(28 days)
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 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.
A mobile medical application (app) is available as an optional device to use with the Tinnitus Sound Generator. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Tinnitus Manager app.
This document describes a 510(k) premarket notification for a Tinnitus Sound Generator Module (K181586). However, the document does not describe acceptance criteria for algorithmic performance or a study proving the device meets such criteria.
Instead, it focuses on demonstrating substantial equivalence to a predicate device (K150171) based on:
- Technological characteristics comparison: Highlighting minor software advancements that improve functionality with minimal risk.
- Performance Data: Stating that risk analysis, verification, and validation activities were conducted to show the modified device meets design input requirements and is substantially equivalent. These activities appear to be internal and relate to the device's design and functionality rather than clinical efficacy.
Therefore, I cannot provide the requested information regarding acceptance criteria for algorithmic performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. The document does not contain details of such a study or information for establishing those criteria.
§ 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.