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The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies).

Tondi BTE Hearing Aid, Models U-2011, U-214, U-03, KA-02, KA-03, KA-UBA, KA-01, KA-04, KA-04A, KA-05

I am sorry, but based on the provided documents, there is no information about acceptance criteria or a study that proves the device meets those criteria.

The documents are a 510(k) premarket notification letter from the FDA to National Hearing Aid Distributors regarding their "Tondi BTE Hearing Aids" (K971296). These documents primarily focus on the FDA's determination of substantial equivalence to previously marketed devices and the device's indications for use.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the device's acceptance for marketing is based on its similarity to existing, legally marketed devices, rather than a specific performance study with defined acceptance criteria.

The subsequent pages (2-6 of 6) detail the "Indications For Use" for various models of the Tondi BTE Hearing Aid, outlining the categories of hearing loss (severity, configuration, and other factors) for which the device is intended. This is about defining the scope of the device's application, not about establishing performance metrics against acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the given text.

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