(55 days)
Not Found
No
The device description focuses on standard hearing aid components and audiological controls, with no mention of AI or ML.
Yes
The device is described for use in "treatment and control of tinnitus," which indicates a therapeutic purpose.
No
The device description and intended use indicate it is for treatment and control of tinnitus, and it's described like a hearing aid (e.g., volume control, audiological controls, standard hearing aid battery). Diagnostic devices are used for identifying or determining the nature of a disease.
No
The device description explicitly mentions hardware components such as a "non-occluding Ultra-helix type shell," "two power levels," "standard components," and a "Standard hearing aid battery (312)." This indicates it is a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in treatment and control of tinnitus." This describes a therapeutic or assistive device used directly on or by the patient, not a test performed on biological samples outside the body.
- Device Description: The description details a hearing aid-like device with components, frequency response, and controls related to sound and hearing, consistent with a device used for auditory conditions.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
for use in treatment and control of tinnitus.
Product codes
77KLW
Device Description
non-occluding Ultra-helix type shell, two power levels; assembled from standard components that are widely used by other hearing aid manufacturers; measured with Fonix 6500, 2cc coupler, "Spectrum Mode"; typical frequency response as shown on specification filed with 510(k). Response can be tailored to the individual via audiological controls; Volume control, one Audiological Control (tone); Standard hearing aid battery (312)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3400 Tinnitus masker.
(a)
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.(b)
Classification. Class II. 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.
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 812-884-0043
| 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 |
| 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). |
| 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 (612) 884-4051 voice (612) 884-0043 fax Tom Scheller 14 December, 1998
Contact: Prepared:
510(k) SUMMARY
1
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
2
Indications for Use Use Use Harris Horn
510(k) Number (if known):
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)