(70 days)
Not Found
No
The document describes a sound generator for tinnitus relief and does not mention any AI or ML components.
Yes
The device is intended to provide "temporary relief from tinnitus" and is described as a "sound enrichment therapy" used as part of a "personalized tinnitus management program." These descriptions indicate a therapeutic purpose.
No
Explanation: The device is described as a "tinnitus masker" and a "broadband sound generator" intended to provide "sound enrichment therapy" and "temporary relief from tinnitus" by distracting the wearer's attention. Its purpose is management and relief, not diagnosis. The text explicitly states it's "fitted by a hearing health care professional familiar with diagnosis and management of tinnitus," implying the diagnosis occurs separately.
No
The device is described as a "feature" within "Unitron Era hearing aid platforms," which are hardware devices. The summary also mentions evaluation against standards for "Hearing Aid Characteristics" and "Medical electrical equipment," further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Unitron Tinnitus Masker is a sound generator integrated into a hearing aid. Its function is to produce sound to help manage tinnitus, not to analyze biological samples.
- Intended Use: The intended use is for "sound enrichment therapy" and "temporary relief from tinnitus" by providing "supplementary noise stimulation." This is a therapeutic and management approach, not a diagnostic one.
- Anatomical Site: The device interacts with the "Auditory system," which is a physiological system, not a biological sample being tested.
The device is clearly a therapeutic device designed to manage a symptom (tinnitus) through sound, not to diagnose a condition by analyzing biological samples.
N/A
Intended Use / Indications for Use
Unitron's tinnitus masker is a broadband sound generator available in Unitron Era hearing aid platforms. It provides a means of sound enrichment therapy that can be used as part of a personalized tinnitus management program to provide temporary relief from tinnitus.
Tinnitus masker is intended for adults 18 years of age or older who have both hearing loss and tinnitus The tinnitus masker within the air conduction hearing instrument is fitted by a hearing health care professional familiar with diagnosis and management of tinnitus.
The underlying principle of sound enrichment is to provide supplementary noise stimulation which can help defocus your attention from your tinnitus and avoid negative reactions. Sound enrichment, coupled with instructional counseling, is an established approach to managing tinnitus.
Product codes (comma separated list FDA assigned to the subject device)
KLW
Device Description
Unitron's Tinnitus Masker feature is a noise generator available as an option, in Unitron Era hearing aid platforms providing a sound enrichment source, to provide stimulation to the auditory system, as part of a comprehensive tinnitus management program that works to help distract the wearer's attention from the sound of their tinnitus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory system
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
hearing health care professional
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)
Unitron Hearing Instruments with the tinnitus masker feature and related software have been evaluated in accordance with ANSI S3.22:2009 American National Standard -Specification of Hearing Aid Characteristics, IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
unitron.
MAY 0 7 2013
5. 510(k) Summary
Submitter: Unitron Hearing Inc. 14755 27th Avenue North, Plymouth MN 55447 Phone (763) 744- 3300 Fax (763) 557-8828
Jim Reiter, Contact Person: Quality Assurance Manager Unitron Hearing Inc. 14755 27th Avenue North, Plymouth MN 55447 Phone (763) 744-3463 Fax (763) 557-8828
Date Prepared: 10-January-2013
Device Name: Unitron Tinnitus Masker feature
Device Class: Class II
Classification Name: Tinnitus Masker
Product Code: KLW
Regulation Number: 21 CFR §874.3400 Tinnitus Masker
Predicate Device(s): K110932, GN ReSound Tinnitus Sound Generator Module
Description of Device: Unitron's Tinnitus Masker feature is a noise generator available as an option, in Unitron Era hearing aid platforms providing a sound enrichment source, to provide stimulation to the auditory system, as part of a comprehensive tinnitus management program that works to help distract the wearer's attention from the sound of their tinnitus.
Indications for Use: Unitron's tinnitus masker is a broadband sound generator available in Unitron Era hearing aid platforms. It provides a means of sound enrichment therapy that can be used as part of a personalized tinnitus management program to provide temporary relief from tinnitus.
Tinnitus masker is intended for adults 18 years of age or older who have both hearing loss and tinnitus The tinnitus masker within the air conduction hearing instrument is fitted by a hearing health care professional familiar with diagnosis and management of tinnitus.
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The underlying principle of sound enrichment is to provide supplementary noise stimulation which can help defocus your attention from your tinnitus and avoid negative reactions. Sound enrichment, coupled with instructional counseling, is an established approach to managing tinnitus.
Substantial Equivalence: Comparison to the Predicate Device indicated above shows the Tinnitus Masker feature has the same intended use and does not raise additional safety and effectiveness questions.
Technology Characteristics Comparison: Unitron Tinnitus Masker uses the same technology used by the predicate device, sharing the following similarities:
-
. Similar indications of use, implementation into software, functionality through digital hearing instruments, fitter adjustments to stimulus shaping, maximum output and end user control.
The technology characteristics that differ from the predicate device are: -
Amplitude Modulation. .
-
. Environment Steering (automatic fluctuation of the noise level based upon the environment).
Performance Data: Unitron Hearing Instruments with the tinnitus masker feature and related software have been evaluated in accordance with ANSI S3.22:2009 American National Standard -Specification of Hearing Aid Characteristics, IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.
Conclusion: Based upon similar indications of use and technology characteristics it is concluded to be substantially equivalent to K110932, GN ReSound Tinnitus Sound Generator Module
510(k) for Unitron Tinnitus Masker Feature
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center - WO66-G609
Silver Spring, MD 20993-0002
May 7, 2013
Unitron Hearing, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K130494
Trade/Device Name: Unitron Tinnitus Masker Feature Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: March 19, 2013 Received: March 20, 2013
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - Mr. Mark Job
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eric Anyann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use
Indication for Use Form
Indications for Use
510(k) Number (if known): K130494
Device Name: Unitron Tinnitus Masker feature
Indications for Use:
Unitron's tinnitus masker is a broadband sound generator available in Unitron Era hearing aid platforms. It provides a means of sound enrichment therapy that can be used as part of a personalized tinnitus management program to provide temporary relief from tinnitus.
Tinnitus masker is intended for adults 18 years of age or older who have both hearing loss and timitus. The tinnitus masker within the air conduction hearing instrument is fitted by a hearing health care professional familiar with diagnosis and management of tinnitus.
The underlying principle of sound enrichment is to provide supplementary noise stimulation which can help defocus your attention from your tinnitus and avoid negative reactions. Sound enrichment, coupled with instructional counseling, is an established approach to managing tinnitus.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Picture/15 description: The image shows the name "Srinivas Nandkumar - S" in a clear, sans-serif font. The text is horizontally aligned and appears to be the primary focus of the image. There is some noise or a watermark-like design behind the name, particularly around "Nandkumar", which adds a textured background effect to the text.