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The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: Slight, Mild, Moderate, Severe, Profound. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat, Other. Other: Low tolerance To Loudness.

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The provided document does not contain information about acceptance criteria or a study proving the device meets those criteria.

Instead, the documents {0}, {1}, {2}, {3}, {4}, {5}, {6}, {7}, {8}, {9}, {10}, {11}, and {12} are composed of:

• A letter from the FDA (K971807 decision letter): This letter serves as notification that the FDA has reviewed the Section 510(k) notification for the Hear-Right Hearing Aids (models Hidden CIC, Cardinal ITC, Eagle ITE) and determined them to be "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This letter emphasizes that it allows the company to begin marketing the device, subject to general controls. It also includes a warning about potential electromagnetic interference from digital cellular phones.
• Multiple "Indications for Use" forms (K971807, Pages 1-12 of 11 in total which is wrong, also 1,2,3... of 1 for some pages, meaning a general confusion and bad structure): These forms detail the general and specific indications for different models of Hear-Right hearing aids. The general indication is to "amplify sound for individuals with impaired hearing." They also specify categories of hearing loss severity (slight, mild, moderate, severe, profound), configuration (high frequency, precipitously sloping, gradually sloping, reverse slope, flat, other), and other conditions (low tolerance to loudness). Notably, section B states: "(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)"

Since the document provided is a 510(k) clearance letter and associated indications for use, it primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study demonstrating performance against those criteria as would be found in a clinical trial report.

Therefore, I cannot extract the requested information based on the provided text. To answer your questions, the following would need to be present in the document:

1. A table of acceptance criteria and the reported device performance: This document does not present any quantitative performance metrics or specific acceptance criteria.
2. Sample size used for the test set and the data provenance: Not mentioned. The 510(k) relies on substantial equivalence to predicate devices, not typically a new test set for primary performance claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned as there's no mention of a test set with established ground truth.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a hearing aid, not an algorithm.
7. The type of ground truth used: Not applicable, as no ground truth is explicitly discussed for performance evaluation.
8. The sample size for the training set: Not applicable, no training set or algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

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