TELEX TINNITUS-COMPANION

K984243 · Telex Communications, Inc. · KLW · Jan 21, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K984243
• Device Name: TELEX TINNITUS-COMPANION
• Applicant: Telex Communications, Inc.
• Product Code: KLW · Ear, Nose, Throat
• Decision Date: Jan 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

for use in treatment and control of tinnitus.

Device Story

Telex Tinnitus-Companion (Models TC TRL and TC TRS) is an air-conduction tinnitus masker. Device features non-occluding Ultra-helix type shell and two power levels. Operates using standard hearing aid battery (312). Includes volume control and one audiological control (tone) for frequency response tailoring. Used by patients to manage tinnitus symptoms. Assembled from standard hearing aid components. Healthcare providers use audiological controls to adjust device output to individual patient needs.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological comparison to the predicate device.

Technological Characteristics

Air-conduction tinnitus masker; non-occluding Ultra-helix shell; two power levels; volume and tone controls; powered by 312 hearing aid battery. Performance measured using Fonix 6500, 2cc coupler, in Spectrum Mode.

Indications for Use

Indicated for the treatment and control of tinnitus in patients requiring 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 TM Air conduction Tinnitus Masker (K963838)

Submission Summary (Full Text)

{0}------------------------------------------------

JAN 2 1 1999 X484245

## TELEX.

5 JO(k) SUMMARY (1) ==========================================================================================================================================================

్రా

South Aldrich Avenue Soull

old 55420 USA

ono 612-BR4-405 )

Fax [phone]

| Trade Name: | Telex Tinnitus-Companion, Models TC TRL and TC TRS | |
|----------------------|----------------------------------------------------|-------|
| Common Name: | tinnitus masker | |
| Classification Name: | Masker, tinnitus | 77KLW |
| Equivalent to: | Starkey TM Air conduction Tinnitus Masker K963838 | |

## Description:

| Intended use: | for use in treatment and control of tinnitus. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Features: | non-occluding Ultra-helix type shell, two power levels |
| Assembly: | assembled from standard components that are widely used by other<br>hearing aid manufacturers. |
| Technical characteristics: | measured with Fonix™ 6500, 2cc coupler, "Spectrum Mode". |
| Fit: | typical frequency response as shown on specification filed with 510(k).<br>Response can be tailored to the individual via audiological controls. |
| Controls: | Volume control, one Audiological Control (tone). |
| Power: | Standard hearing aid battery (312) |

Comparison to predicate device: no significant difference.

Submitted by:

Tom Scheller Chief Engineer Hearing Instruments Group Telex Communications, Inc. 9600 Aldrich Ave S. Minneapolis, MN 55420 [phone] voice [phone] fax Tom Scheller 14 December, 1998

Contact: Prepared:

510(k) SUMMARY

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

JAN

Hearing Instruments Group

Minneapolis, MN 55420

Telex Communications, Inc. 9600 Aldrich Ave. S.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K984243 Re:

> Telex Tinnitus-Companion, Models TC TRL and TC TRS Dated: November 24, 1998 Received: November 27, 1998 Regulatory class: III 21 CFR 874.3400/Procode: 77 KLW

Dear Mr. Scheller:

Tom Scheller

Chief Engineer

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act, You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Use Use Harris Horn

510(k) Number (if known):

K984243

Device Name: Telex Tinnitus-Companion, Models TC TRS and TC TRL

Indications For Use:

- A. General Indications:
The indication for use of the tinnitus masker in this submission is for use in treatment and control of tinnītus.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number ้ง Prescription Use OR Over-The-Counter Use _ (per 21 CFR 901.109)