — STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER · Starkey Laboratories, Inc. · Dec 6, 1996
K982432 — PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5- · Tinnitus Treatment Centers, Inc. · Jan 25, 1999
K041302 — REFUGE SOUND GENERATOR · Micro-Ear Technology, Inc. · Jul 1, 2004
K984243 — TELEX TINNITUS-COMPANION · Telex Communications, Inc. · Jan 21, 1999
K091552 — SWITCH TRT · Audifon GmbH & Co. KG · Aug 12, 2009

Submission Summary (Full Text)

{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