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The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.

The Tinnitus Sound Generator Module is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound Generator Module must be done by a hearing professional participating in a Tinnitus Management Program.

The Tinnitus Sound Generator provides a means for healthcare professionals to create a hearing instrument solution that provides relief for tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user can wear this device all day in all environments. The fitting of the digital device, which contains the Tinnitus Sound Generator Module, is performed by a healthcare professional, in order to meet the exact needs of the tinnitus patient.

The provided FDA 510(k) summary (K110932) for the "Tinnitus Sound Generator Module" does not contain information related to acceptance criteria or a study demonstrating the device meets such criteria in terms of analytical or clinical performance.

This submission is a Special 510(k), which typically relies on comparisons to a predicate device and verification that modifications do not raise new questions of safety or effectiveness. As such, the documented "Performance Data" section focuses on risk analysis and verification/validation activities in relation to design inputs, rather than a clinical performance study with specific acceptance criteria that demonstrate how well the device performs its intended function in a clinical setting (e.g., how effectively it relieves tinnitus).

Here's why the requested information is absent:

• Nature of the Device: The TSG Module is a sound generator designed to be used as part of a Tinnitus Management Program. Its direct "performance" in terms of clinical outcome (tinnitus relief) is inherently subjective and tied to the overall management program, not solely to the sound generator itself.
• 510(k) Pathway: A Special 510(k) is used for modifications to a legally marketed device where the modifications do not affect its intended use or fundamental technological characteristics and do not raise new questions of safety or effectiveness. The focus is on demonstrating that the modified device is still substantially equivalent to the predicate device, not on proving new clinical efficacy.
• Predicate Device Approach: The submission states, "Modifications to the cleared device... are not substantial and do not change the operating principle of the TSG Module. The intended use and fundamental technological characteristics remain the same as the predicate device, and modifications do not affect the safety or effectiveness of the device." This implies that the clinical effectiveness of the type of device (tinnitus masker) was established by the predicate (K073636), and the current submission is concerned with demonstrating that the modifications do not degrade that effectiveness.

Therefore, I cannot provide the requested table or describe a study proving the device meets specific acceptance criteria for clinical performance based on the provided text. The document refers to "risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements," but these are typically engineering and functional tests, not clinical performance studies with acceptance criteria for patient outcomes.

The information you've requested typically appears in traditional 510(k)s or PMAs where clinical performance or analytical performance of a diagnostic device is being established through new studies. This document does not describe such studies.

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