(55 days)
for use in treatment and control of tinnitus.
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)
This document is a 510(k) summary for the Telex Tinnitus-Companion, Models TC TRL and TC TRS. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving performance against those criteria. Therefore, much of the requested information is not available in the provided text.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the device's performance in treating or controlling tinnitus. Instead, it focuses on technical characteristics and comparison to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Intended Use: for use in treatment and control of tinnitus. |
| Not specified | Features: non-occluding Ultra-helix type shell, two power levels. |
| Not specified | Assembly: assembled from standard components widely used by other hearing aid manufacturers. |
| Not specified | Technical characteristics: measured with Fonix™ 6500, 2cc coupler, "Spectrum Mode." |
| Not specified | Fit: typical frequency response as shown on specification filed with 510(k). Response can be tailored to the individual via audiological controls. |
| Not specified | Controls: Volume control, one Audiological Control (tone). |
| Not specified | Power: Standard hearing aid battery (312). |
| Not specified | Comparison to predicate device: no significant difference. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical study or a test set of patients/data to evaluate the device's efficacy or performance in treating tinnitus. The "test set" appears to refer only to the technical measurement of the device characteristics.
- Sample size for test set: Not applicable/not mentioned for clinical performance. Technical measurements were likely performed on a sample of the devices themselves, but the size is not specified.
- Data provenance: Not applicable/not mentioned for clinical performance. Technical measurements were conducted by Telex Communications, Inc. in Minneapolis, MN, USA.
- Retrospective or prospective: Not applicable/not mentioned for clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The 510(k) summary focuses on demonstrating substantial equivalence based on technical specifications and known intended use for tinnitus maskers, not on a clinical trial with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no mention of a test set involving human judgment or interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a tinnitus masker, an auditory device, and not an AI-powered diagnostic or assistive tool for human readers/interpreters. There is no mention of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to a tinnitus masker, which is a physical device intended for use by an individual. It does not contain an algorithm in the sense of AI or automated diagnostic software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe a study involving a clinical ground truth for efficacy. The "ground truth" for the submission is the substantial equivalence to the predicate device, K963838 (Starkey TM Air conduction Tinnitus Masker), based on comparable intended use, technology, principles of operation, and safety/effectiveness considerations.
8. The sample size for the training set
Not applicable. This document describes a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This document describes a medical device, not an AI model.
Summary of available information:
The provided document is a 510(k) premarket notification for a tinnitus masker. Its primary goal is to establish "substantial equivalence" to a predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. It does NOT include a clinical study with acceptance criteria, patient populations, or expert ground truth as would be found for new, complex therapeutic or diagnostic devices. The performance reported is largely in terms of technical specifications and a general statement of "no significant difference" compared to the predicate device.
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JAN 2 1 1999 X484245
TELEX.
5 JO(k) SUMMARY (1) ==========================================================================================================================================================
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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 otherhearing 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
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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)
§ 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.