(70 days)
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.
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.
The Unitron Tinnitus Masker feature is a sound generator designed for temporary relief from tinnitus as part of a comprehensive management program. The device's performance was evaluated for substantial equivalence to a predicate device (K110932, GN ReSound Tinnitus Sound Generator Module) rather than against specific acceptance criteria for a new device's performance.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Demonstrated through compliance with established standards and substantial equivalence to a legally marketed predicate device. |
| Compliance with ANSI S3.22:2009 (Specification of Hearing Aid Characteristics) | Evaluated |
| Compliance with IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Evaluated |
| Compliance with IEC 60601-1-2 (Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests) | Evaluated |
| Substantial Equivalence (to K110932, GN ReSound Tinnitus Sound Generator Module) | |
| Similar Indications for Use | Yes |
| Similar Technology Characteristics | Yes (implementation into software, functionality through digital hearing instruments, fitter adjustments to stimulus shaping, maximum output and end user control) |
| Does not raise additional safety and effectiveness questions | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of clinical performance evaluation using patient data. The evaluation was primarily based on technical standards compliance and comparison to a predicate device. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a test set is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The approval process focused on substantial equivalence and technical compliance, not on a ground truth established by experts on a clinical test set.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
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
No, an MRMC comparative effectiveness study was not done. The device is a "Tinnitus Masker feature," which is a sound generator, not an AI-assisted diagnostic or interpretative tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a standalone sound generator feature within a hearing aid. Its performance in generating sound and adhering to technical specifications was evaluated, but this is a different context than "standalone performance" for an AI algorithm. Its clinical use is always with a human-in-the-loop (the patient wearing the hearing aid and the hearing healthcare professional fitting it).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth or basis for evaluation was:
- Compliance with recognized IEC and ANSI standards for medical electrical equipment and hearing aid characteristics.
- Substantial equivalence in terms of indications for use and technology characteristics to a legally marketed predicate device.
There is no mention of clinical outcomes data, pathology, or expert consensus on patient-specific data for establishing a 'ground truth' of efficacy, as the submission relies on the established safety and effectiveness of the predicate and compliance with technical standards.
8. The Sample Size for the Training Set
Not applicable. The device is not an AI/ML algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML algorithm is described.
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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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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)
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§ 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.