(94 days)
The target group for the Phonak Tinnitus Balance software feature are adults 18 years of age or older with tinnitus who also desire amplification.
The Tinnitus Balance software feature and accompanying hearing aid amplification is fit by a licensed hearing healthcare professional (audiologist, hearing aid specialist, notolaryngologist) familiar with the diagnosis and management of tinnitus. Phonak hearing aids provide amplification to address sensorineural, conductive, or mixed hearing losses. Depending on the specific model, Phonak hearing aids cover fitting ranges from mild to profound hearing losses.
Before being fit with Tinnitus Balance, individuals presenting with tinnitus should be assessed by a licensed ear physician to confirm the source of their tinnitus is not due to any of the following medical conditions:
• Visible congenital or traumatic deformity of the ear
· Any active drainage from the ear within the previous 90 days
· Sudden hearing loss within the previous 90 days
· Acute or chronic dizziness
• Unilateral hearing loss of sudden or recent onset within the previous 90 days
• Pain or discomfort in the ear
The Tinnitus Balance software feature is a broadband noise generator embedded in the firmware of selected Phonak hearing aids. It provides a means of sound enrichment that can be used as part of a tinnitus management program to provide relief from tinnitus. By combining a broadband noise generator and hearing aid, the patient is able to wear a single device throughout the day for both tinnitus relief and amplification. The Tinnitus Balance software is enabled and fit by a licensed hearing healthcare professional together with the hearing aid's amplification to meet the individual needs of the patient.
The provided 510(k) summary for the Phonak Tinnitus Balance software feature lacks detailed performance study information, acceptance criteria, and specific data regarding ground truth establishment as typically found in comprehensive regulatory submissions. This device was cleared in 2013, and regulatory requirements and documentation standards have evolved significantly since then.
Based on the available document, here's what can be inferred:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a readily quantifiable format. Instead, it relies on a comparison to predicate devices and a general statement of safety and effectiveness.
| Acceptance Criteria Category | Specific Criteria (Inferred/Missing) | Reported Device Performance (Inferred/Missing) |
|---|---|---|
| Safety | No new safety concerns introduced. | "Performance testing of the Tinnitus Balance software feature indicates it is safe..." |
| Effectiveness | Performs as well as predicate devices for tinnitus management. | "...effective and performs as well as the predicate devices." |
| Intended Use Fulfillment | Provides supplementary noise for tinnitus relief and amplification for those desiring it. | Device description and intended use section confirms these functionalities. |
| Technical Specifications | Not explicitly stated but implied through comparison with predicates: |
- Broadband noise generation.
- Embeddable in digital hearing aid platforms.
- Max output of generated noise limited to 85 dB(A) SPL.
- Volume adjustment capability.
- Spectral characteristics adjustable by HCP. | The document extensively compares its technical features to three predicate devices, highlighting commonalities and differences. |
Study Details
The document mentions "Performance Testing" and a "review of published scientific literature" but does not describe a specific clinical trial or study with detailed methodology as per modern standards.
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Sample size used for the test set and the data provenance: Not specified. The document states "Performance Testing" was conducted and a "review of published scientific literature" was performed. This implies reliance on existing knowledge rather than a new clinical study with a defined test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. Given the nature of a tinnitus masker, ground truth would typically relate to user perception of tinnitus relief, sound characteristics, and safety. There is no mention of experts establishing a ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the provided information, as no formal test set with ground truth adjudication is described.
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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, not an AI-assisted diagnostic tool that would involve "human readers" or image interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone algorithm (software feature) embedded in a hearing aid, providing noise generation without requiring continuous human interaction during its operation for tinnitus relief. However, "standalone performance" in the context of typical AI medical device studies often refers to the algorithm's diagnostic accuracy without human input. For this device, the "standalone performance" would relate to its ability to generate the specified noise and integrate with the hearing aid's amplification, which is covered by general performance testing and comparison to predicates.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated. For a tinnitus masker, "ground truth" would likely be based on objective sound output measurements, subjective patient feedback regarding tinnitus perception and comfort, and the ability of the device to deliver the intended sound therapy within safe limits. The document only mentions "review of published scientific literature to confirm the safety and effectiveness."
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The sample size for the training set: Not applicable. This device is a software feature implementing a broadband noise generator; it is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its design is based on established principles of sound therapy for tinnitus.
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How the ground truth for the training set was established: Not applicable, as there is no "training set."
In summary:
The 510(k) for the Phonak Tinnitus Balance software feature relies heavily on predicate device comparison and a general statement of safety and effectiveness based on risk analysis, verification/validation, and scientific literature review. It does not present a detailed prospective clinical study with specific acceptance criteria, test sets, ground truth establishment, or human reader performance metrics characteristic of advanced AI/ML device clearances. This is consistent with regulatory submissions for certain types of Class II medical devices, especially those cleared around 2013, which leverage substantial equivalence to existing technologies.
§ 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.