(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.
§ 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.